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SOMAVERT® WITH PREFILLED DILUENT SYRINGE (pegvisomant with PREFILLED DILUENT SYRINGE)

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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 PREFILLED DILUENT SYRINGE Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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4 CONTRAINDICATIONS

None.

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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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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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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Postmarketing reports...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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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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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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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

SOMAVERT® (SOM-ah-vert)
(pegvisomant)
for injection, for subcutaneous use

Read these Instructions for Use before you start using...

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