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U.S. Department of Health and Human Services

Safety

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Suboxone (buprenorphine and naloxone) sublingual film

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

 

April 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.8 Precipitation of Opioid Withdrawal Signs and Symptoms
  • added ......Because it contains naloxone, SUBOXONE sublingual film is highly likely to produce marked and intense withdrawal signs and symptoms .....
5.11 Use in Patients with Impaired Hepatic Function
  • new section added

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

  • Risk Summary. Limited published data on use of buprenorphine, the active ingredient in Suboxone, in pregnancy, have not shown an increased risk of major malformations. All pregnancies, regardless of drug exposure, have ..... in both rats and rabbits.

Clinical Considerations

  • Disease-associated maternal and embryo-fetal risk .....see PI for details

Animal Data

  • added .....An apparent lack of milk production during these studies likely contributed to the decreased pup viability and lactation indices.....
8.3 Nursing Mothers

Risk Summary

  • Based on two studies in 13 lactating women, buprenorphine and its metabolite norbuprenorphine are present in .....No adverse reactions were observed in the infants in these two studies.
8.6 Hepatic Impairment
  • The effect of hepatic impairment on the pharmacokinetics of buprenorphine and naloxone has been evaluated in a pharmacokinetic study. Both drugs are extensively metabolized in the liver. While no clinically .....

17 PATIENT COUNSELLING INFORMATION

17.1 Safe Use
  • added ..... Patients should be advised that if they miss a dose of SUBOXONE they should take it as soon as they remember. If it is almost time for the next dose, they should skip the missed dose and take the next dose at the regular time.
  • added .....Advise women who are breastfeeding to monitor the infant for drowsiness and difficulty breathing.