Dosing & Uses
Dosage Forms & Strengths
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
Inject by deep SC in the superior external quadrant of the buttock; alternate injection site
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Abdominal pain (19%)
Bradyarrhythmia (5% to 18% )
Injection site reaction (subcutaneous depot, 6% to 22% ; intramuscular, up to 50% )
Flatulence (up to 14% )
Anemia (3% to 14% )
Loose stools (6%)
Sinus bradycardia (3%)
Injection site pruritus
Aortic valve regurgitation
Allergic skin reaction
Mitral valve regurgitation
Gastrointestinal disorders: Abdominal pain, diarrhea, and steatorrhea
Hepatobiliary disorders: Cholecystitis, pancreatitis
General disorders and administration site conditions: Injection site reactions
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
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not known whether excreted in breast milk, discontinue drug or do not nurse
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.
Mechanism of Action
Analog of somatostatin, which is a peptide inhibitor of multiple endocrine, neuroendocrine, and exocrine mechanisms
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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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.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.