What is Probuphine?

Probuphine is an implant that contains the medicine buprenorphine. Probuphine is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). Probuphine is part of a complete treatment program that also includes counseling and behavioral therapy. Probuphine implants contain the opioid buprenorphine, which may cause physical dependence.

What Important Safety Information should I know about Probuphine?

What is the most important information I should know about Probuphine? Serious complications may happen from insertion and removal of Probuphine including:

• Nerve or blood vessel injury in your arm
• Movement of the implant (migration)
• Implant sticks out of the skin (protrusion)
• Implant comes out by itself (expulsion)

Call your healthcare provider right away if:

• Probuphine sticks out of the skin or comes out by itself
• You have bleeding or symptoms of infection at the procedure site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling
• You have numbness or weakness in your arm after the insertion or removal procedure
• You have weakness or numbness in your arm, or shortness of breath

Because of the risk of complication of, migration, protrusion, expulsion and nerve injury with insertion and removal of Probuphine, it is only available through a restricted program called the PROBUPHINE REMS Program. Probuphine is not available in retail pharmacies and must be inserted and removed only in the facility of the certified prescriber. The medicine in Probuphine can cause serious and life-threating problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:

• Feel faint or dizzy
• Have slurred speech
• Have mental changes such as confusion
• Cannot think well or clearly
• Have slower breathing than you normally have
• Have a high body temperature
• Have severe sleepiness
• Have slowed reflexes
• Have blurred vision
• Feel agitated
• Have problems with coordination
• Have stiff muscles
• Have trouble walking

These can be signs of an overdose or other serious problems. Coma or death can happen if you take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives, antidepressants, or antihistamines, or drink alcohol during treatment with Probuphine. Tell your healthcare provider if you are taking any of these medicines or if you drink alcohol.

Who should not use Probuphine?

Do not use Probuphine if you are allergic to buprenorphine or any of its ingredients, this includes buprenorphine hydrochloride and the inactive ingredient ethylene vinyl acetate or EVA.

Probuphine may not be right for you. Before starting Probuphine tell your doctor about all of your medical conditions, including: trouble breathing or lung problems, an enlarged prostate gland (men), a head injury or brain problem, problems urinating, a curve in your spine that affects your breathing, liver problems, gallbladder or adrenal gland problems, Addison’s disease, low thyroid hormone levels (hypothyroidism), a history of alcoholism, a history of keloid formation, connective tissue disease (such as scleroderma), or history of MRSA infections, mental problems such as hallucinations, an allergy to numbing medicines or medicines used to clean your skin, are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

What should I avoid while being treated with Probuphine?

• Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you.
• You should not drink alcohol during treatment. You should not take anxiety medicines or benzodiazepines, sleeping pills, tranquilizers, or sedatives that are not prescribed to you during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, delayed reaction time, loss of consciousness or even death.

What are the possible side effects of Probuphine?

Probuphine can cause serious side effects, including:

• Infection at the insertion or removal site. Infection may happen at the implant site during insertion or removal. Do not try to remove Probuphine yourself.
• Opioid withdrawal. If Probuphine comes out of your arm or if you stop treatment, tell your doctor right away as you can have symptoms of shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches.
• Physical dependency.
• Liver problems. Call your doctor right away if you notice signs of liver problems that may include your skin or the white part of your eyes turning yellow (jaundice).
• Allergic reaction. If you get a rash, hives, itching, swelling of your face, or wheezing, low blood pressure, dizziness or decrease in consciousness.
• Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down.

Tell your healthcare provider if you develop any of the symptoms listed.

Common side effects of Probuphine include: Headache, nausea, toothache, constipation, depression, vomiting, back pain, mouth and throat pain.

Common risks with the minor surgical procedure: Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site. Scarring around the insertion site.

The risk information here is not comprehensive. Tell your doctor about any side effect that bothers you and does not go away. For more information, talk with your doctor, visit probuphine.com for approved FDA product labeling or call Braeburn at 1-844-859-6341.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Please see Medication Guide and Full Prescribing Information, including Boxed Warning.

Remember that only your doctor can decide if the Probuphine implant is right for you. Do not use Probuphine if you are allergic to buprenorphine or any ingredients in Probuphine. Before starting Probuphine, tell your doctor about all of your medical conditions and other medications that you are currently taking. Sometimes the doses of certain medicines may need to be changed during your treatment with Probuphine.