octreotide (Rx)

Brand and Other Names:Sandostatin, Sandostatin LAR, more...Bynfezia Pen, Mycapssa

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule, delayed-release (Mycapssa)

  • 20mg

injectable solution (Sandostatin)

  • 0.05mg/mL
  • 0.1mg/mL
  • 0.2mg/mL
  • 0.5mg/mL
  • 1mg/mL

depot injection (Sandostatin LAR Depot)

  • 10mg/kit
  • 20mg/kit
  • 30mg/kit

injectable solution (Bynfezia Pen)

  • 2500mcg/mL (single-patient-use pen)

Acromegaly

Reduction of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adults with acromegaly who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses

Bynfezia Pen

  • 50 mcg SC TID initially
  • Usual dose: 100 mcg SC TID; some patients require up to 500 mcg TID
  • Doses >300 mcg/day seldom result in additional benefit; if an increase in dose fails to provide additional benefit, reduce dosage
  • Dosing titration
    • Measure IGF-I levels q2Weeks after initiation or dosage change
    • Alternatively, measuring growth hormone levels at 1-4 hr intervals for 8-12 hr after administration; goal is to achieve growth hormone levels <5 ng/mL or IGF-I levels within normal reference ranges for age and sex
    • Once biochemical normalization, or maximal benefit is achieved, re-evaluate IGF-I or growth hormone levels at 6-month intervals

Sandostatin LAR depot

  • Patients not currently receiving octreotide
    • Begin therapy with solution as listed above
    • Maintain on SC solution for at least 2 weeks as listed above to determine tolerance to octreotide
    • Patients who responds to the drug, based on GH and IGF-1 levels and who tolerate the drug, then switch to octreotide suspension
  • Patients currently receiving octreotide
    • Switch to octreotide suspension 20 mg IM (gluteal) q4Weeks for 3 months; titrate up or down to 10-30 mg IM q4Weeks, depending on response; not to exceed 40 mg
    • After 3 months, dosage may be adjusted as follows:
    • GH ≤2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: Maintain octreotide suspension at 20 mg q4Weeks
    • GH >2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: Increase octreotide suspension to 30 mg q4Weeks
    • GH ≤1 ng/mL, IGF-1 normal, and clinical symptoms controlled: Reduce octreotide suspension to 10 mg q4Weeks
    • If GH, IGF-1, or symptoms are not adequately controlled at a dose of 30 mg, the dose may be increased to 40 mg q4Weeks; doses >40 mg are not recommended
    • In patients who have received pituitary irradiation, withdraw yearly for ~8 weeks to assess disease activity; if GH or IGF-1 levels increase and signs and symptoms recur, resume therapy

Mycapssa

  • 20 mg PO BID (40 mg/day) initially
  • May titrate up in increments of 20 mg/day, based on IGF-1 levels and signs and symptoms; maximum dosage is 80 mg/day
  • Monitor IGF-1levels and signs and symptoms q2Weeks during the dose titration, monthly during maintenance dosage, or as indicated
  • For 60 mg/day dose, administer as 40 mg in the AM and 20 mg in the PM
  • Dosage interruptions and modifications
    • If IGF-1 levels remain above the UNL after treatment with the maximum recommended dosage of 80 mg/day or the patient cannot tolerate treatment, consider discontinuing treatment and switching patient to another somatostatin analog
    • Withdraw therapy periodically to assess disease activity
    • If IGF-1 levels increase and signs and symptoms recur, resume therapy

Carcinoid Tumor

Indicated for treatment of adults with severe diarrhea and flushing episodes associated with metastatic carcinoid tumors

Bynfezia Pen

  • 100-600 mcg/day SC in 2-4 divided doses for the first 2 weeks
  • In clinical studies, median daily maintenance dosage was ~450 mcg, but clinical and biochemical benefits were obtained in some patients ranged from 50-1,500 mcg/day
  • Experience with doses >750 mcg/day is limited
  • Monitor urinary 5-hydroxyindole acetic acid (5-HIAA), plasma serotonin, and plasma substance

Sandostatin LAR depot

  • Patients not currently receiving octreotide
    • Begin therapy with solution as listed above
    • Maintain on SC solution for at least 2 weeks as listed above to determine tolerance to octreotide
    • Patients who responds to the drug, based on GH and IGF-1 levels and who tolerate the drug, then switch to octreotide suspension
  • Patients currently receiving octreotide
    • 20 mg IM q4Weeks for 2 months then modify dose based on response; may increase to 30mg q4Weeks if symptoms are inadequately controlled; decrease to 10 mg IM q4Weeks for trial period if initially responsive to 20 mg dose; dose >30 mg not recommended
    • Patients who have periodic exacerbation of symptoms (regardless of whether they are being maintained on Sandostatin injection or Sandostatin LAR Depot)
    • During these periods, SC Sandostatin injection may be given for a few days at the dosage they were receiving prior to switching to Sandostatin LAR depot; once symptoms resolve; discontinue SC Sandostatin injection

VIPoma

Indicated for treatment of adults with the profuse watery diarrhea associated with VIP-secreting tumors

Bynfezia Pen

  • 200-300 mcg/day SC in 2-4 divided doses for the first 2 weeks
  • Adjust dosage to achieve a therapeutic response; daily dosage is 150-750 mcg but usually doses >450 mcg/day are not required
  • Monitor plasma vasoactive intestinal peptide (VIP)

