Pegvisomant

DAE Class; Rx

Common Brand Names; Somavert

• Metabolic & Endocrine, Other

Growth hormone receptor antagonist, given subcutaneously
Used for treatment of acromegaly
Established efficacy and tolerability profile

Indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate.

Hypersensitivity to pegvisomant or latex (vial stopper contains latex)

>10%

Pain

Injection site reaction

Diarrhea

Nausea

Flu syndrome

1-10%

Injury

Back pain

Chest pain

Dizziness

Paresthesia

Edema

Hypertension

Sinusitis

Lipohypertrophy

Postmarketing Reports

Elevated transaminases

Systemic hypersensitivity reactions including anaphylactic/anaphylactoid reactions, laryngospasm, angioedema, generalized skin reactions (rash, erythema, pruritus, urticaria)

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; obtain baseline serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum total bilirubin (TBIL), and alkaline phosphatase (ALP) levels prior to initiating therapy

Pregnancy

Postmarketing reports of use in pregnant women are insufficient to establish a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes

Lactation

Limited information from a case report in published literature reported that the level of the drug in human milk was below the level of detection

There is no information available on effects of the drug on breastfed infant or effects on milk production; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

Adults

40 mg loading dose; 30 mg/day during maintenance therapy.

Elderly

40 mg loading dose; 30 mg/day during maintenance therapy.

Adolescents

Safety and efficacy have not been established.

Children

Safety and efficacy have not been established.

Pegvisomant