Generic name: BUPRENORPHINE HYDROCHLORIDE 1.4mg, NALOXONE HYDROCHLORIDE 0.36mg
Dosage form: sublingual tablet, orally disintegrating
Medically reviewed on January 15, 2018.
2.1 Drug Addiction Treatment Act
Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
2.2 Important Dosage and Administration Information
The difference in bioavailability of ZUBSOLV compared to Suboxone® sublingual tablet requires a different tablet strength to be given to the patient. One ZUBSOLV 5.7 mg/1.4 mg sublingual tablet provides equivalent buprenorphine exposure to one Suboxone 8 mg/2 mg sublingual tablet.
Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits.
Prior to induction, consideration should be given to the type of opioid dependence i.e., long- or short-acting opioid products, the time since last opioid use, and the degree or level of opioid dependence.
Patients dependent on heroin or other short-acting opioid products
Patients dependent on heroin or other short-acting opioid products may be induced with either ZUBSOLV or with sublingual buprenorphine monotherapy. At treatment initiation, the first dose of ZUBSOLV should be administered when objective signs of moderate opioid withdrawal appear, not less than six hours after the patient last used opioids, to avoid precipitating an opioid withdrawal syndrome.
It is recommended that an adequate treatment dose, titrated to clinical effectiveness, be achieved as rapidly as possible. In some studies, a too-gradual induction over several days led to a high rate of drop-out of buprenorphine patients during the induction period.
On Day 1, an induction dosage of up to 5.7 mg/1.4 mg ZUBSOLV is recommended. Clinicians should start with an initial dose of 1.4 mg/0.36 mg ZUBSOLV. The remainder of the Day 1 dose of up to 4.2 mg/1.08 mg should be divided into doses of 1 to 2 tablets of 1.4 mg/0.36 mg at 1.5 to 2 hour intervals. Some patients (e.g., those with recent exposure to buprenorphine) may tolerate up to 3 x 1.4 mg/0.36 mg ZUBSOLV as a single, second dose.
On Day 2, a single daily dose of up to 11.4 mg/2.9 mg ZUBSOLV is recommended.
Patients dependent on methadone or long-acting opioid products
Patients dependent on methadone or long-acting opioid products may be more susceptible to precipitated and prolonged withdrawal during induction than those on short-acting opioid products.
Buprenorphine/naloxone combination products have not been evaluated in adequate and well-controlled studies for induction in patients who are physically dependent on long-acting opioid products, and the naloxone in these combination products is absorbed in small amounts by the sublingual route and could cause worse precipitated and prolonged withdrawal. For this reason, buprenorphine monotherapy is recommended in patients taking long-acting opioids when used according to approved administration instructions. Following induction, the patient may then be transitioned to once-daily ZUBSOLV.
- The dosage of ZUBSOLV from Day 3 onwards should be progressively adjusted in increments/decrements of 2.9 mg/0.71 mg or lower of buprenorphine/naloxone to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms.
- After treatment induction and stabilization, the maintenance dose of ZUBSOLV is generally in the range of 2.9 mg/0.71 mg buprenorphine/naloxone to 17.2 mg/4.2 mg buprenorphine/naloxone per day depending on the individual patient and clinical response. The recommended target dosage of ZUBSOLV during maintenance is 11.4 mg/2.9 mg as a single daily dose. Dosages higher than 17.2 mg/4.2 mg buprenorphine/naloxone 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.
- There is no maximum recommended duration of maintenance treatment. Patients may require treatment indefinitely and should continue for as long as patients are benefiting and the use of ZUBSOLV contributes to the intended treatment goals.
2.5 Method of Administration
ZUBSOLV must be administered whole. Do not cut, chew, or swallow ZUBSOLV. Advise patients not to eat or drink anything until the tablet is completely dissolved. ZUBSOLV should be placed under the tongue until dissolved. The dissolve time for ZUBSOLV varies between individuals, and the median dissolve time observed was 5 minutes. For dosages requiring more than one sublingual tablet, place all tablets in different places under the tongue at the same time. Patients should keep the tablets under the tongue until dissolved; swallowing the tablets reduces the bioavailability of the drug. To ensure consistency in bioavailability, patients should follow the same manner of dosing with continued use of the product.
If a sequential mode of administration is preferred, patients should follow the same manner of dosing to ensure consistency in bioavailability.
