Buprenorphine, Implant

________________________________________________________________________

KEY POINTS

• This medicine is implanted under the skin to treat narcotic (opioid) addiction. Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death.
• This medicine may cause serious or life-threatening breathing problems, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine with alcohol or other medicines that make you sleepy or slow your breathing can cause coma or death. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: partial narcotic (opioid) agonist

Generic and brand names: buprenorphine, implant; Probuphine

What is this medicine used for?

This medicine is implanted under the skin to treat narcotic (opioid) addiction. You must be enrolled in a special program before you can receive this medicine. Talk with your healthcare provider about this.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to skin adhesives
• A blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• A stroke, head injury, or brain tumor
• Addison's disease
• Heart disease or long QT syndrome
• Low levels of potassium in your blood
• Liver or kidney disease
• Low blood pressure
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Mental health problems such as depression or bipolar disorder
• Pancreas or gallbladder problems
• Problems with alcohol or drug abuse
• Seizures
• Skin problems such as MRSA infections, keloid (scar formation), scleroderma, lupus, or other connective tissue disease
• Thyroid problems
• Trouble urinating or an enlarged prostate gland

Also tell your provider if you have recently had any kind of fever or infection.

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. Long-term use of this medicine during pregnancy can cause withdrawal symptoms in your newborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes with the medicine when you start receiving this medicine or if you have another implant inserted later.

This medicine is inserted by your healthcare provider just under the skin of the inside of your upper arm and will last for 6 months. The implants are removed by your healthcare provider at the end of 6 months. Your provider will give you a card with the date the implants were inserted and the date the implants are to be removed. Schedule an appointment with your healthcare provider to remove the implants on that date.

Do NOT try to remove the implants yourself. This could lead to infection or you could go into withdrawal.

If an implant comes out of your arm, keep the implant in a safe and secure place away from others, especially children. This medicine can be fatal to a child. Wash your hands if you touch an implant. Protect the implant from theft and contact your healthcare provider right away.

What should I watch out for?

Do not take other medicines unless you check with your healthcare provider first. Taking this medicine with alcohol or medicines that make you sleepy or slow your breathing can cause life-threatening side effects. Tell your healthcare if you take any kind of sleeping pill, pain medicine, muscle relaxant, nausea medicine, or medicine to treat anxiety, depression, or seizures. This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as migraine medicines, some cough medicines, St. John’s wort, and others. Make sure that your healthcare providers know ALL of the medicines that you take.

This medicine may cause life-threatening or fatal breathing problems. Taking this medicine for a long time may also cause a rare but very serious adrenal gland problem or decreased sex hormone levels. Talk with your healthcare provider about this.

Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death. Take it exactly as directed by your healthcare provider. Do not take more of it or take it more often than directed. Taking too much of this medicine increases your chance of side effects. If you use this medicine regularly for a long time or in high doses, ask your healthcare provider how to reduce your dose gradually. Follow your provider’s instructions about how to stop taking the medicine.

This medicine is a controlled substance. It is illegal for you to give it to anyone else. Keep this medicine away from children. Accidental use by a child can cause death.

If you develop swelling, redness, bleeding, or pain at the insertion site, or numbness or weakness in your arm, or shortness of breath, contact your healthcare provider right away. These may be signs of nerve or blood vessel damage that can be life-threatening. Contact your healthcare provider right away if the implant sticks out of the skin or comes out by itself.

Your healthcare provider will want to check you regularly while you are receiving this medicine. Keep all appointments.

This medicine may make you dizzy or drowsy, especially for the first 24 to 48 hours after insertion. Do not drive or operate machinery unless you are fully alert and you know how this medicine will affect you. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may lessen this effect.

This medicine may make you constipated. Drinking lots of water, exercising, and taking more fiber may help. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

Adults over the age of 65 may be at greater risk for side effects from this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Trouble breathing; slow or shallow breathing; extreme sleepiness; confusion; seizures; hallucinations (seeing or hearing things that are not there); chest pain; fast, slow, or irregular heartbeat; yellowing of your skin or eyes; dark urine; light-colored bowel movements; severe stomach pain; severe nausea or vomiting; severe constipation; severe dizziness or fainting; problems walking or talking; severe weakness or tiredness; unusual mood changes; unexplained swelling in arms or legs; severe pain, swelling, redness, or bleeding around the insertion site; numbness or weakness in the arm where the implant was put in.

Other: Nausea, vomiting, headache, constipation, mild drowsiness or dizziness, dry mouth, sweating, trouble sleeping; decreased appetite, change in sexual desire or ability, mouth or throat pain; back pain; mild itching or redness at the insertion site.

What products might interact with this medicine?

This medicine may interact with MANY other medicines and cause life-threatening side effects. This list does not include all possible medicines that may interact. Do not start or stop ANY medicine unless you check with your healthcare provider or pharmacist first. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Tell your healthcare provider all the products you take, for example:

• Alcohol
• Alvimopan (Entereg)
• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), dronedarone (Multaq), procainamide, quinidine, and others
• Antibiotics such as erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), rifampin (Rifadin), telithromycin (Ketek), and others
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), and others
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), mirtazapine (Remeron), nefazodone, trazodone, and others
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil), voriconazole (Vfend), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), meclizine (Dramamine), and others
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), gabapentin (Neurontin), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), and others
• Antiviral medicines such as ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira) and ombitasvir/paritaprevir/ritonavir (Technivie)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, secobarbital (Seconal), and others
• Bladder control medicines such as darifenacin (Enablex), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and tolterodine (Detrol)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), nicardipine (Cardene), verapamil (Calan, Covera, Verelan), and others
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), nilotinib (Tasigna), and others
• Cimetidine (Tagamet)
• Cisapride
• Conivaptan (Vaprisol)
• Dextromethorphan/quinidine (Nuedexta)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Eluxadoline (Viberzi)
• Flibanserin (Addyi)
• HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Lorcaserin (Belviq)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines that block or may partially block the effect of narcotic pain medicines such as buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv), bupropion/naltrexone (Contrave), naltrexone (ReVia, Vivitrol), and others
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta), and others
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), naratriptan (Amerge), sumatriptan (Alsuma, Imitrex, Sumavel), and others
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), tizanidine (Zanaflex), and others
• Narcotic allergy, cold, or cough medicines such as guaifenesin/codeine (Robitussin AC, Tussi-Organidin), hydrocodone/chlorpheniramine (Tussionex), promethazine/codeine (Phenergan with codeine), and others
• Natural remedies such as gotu kola, kava, St. John's wort, valerian, and others
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), promethazine, and others
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Rasagiline (Azilect)
• Sleeping pills such as eszopiclone (Lunesta), triazolam (Halcion), zaleplon (Sonata), zolpidem (Ambien, Edluar, Intermezzo), and others
• Tedizolid (Sivextro)
• Tetrabenazine (Xenazine)

Do not drink alcohol while you are taking this medicine.

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, or tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.