What should I Know Regarding Pregnancy, Nursing and Administering Rebetron 1000/MDV Kit to Children or the Elderly?

If you are PREGNANT

  • FDB Contraindicated or Not Recommended:
  • Only When Necessary: INSUFFICIENT HUMAN DATA; ANIMAL DATA SUG DEV TOX

If you are NURSING

  • Precaution: INSUFFICIENT DATA AVAILABLE
  • Absolute Contraindication: USE NOT RECOMMENDED. POSSIBILITY FOR SERIOUS ADVERSE EFFECTS EXISTS.

If you are an adult over 60

  • management or monitoring precaution: Elderly at increased risk for anemia, cardiovascular and CNS effects, including encephalopathy. Use cautiously especially in renal impairment.
  • management or monitoring precaution: Renal-Drug accumulation occurs with CrCL<50mL/min which is documented to increase rates of dose-limiting anemia. Contraindicated with CrCL< 50mL/min. Hepatic-Risk of hepatic decompensation with advanced cirrhosis. Pulmonary-Risks for pneumonitis and fatal pneumonias.

Giving Rebetron 1000/MDV Kit to a child under 12

  • Severe Precaution: Growth delay observed when used in combination with interferon. Data insufficient to determine if adult height is reduced. Possible suicidal ideation in adolescents, observe behavior.
  • Severe Precaution: Possible increased suicidal ideation and attempt. Monitor behavior.
  • management or monitoring precaution: Safety and efficacy not established in pediatrics age < 1 year.
  • Severe Precaution: Reports of growth inhibition in combination therapy with interferon. Limited data to determine if ultimate adult height is reduced. Safety and efficacy not established age < 3 years.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.