Sandostatin LAR depot

  • Patients not currently receiving octreotide
    • Begin therapy with solution as listed above
    • Maintain on SC solution for at least 2 weeks as listed above to determine tolerance to octreotide
    • Patients who responds to the drug, based on GH and IGF-1 levels and who tolerate the drug, then switch to octreotide suspension
  • Patients currently receiving octreotide
    • 20 mg IM q4Weeks for 2 months then modify dose based on response; may increase to 30mg q4Weeks if symptoms are inadequately controlled; decrease to 10 mg IM q4Weeks for trial period if initially responsive to 20 mg dose; dose >30 mg not recommended
    • Patients who have periodic exacerbation of symptoms (regardless of whether they are being maintained on Sandostatin injection or Sandostatin LAR Depot)
    • During these periods, SC Sandostatin injection may be given for a few days at the dosage they were receiving prior to switching to Sandostatin LAR depot; once symptoms resolve; discontinue SC Sandostatin injection

Esophageal Variceal Bleeding (Off-label)

Solution: 25-100 mcg IV bolus (usual bolus dose: 50 mcg); follow by continuous IV infusion of 25-50 mcg/hr for 2-5 days; may repeat bolus in first hr if hemorrhage not controlled

GI or Pancreatic Fistula (Off-label)

Solution: 50-200 mcg SC q8hr for 2-12 days

AIDS-Related Diarrhea (Off-label)

Solution: 100-500 mcg SC q8hr

Ileostomy-Related Diarrhea (Off-label)

Solution: 25 mcg/hr IV or 50 mcg SC q12hr  

Chemotherapy-Related Diarrhea (Off-label)

Low-grade or uncomplicated: Solution: 100-150 mcg SC q8hr for 1-30 days

Complicated: Solution: 100-150 mcg SC q8hr or 25-50 mcg/hr IV; may increase to 500 mcg q8hr until controlled

Severe: Solution: 100-150 mcg SC q8hr; may increase to 500-1500 mcg SC/IV q8hr

Dumping Syndrome (Off-label)

Solution: 50-150 mcg/day IV; may adjust to 25-600 mcg/day dose range

Suspension (depot injection): 10-20 mg/month IM

Chylothorax (Off-label)

Solution: 50-100 mcg SC q8hr

Dosage Modifications

Coadministration with proton pump inhibitors, H2-receptor antagonists, or antacids

  • Mycapssa only
  • Concomitant use of oral octreotide and proton pump inhibitors, H2-receptor antagonists, or antacids may require increased dosages of oral octreotide

Renal impairment

  • Sandostatin or Sandostatin LAR depot
    • Mild-to-severe without dialysis: No dosage adjustment necessary
    • With dialysis: 10 mg IM q4Weeks initially, then titrate to effect
  • Mycapssa
    • Mild-to-severe: No dosage adjustment necessary
    • End-stage renal disease: 20 mg PO qDay initially, then titrate to effect
  • Bynfezia Pen
    • Patients on dialysis: Half-life of octreotide may increase, may require dosage adjustment on maintenance dose

Hepatic impairment

  • Sandostatin or Sandostatin LAR depot
    • Cirrhosis: 10 mg IM q4Weeks initially, then titrate to effect
  • Mycapssa
    • Patients with liver cirrhosis and patients with fatty liver disease showed prolonged elimination of octreotide following SC administration

Neuroendocrine Tumors (Orphan)

Orphan indication sponsor

  • Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080

Dosage Forms & Strengths

injectable solution (Sandostatin)

  • 0.05mg/mL
  • 0.1mg/mL
  • 0.2mg/mL
  • 0.5mg/mL
  • 1mg/mL

Safety and efficacy not established

GI Bleeding (Off-label)

1 mcg/kg bolus, then 1 mcg/kg/hr infusion; taper by 50% when no active bleeding for 24 hours  

Diarrhea (Off-label)

1-10 mcg/kg/day IV/SC  

Chylothorax (Off-label)

0.3-4 mcg/kg/hr SC/IV, depending on nature of chylothorax  

Hyperinsulinemia/Hypoglycemia of Infancy (Off-label)

2-10 mcg/kg/day SC/IV divided q12hr; increase on basis of response  

Sulfonylurea Overdose (Off-label)

1 mcg/kg SC/IV q12hr OR 25 mcg once; monitor blood glucose concentrations  

Acromegaly

Solution: 50 mcg SC q8-12hr initially; titrate up to 500 mcg SC q8hr if necessary; after successful treatment with solution for 2 weeks, initiate treatment with suspension (depot injection)

Suspension (depot injection): 20 mg IM intragluteally every 4 weeks for 3 months; titrate up or down to 10-30 mg IM every 4 weeks, depending on response; not to exceed 40 mg

Dosing Considerations

Dose adjustment may be necessary; clearance may decrease by 26% and half-life by 46%

Monitor IGF-1 levels every 2 weeks to guide titration; goal: GH levels <5 ng/mL or IGF-1 levels <1.9 units/mL (men) and <2.2 units/mL (women)

Monitor IGF-1 or GH levels every 6 months

Withdraw drug yearly for 4 weeks (solution) or 8 weeks (suspension) from patients who have undergone irradiation to assess

Carcinoid Tumor

Solution: 100-600 mcg/day SC divided q6-12hr; may titrate to 1500 mcg/day; after successful treatment with solution for 2 weeks, initiate treatment with suspension (depot injection)

Suspension (depot injection): 20 mg IM every 4 weeks if regular injection well tolerated

VIPoma

Solution: 200-300 mcg/day SC divided q6-12hr; after successful treatment with solution for 2 weeks, initiate treatment with suspension (depot injection)

Suspension (depot injection): 20 mg IM (gluteal) every 4 weeks for 2 months; continue solution for first 2 weeks; titrate suspension up or down to 10-30 mg IM every 4 weeks

Esophageal Variceal Bleeding (Off-label)

Solution: 50 mcg IV bolus, then 25-50 mcg/hr for 1-5 days

Next:

Interactions

Interaction Checker

and octreotide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            All Interactions Sort By:
             activity indicator 

            Contraindicated (8)

            • disopyramide

              disopyramide and octreotide both increase QTc interval. Contraindicated.

