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GENOTROPIN® (somatropin)
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Our medical information is accurate, up to date, and scientifically balanced.
GENOTROPIN® Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Pediatric Patients
GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
The weekly dose should be divided into 6 or 7 subcutaneous injections. GENOTROPIN must not be injected intravenously.
Therapy with...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
GENOTROPIN lyophilized powder:
- 5 mg two-chamber cartridge (green tip, with preservative)...
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Contraindications
4 CONTRAINDICATIONS
• Acute Critical Illness
Treatment with pharmacologic amounts of somatropin is contraindicated in patients with...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Acute Critical Illness
Increased mortality in patients with acute critical illness due to complications following open heart surgery,...
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Adverse Reactions
6 ADVERSE REACTIONS
The following important adverse reactions are also described elsewhere in the labeling:
- Increased mortality in patients with acute critical illness [see...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 11 β-Hydroxysteroid Dehydrogenase Type 1
The microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category B. Reproduction studies carried out with GENOTROPIN at...
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Overdosage
10 OVERDOSAGE
Short-Term
Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Furthermore, overdose...
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Description
11 DESCRIPTION
GENOTROPIN lyophilized powder contains somatropin, which is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and a molecular weight of 22,124 daltons. The amino acid sequence of...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
In vitro, preclinical, and clinical tests have demonstrated that GENOTROPIN lyophilized powder is therapeutically...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with GENOTROPIN. No potential...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Adult Growth Hormone Deficiency (GHD)
GENOTROPIN lyophilized powder was compared with placebo in six randomized clinical trials involving a...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
GENOTROPIN lyophilized powder is available in the following packages:
5 mg two-chamber cartridge (with preservative)
Concentration of 5 mg/mL
...
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Patients being treated with GENOTROPIN (and/or their parents) should be informed about the potential benefits and risks associated with GENOTROPIN treatment. This information is intended to...
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Instructions For Use
INSTRUCTIONS FOR USE
...
INSTRUCTIONS FOR USE
GENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)
Growth Hormone Delivery Device containing GENOTROPIN® (somatropin) for injection
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Report Adverse Event
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*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
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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.