PROBUPHINE maintains stable blood levels of buprenorphine starting at the end of month 1 through the end of month 6.1 Some patients may require occasional supplemental oral dosing.

Continuous bupe delivery
one dose, 6 months1

Is It Right For You?

Questions to ask yourself:

  • Have you been taking 8 mg or less of buprenorphine (some people call it bupe) daily for at least 3 months to treat an opioid addiction?
  • Are you able to manage opioid cravings and withdrawal symptoms?
  • Would you be interested in an addiction medication you don’t have to take every day?
  • Do you want to get buprenorphine without taking a pill or using film?
  • Are you nervous or worried about having a bupe pill or film in your medicine cabinet?
  • Are you at least 16 years old?

 

If you answered “YES” to these questions, talk to your healthcare provider to find out if PROBUPHINE is an option for you.

When discussing with your healthcare provider, note that you should not be tapered to a lower dose of buprenorphine for the sole purpose of transitioning to PROBUPHINE, and a parent or guardian must be involved in any discussion about any medical treatment with a patient younger than 18, unless that patient is an emancipated minor.

What is PROBUPHINE?

PROBUPHINE is an implant that contains the medicine buprenorphine. Inserted just under the skin in the upper arm, PROBUPHINE is used to treat certain adults who are addicted to (dependent on) opioid drugs (either prescription or illegal). PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses (doses no more than 8 mg per day) of a buprenorphine containing product.

PROBUPHINE is part of a complete treatment program that also includes counseling and behavioral therapy.

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

To learn more, find a doctor who can prescribe and implant PROBUPHINE

Continuous bupe delivery
one dose, 6 months1

PROBUPHINE maintains stable blood levels of buprenorphine starting at the end of month 1 through the end of month 6. Some patients may require occasional supplemental oral dosing.

WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE
See Full Prescribing Information for complete Boxed Warning
Serious complications may happen from insertion and removal of PROBUPHINE, including:

  • Nerve or blood vessel injury in your arm
  • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
  • Implant sticks out of the skin (protrusion)
  • Implant comes out by itself (expulsion)

References: 1. PROBUPHINE [prescribing information]. South San Francisco, CA: Titan Pharmaceuticals, Inc.; 2018. 2. SUBLOCADE [prescribing information]. North Chesterfield, VA: Indivior Inc.; 2018. 3. SUBOXONE [prescribing information]. North Chesterfield, VA: Indivior Inc.; 2018.

Please see Full Important Safety Information, Medication Guide and Boxed Warning regarding implant migration, protrusion, expulsion and nerve damage associated with insertion and removal.

About PROBUPHINE

How PROBUPHINE delivers bupe continuously

A specially trained healthcare provider inserts PROBUPHINE implants on the inside of your upper arm.

Implant insertion process

PROBUPHINE consists of 4 flexible implants that contain the medicine buprenorphine

In-office Procedure
The implants are inserted under local anesthesia in the office of a specially trained doctor

Four 1-inch Implants
Placed under the skin in a discreet area on the inside of your upper arm

Less than 30 Minutes
The procedure usually takes less than 30 minutes

Patient Identification Card
Important: Keep card and carry with you

Your healthcare provider will give you a patient identification card with the date the implants are inserted and when they should be removed.

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. To learn more about REMS, click here.

PROBUPHINE maintains stable blood levels of buprenorphine starting at the end of month 1 through the end of month 6. Some patients may require occasional supplemental oral dosing.

  • During the course of 6 months, PROBUPHINE implants slowly release buprenorphine into the bloodstream, which travels to the brain, where it latches onto opioid receptors and helps block cravings
  • By the end of month 1 after insertion, bupe concentration in your blood (plasma) reaches a “steady state,” meaning the PROBUPHINE implants release the same amount of bupe as your body eliminates naturally
  • After the 6-month period, your healthcare provider will remove the implants
  • If you wish to continue PROBUPHINE, your healthcare provider may insert new implants into your other arm to continue treatment. This can be done on the same day the old implants are removed
  • PROBUPHINE can be removed sooner than the 6-month period, if needed, by your healthcare provider

 

To learn more, including FAQs about PROBUPHINE, download the PROBUPHINE patient brochure or find a doctor who can prescribe and implant PROBUPHINE

Reference: 1. PROBUPHINE [prescribing information]. South San Francisco, CA: Titan Pharmaceuticals, Inc.; 2018.

