You have questions. We have answers.

How is ZUBSOLV different?

Zubsolv is an advanced formulation to meet patient preference.

Why does ZUBSOLV contain less buprenorphine than Suboxone® tablet?

The advanced sublingual tablet formulation of ZUBSOLV offers higher bioavailability relative to the Suboxone tablet. This means more of the drug reaches the bloodstream, which allows your patients to take a lower daily dose. In an open-label, randomized bioavailability study in 60 healthy volunteers, ZUBSOLV 5.7-mg/1.4-mg tablets demonstrated equivalent plasma concentration or exposure to Suboxone 8-mg/2-mg tablets.1

Which ZUBSOLV doses correspond to Suboxone 2 mg and Suboxone 8 mg?
  • For patients being switched between ZUBSOLV sublingual tablets and other buprenorphine/naloxone products dosage adjustments may be necessary
  • There is no corresponding dose for ZUBSOLV 0.7 mg buprenorphine/0.18 mg naloxone
  • Patients should be monitored for over-medication as well as withdrawal or other signs of under-dosing

The following table shows the corresponding doses of Suboxone and ZUBSOLV2:

DosageChart

Can I use ZUBSOLV for both induction and maintenance treatment of opioid dependence?

ZUBSOLV sublingual tablets are indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan that includes counseling and psychosocial support. ZUBSOLV sublingual tablet is administered sublingually as a single daily dose for maintenance treatment or in divided doses for induction treatment.²

ZUBSOLV sublingual tablet should not be used by patients hypersensitive to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

How do I dose ZUBSOLV?

Induction:

  • For patients dependent on short-acting opioid products who are in opioid withdrawal; on Day 1, administer up to 5.7 mg/1.4 mg of ZUBSOLV sublingual tablet (in divided doses)
  • On Day 2, administer up to a total dose of 11.4 mg/2.9 mg of ZUBSOLV sublingual tablet as a single dose
  • For patients dependent on methadone or long-acting opioid products, induction onto sublingual buprenorphine monotherapy is recommended on Days 1 and 2 of treatment

Maintenance:

  • Zubsolv should be progressively adjusted in increments/decrements of 1.4 mg/0.36 mg or 2.8 mg/0.72 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
  • Dosages are maintained in the general range of 2.8 mg/0.72 mg to 17.1 mg/4.2 mg per day depending on the individual patient
  • Dosages higher than this have not been demonstrated to provide any clinical advantage
  • When determining the prescription quantity for unsupervised administration, consider the patient’s level of stability, the security of his or her home situation, and other factors likely to affect the ability to manage supplies of take-home medication

Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.

For complete prescribing and dosing information please see the Full Prescribing Information.

Will insurance cover the cost of ZUBSOLV?

Insurance coverage for ZUBSOLV varies based on your patients’ individual plans.

Does ZUBSOLV offer a copay card, and how do I get one for my patient?

Yes, ZUBSOLV offers a copay card. Orexo is committed to helping patients access the treatment they need. If your patient is eligible, the copay card for ZUBSOLV can help lower their out-of-pocket costs like copayments, coinsurance, or deductibles on prescriptions for ZUBSOLV. The copay card for ZUBSOLV covers up to $225 off each prescription for eligible patients using either cash or insurance. Insured patients are responsible for the first $10. To see if they are eligible for a copay card for ZUBSOLV, patients can call toll free 1-877-264-2440.

How can I contact an Orexo representative?

To contact an Orexo representative, call 855-982-7658.


References:
  1. Fischer A, Jönsson M, Hjelmström P. Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in healthy volunteers. Drug Dev Ind Pharm. 2013;1-6. DOI: 10.3109/03639045.2013.846365.
  2. ZUBSOLV [prescribing information]. Orexo US, Inc.; 2016.

Indication

ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Treatment should be initiated under the direction of healthcare providers who meet certain qualifying requirements under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).

IMPORTANT SAFETY INFORMATION

Contraindications

  • ZUBSOLV is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

Warnings and Precautions

  • Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.

  • Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with ZUBSOLV.

  • Unintentional Pediatric Exposure: 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): Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.

  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patients off of the opioid.

  • Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.

  • Risk of Hepatitis; Hepatic Events: Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.

  • Precipitation of Opioid Withdrawal Signs and Symptoms: An opioid withdrawal syndrome is likely to occur with parenteral misuse of ZUBSOLV by individuals physically dependent on full opioid agonists or by sublingual administration before the agonist effects of other opioids have subsided.

  • Risk of Overdose in Opioid-Naïve Patients: ZUBSOLV 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

  • Lactation: Buprenorphine passes into mother’s milk.

  • Geriatric Patients: Monitor for sedation and respiratory depression.

  • Moderate and Severe Hepatic Impairment: Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

Adverse Reactions & Drug Interactions

  • Adverse events commonly observed with the sublingual administration of ZUBSOLV are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

  • Benzodiazepines: Use caution in prescribing ZUBSOLV for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration/misuse.

  • CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing.

  • Antiretrovirals: Patients who are on chronic buprenorphine treatment should have their dose monitored if NNRTIs are added to their treatment regimen. Monitor patients taking buprenorphine and atazanavir with and without ritonavir, and reduce dose of buprenorphine if warranted.

  • Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue ZUBSOLV if serotonin syndrome is suspected.

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.