Proper administration technique should be demonstrated to the patient.
2.6 Clinical Supervision
Treatment should be initiated with supervised administration, progressing to unsupervised administration as the patient’s clinical stability permits. ZUBSOLV is subject to diversion and abuse. 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.
Ideally patients should be seen at reasonable intervals (e.g., at least weekly during the first month of treatment) based upon the individual circumstances of the patient. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised early in treatment or without appropriate patient follow-up visits. Periodic assessment is necessary to determine compliance with the dosing regimen, effectiveness of the treatment plan, and overall patient progress.
Once a stable dosage has been achieved and patient assessment (e.g., urine drug screening) does not indicate illicit drug use, less frequent follow-up visits may be appropriate. A once-monthly visit schedule may be reasonable for patients on a stable dosage of medication who are making progress toward their treatment objectives. Continuation or modification of pharmacotherapy should be based on the healthcare provider’s evaluation of treatment outcomes and objectives such as:
- Absence of medication toxicity
- Absence of medical or behavioral adverse effects
- Responsible handling of medications by the patient
- Patient’s compliance with all elements of the treatment plan (including recovery-oriented activities, psychotherapy, and/or other psychosocial modalities)
- Abstinence from illicit drug use (including problematic alcohol and/or benzodiazepine use)
If treatment goals are not being achieved, the healthcare provider should re-evaluate the appropriateness of continuing the current treatment.
2.7 Unstable Patients
Healthcare providers will need to decide when they cannot appropriately provide further management for particular patients. For example, some patients may be abusing or dependent on various drugs, or unresponsive to psychosocial intervention such that the healthcare provider does not feel that he/she has the expertise to manage the patient. In such cases, the healthcare provider may want to assess whether to refer the patient to a specialist or more intensive behavioral treatment environment. Decisions should be based on a treatment plan established and agreed upon with the patient at the beginning of treatment.
Patients who continue to misuse, abuse, or divert buprenorphine products or other opioids should be provided with, or referred to, more intensive and structured treatment.
2.8 Discontinuing Treatment
The decision to discontinue therapy with ZUBSOLV after a period of maintenance should be made as part of a comprehensive treatment plan. Advise patients of the potential to relapse to illicit drug use following discontinuation of opioid agonist/partial agonist medication-assisted treatment. Taper patients to avoid the occurrence of withdrawal signs and symptoms [see Warnings and Precautions (5.7)].
2.9 Switching between ZUBSOLV Sublingual Tablets and Other Buprenorphine/Naloxone Combination Products
For patients being switched between ZUBSOLV and other buprenorphine/naloxone products dosage adjustments may be necessary. Patients should be monitored for over-medication as well as withdrawal or other signs of under-dosing.
The differences in bioavailability of ZUBSOLV compared to Suboxone tablet require that different tablet strengths be given to the patient. One ZUBSOLV 5.7 mg/1.4 mg sublingual tablet provides equivalent buprenorphine exposure to one Suboxone 8 mg/2 mg sublingual tablet.
When switching between Suboxone dosage strengths and ZUBSOLV dosage strengths the corresponding dosage strengths are:
|Suboxone sublingual tablets, including generic equivalents||Corresponding dosage strength of ZUBSOLV sublingual tablets|
|One 2 mg/0.5 mg sublingual buprenorphine/naloxone tablet
||One 1.4 mg/0.36 mg ZUBSOLV sublingual tablet
|4 mg/1 mg buprenorphine/naloxone taken as:
• Two 2 mg/0.5 mg sublingual buprenorphine/naloxone tablets
|One 2.9 mg/0.71 mg ZUBSOLV sublingual tablet|
|One 8 mg/2 mg sublingual buprenorphine/naloxone tablet
||One 5.7 mg/1.4 mg ZUBSOLV
|12 mg/3 mg buprenorphine/naloxone, taken as:
• One 8 mg/2 mg sublingual buprenorphine/naloxone tablet AND
• Two 2 mg/0.5 mg sublingual buprenorphine/naloxone tablets
|One 8.6 mg/2.1 mg ZUBSOLV
|16 mg/4 mg buprenorphine/naloxone, taken as:
• Two 8 mg/2 mg sublingual buprenorphine/naloxone tablets
|One 11.4 mg/2.9 mg ZUBSOLV
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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