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The Drug Addiction Treatment Act of 2000 (DATA 2000) enables physicians who meet specific qualifications to prescribe ZUBSOLV® (buprenorphine and naloxone) CIII.

This is not a comprehensive list. The physicians included here are part of a publicly available database from the Substance Abuse and Mental Health Services Administration (SAMHSA) or are physicians who have chosen to be a part of the zubsolv.com physician locator program. This does not include all physicians who are waivered.

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Terms and Conditions

All eligible physicians, who are waivered under DATA 2000, are invited to participate in the Orexo US, Inc. Find a Physician locator. There is no fee or cost for your participation in or use of the locator. Qualifying criteria are listed below:

  • You must be waivered under DATA 2000, and continue to comply with its rules and regulations
  • Your medical license must be active and in good standing
  • You must have a unique identifier, issued by the Drug Enforcement Administration (DEA) that is active and in good standing, and that shows you are waivered under DATA 2000
  • You have agreed to these Terms and Conditions and have agreed to participate in writing on the downloadable Agreement
  • You agree that if, at any time, you no longer meet all the qualifying criteria it is your responsibility to notify Orexo immediately, in writing, so that Orexo may remove your name from the Find a Physician locator

You also acknowledge that Orexo US, Inc. does not track prescription volume or value based on referrals through its Find a Physician locator.

You may request to be removed from the Find a Physician locator and Orexo US, Inc. retains the right to remove physicians from the Find a Physician locator for any of the following reasons:

  • Your contact information is no longer valid
  • Your DATA 2000 waiver or medical license is suspended, revoked, or restricted
  • Your are not in compliance with Data 2000 and its implementing regulations
  • Orexo US, Inc. has information or determines that you may be engaging in the unsafe prescribing of our product(s)

Limitation of Orexo US, Inc. Liabilities: This Find a Physician locator is compiled for informational purposes only. No fees have been or will be paid or received in exchange for participation in this locator. In no event shall Orexo US, Inc. or its employees or agents be liable for any damages resulting from or related to the Find a Physician locator. All providers and other users of this information agree that the use of this locator is at their own risk.

Orexo US, Inc. is not responsible for the medical care or advice given by any participating physician. Inclusion in the Orexo US, Inc. Find a Physician locator does not represent an endorsement, referral, or recommendation from Orexo US, Inc. Moreover, participating in this locator does not endorse the use of any Orexo US, Inc. product(s).

ZUBSOLV is a licensed trademark of Orexo US, Inc.

Indication

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

Contraindications

  • 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 Reactions

  • 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.

Please see accompanying full Prescribing Information and Medication Guide.