Somavert

— THERAPEUTIC DISORDERS TREATED —
  • Pituitary disorders

Somavert Generic Name & Formulations

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