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.

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