            • ibutilide

              ibutilide and octreotide both increase QTc interval. Contraindicated.

            • indapamide

              indapamide and octreotide both increase QTc interval. Contraindicated.

            • pentamidine

              octreotide and pentamidine both increase QTc interval. Contraindicated.

            • pimozide

              octreotide and pimozide both increase QTc interval. Contraindicated.

            • procainamide

              octreotide and procainamide both increase QTc interval. Contraindicated.

            • quinidine

              quinidine and octreotide both increase QTc interval. Contraindicated.

            • sotalol

              octreotide and sotalol both increase QTc interval. Contraindicated.

            Serious - Use Alternative (76)

            • adagrasib

              adagrasib, octreotide. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients.

            • amiodarone

              amiodarone and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • amisulpride

              amisulpride and octreotide both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.

            • amitriptyline

              amitriptyline and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • amoxapine

              amoxapine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • anagrelide

              anagrelide and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • apomorphine

              apomorphine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether

              artemether and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether/lumefantrine

              artemether/lumefantrine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • asenapine

              asenapine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • asenapine transdermal

              asenapine transdermal and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine

              buprenorphine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine buccal

              buprenorphine buccal and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine subdermal implant

              buprenorphine subdermal implant and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine transdermal

              buprenorphine transdermal and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • buprenorphine, long-acting injection

              buprenorphine, long-acting injection and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • ceritinib

              ceritinib and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • chlorpromazine

              chlorpromazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • clarithromycin

              clarithromycin and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • clomipramine

              clomipramine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • desflurane

              desflurane and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • desipramine

              desipramine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • dofetilide

              dofetilide and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • doxepin

              doxepin and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • dronedarone

              dronedarone and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • droperidol

              droperidol and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • encorafenib

              encorafenib and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • entrectinib

              entrectinib and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • epinephrine

              epinephrine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • epinephrine racemic

              epinephrine racemic and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • eribulin

              eribulin and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin base

              erythromycin base and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin lactobionate

              erythromycin lactobionate and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • erythromycin stearate

              erythromycin stearate and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • fluconazole

              fluconazole and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • fluphenazine

              fluphenazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • formoterol

              formoterol and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • haloperidol

              haloperidol and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • imipramine

              imipramine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • isoflurane

              isoflurane and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • ivosidenib

              ivosidenib and octreotide both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

            • ketoconazole

              ketoconazole and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • levoketoconazole

              levoketoconazole and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • lofepramine

              lofepramine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • lumefantrine

              lumefantrine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • macimorelin

              macimorelin and octreotide both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

              octreotide, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that directly affect the pituitary secretion of growth hormone (GH) may impact the accuracy of the macimorelin diagnostic test. Allow sufficient washout time of drugs affecting GH release before administering macimorelin. .

            • maprotiline

              maprotiline and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • mefloquine

              mefloquine increases toxicity of octreotide by QTc interval. Avoid or Use Alternate Drug. Mefloquine may enhance the QTc prolonging effect of high risk QTc prolonging agents.

            • mobocertinib

              mobocertinib and octreotide both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

            • moxifloxacin

              moxifloxacin and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • nilotinib

              nilotinib and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • nortriptyline

              nortriptyline and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • ondansetron

              octreotide and ondansetron both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.

            • oxaliplatin

              oxaliplatin and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • perphenazine

              perphenazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • ponesimod

              ponesimod, octreotide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Coadministration of ponesimod with drugs that decrease HR may have additive effects on decreasing HR and should generally not be initiated in these patients.

            • prochlorperazine

              prochlorperazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • promazine

              promazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • promethazine

              promethazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • protriptyline

              protriptyline and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • ribociclib

              ribociclib increases toxicity of octreotide by QTc interval. Avoid or Use Alternate Drug.

            • sevoflurane

              sevoflurane and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • siponimod

              siponimod and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • tetrabenazine

              tetrabenazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • thioridazine

              thioridazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • trazodone

              trazodone and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • trifluoperazine

              trifluoperazine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • trimipramine

              trimipramine and octreotide both increase QTc interval. Avoid or Use Alternate Drug.

            • umeclidinium bromide/vilanterol inhaled

              octreotide increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vandetanib

              octreotide, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.

            • vemurafenib

              vemurafenib and octreotide both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended.

            • vilanterol/fluticasone furoate inhaled

              octreotide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vilazodone

              octreotide increases levels of vilazodone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If intolerable adverse effects occur when coadministered with moderate CYP3A4 inhibitors, reduce daily dose to 20 mg.

            • ziprasidone

              octreotide and ziprasidone both increase QTc interval. Avoid or Use Alternate Drug.

            Monitor Closely (96)

            • albuterol

              albuterol and octreotide both increase QTc interval. Use Caution/Monitor.

            • alfuzosin

              octreotide and alfuzosin both increase QTc interval. Use Caution/Monitor.

              alfuzosin and octreotide both increase QTc interval. Use Caution/Monitor.

            • arformoterol

              arformoterol and octreotide both increase QTc interval. Use Caution/Monitor.

            • aripiprazole

              aripiprazole and octreotide both increase QTc interval. Use Caution/Monitor.

            • arsenic trioxide

              arsenic trioxide and octreotide both increase QTc interval. Use Caution/Monitor.

            • atomoxetine

              atomoxetine and octreotide both increase QTc interval. Use Caution/Monitor.

            • azithromycin

              azithromycin and octreotide both increase QTc interval. Use Caution/Monitor.

