Zubsolv

Zubsolv (buprenorphine and naloxone) sublingual tablets are used for opioid dependence to reduce opioid cravings and withdrawal symptoms.

Buprenorphine is a partial opioid agonist that helps to reduce dependency, and naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Following induction, Zubsolv is taken once daily. The tablet should be placed under the tongue and allowed to dissolve.

Zubsolv should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Zubsolv is not approved for use as a pain medication.

Use Zubsolv exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides. Never use Zubsolv in larger amounts or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Zubsolv comes in a blister pack with 10 blister units. Each blister unit contains one Zubsolv tablet. Remove one single blister unit by tearing along the perforations until it is fully separated. Then fold the single unit along the dotted line. Do not push the Zubsolv tablets through the foil as this could cause the tablet to break.

Use dry hands when handling Zubsolv sublingual tablets. Place the sublingual tablet under your tongue. Allow the tablet to dissolve slowly. Let the tablet dissolve completely. ZUBSOLV usually dissolves in your mouth within 5 minutes. Do not chew or swallow the tablet whole.

For dosages requiring more than one sublingual tablet, place all tablets in different places under the tongue at the same time.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using Zubsolv suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

All your medical care providers should know that you are being treated for opioid addiction, and that you take Zubsolv. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Rinse your mouth with water after the Zubsolv tablet dissolves. Wait one hour after the medicine dissolves to brush your teeth to prevent damage to the teeth and gums. You should receive regular dental checkups while using Zubsolv..

Never crush or break a Zubsolv sublingual tablet and inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store Zubsolv securely in its original blister packaging at room temperature, away from moisture and heat. Discard an empty blister in a place children and pets cannot get to. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using Zubsolv accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, remove any unused tablets from the blister pack and flush the tablets down the toilet. Throw the empty blister pack into the trash.

Zubsolv contains a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs.

Ask your healthcare provider about medications like naloxone or nalmefene that can be used in an emergency to reverse opioid overdose, including accidental use of Zubsolv sublingual tablet by a child. If naloxone or nalmefene is given, you must call 911 or get emergency medical help right away to treat an overdose or accidental use of an opioid.

Zubsolv may cause serious and life-threatening breathing problems. Get emergency help right away if:

• feel faint
• feel dizzy
• are confused
• feel sleepy or uncoordinated
• have blurred vision
• have slurred speech
• are breathing slower than normal
• cannot think well or clearly

Do not take Zubsolv with certain medicines. Taking Zubsolv with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Do not inject (“shoot-up”) Zubsolv. Injecting Zubsolv may cause life-threatening infections and other serious health problems. Injecting Zubsolv may cause sudden, serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Do not switch from Zubsolv to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of Zubsolv is not the same as in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of buprenorphine that may be different than other buprenorphine containing medicines you may have been taking.

Do not stop taking Zubsolv suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine (physical dependence). Physical dependence is not the same as drug addiction.

In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with Zubsolv.

Never give anyone else your tablets. They could die from taking it. Selling or giving away Zubsolv is against the law.

Store tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Zubsolv can slow or stop your breathing, and may be habit-forming

You should not use Zubsolv if you are allergic to buprenorphine or naloxone (Narcan).

To make sure Zubsolv is safe for you, tell your doctor if you have ever had:

• tooth problems, including a history of cavities;
• breathing problems, sleep apnea;
• enlarged prostate, urination problems;
• liver or kidney disease;
• abnormal curvature of the spine that affects breathing;
• problems with your gallbladder, adrenal gland, or thyroid;
• a head injury, brain tumor, or seizures; or
• alcoholism or drug addiction.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Get emergency medical help if you have signs of an allergic reaction to Zubsolv: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once or seek emergency medical attention if you have:

• any problems with your teeth or gums;
• weak or shallow breathing, breathing that stops during sleep;
• a light-headed feeling, like you might pass out;
• confusion, loss of coordination, extreme weakness;
• blurred vision, slurred speech;
• liver problems - upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high levels of serotonin in the body - agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, muscle pain.