PROBUPHINE is a Boxed Warning drug because of the risk of complication of migration, protrusion, expulsion, and nerve injury with insertion and removal. Please see Full Important Safety Information, Medication Guide and Boxed Warning.

Safety

Important Safety Information when considering treatment with PROBUPHINE

Buprenorphine, the medicine in PROBUPHINE, can cause serious and life-threatening problems. Call your healthcare provider right away if you experience any of the following as these could be signs of an overdose or other serious problems:

  • Feel faint or dizzy
  • Have mental changes such as confusion
  • Have slower breathing than you normally have
  • Have severe sleepiness
  • Have blurred vision
  • Have problems with coordination
  • Have slurred speech
  • Cannot think well or clearly
  • Have a high body temperature
  • Have slowed reflexes
  • Feel agitated
  • Have stiff muscles
  • Have trouble walking
  • You have weakness or numbness in your arm, or shortness of breath
  • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling

PROBUPHINE should be used as part of a complete treatment plan including counseling and behavioral therapy.

You should continue to see your healthcare provider at least every month while on PROBUPHINE therapy.

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.

Serious complications may happen from insertion and removal of PROBUPHINE, including:

  • Nerve or blood vessel injury in your arm
  • Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels, possibly to your lung, and could lead to death
  • Implant sticks out of the skin (protrusion)
  • Implant comes out by itself (expulsion)

What is REMS?

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure the benefits of a drug outweigh its risks. Titan Pharmaceuticals has worked with the FDA to develop the PROBUPHINE REMS Program to mitigate the risk of complications of migration, protrusion, expulsion, and nerve damage associated with the insertion and removal of PROBUPHINE and the risks of accidental overdose, misuse and abuse.

Opioid dependence: What caregivers should know

Opioid dependence

Opioids are a broad class of drugs, including those prescribed by a healthcare provider for pain management, as well as illegal drugs such as heroin. Misusing any opioid may lead to physical dependency—also known as opioid use disorder, a medical condition defined by not being able to abstain from using opioids, as well as behaviors centered around opioid use that interfere with daily life.

Common signs of opioid use disorder include:

  • Inability to control opioid use or cravings
  • Drowsiness or changes in sleep habits
  • Weight loss
  • Frequent flu-like symptoms
  • Decreased libido
  • Lack of hygiene
  • Changes in exercise habits
  • Isolation from family and friends
  • Stealing from family, friends, or businesses
  • New financial difficulties

Treatment options

Fortunately, treatment for opioid use disorder is available. This includes medicines prescribed for opioid use disorder, such as methadone, naltrexone, as well as buprenorphine. Buprenorphine is available in daily oral and monthly injectable forms, and PROBUPHINE, a 6-month implant. PROBUPHINE, a 6-month implant version. Along with support programs, these medicines may help patients in their recovery journey.

How PROBUPHINE differs from other buprenorphine products

Because PROBUPHINE is implanted in the arm, it may help ensure that medication is taken as prescribed. Patients won’t have to remember to fill their prescriptions, nor worry about forgetting to take their medications or decide not to do so.1 PROBUPHINE may also help reduce the risk of diversion of the medicine, either on purpose or someone else taking it by accident.

To learn more, including FAQs about PROBUPHINE, download the PROBUPHINE patient brochure.

Reference: 1. PROBUPHINE [prescribing information]. South San Francisco, CA: Titan Pharmaceuticals, Inc.; 2018.

PROBUPHINE is a Boxed Warning drug because of the risk of complication of migration, protrusion, expulsion, and nerve injury with insertion and removal. Please see Full Important Safety Information, Medication Guide and Boxed Warning.