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

60-120 mg (recommended 90 mg) deep SC in superior external quadrant of buttock q4week for 3 months; THEN adjust based on GH and/or IGF-1 levels

Dose adjustments after 3 months (acromegaly)

  • GH >1 to ≤2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: Maintain dose at 90 mg q4wk
  • GH >2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: Increase dose to 120 mg q4wk
  • GH ≤1 ng/mL, IGF-1 normal and clinical symptoms controlled: Reduce dose to 60 mg q4wk
  • Patients controlled on 60-90 mg q4wk may be considered for an extended dosing interval of 120 mg q6-8wk

Renal & hepatic impairment (acromegaly)

  • Moderate-to-severe: Initial 60 mg deep SC in superior external quadrant of buttock q4week for 3 months; THEN adjust based on GH and/or IGF-I levels

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 q4wk by deep SC injection

Renal & hepatic impairment (GEP-NETs)

  • Mild or moderate renal impairment: No recommendation for dose adjustment
  • Severe renal impairment: Insufficient information to recommend a dose
  • Hepatic impairment (any severity): Insufficient information to recommend a dose

Carcinoid Syndrome (Orphan)

Treatment of symptoms associated with carcinoid syndrome

Orphan indication sponsor

  • Ipsen Pharma; 65 quai George Gorse, 92650 Boulogne Billancourt; France

Administration

Inject by deep SC in the superior external quadrant of the buttock; alternate injection site

Monitoring

Blood glucose

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

            Cautions

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

            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

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

            Use caution in renal/hepatic impairment, diabetes

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Not known whether excreted in breast milk, discontinue drug or do not nurse

            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

            Pharmacokinetics

            Bioavailability: ~69-83%

            Vd: 0.2 L/kg

            Half-Life: 23-36 days

            Excretion: intact urine <5%; feces <0.5%

            Peak plasma time: 7-12 hr

            Protein binding: 79-83%

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            Formulary

            FormularyPatient Discounts

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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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