hand-holding-implant Actual implant length = 1 inch (26mm)

What is Probuphine (buprenorphine)?

Probuphine is the first and only 6-month treatment for opioid dependence.

  • Probuphine consists of 4 implants that contain the medication buprenorphine.
  • Probuphine is indicated for treatment of opioid dependence in patients who have achieved and maintained low to moderate daily doses of buprenorphine.

It is not known if Probuphine is safe or effective in children less than 16 years of age.

Buprenorphine is the medication frequently prescribed to treat opioid addiction in the U.S. today, Buprenorphine has been combined with implant technology, which has been used in other medical treatments for a number of years.

The Probuphine implants, placed in the arm gives up to 6 months continuous, steady release of a low-dose buprenorphine – helping to prevent withdrawal symptoms and cravings.

Serious complications may happen from insertion and removal of Probuphine. See Important Safety Information.

Because of the risk of complications 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.

sleeping-patient-implant-img Four 1” implants are placed discreetly in the underside of the upper arm, just beneath the skin.

The Probuphine Treatment:

  • consists of 4 soft, flexible rods, roughly 1 inch in length each.
  • is placed discreetly under the skin on the inside of your upper arm.
  • is inserted in your doctor’s office, usually in less than 30 minutes.

Once inserted, Probuphine may free you from your daily dosing routine of buprenorphine. Probuphine should be used as part of a complete treatment plan including counseling and other support.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how Probuphine affects you.

You should not drink alcohol while you have the implant. This can lead to slowed breathing, drowsiness, slow reaction time, fainting, or even death.

*82.1% of patients did not require supplemental buprenorphine over the six-month study.

How Probuphine Works

Probuphine, with its 6-month delivery system, gives you an ongoing treatment against opioid dependence.

The Probuphine implant slowly releases buprenorphine into the bloodstream, which then travels to the brain, where it latches onto opioid receptors and effectively blocks cravings.

Watch how Probuphine works by clicking on the video.

Probuphine remains in your arm for up to six months.

  • After the 6-month period, your doctor should remove the implant.
  • If you wish to continue Probuphine, your doctor may insert a new implant into your other arm to continue treatment. This can be done the same day.
  • Probuphine can be removed sooner than the six-month period if needed, under the guidance of your doctor.
  • Patients must continue to see their doctor at least every month while on Probuphine therapy.

Although hidden from view, Probuphine is continuously working to help suppress withdrawal symptoms and reduce cravings.

How do i benefit from Probuphine?

Arm yourself with this innovative, effective treatment.

In a 6-month clinical study among patients who were treated with Probuphine:

  • 3 out of 4 patients (75.8%) remained free from illicit opioid use.*
  • 82.1% of patients did not need supplemental buprenorphine, which was available at the discretion of the doctor.
  • Patients continued their regular counseling visits over the 6-month study as part of their overall treatment plan.

Probuphine can free you from the hassle of daily dosing:

  • You can eat or drink any time you want to without having to worry about your medication.
  • Unlike pills or film, Probuphine can’t be lost or stolen.

Keep your opioid dependence to yourself.

The Probuphine implant is discreet so only you know it provides steady and continuous medication 24 hours, 7 days a week, for 6 months. Probuphine may not be for everyone.

Probuphine may not be for everyone. Talk with your doctor if you have questions about Probuphine.
*75.8% Probuphine alone vs. 64% sublingual buprenorphine

NEVER MISS A DOSE

HOURS A DAY
DAYS A WEEK
MONTHS AT A TIME

Insertion and Removal

Your doctor will explain the risks related to the insertion and removal of a Probuphine implant and can perform the procedure right there in the office.

Insertion of Probuphine:

You’ll lie on your back with your bent arm resting next to your head. Your doctor will clean and numb the insertion area on the inside of your upper arm. The 4 small flexible rods will be placed just under the skin through the same small incision.

After the rods are in place, your doctor will gently feel for them to ensure they are placed in the arm correctly.

A small bandage will cover the incision and should remain in place for 3 to 5 days. You’ll wear a larger pressure bandage covering the full implant area for the first 24 hours.

Your doctor will provide you with wound care instructions and advice including:

  • For the first 24 hours:
    • Apply an ice pack to your arm for 40 minutes every 2 hours while you are awake to help reduce bruising and swelling and as needed.
    • Avoid showers or swimming to keep the site dry.
  • Avoid strenuous activities for the first week.
  • Schedule a visit during first week after insertion.

As a helpful tool, you will be given a patient identification card with the date Probuphine was inserted and the date it is to be removed.  As with all medications it is important that other healthcare professionals know that you are being treated with Probuphine.

Removal of Probuphine:

Probuphine is intended to remain in your arm for 6 months, but your doctor can remove it sooner if needed.

After the 6-month period, if you wish to continue treatment with Probuphine, talk with your doctor. He or she may replace it with a new Probuphine implant in the other arm for one additional 6-month treatment.

If a new Probuphine implant is not inserted on the same day as removal, you should take oral buprenorphine again under the guidance of your doctor,

Do not try to remove the Probuphine implant 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 doctor how to stop Probuphine treatment.

WHAT ARE THE POSSIBLE RISKS AND SIDE EFFECTS OF PROBUPHINE?

What are the possible side effects of PROBUPHINE? 

PROBUPHINE can cause serious side effects, including:

  • Infection at the insertion or removal site.
  • Opioid withdrawal.
  • Physical dependency.
  • Liver problems.
  • Allergic reaction.
  • Decrease in blood pressure.

Common side effects of PROBUPHINE include: headache, depression, constipation, nausea, vomiting, back pain, toothache, 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. For more information, please see Full Prescribing Information, including Boxed WARNING and Medication Guide.

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-threatening problems, especially if you take or use certain other medicines of 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 or 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 notice signs of 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. Call 1-800-FDA-1088 or visit

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