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 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.