            • bedaquiline

              octreotide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

            • bromocriptine

              octreotide increases levels of bromocriptine by decreasing metabolism. Use Caution/Monitor. Somatropin may increase CYP450 enzymes and, therefore, suppression of growth hormone secretion by somatostatin analogs including pasireotide may decrease the metabolic clearance of compounds metabolized by CYP450 enzymes.

            • citalopram

              octreotide and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • clozapine

              clozapine and octreotide both increase QTc interval. Use Caution/Monitor.

            • copper CU 64 dotatate

              octreotide decreases effects of copper CU 64 dotatate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as CU 64 dotatate and may affect imaging. Image patients just prior to dosing with somatostatin analogs. Washout period of 28 days recommended for patients on long-acting somatostatin analogs before imaging; whereas, 2 days washout recommended for short-acting somatostatin analogs.

            • crizotinib

              crizotinib and octreotide both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • cyclosporine

              octreotide decreases levels of cyclosporine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.

            • dasatinib

              dasatinib and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • degarelix

              degarelix and octreotide both increase QTc interval. Use Caution/Monitor.

            • deutetrabenazine

              deutetrabenazine and octreotide both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).

            • dienogest/estradiol valerate

              octreotide will increase the level or effect of dienogest/estradiol valerate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for potential adverse effects such as nausea, irregular uterine bleeding, breast tenderness and headache.

            • dolasetron

              dolasetron and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • donepezil

              donepezil and octreotide both increase QTc interval. Use Caution/Monitor.

            • efavirenz

              efavirenz and octreotide both increase QTc interval. Use Caution/Monitor.

            • eliglustat

              eliglustat and octreotide both increase QTc interval. Use Caution/Monitor.

            • escitalopram

              escitalopram increases toxicity of octreotide by QTc interval. Use Caution/Monitor.

            • ezogabine

              ezogabine, octreotide. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.

            • fingolimod

              fingolimod and octreotide both increase QTc interval. Use Caution/Monitor.

            • flecainide

              flecainide and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluoxetine

              fluoxetine and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluvoxamine

              fluvoxamine and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • foscarnet

              foscarnet and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • gallium Ga 68 dotatate

              octreotide decreases effects of gallium Ga 68 dotatate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatate and may affect imaging. Image patients with Ga 68 dotatate PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatate.

            • gallium Ga 68 dotatoc

              octreotide decreases effects of gallium Ga 68 dotatoc by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatoc and may affect imaging. Image patients with Ga 68 dotatoc PET just prior to dosing with long-acting somatostatin analogs. Short-acting somatostatin analogs can be used up to 24 hr before imaging with Ga 68 dotatoc.

            • gemifloxacin

              gemifloxacin and octreotide both increase QTc interval. Use Caution/Monitor.

            • gepirone

              gepirone and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • gilteritinib

              gilteritinib and octreotide both increase QTc interval. Use Caution/Monitor.

            • granisetron

              granisetron and octreotide both increase QTc interval. Use Caution/Monitor.

            • hydroxyzine

              hydroxyzine and octreotide both increase QTc interval. Use Caution/Monitor.

            • iloperidone

              iloperidone and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • indacaterol, inhaled

              indacaterol, inhaled, octreotide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • insulin aspart

              octreotide increases effects of insulin aspart by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin aspart protamine/insulin aspart

              octreotide increases effects of insulin aspart protamine/insulin aspart by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin degludec

              octreotide, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

              octreotide increases effects of insulin degludec by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin degludec/insulin aspart

              octreotide, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

            • insulin detemir

              octreotide increases effects of insulin detemir by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin glargine

              octreotide increases effects of insulin glargine by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin glulisine

              octreotide increases effects of insulin glulisine by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin inhaled

              octreotide, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.

              octreotide increases effects of insulin inhaled by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin isophane human/insulin regular human

              octreotide increases effects of insulin isophane human/insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin lispro

              octreotide increases effects of insulin lispro by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin lispro protamine/insulin lispro

              octreotide increases effects of insulin lispro protamine/insulin lispro by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin NPH

              octreotide increases effects of insulin NPH by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • insulin regular human

              octreotide increases effects of insulin regular human by unspecified interaction mechanism. Use Caution/Monitor. Concomitant use of insulin and somatostatin analogs may require insulin dosage adjustment and increased glucose monitoring.

            • itraconazole

              itraconazole and octreotide both increase QTc interval. Use Caution/Monitor.

            • lapatinib

              lapatinib and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • levofloxacin

              levofloxacin and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • lithium

              lithium and octreotide both increase QTc interval. Use Caution/Monitor.

            • lurasidone

              octreotide increases levels of lurasidone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Manufacturer recommends decreasing starting dose of lurasidone to 20 mg/day and maximum daily dose of lurasidone 80 mg when coadministered with moderate CYP3A4 inhibitors. Concurrent use may increase risk of lurasidone-related adverse reactions.

            • lutetium Lu 177-dota-tate

              octreotide decreases effects of lutetium Lu 177-dota-tate by receptor binding competition. Modify Therapy/Monitor Closely. Somatostatin analogs competitively bind to the same somatostatin receptors as lutetium Lu 177-dota-tate and may affect its efficacy. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hr prior to each lutetium Lu 177-dota-tate dose. Administer short- and long-acting octreotide during treatment as recommended.

            • maraviroc

              octreotide increases levels of maraviroc by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

            • metformin

              octreotide decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.

            • methadone

              methadone and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • metoclopramide intranasal

              octreotide will decrease the level or effect of metoclopramide intranasal by Other (see comment). Use Caution/Monitor. Coadministration of metoclopramide intranasal with drugs that impair GI motility may decrease systemic absorption of metoclopramide. Monitor for reduced therapeutic effect.

            • mifepristone

              mifepristone, octreotide. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.

