Interactions

No interaction studies have been performed with Buvidal®.

Buprenorphine should be used cautiously when co-administered with:

Benzodiazepines

This combination may result in death due to respiratory depression of central origin. Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse. Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines whilst taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician.

Gabapentinoids

This combination may result in death due to respiratory depression. Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse. Patients should be cautioned to use gabapentinoids (such as pregabalin and gabapentin) concurrently with this product only as directed by their physician.

Alcoholic drinks or medicinal products containing alcohol

Buprenorphine has minor to moderate influence on the ability to drive and use machines when administered to opioid-dependent patients. Buprenorphine may cause drowsiness, dizziness or impaired thinking, especially during treatment induction and dose adjustment. If used together with alcohol, the effect is likely to be more pronounced.

Other central nervous system depressants

Other opioid derivatives (e.g. methadone, analgesics and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, antipsychotics, clonidine and related substances. These combinations increase central nervous system depression. The reduced level of alertness can make driving and using machinery hazardous.

Opioid analgesics

Adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine. The potential for overdose also exists with a full agonist, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining.

Naltrexone and nalmefene

Naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine. For opioid-dependent patients currently receiving buprenorphine treatment, naltrexone may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms. For patients currently receiving naltrexone treatment, the intended therapeutic effects of buprenorphine administration may be blocked by naltrexone.

CYP3A4 inhibitors

Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4. The effects on buprenorphine exposure in patients treated with Buvidal have not been studied. Interaction with co-administered inducers or inhibitors have been established in studies using transmucosal and transdermal buprenorphine.

Buvidal avoids first-pass effects and CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole or itraconazole, or macrolide antibiotics) are expected to have less effects on buprenorphine metabolism when co-administered with Buvidal as compared to when co-administered with sublingual buprenorphine.

When switching from sublingual buprenorphine to Buvidal, patients may need to be monitored to ensure plasma buprenorphine levels are adequate.

Patients already on Buvidal who start treatment with CYP3A4 inhibitors should be treated with weekly Buvidal and be monitored for signs and symptoms of overtreatment.

Conversely if a patient who is concomitantly treated with Buvidal and a CYP3A4 inhibitor stops treatment with the CYP3A4 inhibitor, the patient should be monitored for symptoms of withdrawal.

CYP3A4 inducers

Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4. The effects on buprenorphine exposure in patients treated with Buvidal have not been studied. Interaction with co-administered inducers or inhibitors have been established in studies using transmucosal and transdermal buprenorphine.

Buvidal avoids first-pass effects and CYP3A4 inducers (e.g. phenobarbital, carbamazepine, phenytoin or rifampicin) are expected to have less effects on buprenorphine metabolism when co-administered with Buvidal as compared to when co-administered with sublingual buprenorphine.

When switching from sublingual buprenorphine to Buvidal, patients may need to be monitored to ensure plasma buprenorphine levels are adequate.

Patients already on Buvidal who start treatment with CYP3A4 inducers should be treated with weekly Buvidal and be monitored for signs and symptoms of withdrawal.

Conversely if a patient who is concomitantly treated with Buvidal and a CYP3A4 inducer stops treatment with the CYP3A4 inducer, the patient should be monitored for symptoms of overtreatment.

UGT1A1 inhibitors

UGT1A1 inhibitors may affect the systemic exposure of buprenorphine.

Monoamine oxidase inhibitors (MAOIs)

Possible exacerbation of the opioid’s effects, based on experience with morphine.

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© 2020 Camurus AB. All rights reserved | INT-BUV-1900007 | Date of preparation: February 2019

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