ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support
Change their approach to recovery. Help them take a different path.
Opioid dependence remains a growing problem despite the availability of effective treatments1
Opioid dependence is a chronic, neurobiological disorder with relapse rates remaining high, even among treated patients
Change and a multifaceted, comprehensive treatment approach are the hallmarks to successful addiction recovery2,3
- Recovery is a journey requiring a commitment to changes, both big and small on an ongoing basis, including medication
ZUBSOLV offers your patients the opportunity for a change in treatment, so you can help them take a different path on their journey to recovery
With ZUBSOLV, you can help your patients make a change on their path to recovery with no increased rate of withdrawal symptoms or discontinuation over Suboxone film. 4
More than 70% of patients preferred the attributes of ZUBSOLV overall after experiencing both ZUBSOLV and Suboxone® film4
- Dreifuss JA, Griffin ML, Frost K, et al. Patient characteristics associated with buprenorphine/naloxone treatment outcome for prescription opioid dependence: Results from a multisite study. Drug Alcohol Depend. 2013;131(1-2):112-118. DOI: 10.1016/j.drugalcdep.2012.12.010.
- DiClemente C. Addiction and change: understanding initiation and promoting recovery. http://habitslab.umbc.edu/learning-tools/. Accessed September 21, 2014.
- National Institute on Drug Abuse, National Institutes of Health, US Department of Health and Human Services. Principles of Drug Addiction Treatment: A Research-Based Guide. 3rd ed. NIH Publication No. 12-4180; Revised December 2012. http://www.drugabuse.gov/sites/default/files/podat_1.pdf. Accessed September 21, 2014.
- Data on file. Orexo US, Inc
ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of physicians who are certified under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).
IMPORTANT SAFETY INFORMATION
ZUBSOLV sublingual tablet should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.
Warnings and Precautions
ZUBSOLV sublingual tablet can be abused in a manner similar to other opioids, legal or illicit. Clinical monitoring appropriate to the patient’s level of stability is essential. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.
ZUBSOLV sublingual tablet can cause serious, life-threatening, respiratory depression and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (e.g., sedatives, tranquilizers, or alcohol). Patients should be warned against self-administration or misuse of these combinations.
ZUBSOLV sublingual tablet is not recommended in patients with severe hepatic impairment.
Not recommended for initiation of treatment (induction) in patients with moderate hepatic impairment due to the increased risk of precipitated withdrawal. Buprenorphine/naloxone products may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone. However, patients should be carefully monitored and consideration given to the possibility of naloxone interfering with buprenorphine’s efficacy.
Dose reduction of CNS depressants, ZUBSOLV sublingual tablet, or both should be considered in situations of concomitant prescriptions, as patients may exhibit increased CNS depression.
Store ZUBSOLV safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal respiratory depression in children.
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit.
Intravenous misuse or taking ZUBSOLV sublingual tablet before the effects of full-agonist opioids (e.g., heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is likely to cause opioid withdrawal syndrome.
Chronic use of opioids may cause reduced fertility in females and males of reproductive potential. It is not known whether these effects on fertility are reversible.
ZUBSOLV sublingual tablet is not appropriate as an analgesic. There have been reported deaths of opioid-naïve individuals who received a 2-mg sublingual dose of buprenorphine.
Use in Specific Populations
Pregnancy: Based on animal data, buprenorphine may cause fetal harm. Use of ZUBSOLV sublingual tablet in pregnant women or during breastfeeding should only be considered if the potential benefit justifies the potential risk.
Nursing mothers: Advise breastfeeding women taking buprenorphine products to monitor the infant for increased drowsiness and breathing difficulties.
Not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.
Adverse events commonly observed with the sublingual administration of buprenorphine/naloxone sublingual tablets during clinical trials and post-marketing experience are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.
This is not a complete list of potential adverse events associated with buprenorphine/naloxone sublingual tablets. Please see full Prescribing Information for a complete list.
To report an adverse event associated with taking ZUBSOLV sublingual tablet, please call 1-888-ZUBSOLV (1-888-982-7658). You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.