Generic Name and Formulations:
Pegvisomant 10mg, 15mg, 20mg; per vial; lyophilized pwd for SC inj after reconstitution; contains mannitol.
Indications for SOMAVERT:
Treatment of acromegaly when response to surgery and/or radiation therapy and/or other medical therapies is inadequate or inappropriate.
Inject SC into thigh, buttocks, upper arm, or abdomen; rotate site. Loading dose: 40mg once. Maintenance therapy: 10mg daily; may adjust dose in increments/decrements of 5mg every 4–6 weeks based on IGF-1 levels; max 30mg per day.
Monitor tumor growth, IGF-1 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 closely and use caution if re-initiating therapy after systemic hypersensitivity reaction. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers.
Growth hormone (GH) receptor antagonist.
May need to reduce dose of insulin, other antidiabetic agents. Antagonized by opioids. May cause falsely elevated GH assays.
Infection, pain, diarrhea, nausea, elevated LFTs, flu syndrome, lipohypertrophy, functional GH deficiency; systemic hypersensitivity (eg, anaphylaxis, laryngospasm, angioedema, skin reactions).
Single-dose vial—1 (w. diluent)