Brand and Other Names:Somavert
- Classes: Metabolic & Endocrine, Other
Dosing & Uses
Dosage Forms & Strengths
powder for injection
Load: 40 mg SC under physician supervision
Maintenance: 10 mg SC qDay; titrate by 5 mg increments q4-6Weeks according to IGF-1 levels
No more than 30 mg/day maintenance
Monitor: Growth hormone (GH), IGF-1, LFTs (see cautions)
- Reconstitiute with 1 mL supplied diluent (sterile water for injection)
- Inject within 6 hours of reconstitution
- Rotate injection sites daily
Obtain baseline LFTs
- WNL: monitor qMonth for 6 months, then quarterly for 6 months, then bianually for 1yr
- Elevated, but ≤ 3 times ULN: monitor qMonth for 1 yr, then bianually for 1 yr
- >3 times ULN: Do not use pegvisomant until full workup for cause of liver dysfunction; if decision made to initiate treatment, monitor LFTs very closely
LFTs During Treatment
- ≥3 times, but less than 5 times ULN: continue treatment; monitor LFTs qWk and perform comprehensive hepatic workup
- ≥5 times ULN: Discontinue pegvisomant; perform hepatic workup & monitor serial LFTs; if LFTs normalize, may re-initiate treatment with frequent monitoring
- Signs or symptoms of hepatitis or other liver injury: hepatic workup; if liver injury confirmed, discontinue pegvisomant
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Injection site reaction
Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria)
Hypersensitivity to pegvisomant or latex (vial stopper contains latex)
Potential for GH deficiency; observe patients for signs or symptoms of GH deficiency; monitor serum IGF-1 q4-6wk
Lipohypertrophy may occur; rotation of injection site may reduce occurence
May increase liver function tests
Pregnancy & Lactation
Pregnancy Category: B
Lactation: not known if crosses in to breast milk, use caution
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
Recombinant human growth hormone receptor antagonist, with several polyethylene glycol (PEG) polymers covalently bound
Half-Life: 6 days
Onset: within 2 wk
Peak Plasma Time: 33-77 hr
Bioavailability: 57% (SC)
Vd: 7 L
Clearance: Total body: 28-36 mL/hr
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