            • mirtazapine

              mirtazapine and octreotide both increase QTc interval. Use Caution/Monitor.

            • ofloxacin

              octreotide and ofloxacin both increase QTc interval. Modify Therapy/Monitor Closely.

            • olodaterol inhaled

              octreotide and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias

            • osimertinib

              osimertinib and octreotide both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

            • ozanimod

              ozanimod and octreotide both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • paliperidone

              octreotide and paliperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • paroxetine

              octreotide and paroxetine both increase QTc interval. Modify Therapy/Monitor Closely.

            • pasireotide

              octreotide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • pazopanib

              octreotide and pazopanib both increase QTc interval. Use Caution/Monitor.

            • posaconazole

              octreotide and posaconazole both increase QTc interval. Modify Therapy/Monitor Closely.

            • primaquine

              primaquine and octreotide both increase QTc interval. Use Caution/Monitor.

            • quetiapine

              quetiapine, octreotide. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.

            • quinine

              octreotide and quinine both increase QTc interval. Use Caution/Monitor.

            • quizartinib

              quizartinib, octreotide. Either increases effects of the other by QTc interval. Modify Therapy/Monitor Closely. Monitor patients more frequently with ECG if coadministered with QT prolonging drugs.

            • ranolazine

              octreotide and ranolazine both increase QTc interval. Modify Therapy/Monitor Closely.

            • rilpivirine

              rilpivirine increases toxicity of octreotide by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.

            • risperidone

              octreotide and risperidone both increase QTc interval. Modify Therapy/Monitor Closely.

            • romidepsin

              octreotide and romidepsin both increase QTc interval. Modify Therapy/Monitor Closely.

            • selpercatinib

              selpercatinib increases toxicity of octreotide by QTc interval. Use Caution/Monitor.

            • sertraline

              sertraline and octreotide both increase QTc interval. Use Caution/Monitor.

            • solifenacin

              solifenacin and octreotide both increase QTc interval. Use Caution/Monitor.

            • sorafenib

              sorafenib and octreotide both increase QTc interval. Use Caution/Monitor.

            • sulfamethoxazole

              sulfamethoxazole and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • sunitinib

              sunitinib and octreotide both increase QTc interval. Use Caution/Monitor.

            • tacrolimus

              tacrolimus and octreotide both increase QTc interval. Use Caution/Monitor.

            • telavancin

              octreotide and telavancin both increase QTc interval. Modify Therapy/Monitor Closely.

            • telotristat ethyl

              octreotide decreases levels of telotristat ethyl by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Administer short-acting octreotide at least 30 minutes after telotristat ethyl.

            • trimethoprim

              octreotide and trimethoprim both increase QTc interval. Modify Therapy/Monitor Closely.

            • tropisetron

              octreotide and tropisetron both increase QTc interval. Modify Therapy/Monitor Closely.

            • valbenazine

              valbenazine and octreotide both increase QTc interval. Use Caution/Monitor.

            • venlafaxine

              octreotide and venlafaxine both increase QTc interval. Modify Therapy/Monitor Closely.

            • voclosporin

              voclosporin, octreotide. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • voriconazole

              octreotide and voriconazole both increase QTc interval. Modify Therapy/Monitor Closely.

            • vorinostat

              vorinostat and octreotide both increase QTc interval. Use Caution/Monitor.

            Minor (4)

            • chloroquine

              chloroquine increases toxicity of octreotide by QTc interval. Minor/Significance Unknown.

            • cyanocobalamin

              octreotide decreases levels of cyanocobalamin by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • food

              food decreases levels of octreotide by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Particularly high fat food.

            • methadone

              octreotide decreases levels of methadone by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Oral

            • Headache (33%)
            • Nausea (30%)
            • Diarrhea (29%)
            • Arthralgia (26%)
            • Asthenia (22%)
            • Hyperhidrosis (21%)
            • Nausea (21%)
            • Diarrhea (18%)
            • Peripheral swelling (16%)
            • Increased blood glucose (14%)
            • Vomiting (14%)
            • Abdominal discomfort (14%)
            • Dyspepsia (11%)
            • Sinusitis (11%)
            • Osteoarthritis (11%)

            Sandostatin

            • Diarrhea, loose stools, nausea and abdominal discomfort (34-61%)
            • Sinus bradycardia (25%)
            • Hyperglycemia (16%)
            • Biochemical hypothyroidism (12%)

            Sandostatin LAR

            • Diarrhea (36.4%)
            • Abdominal pain or discomfort (29.1%)
            • Hyperglycemia (27%)
            • Flatulence (25.7%)
            • Sinus bradycardia (<50 bpm) (25%)
            • Constipation (18.8%)
            • Biochemical hypothyroidism (12%)
            • Nausea (10.3%)

            1-10%

            Oral

            • Dyspepsia (8%)
            • Urinary tract infection (7%)
            • Pain (7%)
            • Large intestine polyp (7%)
            • Cholelithiasis (7%)
            • Blood glucose increased (6%)
            • Vomiting (6%)
            • Flatulence (6%)
            • Back pain (6%)
            • Abdominal pain (5%)
            • Dizziness (5%)
            • Fatigue (5%)
            • Upper respiratory tract infection (5%)
            • Hypertension (5%)
            • Cholelithiasis (4.5%)
            • Sandostatin H4
            • Conduction abnormalities (10%)
            • Arrhythmias (9%)
            • Pain on injection (7.7%)
            • Headache (6%)
            • Goiter (6%)
            • Dizziness (5%)
            • Hypoglycemia (3%)
            • Other adverse events (1-4%) H5
              • Fatigue, weakness, pruritus, joint pain, backache, urinary tract infection, cold symptoms, flu symptoms, injection site hematoma, bruise, edema, flushing, blurred vision, pollakiuria, fat malabsorption, hair loss, visual disturbance and depression

