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SOMAVERT
Pituitary disorders
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Drug Name:

SOMAVERT Rx

Generic Name and Formulations:
Pegvisomant 10mg, 15mg, 20mg; per vial; lyophilized pwd for SC inj after reconstitution; contains mannitol.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for SOMAVERT:

Treatment of acromegaly when response to surgery and/or radiation therapy and/or other medical therapies is inadequate or inappropriate.

Adult:

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.

Children:

Not established.

Warnings/Precautions:

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.

Interactions:

May need to reduce dose of insulin, other antidiabetic agents. Antagonized by opioids. May cause falsely elevated GH assays.

Pharmacological Class:

Growth hormone (GH) receptor antagonist.

Adverse Reactions:

Infection, pain, diarrhea, nausea, elevated LFTs, flu syndrome, lipohypertrophy, functional GH deficiency; systemic hypersensitivity (eg, anaphylaxis, laryngospasm, angioedema, skin reactions).

Generic Availability:

NO

How Supplied:

Single-dose vial—1 (w. diluent)

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