Pegvisomant
Also known as: B2036, B2036-PEG, GH receptor antagonist, PEGvisomant, Somavert
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Summary
Pegvisomant is a PEGylated recombinant protein that antagonizes the growth hormone receptor. It is approved for the treatment of acromegaly in adults inadequately controlled by surgery, radiotherapy, or other pharmacologic agents.
Mechanism of Action
Binds to growth hormone receptor, preventing receptor dimerization and downstream signaling, thereby reducing IGF-1 production
Routes of Administration
Goals & Uses
- Combination therapy with somatostatin analogsEndocrine / Combination TherapyModerate
- Normalization of IGF-1 levels in acromegalyEndocrine / MetabolicHigh
- Management of acromegaly in patients not candidates for surgeryMedical ManagementHigh
- Symptom control in acromegaly (headache, soft tissue swelling, diaphoresis)Symptomatic ReliefHigh
- Acromegaly controlEndocrinologyHigh
Contraindications
- Significant hepatic impairment or active liver diseaseHepaticHigh
- Severe hepatic impairmentOrganModerateLiver function concerns
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Hypersensitivity to pegvisomant or any excipientAllergy / ImmunologicHigh
- Rapidly growing pituitary tumor at risk for chiasmal compressionOncologic / NeurologicHigh
Adverse Effects
- Elevated liver transaminases (hepatotoxicity)HepaticUncommon
- Injection site reactionsLocalCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Pituitary tumor growthOncologic / EndocrineUncommon
- Fatigue and dizzinessGeneral / NeurologicCommon
- Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers
- Hyperglycemia or altered glucose metabolismMetabolic / EndocrineUncommon
Drug Interactions
- Somatostatin analogs (octreotide, lanreotide)Low
- Cytochrome P450 inducersModerate
- Insulin / Oral antidiabetic agentsModerate
- OpioidsLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeAbsolute
- Patients with diabetes mellitusMetabolicRelative
- Pregnant womenReproductiveAbsolute
- BreastfeedingReproductiveRelative
Regulatory Status
- European UnionApprovedApproved: AcromegalyEMA approval 2004
- United StatesApprovedApproved: Acromegaly in adultsFDA approval 2003
- United KingdomApprovedApproved: AcromegalyMHRA approved
FDA approved (2003) for acromegaly; EMA and MHRA approvals followed. Indicated for adults only; not recommended in pregnancy.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Pegvisomant?
Pegvisomant is a PEGylated recombinant protein that antagonizes the growth hormone receptor. It is approved for the treatment of acromegaly in adults inadequately controlled by surgery, radiotherapy, or other pharmacologic agents.
What is Pegvisomant used for?
Pegvisomant is educationally associated with: Combination therapy with somatostatin analogs, Normalization of IGF-1 levels in acromegaly, Management of acromegaly in patients not candidates for surgery, Symptom control in acromegaly (headache, soft tissue swelling, diaphoresis), Acromegaly control. Educational only — not medical advice.
How is Pegvisomant administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Pegvisomant?
Reported adverse effects include: Elevated liver transaminases (hepatotoxicity), Injection site reactions, Headache, Pituitary tumor growth, Fatigue and dizziness, Elevated liver enzymes, Hyperglycemia or altered glucose metabolism. This list is not exhaustive — consult a qualified clinician.
Who should avoid Pegvisomant?
Recorded contraindications: Significant hepatic impairment or active liver disease, Severe hepatic impairment, Pregnancy, Hypersensitivity to pegvisomant or any excipient, Rapidly growing pituitary tumor at risk for chiasmal compression. Consult a qualified clinician before use.