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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
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*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 or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety 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.