Pegvisomant
Generic Name: pegvisomant
Brand Names:
Somavert
11 DESCRIPTION Pegvisomant is an analog of human growth hormone (GH) of recombinant DNA origin that acts as a GH receptor antagonist. It contains 191 amino acid residues. The molecular weight of pegvisomant is 22 kDa. The molecular weight of the PEG portion of pegvisomant is approximately 5 kDa. The predominant molecular weights of pegvisomant are thus approximately 42, 47, and 52 kDa.
Overview
11 DESCRIPTION Pegvisomant is an analog of human growth hormone (GH) of recombinant DNA origin that acts as a GH receptor antagonist. It contains 191 amino acid residues. The molecular weight of pegvisomant is 22 kDa. The molecular weight of the PEG portion of pegvisomant is approximately 5 kDa. The predominant molecular weights of pegvisomant are thus approximately 42, 47, and 52 kDa.
Uses
1 INDICATIONS AND USAGE SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. SOMAVERT is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION • Administer a 40 mg loading dose subcutaneously under physician supervision. ( 2.1 ) • After proper injection instruction, on day after loading dose, patients or caregivers begin daily subcutaneous injections of 10 mg. ( 2.1 ) • Adjust dosage in 5 mg increments or decrements until serum IGF-1 concentrations are maintained within age-adjusted normal range. Do not adjust dosage based on growth hormone (GH) levels or signs or symptoms of acromegaly. ( 2.1 ) • Dosage range is 10 mg to 30 mg once daily. ( 2.1 ) • Perform liver tests prior to first dosage and if greater than 3 times upper limit of normal should work-up prior to SOMAVERT administration. ( 2.2 ) • Follow reconstitution and injection procedures.
Side Effects
6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other section of the labeling include: • Hypoglycemia Associated with GH Lowering in Patients with Diabetes Mellitus [see Warnings and Precautions (5.1) ] • Liver Toxicity [see Warnings and Precautions (5.2) ] • Cross-Reactivity with GH Assays [see Warnings and Precautions (5.3) ] • Lipohypertrophy [see Warnings and Precautions (5.4) ] • Systemic Hypersensitivity [see Warnings and Precautions (5.5) ] Elevations of serum concentrations of ALT and AST greater than ten times the ULN were reported in two patients (0.8%) exposed to SOMAVERT in pre-approval clinical studies.
Interactions
7 DRUG INTERACTIONS • Insulin and/or Oral hypoglycemic Agents: Patients with acromegaly and with diabetes mellitus may require careful monitoring and dose reductions of insulin and/or oral hypoglycemic agents. ( 5.2 , 7.1 ) • Opioids: Patients on opioids may need higher SOMAVERT doses to achieve appropriate IGF-1 suppression. ( 7.2 ) 7.1 Insulin and/or Oral Hypoglycemic Agents After initiation of SOMAVERT, patients with acromegaly and diabetes mellitus treated with insulin and/or oral hypoglycemic agents may require dose reductions of insulin and/or oral hypoglycemic agents [see Warnings and Precautions (5.1) ] . 7.2 Opioids In clinical studies, patients taking opioids often needed higher SOMAVERT doses to normalize IGF-1 concentrations compared with patients not receiving opioids.
Warnings
5 WARNINGS AND PRECAUTIONS • Hypoglycemia : Monitor blood glucose in patients with diabetes mellitus and reduce anti-diabetic drug therapy as necessary. ( 5.1 ) • Liver Toxicity: Should have more frequent liver tests and/or discontinue SOMAVERT. ( 5.2 ) • Systemic Hypersensitivity : Monitor closely when re-initiating SOMAVERT in patients with systemic hypersensitivity. ( 5.5 ) 5.1 Hypoglycemia Associated With GH Lowering in Patients With Diabetes Mellitus GH opposes the effects of insulin on carbohydrate metabolism by decreasing insulin sensitivity; thus, glucose tolerance may improve in some patients treated with SOMAVERT. Patients should be carefully monitored and doses of anti-diabetic drugs reduced as necessary to avoid hypoglycemia in patients with diabetes mellitus. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Postmarketing reports of SOMAVERT use in pregnant women are insufficient to establish a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Acromegaly may improve during pregnancy (see Clinical Considerations ) . In animal reproduction studies, fetotoxicity was observed at a dose that was 6 times the maximum recommended human dose based on body surface area following subcutaneous administration of pegvisomant during organogenesis or during the preimplantation period (see Data ) .
Storage
Storage Prior to reconstitution: • The One Day Package of SOMAVERT should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). • For the 30-Day Package, remove the three intermediate cartons containing the SOMAVERT vials and store in a refrigerator at 2°C to 8°C (36°F to 46°F).
Frequently Asked Questions
What is Pegvisomant used for?▼
1 INDICATIONS AND USAGE SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. SOMAVERT is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. ( 1 )
What are the side effects of Pegvisomant?▼
6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other section of the labeling include: • Hypoglycemia Associated with GH Lowering in Patients with Diabetes Mellitus [see Warnings and Precautions (5.1) ] • Liver Toxicity [see Warnings and Precautions (5.2) ] • Cross-Reactivity with GH Assays [see Warnings and Precautions (5.3) ] • Lipohypertrophy [see Warnings and Precautions (5.4) ] • Systemic Hypersensitivity [see Warnings and Precautions (5.5) ] Elevations of serum concentrations of ALT and AST greater than ten times the ULN were reported in two patients (0.8%) exposed to SOMAVERT in pre-approval clinical studies.
Can I take Pegvisomant during pregnancy?▼
8.1 Pregnancy Risk Summary Postmarketing reports of SOMAVERT use in pregnant women are insufficient to establish a drug-associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Acromegaly may improve during pregnancy (see Clinical Considerations ) . In animal reproduction studies, fetotoxicity was observed at a dose that was 6 times the maximum recommended human dose based on body surface area following subcutaneous administration of pegvisomant during organogenesis or during the preimplantation period (see Data ) .
What are the important warnings for Pegvisomant?▼
5 WARNINGS AND PRECAUTIONS • Hypoglycemia : Monitor blood glucose in patients with diabetes mellitus and reduce anti-diabetic drug therapy as necessary. ( 5.1 ) • Liver Toxicity: Should have more frequent liver tests and/or discontinue SOMAVERT. ( 5.2 ) • Systemic Hypersensitivity : Monitor closely when re-initiating SOMAVERT in patients with systemic hypersensitivity. ( 5.5 ) 5.1 Hypoglycemia Associated With GH Lowering in Patients With Diabetes Mellitus GH opposes the effects of insulin on carbohydrate metabolism by decreasing insulin sensitivity; thus, glucose tolerance may improve in some patients treated with SOMAVERT. Patients should be carefully monitored and doses of anti-diabetic drugs reduced as necessary to avoid hypoglycemia in patients with diabetes mellitus. 4 CONTRAINDICATIONS None. None. ( 4 )
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*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.