Somavert Generic Name & Formulations
Legal Class
Rx
General Description
Pegvisomant 10mg, 15mg, 20mg, 25mg, 30mg; per vial; lyophilized pwd for SC inj after reconstitution; contains mannitol.
Pharmacological Class
Growth hormone (GH) receptor antagonist.
How Supplied
Single-dose vial—1 (w. diluent)
Manufacturer
Generic Availability
NO
Somavert Indications
Indications
Treatment of acromegaly when response to surgery and/or radiation therapy and/or other medical therapies is inadequate or inappropriate.
Somavert Dosage and Administration
Adult
Give by SC inj into upper arm, upper thigh, buttocks, or abdomen; rotate inj site. Loading dose: 40mg once (under physician supervision). Maintenance therapy: 10mg daily; may adjust dose in increments/decrements of 5mg every 4–6 weeks based on IGF-I levels. Usual range: 10–30mg daily; max 30mg/day.
Children
Not established.
Somavert Contraindications
Not Applicable
Somavert Boxed Warnings
Not Applicable
Somavert Warnings/Precautions
Warnings/Precautions
Monitor tumor growth, IGF-I levels, and for the development of GH deficiency. Obtain baseline ALT, AST, TBIL, ALP; if normal, monitor liver function monthly for first 6 months, then quarterly for next 6 months, then biannually for the next year; if elevated but ≤3xULN, monitor monthly for ≥1yr, then biannually for the next year; if >3xULN, do not treat until cause of liver dysfunction determined. Liver dysfunction during therapy: if ≥3xULN but <5xULN, monitor liver function weekly; if ≥5xULN, or transaminase elevations ≥3xULN associated with increase in TBIL, discontinue immediately, consider reinitiation if liver function normalizes with frequent monitoring; if liver injury occurs, discontinue therapy. Diabetes (monitor and adjust doses). Monitor closely when re-initiating therapy after systemic hypersensitivity reactions. Elderly. Pregnancy. Nursing mothers.
Somavert Pharmacokinetics
See Literature
Somavert Interactions
Interactions
May need to reduce dose of insulin, oral hypoglycemics. Antagonized by opioids (higher pegvisomant doses may be needed). May cause falsely elevated GH assays.
Somavert Adverse Reactions
Adverse Reactions
Infection, pain, diarrhea, nausea, elevated LFTs, flu syndrome, inj site reaction; lipohypertrophy, systemic hypersensitivity (eg, anaphylaxis, laryngospasm, angioedema, skin reactions).
Somavert Clinical Trials
See Literature
Somavert Note
Not Applicable
Somavert Patient Counseling
See Literature