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Label Changes for:

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

October 2008

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

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.

WARNINGS AND PRECAUTIONS

Prader-Willi Syndrome in Children

...Norditropin is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.