These can be signs of an overdose or other serious problems.
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.
Do not use PROBUPHINE if you are allergic to buprenorphine or any ingredients in PROBUPHINE. See the end of this Medication Guide for a list of ingredients in PROBUPHINE.
PROBUPHINE may not be right for you. Before starting PROBUPHINE, tell your healthcare provider about all of your medical conditions, including:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
PROBUPHINE may affect the way other medicines work and other medicines may affect how PROBUPHINE works. Some medicines may cause serious or life-threatening medical problems when taken with PROBUPHINE.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
Do not try to remove PROBUPHINE implants yourself. This could lead to infection. You could also go into opioid withdrawal and become sick because your body has become used to the medicine in PROBUPHINE. Ask your healthcare provider how to stop PROBUPHINE treatment.
If a PROBUPHINE implant sticks out or comes out of your skin:
PROBUPHINE can cause serious side effects, including:
Common side effects of PROBUPHINE include:
Common risks with minor surgical procedure include:
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of PROBUPHINE.
Call your doctor for medical advice about side effects. You may also report side effects to the FDA at 1-800-FDA-1088.
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 is the most important information I should know about Probuphine? Serious complications may happen from insertion and removal of Probuphine including:
Call your healthcare provider right away if:
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:
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.
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.
Probuphine can cause serious side effects, including:
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.