
Important Titan Pharmaceuticals Patient Information
Dear Patient,
We are sending this information to your Healthcare Provider so you may discuss any questions that you may have regarding your treatment with Probuphine.
We wish to inform you that Titan Pharmaceuticals voluntarily withdrew and discontinued all commercialization of Probuphine® (buprenorphine) implant CIII in the United States effective October 15, 2020. It is important to note that this difficult but necessary decision was unrelated to any safety concerns.
Titan has prepared a list of frequently asked questions “FAQ” for you to discuss with your Healthcare provider, if you wish. This information is intended to help answer any questions you may have regarding Titan’s decision as well as help you to determine next steps in your treatment plan. Please discuss your ongoing treatment with your HCP.
Also, please refer to the following guides for additional information regarding Probuphine:
https://probuphinerems.com/wp-content/uploads/2018/11/PRO-18REMS012-What-You-Need-to-Know-about-Probuphine-A-Patients-Guide.pdf, and https://probuphinerems.com/wp-content/uploads/2019/11/Probuphine-MedGuide-PROAW00008-R1-Oct19.pdf.
If you require more information about Probuphine, please contact Titan at 1-844-859-6341.
With sincere regards,
Kate Beebe DeVarney, Ph.D.
President and Chief Operating Officer
Titan Pharmaceuticals, Inc.
TTN-PRO-264-1-OCT20
PATIENT FREQUENTLY ASKED QUESTIONS
- Why was Probuphine discontinued in the United States (US)?
- The difficult decision to end the availability of Probuphine, effective October 15, 2020, was not related to any safety issues. Despite our efforts, the special requirements needed to maintain Probuphine on the market were too onerous to be sustainable. With the Company’s financial constraints and challenges faced due to the global COVID-19 pandemic, the conclusion was unavoidable.
- Was it due to safety issues?
- Probuphine was not withdrawn from US market due to safety reasons.
- Can I get additional implants beyond 6 months of treatment?
- Effective October 15, 2020 Probuphine is no longer available in the US.
- What is my next step after I have completed my 6-month Probuphine treatment?
- Contact your healthcare provider (HCP) to discuss the next steps in your treatment.
- At the end of your 6-months of treatment, the Probuphine implants must be removed.
- You and your HCP will determine the best ongoing treatment option for you once your implants have been removed.
- I recently had Probuphine implants inserted, may I continue treatment?
- Yes, ongoing care should be provided under the direction of your HCP. You may continue your treatment with Probuphine until the end of the 6-month treatment period.
- At the end of the 6-months of treatment, the Probuphine implants must be removed.
- What happens if an implant sticks out of the skin or comes out, will I be able to obtain a replacement implant?
- What if I have additional questions regarding Probuphine?
- Where do I get my Probuphine removed?
- Please follow up with your HCP for removal of Probuphine.
- If you have moved or you no longer have access to your HCP please contact Titan at 1-844-859-6341
- Will my insurance still cover the removal procedure?
- If your insurance provider covered the cost of your Probuphine treatment, they should cover the cost of the removal procedure. However, if you have a question about the coverage regarding the removal procedure please contact your insurance provider directly.
- Please contact Titan at 1-844-859-6341 for further inquiries.
- If I have any other questions about my treatment, what should I do?
TTN-PRO-265-1-OCT20
INDICATION
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 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.
IMPORTANT SAFETY INFORMATION
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)
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 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
If the implant comes out by itself, keep it away from others, especially children, as it may cause severe difficulty in breathing and possibly death.
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. Healthcare providers who prescribe and/or insert
PROBUPHINE must be certified with the program by enrolling and completing live training.
- PROBUPHINE is not available in retail pharmacies
- PROBUPHINE must be inserted or removed only in the facility of the certified prescriber
Implants may be difficult to locate if inserted too deeply, if you manipulate them, or if you gain significant weight after insertion. Your healthcare provider may do special procedures or tests, or refer you to a surgical specialist to remove the implants if they are difficult to locate.
The medicine in PROBUPHINE can cause serious and life-threatening 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 mental changes such as confusion, slower breathing than you normally have, severe sleepiness, blurred vision, problems with coordination, slurred speech, cannot think well or clearly, high body temperature, slowed reflexes, feel agitated, stiff muscles or 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 implants 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
- Sleep Apnea. Call your doctor right away if you or someone close to you notices: Observed episodes of stopped breathing or abnormal breathing patterns during sleep
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.
Please read Full Prescribing Information, including BOXED WARNING regarding IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION AND REMOVAL.
Titan encourages you to report negative side effects of prescription drugs to the FDA. You can visit www.fda.gov/safety/medwatch/ or call 1-800-FDA-1088.