• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Omnitrope [somatropin (rDNA origin) injection] For Subcutaneous Use


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Acute Critical Illness
  • Prader-Willi Syndrome in Children
  • Active Malignancy
  • Diabetic Retinopathy
  • Hypersensitivity
  • Benzyl Alcohol Sensitivity

WARNINGS AND PRECAUTIONS

  • Acute Critical Illness
  • Neoplasms
  • Glucose Intolerance
  • Intracranial Hypertension (IH)
  • Fluid Retention
  • Hypothyroidism
  • Slipped Capital Femoral Epiphysis in Pediatric Patients
  • Local and Systemic Reactions
  • Laboratory Tests

ADVERSE REACTIONS

  • Most Serious and/or Most Frequently Observed Adverse Reactions
  • Clinical Trials Experience
    • Clinical Trials in Pediatric GHD Patients
      • Table 1
  • Postmarketing Surveillance

DRUG INTERACTIONS

  • Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1 (11ßHSD-1)
  • Glucocorticoid Replacement
  • Cytochrome P450-Metabolized Drugs
  • Oral Estrogen
  • Insulin and/or Oral Hypoglycemic Agents

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Geriatric Use

PATIENT COUNSELING INFORMATION

  • If patients are prescribed Omnitrope Cartridge 5 mg/1.5 mL (to be inserted into Omnitrope Pen 5 delivery systems)...

PATIENT PACKAGE INSERT

  • Instructions for Use: Omnitrope Pen 5 (new)

CONTRAINDICATIONS

See highlighted text for labeling revisions.

WARNINGS AND PRECAUTIONS

See highlighted text for labeling revisions.