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SOMAVERT® WITH DILUENT VIAL (pegvisomant)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
SOMAVERT® WITH DILUENT VIAL Quick Finder
Highlights
Indications and Usage
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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Dosage Information
The recommended loading dose of SOMAVERT is 40 mg given subcutaneously, under healthcare provider supervision....
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For injection: 10 mg, 15 mg, 20 mg, 25 mg or 30 mg white lyophilized powder in a single-dose vial for reconstitution supplied with a prefilled syringe containing 1 mL of diluent (Sterile Water...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Hypoglycemia Associated With GH Lowering in Patients With Diabetes Mellitus
GH opposes the effects of insulin on carbohydrate...
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Adverse Reactions
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...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Insulin and/or Oral Hypoglycemic Agents
After initiation of SOMAVERT, patients with acromegaly and diabetes mellitus treated with insulin and/...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Postmarketing reports...
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Overdosage
10 OVERDOSAGE
In one reported incident of acute overdose with SOMAVERT during pre-marketing clinical studies, a patient self-administered 80 mg/day (2.7 times the maximum recommended maintenance dosage) for seven days. The...
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Description
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....
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Pegvisomant selectively binds to growth hormone (GH) receptors on cell surfaces, where it blocks the binding of...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
14 CLINICAL STUDIES
A total of one hundred twelve patients (63 men and 49 women) with acromegaly participated in a 12-week, randomized, double-blind, multi-center study comparing placebo and SOMAVERT. The mean ±SD age was 48...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
SOMAVERT (pegvisomant) for injection is a white lyophilized powder supplied in the following strengths and package configurations:
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Inform patients (and/or their caregivers) of the following information to...
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Instructions For Use
INSTRUCTIONS FOR USE
SOMAVERT® (SOM-ah-vert)
(pegvisomant)
for injection, for subcutaneous use
Read these...
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Resources
Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.