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GENOTROPIN®(somatropin)

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GENOTROPIN® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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3 DOSAGE FORMS AND STRENGTHS

GENOTROPIN lyophilized powder:

  • 5 mg two-chamber cartridge (green tip, with preservative)...
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4 CONTRAINDICATIONS

Acute Critical Illness

Treatment with pharmacologic amounts of somatropin is contraindicated in patients with...

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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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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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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category B. Reproduction studies carried out with GENOTROPIN at...

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10 OVERDOSAGE

Short-Term

Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Furthermore, overdose...

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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with GENOTROPIN. No potential...

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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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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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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
GENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)
Growth Hormone Delivery Device containing GENOTROPIN® (somatropin) for injection

...
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Manufactured by:

Vetter Pharma-Fertigung GmbH & Co. KG
Ravensburg, Germany

Or

Vetter Pharma-Fertigung GmbH & Co. KG
Langenargen, Germany

...
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Resources

PFIZER BRIDGE PROGRAM - Genotropin

To contact the Pfizer Bridge Program for device training, to address issues to avoid treatment interruptions or delays, for assistance with the insurance process, or for questions on the GENOTROPIN Savings Program, please call (800) 645-1280

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