            Sandostatin LAR

            • Conduction abnormalities (10%)
            • Nausea (6-9%)
            • Arrhythmia (9%)
            • Goiter (8%)
            • Abdominal pain (2-8%)
            • Fatigue (2-7%)
            • Vomiting (4-6.5%)
            • Headache (4-6%)
            • Back pain (2-6%)
            • Dizziness (4-5%)
            • Pruritus (4%)
            • Hypoglycemia (4%)
            • Flatulence (2-4%)
            • Upper respiratory tract infection (2-4%)
            • Myalgia (1-4%)
            • Rash (3%)
            • Arthropathy (2-3%)
            • Sinusitis (1-3%)
            • Generalized pain (1-3%)
            • Musculoskeletal pain (1%)

            <1%

            Sandostatin or Sandostatin LAR

            • Gastrointestinal: Hepatitis, jaundice, increase in liver enzymes, GI bleeding, hemorrhoids, appendicitis, gastric/peptic ulcer, gallbladder polyp
            • Integumentary: Rash, cellulitis, petechiae, urticaria, basal cell carcinoma
            • Musculoskeletal: Arthritis, joint effusion, muscle pain, Raynaud phenomenon
            • Cardiovascular: Chest pain, shortness of breath, thrombophlebitis, ischemia, congestive heart failure, hypertension, hypertensive reaction, palpitations, orthostatic BP decrease, tachycardia
            • Central nervous system (CNS): Anxiety, libido decrease, syncope, tremor, seizure, vertigo, Bell’s Palsy, paranoia, pituitary apoplexy, increased intraocular pressure, amnesia, hearing loss, neuritis
            • Respiratory: Pneumonia, pulmonary nodule, status asthmaticus
            • Endocrine: Galactorrhea, hypoadrenalism, diabetes insipidus, gynecomastia, amenorrhea, polymenorrhea, oligomenorrhea, vaginitis
            • Urogenital: Nephrolithiasis, hematuria
            • Hematologic: Anemia, iron deficiency, epistaxis
            • Miscellaneous: Otitis, allergic reaction, increased CK, weight loss
            • Anaphylactoid reactions, including anaphylactic shock

            Postmarketing experience

            Sandostatin

            • Hepatobiliary: Cholelithiasis, cholecystitis, cholangitis and pancreatitis, which have sometimes required cholecystectomy
            • Gastrointestinal: Intestinal obstruction
            • Hematologic: Thrombocytopenia

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            Use caution in patients with hepatic impairment; patients with established cirrhosis may necessitate dosage adjustment

            Use caution in patients with renal impairment; patients receiving dialysis may necessitate dosage adjustment; in patients with severe renal failure requiring dialysis, the half-life of the drug may be increased, necessitating adjustment of maintenance dosage

            May alter fat absorption in some patients (monitor for pancreatitis)

            Monitor for cholelithiasis; may impair gallbladder function; incidence of gallbladder stone or biliary sludge increases with duration of therapy exceeding 12 months; prophylactic cholecystectomy recommended if octreotide treatment is planned in in patients with gastrointestinal or pancreatic neuroendocrine tumors

            There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications requiring cholecystectomy; if complications of cholelithiasis are suspected, discontinue drug and treat appropriately

            Depressed vitamin B12 levels and abnormal Schilling’s tests reported in some patients receiving therapy; monitoring of vitamin B12 levels is recommended during chronic therapy

            Monitor for hypothyroidism (octreotide suppresses secretion of TSH); baseline and periodic assessment of thyroid function (TSH, total, and/or free T4) recommended during chronic therapy

            Therapy may alter absorption of dietary fats in some patients

            Use caution when giving drug to patients with cardiovascular disease

            May enhance toxicity of QTc-prolonging agents

            Use caution in patients with heart failure or concomitant medications that may alter heart rate or rhythm; arrhythmia, conduction abnormalities, and bradycardia reported in acromegalic and carcinoid syndrome patients; cardiovascular medications requirements may change

            Depot formulation, not for treatment of sulfonylurea-induced hypoglycemia

            Somatostatin analogs may affect glucose regulation; severe hypoglycemia may occur in type 1 diabetes patients; hyperglycemia may occur in type 2 diabetes or patients without diabetes; therapy may worsen hypoglycemia in patients with insulinomas; use with caution; glucose tolerance and anti- diabetic treatment should be periodically monitored during therapy

            Dosage adjustments may be necessary in the elderly

            Females of childbearing age should use adequate contraception because the treatment may restore fertility

            In patients maintained on total parenteral nutrition (TPN), monitoring for elevations in zinc levels recommended

            May reduce excessive fluid loss in patients with conditions that cause fluid losses

            Although acromegaly may lead to infertility, there are reports of pregnancy in acromegalic women; in women with active acromegaly who have been unable to become pregnant, normalization of GH and IGF-1 (somatomedin C) may restore fertility; female patients of child­bearing potential should be advised to use adequate contraception during treatment

            Cardiac abnormalities

            • Bradycardia and arrhythmia may occur; electrocardiogram (ECG) changes observed include QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, and early R-wave progression; these ECG changes are not uncommon in acromegalic patients
            • Dose adjustments in drugs such as beta-blockers that have bradycardia effects may be necessary
            • In one acromegalic patient with severe congestive heart failure, initiation of herapy resulted in worsening of congestive heart failure with improvement when drug was discontinued
            • Complete atrioventricular block
              • Patients who receive Injection intravenously may be at increased risk for higher degree atrioventricular blocks; the safety of continuous intravenous infusion has not been established in patients receiving the drug for the approved indications; consider cardiac monitoring in patients receiving the drug intravenously

