Patients

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 a part of a complete treatment program that also includes counseling and behavioral therapy.
Probuphine implants contain the opioid buprenorphine, which may cause physical dependence.

How does Probuphine Work?

Four implants are inserted under the skin of your upper arm during a procedure done in your physician's office or Opioid Treatment Program (OTP).
The implants remain in your arm for six months.
After the six-month period, your doctor must remove the implants.
If you wish to continue Probuphine, your doctor may insert new implants to continue treatment.
The implants can be removed sooner if you want to stop treatment.
Patients must continue to see their doctor at least every month while on Probuphine therapy.

What are the Risks Related to the Insertion and Removal of Probuphine Implants?

There is a risk of accidental overdose, abuse, and misuse for others if the implants come out and others are exposed to them.
There is a rare but serious risk that the drug implant, if inserted improperly, may move (migrate) into the blood vessels and to your lung, and could lead to death.
An implant may come out by itself, or an end of an implant may begin sticking out of your skin.
Injury or damage to nerves or blood vessels in your arm may happen during the insertion and/or removal procedures.
Implants may be hard to find if:
- They are too deep for your doctor to feel.
- You try to move them around under your skin.
- You have gained a lot of weight since they were inserted.
Special procedures, tests, or a referral to a specialist may be needed to find and remove the implants if they are difficult to locate.
There are common risks associated with any minor surgical procedure, such as:
- Itching, pain, irritation or redness, swelling, bleeding, or bruising at the insertion site.
- Scarring around the insertion site.

What Should I do After the Probuphine Implants Have Been Inserted?

Follow your doctor's instructions for wound care of the place where the implants were inserted or removed.
Do not try to remove Probuphine implants yourself.
- Improper removal carries the risk of implant site infection.
- If you remove the implants, you could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
If the Probuphine implants come out:
- Wash your hands if you have touched the Probuphine implants.
- Cover the area where the implants were inserted with a clean bandage.
- Do not allow others to touch or use the Probuphine implants, since this could be very dangerous.
- Put the implants in a plastic bag and take the implants to your doctor right away.
- Keep the implants in a safe and secure place, away from others, especially children.
- Protect the implants from theft until you can return them to your doctor.

Where Can I Get More Information About Probuphine?

Read:

What You Need to Know about Probuphine: A Patient’s Guide The healthcare provider who prescribes Probuphine for you will give this guide to you to help you understand the risks and benefits of Probuphine. This helpful guide is also available by clicking here.
Probuphine Medication Guide The healthcare provider who inserts Probuphine will give this guide to you each time the implants are inserted. This medication guide is also available by clicking here.

Ask your healthcare provider any questions you may have about Probuphine.

Call the Probuphine REMS Program at 1-866-397-8939.

Your Training Requirements can be found at the intersection of the row and column you select below based upon your personal experience:

I have current operating privileges at hospitals or out-patient surgical centers: (Select the “yes” or “no” Column below that Applies)
If YES	IF NO
I must review the *Probuphine REMS Program Probuphine Surgical Procedures Recertification Video* found on the Probuphine REMS website every year.	Number of Probuphine procedures in the past 12 months (Select the Row that applies)
	10 or More Performed 10 or more successful² procedures (comprised of at least five insertions and five removals)	I must review the *Probuphine REMS Program Surgical Procedures Recertification Video* found on the Probuphine REMS website every year. I understand that I should keep documentation of all successfully completed procedures on the *Probuphine REMS Program Procedure Record for Recertification* or another record of my choosing - which must be provided to the Probuphine REMS Program if I am audited.
	Less than 10 Performed less than 10 successful² procedures (comprised of at least five implantations and five removals)	I must (annually): attend a *Probuphine REMS Program Live Training: Lecture and Practicum* session successfully complete the *Probuphine REMS Program Knowledge Assessment* test meet the *Probuphine REMS Program Criteria for Procedural Competency*

¹ Denotes the minimal requirements. Healthcare Providers should utilize the tools provided for recertification as needed to ensure proper insertion/ removal of Probuphine is conducted in accordance with the Probuphine REMS Program.

² “Successful” implantation and removal procedures exclude attempted procedures that require assistance of other surgical specialties for completion. Removal procedures assisted by imaging studies prior to completion can be included, provided that the HCP successfully removes all implants identified by imaging without involving additional surgical consultants.