Safety

Resources for You

Norditropin Cartridges [somatropin (rDNA origin) injection] Prescribing Information and Patient Package Insert Oct 2008

Norditropin Cartridges [somatropin (rDNA origin) injection] for Subcutaneous Use October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 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. Read about the new physician labeling format.

Summary View

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

Prader-Willi Syndrome in Children

WARNINGS AND PRECAUTIONS

Prader-Willi Syndrome in Children

ADVERSE REACTIONS

Clinical Trials Experience
- Clinical Trials in Children Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 - 4 Years
  - Study 1 (Long-Term)
  - Study 2 (Short-Term)

PATIENT PACKAGE INSERT

What is Norditropin NordiFlex?
- Norditropin is used to treat the following:
  - children with short stature born small for gestational age (SGA) with no catch-up growth by age 2 - 4 years.
How much Norditropin should you take?
- Children born small for gestational age (SGA) with no catch-up growth by age 2 - 4 years: Up to 0.067 mg/kg/day.

INSTRUCTIONS FOR USE (see highlighted PATIENT PACKAGE INSERTS for new text).

CONTRAINDICATIONS

Prader-Willi Syndrome in Children

...There have been reports of sudden death when somatropin was used in such patients [see Warnings and Precautions (5.2)]. Norditropin is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.