            Drug interaction overview

            • Coadministration with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection
            • Octreotide inhibits the secretion of insulin and glucagon; monitor blood glucose levels upon initiation or dose adjustment; patients with diabetes mellitus may require dose adjustments of insulin or other antidiabetic agents
            • Coadministration with bromocriptine increases the availability of bromocriptine
            • Patients receiving beta blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may require dose adjustments of these therapeutic agents
            • Octreotide has been associated with alterations in nutrient absorption, so it may have an effect on absorption of orally administered drugs
            • Limited published data indicate that somatostatin analogs might decrease the metabolic clearance of compounds known to be metabolized by cytochrome P450 enzymes, which may be due to the suppression of growth hormones
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            Pregnancy & Lactation

            Pregnancy

            Limited data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

            Reproductive potential

            • Discuss potential for unintended pregnancy with premenopausal women as therapeutic benefits of a reduction in growth hormone (GH) levels and normalization of insulin-like growth factor 1 (IGF-1) concentration in acromegalic females treated with drug may lead to improved fertility

            Animal data

            • In animal reproduction studies, no-adverse- developmental-effects were observed with intravenous administration of drug to pregnant rats and rabbits during organogenesis at doses 7 and 13-times, respectively the maximum recommended human dose (MRHD) of 1500 mcg/day based on body surface area
            • Transient growth retardation, with no impact on postnatal development, was observed in rat offspring from a pre- and post-natal study of octreotide at intravenous doses below the MRHD based on body surface area

            Lactation

            There is no information available on presence of drug in human milk, effects on breastfed infant, or on milk production; studies show that drug administered subcutaneously passes into milk of lactating rats

            Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Somatostatin analog; decreases GH secretion, secretion of gastrin, VIP, glucagon, secretin, serotonin release and pancreatic polypeptide; in acromegaly, octreotide decreases growth hormone and IGF-1 secretion; suppresses LH response to GnRH secretion and decreases splanchnic blood flow

            Absorption

            Absorption rapid and complete (SC)

            Bioavailability: SC, 100%; IM, 60%

            Peak plasma time: IV, immediately after injection; SC, 15-30 min; PO, 90-120 min; IM, 60 min

            Distribution

            Protein bound: 65% binds to lipoprotein

            Vd: 13.6 L

            Metabolism

            Metabolized by liver

            Elimination

            Half-life: 1.7 hr

            Total body clearance: 10 L/hr

            Excretion: Urine (32%)

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            Administration

            IV Incompatibilities

            Total parenteral nutrition solutions because of the formation of a glycosyl octreotide conjugate which may decrease the efficacy of the product

            IV Compatibilities

            Dextrose 5%

            IV Administration (Sandostatin)

            Diluted volumes of 50-200 mL: Infuse over 15-30 min

            Undiluted volumes

            • Administer IV push over 3 min
            • In emergency situation (eg, carcinoid crisis), it may be given by rapid bolus

            IM Administration (Sandostatin LAR Depot)

            IM administration only; should not be administer IV or SC

            Administer immediately after mixing; do not directly inject diluent without preparing suspension

            Recommended needle size for administration is the 1.5 inch 19 gauge safety injection needle (supplied in the kit)

            For patients with a greater skin to muscle depth, a size 2 inch 19 gauge needle (not supplied) may be used

            Rotate injection sites in a systematic manner to avoid irritation; deltoid injections should be avoided due to significant discomfort at the injection site when given in that area

            Oral Administration (Mycapssa)

            Take with a glass of water on an empty stomach, at least 1 hr before a meal or at least 2 hr after a meal

            Swallow capsules whole; do not crush or chew

            SC Administration (Bynfezia Pen or Sandostatin)

            Visually inspect for particulate matter and discoloration; solution should appear colorless with no visible particles

            Sandostatin

            • Use of smaller volumes to deliver desired dose will reduce pain with administration
            • Avoid multiple SC injections at the same site within short periods of time
            • Rotate sites in a systematic manner

            Bynfezia Pen

            • Pen should be at room temperature before injecting to reduce potential injection site reactions
            • Administer by SC into the abdomen, the front of the middle thighs, or the back/outer area of the upper arms
            • Rotate injection sites so that the same site is not used repeatedly; injection sites should be at least 2 inches away from last injection site
            • Provide proper training to patients and/or caregivers on administration; and refer to “Instruction for Use”

            Storage

            Bynfezia Pen

            Unopened pen
            • Refrigerate at 2-8ºC (36-46ºF)
            • Protect from light
            • Do not freeze
            Opened pen
            • Store at room temperature (20-25ºC [68-77ºF]) for up to 28 days
            • Store pen with the pen cap on; do not store pen with needle attached
            • Protect from light
            • Do not freeze
            Mycapssa
            • Unopened wallet: Refrigerate at 2-8ºC (36-46ºF); do not freeze
            • After first use, opened wallets may be stored at 20-25ºC (68-77ºF) for up to 1 month

            Sandostatin

            • Unopened ampules and multidose vials
              • Refrigerate at 2-8ºC (36-46ºF) and store in ºouter carton in order to protect from light
              • Store at room temperature (20-25ºC [68-77F]) for up to14 days if protected from light
              • Allow solution to come to room temperature before administration; do not warm artificially
              • After initial use, discard multidose vials within 14 days
              • Open ampules just prior to administration and discard any unused portion discarded