Serious breathing problems may be more likely in older adults and those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Zubsolv side effects may include:

• dizziness, drowsiness, blurred vision, feeling drunk, trouble concentrating;
• withdrawal symptoms;
• tongue pain, redness or numbness inside your mouth;
• nausea, vomiting, constipation;
• headache, back pain;
• fast or pounding heartbeats, increased sweating; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Opiate Dependence - Induction:

INDUCTION: For those Dependent on Heroin or Other Short-acting Opioid Products:-INITIAL DOSES should begin when objective signs of moderate opioid withdrawal appear and not less than 6 hours after the patient last used opioids to avoid precipitating an opioid withdrawal syndrome:Zubsolv Sublingual Tablets:Day 1: up to 5.7 mg/1.4 mg sublingually; administer as an initial dose of 1.4 mg/0.36 mg and then up to 4.2 mg/1.08 mg should be divided into doses 1.4 mg/0.36 mg or 2.8 mg/0.72 mg and administered in 1.5 to 2 hour intervals (some patients with recent exposure to buprenorphine may tolerate a single second dose of 4.2 mg/1.08 mg)Day 2: 11.4 mg/2.9 mg sublingually as a single doseComments:-Patients dependent on heroin or other short-acting opioid products may be inducted with combination buprenorphine/naloxone or buprenorphine monotherapy; to avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear, and no sooner than 6 hours after last use of heroin or other short-acting opioid.-In some studies, too-gradual induction over several days has led to a high dropout; it is recommended that an adequate treatment dose, titrated to clinical effectiveness, be achieved as rapidly as possible.-For patient's dependent on methadone or long-acting opioid products, buprenorphine monotherapy should be used during the induction phase as naloxone may be absorbed in small amounts and could precipitate or prolong withdrawal during induction.-Maintenance treatment begins on day 3.

Usual Adult Dose for Opiate Dependence - Maintenance:

MAINTENANCE Treatment:-Doses of buprenorphine/naloxone should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.Zubsolv Sublingual Tablets:-Progressively adjust in increments/decrements of 1.4 mg/0.36 mg or 2.9 mg/0.71 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms-Recommended target dose: 11.4 mg/2.9 mg sublingually once a day; dose range 2.9 mg/0.71 mg to 17.2 mg/4.2 mg-Maximum dose: 17.2 mg/4.2 mg per dayComments:-Following induction, maintenance therapy is provided to hold a patient in treatment and suppress opioid withdrawal signs and symptoms; there is no maximum recommended duration for maintenance treatment and some patients may require treatment indefinitely.-There are multiple buprenorphine/naloxone products available for maintenance treatment; these products are not bioequivalent and dose adjustments may be necessary when switching products; e.g., Zubsolv 4.2 mg/0.7 mg buccal film provides equivalent buprenorphine exposure as Suboxone 8 mg/2 mg sublingual tablet.Use: For the treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An opioid overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Keep an overdose rescue medicine on hand

Talk to your doctor about overdose rescue medicine: Patients and caregivers should learn about medicines that can reverse an opioid overdose, such as naloxone or nalmefene.

Keep overdose rescue medicine available: It is important to have access to one of these medicines, especially if you have a higher risk of overdose. This includes people who take other medicines that can cause drowsiness, have a history of opioid use disorder, or have had an opioid overdose before. It is also important if there are children or others in the home who could accidentally use the medicine.

Pain treatment should still be considered: Having risk factors for overdose does not mean pain should go untreated. Your doctor can help manage your pain while also taking steps to reduce risk.

Know how to get it: Ask your doctor or pharmacist about ways to get an overdose rescue medicine. It may be available by prescription, over the counter, or through a community program.

These medicines are not all the same: Overdose rescue medicines can differ in how they are given, how strong they are, who can use them, and how long they last. Your doctor or pharmacist should help you choose the right one and explain how to use it.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other opioids - opioid pain medicine or prescription cough medicine;
• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;
• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with buprenorphine and naloxone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

There are alternative drugs in different forms available to treat opioid use disorder.

Talk with your healthcare provider which option would be best suited to you.

Buprenorphine

• IM injection (Sublocade), Implant (Probuphine), Sublingual (Subutex)

Buprenorphine and naloxone

• Sublingual (Bunavail, Suboxone)

Lofexidine

• Tablets (Lucemyra)

Methadone

• Tablets (Dolophine)

Naltrexone

• IM injection (Vivitrol), Naltrexone tablets

For opioid overdose in an emergency situation:

Naloxone

• Nasal spray (Narcan, Kloxxado), Naloxone injection

Other related medicines:

Buprenorphine for severe pain:

• IM injection (Buprenex), Sublingual (Belbuca), Transdermal patch (Butrans)