Butrans is a Schedule III transdermal extended-release opioid
- Butrans has an abuse potential similar to other Schedule III opioids
- Butrans can be abused and is subject to misuse, addiction, and criminal diversion. The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse
- Butrans is subject to the same requirements of the class Risk Evaluation and Mitigation Strategy (REMS) for all Extended-Release and Long-Acting (ER/LA) opioid analgesics
*Refills may vary from state to state; please check with state guidelines.
†Patients should verify with their mail-order pharmacies, as policies may vary
Use in specific patient populations
Renal impairment
- No dose adjustments for patients with renal impairment are noted in the Full Prescribing Information.
- No studies in patients with renal impairment have been performed with Butrans. However, no notable relationship was observed between estimated creatinine clearance rates and steady-state buprenorphine concentrations among patients during Butrans therapy.
- In an independent study, the effect of impaired renal function on buprenorphine pharmacokinetics after IV bolus and after continuous IV infusion administrations was evaluated. It was found that plasma buprenorphine concentrations were similar in patients with normal renal function and in patients with impaired renal function or renal failure.
- In a separate investigation of the effect of intermittent hemodialysis on buprenorphine plasma concentrations in chronic pain patients with end-stage renal disease who were treated with a transdermal buprenorphine product (marketed outside the US) up to 70 mcg/hour, no significant differences in buprenorphine plasma concentrations before or after hemodialysis were observed.
Hepatic impairment
- In a study utilizing intravenous buprenorphine, peak plasma levels (Cmax) and exposure (AUC) of buprenorphine in patients with mild and moderate hepatic impairment did not increase as compared to those observed in subjects with normal hepatic function. Butrans has not been evaluated in patients with severe hepatic impairment.
Geriatric use
- In the clinical program, the incidences of selected Butrans-related adverse events were higher in older subjects. Although specific dose adjustments on the basis of advanced age are not required for pharmacokinetic reasons, use caution in the elderly population to ensure safe use.
- Respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. Titrate the dosage of Butrans slowly in geriatric patients and monitor closely for signs of central nervous system and respiratory depression.
Pregnancy
- Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with Butrans in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.
- Fetal/Neonatal Adverse Reactions: Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly.
- Labor and Delivery: Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. Butrans is not recommended for use in women immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.
Lactation
- Because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Butrans.
Females and Males of Reproductive Potential
- Infertility: Chronic use of opioids may cause reduced fertility in females and males of reproductive potential.
Pediatric Use
- The safety and efficacy of Butrans in patients under 18 years of age has not been established.