            Sandostatin LAR Depot

            • Refrigerate at 2-8ºC (36-46ºF)
            • Kit should remain at room temperature for 30-60 min prior to preparation of the drug suspension
            • Protect from light
            • After preparation, administer suspension immediately
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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            octreotide acetate injection
            -
            1,000 mcg/mL vial
            octreotide acetate injection
            -
            500 mcg/mL solution
            octreotide acetate injection
            -
            500 mcg/mL vial
            octreotide acetate injection
            -
            100 mcg/mL vial
            octreotide acetate injection
            -
            100 mcg/mL (1 mL) solution
            octreotide acetate injection
            -
            1,000 mcg/mL vial
            octreotide acetate injection
            -
            200 mcg/mL vial
            octreotide acetate injection
            -
            100 mcg/mL solution
            octreotide acetate injection
            -
            50 mcg/mL solution
            octreotide acetate injection
            -
            500 mcg/mL vial
            octreotide acetate injection
            -
            100 mcg/mL vial
            octreotide acetate injection
            -
            50 mcg/mL vial
            octreotide acetate injection
            -
            50 mcg/mL vial
            octreotide acetate injection
            -
            500 mcg/mL vial
            octreotide acetate injection
            -
            50 mcg/mL vial
            octreotide acetate injection
            -
            1,000 mcg/mL vial
            octreotide acetate injection
            -
            200 mcg/mL vial
            octreotide acetate injection
            -
            200 mcg/mL vial
            octreotide acetate injection
            -
            200 mcg/mL vial
            octreotide acetate injection
            -
            50 mcg/mL vial
            octreotide acetate injection
            -
            500 mcg/mL (1 mL) solution
            octreotide acetate injection
            -
            50 mcg/mL (1 mL) solution
            octreotide acetate injection
            -
            200 mcg/mL vial
            octreotide acetate injection
            -
            50 mcg/mL vial
            octreotide acetate injection
            -
            1,000 mcg/mL vial
            octreotide acetate injection
            -
            500 mcg/mL vial
            octreotide acetate injection
            -
            100 mcg/mL vial
            octreotide acetate injection
            -
            50 mcg/mL vial
            octreotide acetate injection
            -
            500 mcg/mL vial
            octreotide acetate injection
            -
            100 mcg/mL vial
            Sandostatin injection
            -
            500 mcg/mL solution
            Sandostatin injection
            -
            100 mcg/mL solution
            Sandostatin injection
            -
            50 mcg/mL solution
            Mycapssa oral
            -
            20 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            octreotide acetate injection

            OCTREOTIDE - INJECTION

            (ok-TREE-oh-tide)

            COMMON BRAND NAME(S): Sandostatin

            USES: Octreotide is used to treat severe watery diarrhea and sudden reddening of the face and neck caused by certain types of tumors (such as carcinoid tumors, vasoactive intestinal peptide tumors) that are found usually in the intestines and pancreas. The symptoms occur when these tumors make too much of certain natural substances (hormones). This medication works by blocking the production of these hormones. By decreasing watery diarrhea, octreotide helps to reduce the loss of body fluids and minerals.Octreotide is also used to treat a certain condition (acromegaly) that occurs when the body makes too much of a certain natural substance called growth hormone. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Octreotide works by decreasing the amount of growth hormone to normal levels.This drug is not a cure for these conditions. This medication is usually used with other treatment (such as surgery, radiation, other drugs).

            HOW TO USE: This medication is usually given by injection under the skin as directed by your doctor, usually 2 to 3 times a day. Depending on your condition, it may be given by injection into a vein by a health care professional. The dosage is based on your medical condition and response to treatment.If your doctor directs you to inject this medication under the skin yourself, learn all preparation and usage instructions from your health care professional. Learn how to store and discard needles and medical supplies safely. If you have questions, ask your health care professional.Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the location of the injection site each time to avoid problem areas under the skin.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.Tell your doctor if your condition does not improve or if it worsens.

            SIDE EFFECTS: Nausea, vomiting, loose/oily stools, constipation, stomach upset, gas, bloating, dizziness, or headache may occur. Pain and irritation at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of gallbladder/liver problems (such as fever, stomach/abdominal pain, severe nausea/vomiting, yellowing eyes/skin, unexplained pain in the back/right shoulder), signs of underactive thyroid (such as unexplained weight gain, cold intolerance, slow heartbeat, severe constipation, unusual/extreme tiredness, growth/lump/swelling on the front of the neck), worsening heart condition symptoms (such as trouble breathing, slow/fast/irregular heartbeat), numbness/tingling of the arms/legs.This medication may rarely cause changes in blood sugar, especially if you have diabetes. Symptoms of high blood sugar include increased thirst and urination. Symptoms of low blood sugar include nervousness, shakiness, sweating, fast heartbeat, and hunger. Follow your doctor's instructions to treat low blood sugar (for example, by eating a quick source of sugar such as glucose gel/tablets, table sugar, or honey, or drinking fruit juice or non-diet soda). Tell your doctor right away if you experience symptoms of high or low blood sugar while using this medication. Monitor your blood sugar levels as directed by your doctor. Your doctor may need to adjust your diabetes medications.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before using octreotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (such as cirrhosis), diabetes, thyroid problems, gallbladder problems (such as gallstones), heart problems (such as heart failure), nutrition problems (such as decreased fat absorption, vitamin B12 deficiency).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If used for a long time (such as longer than 1 year), this medication may slow a child's growth rate. However, the growth rate catches up after treatment with the drug is stopped. Consult your doctor for more information.This medication may restore the normal ability to become pregnant in females with acromegaly who have infertility. Females of childbearing age should discuss reliable forms of birth control with the doctor. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood glucose tests, thyroid function tests, hormone levels, vitamin B12 levels) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store this medication in the refrigerator away from light. Allow the medication to come to room temperature before using. This medication is good for 2 weeks if stored at room temperature away from light. Multi-use vials should be discarded 2 weeks after opening. Ampules should be opened just before each dose, and any unused portion should be discarded. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised October 2022. Copyright(c) 2023 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.