The Probuphine implant is FDA approved for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to moderate doses of buprenorphine, as part of a complete treatment program that includes counseling. Here are some questions to reflect on as you consider whether Probuphine may be a good fit for you:

  • Are you currently taking 8 mg or less of daily buprenorphine?
  • Would you be interested in a medication you don’t have to take every day?
  • Do you wish there was a way to get buprenorphine that didn’t involve taking a pill, or using film?
  • Are you at least 16 years old?

If you answered ‘YES’ to any of these questions, and your cravings and withdrawal symptoms are under control on your current dose of buprenorphine, then you may be a candidate for Probuphine. Talk to your healthcare provider.

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Questions & Answers About Probuphine

Here are the answers to some questions you may have about the Probuphine implant:

Question Answer
1. Can my doctor prescribe and insert Probuphine? Doctors are required to be trained on the appropriate use and insertion of Probuphine and certified as a Probuphine provider. To be certified, healthcare providers go through a training program called Risk Evaluation and Mitigation Strategies (REMS). You can see if your doctor has been trained by visiting the “Find a Doctor” tab on this website. If not, you will be able to find another doctor in your area.
2. What should I do after the Probuphine implant has been inserted? Follow your doctor’s instructions for wound care around the area where the implant was inserted. Your physician will discuss follow up visits after the procedure. Probuphine should be used as part of a complete treatment program that may include counseling and psychosocial support. Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support.
3. Do I need to let other healthcare providers know that I am being treated with Probuphine? It is important that any healthcare provider treating you is aware of all medications you are taking. As a helpful tool after insertion of Probuphine, your doctor will give you a patient identification card to carry with you.

In an emergency, have family members tell the emergency medical staff that you are being treated with buprenorphine and/or Probuphine.

4. How do I know that Probuphine is working? Once Probuphine has been inserted, the medication, buprenorphine, will immediately start to be continuously released into your bloodstream for up to 6 months, helping to reduce your cravings.
5. What should I avoid while being treated with Probuphine? For some, buprenorphine can cause drowsiness and slow reaction times during dose adjustment periods. For Probuphine, this may happen more often in the first few days after insertion. Until you know how the medication affects you, do not drive, operate heavy machinery, or perform any other dangerous activities.

You should not drink alcohol during treatment with Probuphine or any buprenorphine medication, as this can lead to slowed breathing, drowsiness, slow reaction time, loss of consciousness or even death.

6. What if I need additional buprenorphine while on Probuphine? 82.1% of the patients on Probuphine went through the 6-month clinical study without a supplemental dose of buprenorphine. However, if necessary, the dosage of buprenorphine can be adjusted upward. If symptoms persist during the initial 2 weeks of treatment, your doctor may provide supplemental sublingual buprenorphine.
7. What if I want to stop treatment with the Probuphine implant before the 6 months is up? Probuphine implant can be removed before the end of 6-months by your doctor if you or your doctor decides to change your treatment plan.

Do not try to remove the Probuphine implant yourself. The improper removal carries the risk of implant site infection. You could also experience moderate withdrawal signs and symptoms if you discontinue treatment abruptly because your body has become used to this medicine.

8. What happens after 6 months? After the 6-month period, your doctor should remove the implant. If you wish to continue Probuphine, your doctor may replace it with a new Probuphine implant. Before each new set of implants you should discuss the benefits of continuing therapy with your doctor.

If new implants are not inserted on the same day as the removal, you should take sublingual buprenorphine again under the guidance of your doctor.

9. Is Probuphine an Opioid? Is it addictive? The medicine in Probuphine is buprenorphine, a partial opioid agonist, which may cause physical dependence. Physical dependence means that the body relies on an external source to prevent withdrawal. Physical dependence is predictable, easily managed with medication, and may ultimately be resolved with a slow taper off of the partial opioid agonist. [explanation sourced from National Alliance] The withdrawal syndrome is typically milder than seen with full agonists and illicit opioids, and may be delayed in onset.
10. Does Probuphine work as well as oral products with buprenorphine? Yes, in order to earn FDA approval, in a clinical study, Probuphine efficacy and safety were compared to sublingual buprenorphine among patients who had been clinically stable. At the end of the 6 months, 75.8% of the patients (or people?) on Probuphine were free from illicit drug use

As the first buprenorphine implant for the maintenance treatment of opioid dependence, Probuphine offers people who are stable on buprenorphine, a unique and convenient benefit—freedom from daily dosing for up to 6 months.

Ask your doctor if Probuphine could be right for you.

Download Questions and Answers and Important Safety Information Here

SEE IMPORTANT SAFETY INFORMATION

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.