lanreotide (Rx)

Brand and Other Names:Somatuline Depot
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection solution

  • 60mg/0.2mL
  • 90mg/0.3mL
  • 120mg/0.5mL
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Acromegaly

Indicated for acromegaly in patients with failed or contraindicated radiation/surgery

90mg SC q4Week for 3 months; THEN adjust based on GH and/or IGF-1 levels

Dose adjustments after 3 months

  • GH >1 to ≤2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: Maintain dose at 90 mg q4Week
  • GH >2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: Increase dose to 120 mg q4Week
  • GH ≤1 ng/mL, IGF-1 normal and clinical symptoms controlled: Reduce dose to 60 mg q4Week
  • Patients controlled on 60-90 mg q4Week may be considered for an extended dosing interval of 120 mg q6-8Week

Gastroenteropancreatic Neuroendocrine Tumors

Indicated for unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival

120 mg SC q4Week

Carcinoid Syndrome

Indicated for carcinoid syndrome

120 mg SC q4Week

Dosage Modifications

Renal impairment

  • Acromegaly
    • Mild: Safety and efficacy not established
    • Moderate-severe: 60 mg deep SC q4Week for 3 months initially; adjust based on GH and/or IGF-I levels thereafter
  • Gastroenteropancreatic neuroendocrine tumors
    • Mild-moderate: No dosage adjustment necessary
    • Moderate-severe: Safety and efficacy not established

Hepatic impairment

  • Gastroenteropancreatic neuroendocrine tumors: Safety and efficacy not established
  • Acromegaly
    • Mild: Safety and efficacy not established
    • Moderate-severe (Child Pugh B or C): 60 mg deep SC q4Week for 3 months initially; adjust based on GH and/or IGF-I levels thereafter

Safety and efficacy not established

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Interactions

Interaction Checker

and lanreotide

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Abdominal pain (19%)

            Cholelithiasis (20%)

            Diarrhea (57%)

            Nausea (11%)

            Bradyarrhythmia (5% to 18% )

            Injection site reaction (subcutaneous depot, 6% to 22% ; intramuscular, up to 50% )

            Flatulence (up to 14% )

            Anemia (3% to 14% )

            1-10%

            Arthralgia (7%)

            Constipation (8%)

            Headache (7%)

            Loose stools (6%)

            Vomiting (7%)

            Hyper-/hypoglycemia/diabetes (7%)

            Sinus bradycardia (3%)

            <1%

            Injection site pruritus

            Steatorrhea

            Aortic valve regurgitation

            Allergic skin reaction

            Mitral valve regurgitation

            Pancreatitis

            Postmarketing Reports

            Angioedema

            Anaphylaxis

            Gastrointestinal disorders: Abdominal pain, diarrhea, and steatorrhea

            Hepatobiliary disorders: Cholecystitis, pancreatitis

            General disorders and administration site conditions: Injection site reactions

            Cardiac: Hypertension

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            Warnings

            Contraindications

            Hypersensitivity to lanreotide

            Cautions

            Risk of reducing gallbladder motility, which could lead to gallstone formation; monitor periodically

            Inhibition of insulin and glucagon secretion; may affect glucose regulation, which can lead to hyper-hypoglycemia; glucose monitoring is recommended; adjust antidiabetic treatment accordingly

            Decreases in thyroid function reported; thyroid function tests are recommended where clinically indicated

            Bradycardia, hypertension, and sinus bradycardia reported; use with caution in at-risk patients; initiate appropriate medical management in patients who develop symptomatic bradycardia

            Pharmacological gastrointestinal effects of lanreotide may reduce the intestinal absorption of concomitant drugs; lanreotide may decrease the relative bioavailability of cyclosporine; concomitant administration of lanreotide and cyclosporine may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels

            Use caution in renal/hepatic impairment, diabetes

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            Pregnancy & Lactation

            Pregnancy

            Limited available data based on postmarketing case reports, use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes

            A reproductive study in pregnant rats given 30 mg/kg of lanreotide by subcutaneous injection every 2 weeks (5 times the human dose, based on body surface area comparisons) resulted in decreased embryo/fetal survival

            Lactation

            There is no information available on presence of lanreotide in human milk, effects of drug on breastfed infant, or on milk production; studies show that lanreotide acetate administered subcutaneously passes into the milk of lactating rats; due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk

            Because of potential for serious adverse reactions in breastfed infants, including effects on glucose metabolism and bradycardia, advise women not to breastfeed during treatment and for 6 months (6 half-lives) following the last dose

            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

            Analog of somatostatin, which is a peptide inhibitor of multiple endocrine, neuroendocrine, and exocrine mechanisms

            Absorption

            Peak plasma concentration (single dose): 3.8 ng/mL (60 mg-dose); 5.7 ng/mL (90 mg-dose); 7.7 ng/mL (120 mg-dose)

            Peak plasma time: 7-12 hr

            Distribution

            Protein binding: 79-83%

            Vd: 0.2 L/kg

            Bioavailability: ~69-83%

            Metabolism

            Half-Life: 23-36 days

            Excretion: Urine (<5%); feces (<0.5%)

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            Administration

            SC Preparation

            Remove lanreotide from refrigerator 30 minutes prior to administration; allow to come to room temperature

            Visually inspect injection for particulate matter and discoloration

            Do not administer if particulate matter or discoloration is observed

            SC Administration

            Administer as a deep SC injection only in the superior external quadrant of the buttock

            Alternate the injection site between the right and left sides from one injection to another

            Storage

            Store in refrigerator at 2-8°C (36- 46°F)

            Protect from light

            Store in the original package

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            Images

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            Formulary

            FormularyPatient Discounts

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

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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