Dosage & Administration
Change is possible.
ZUBSOLV is available in 6 dosage strengths, including 0.7-mg/0.18-mg buprenorphine/naloxone. This is the lowest dose of any buprenorphine/naloxone medication.1-3 NIDA recommends that opioid dependence treatment be individualized to meet the needs of each patient4:
- Recommended dose*: Two 5.7-mg/1.4-mg tablets per day (11.4 mg/2.8 mg buprenorphine/naloxone) administered as a single daily dose
- For patients being switched between ZUBSOLV sublingual tablets 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
- 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
- Maintained in 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 17.1 mg/4.2 mg per day 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.
*ZUBSOLV should be used in patients who have been initially induced using buprenorphine-containing medications.
1. ZUBSOLV [prescribing information]. Orexo US, Inc.; 2016.
2. Bunavail [prescribing information]. BioDelivery Sciences International, Inc.; 2015.
3. Suboxone [prescribing information]. Indivior Inc.; 2016.
4. Study points to individualized therapy for opioid addiction. National Institute on Drug Abuse website. https://www.drugabuse.gov/news-events/nida-notes/2015/02/study-points-to-individualized-therapy-opioid-addiction#.WFCWHSw_wmE.email. Accessed December 13, 2016.
ZUBSOLV offers easy administration
As soon as patients remove their prescribed dose of ZUBSOLV from the blister pack, they should be instructed to:
- Place the tablet under the tongue. If more than 1 tablet is required, tablets should be placed in different places under the tongue at the same time
- Allow the tablet to dissolve completely. If patients have dry mouth, instruct them to take a sip of water to moisten it. Water should be spit out or swallowed and hands must be dry before the tablet can be placed under the tongue
Important patient counseling information
- Distribute Medication Guide to your patient.
- Chewing or swallowing the tablet while it is dissolving will prevent the medication from working as it should
- Instruct patients to not eat, drink, or talk while the tablet is dissolving as this can affect how well the medicine in ZUBSOLV is absorbed
- If patients miss a dose of ZUBSOLV, they should take their medicine when they remember. If it is almost time for their next dose, advise patients to skip the missed dose and take the next dose at their regular time. Patients should not take 2 doses at the same time unless advised by a physician
- Patients should not stop taking ZUBSOLV suddenly. They could become sick and have withdrawal symptoms because their body has become used to the medicine
- If too much ZUBSOLV is taken, advise patients to go to the nearest hospital emergency room right away
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.