Medication Guide
PROBUPHINE® (pro-bú-feen)
(buprenorphine)
implant (CIII) |
Read this Medication Guide before starting PROBUPHINE and each time PROBUPHINE is inserted. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider. Talk to your healthcare provider if you have questions about PROBUPHINE.
Share the important information in this Medication Guide with members of your household. Carry your Patient Identification Card with you at all times. |
What is the most important information I should know about PROBUPHINE?
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Serious complications may happen from insertion and removal of PROBUPHINE, including:
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- Nerve or blood vessel injury in your arm
- Movement of implant (migration). PROBUPHINE or pieces of it can move into blood vessels and to your lung, and could lead to death.
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- Implant sticks out of the skin (protrusion)
- Implant comes out by itself (expulsion)
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| 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
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- 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.
- 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.
- In an emergency, have family members tell the emergency medical staff that you are physically dependent on an opioid and are being treated with PROBUPHINE.
- PROBUPHINE contains a medicine called buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs. Call your healthcare provider right away or get emergency help if you:
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- 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
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- Cannot think well or clearly
- Have a high body temperature
- Have slowed reflexes
- Feel agitated
- Have stiff muscles
- Have trouble walking
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| | These can be signs of an overdose or other serious problems. |
- Talk to your healthcare provider about naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose, including accidental exposure to PROBUPHINE by a child.
- 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.
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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.
- It is not known if PROBUPHINE is safe or effective in children less than 16 years of age.
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| | PROBUPHINE is a controlled substance (CIII) because it contains buprenorphine that can be a target for people who abuse prescription medicines or street drugs. If it comes out of your arm, keep the implant in a safe and secure place away from others, especially children. Tell your healthcare provider if you are living in a household where there are small children. If a child is accidentally exposed to PROBUPHINE, get emergency help or call 911 right away. Protect the implants from theft until you can return them to your healthcare provider. Never give your PROBUPHINE to anyone else, because it may cause death or harm them. Selling or giving away PROBUPHINE is against the law. | |
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Who should not use PROBUPHINE?
Do not use PROBUPHINE if you are allergic to buprenorphine or any ingredients in PROBUPHINE. See the end of this Medication Guide for a list of ingredients in PROBUPHINE. |
PROBUPHINE may not be right for you. Before starting PROBUPHINE, tell your healthcare provider 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 problems
- 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 (seeing or hearing things that are not there).
- An allergy to numbing medicines (anesthetics) or medicines used to clean your skin (antiseptics). These medicines will be used when the implants are placed into and removed from your arm.
- Are pregnant or plan to become pregnant. It is not known if PROBUPHINE will harm your unborn baby. If you are treated with PROBUPHINE while pregnant, your baby may have symptoms of opioid withdrawal at birth.
- Are breastfeeding or plan to breastfeed. PROBUPHINE can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with PROBUPHINE. Monitor your baby for increased drowsiness and breathing problems.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. PROBUPHINE may affect the way other medicines work and other medicines may affect how PROBUPHINE works. Some medicines may cause serious or life-threatening medical problems when taken with PROBUPHINE.
- Sometimes the doses of certain medicines may need to be changed if used during treatment with PROBUPHINE. Do not take any medicine during treatment with PROBUPHINE until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines during treatment with PROBUPHINE.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. |
How are the PROBUPHINE implants inserted and removed?
- PROBUPHINE is inserted and removed by a trained healthcare provider.
- The PROBUPHINE implants are placed just under the skin of the inside of your upper arm through a minor surgical procedure. The implants are soft, flexible, and about the size of a matchstick.
- Your healthcare provider will cover the site where PROBUPHINE was inserted with 2 bandages. Leave the top bandage on for 24 hours. Keep the smaller, bottom bandage clean, dry, and in place for 3 to 5 days.
- You should apply an ice pack to your arm for 40 minutes every 2 hours for the first 24 hours after insertion of PROBUPHINE implants and as needed.
- Your healthcare provider will give you a PATIENT IDENTICATION CARD to carry with you. Your healthcare provider will fill out the PATIENT IDENTICATION CARD with the date the implants were inserted and the date the implants are to be removed. Keep track of the date the implants are to be removed. Schedule an appointment with your healthcare provider to remove the implants on or before the removal date.
- Your healthcare provider will decide how long the PROBUPHINE implants will stay in your arm. You should talk with your healthcare provider about continuing treatment with PROBUPHINE.
Do not try to remove PROBUPHINE implants 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 healthcare provider how to stop PROBUPHINE treatment.
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What should I do if PROBUPHINE implant sticks out or comes out?
If a PROBUPHINE implant sticks out or comes out of your skin:
- Wash your hands if you touch the PROBUPHINE implant.
- Cover the area where the implants were inserted with a clean bandage.
- Do not allow others to touch or use the PROBUPHINE implant, since it contains buprenorphine and could be dangerous.
- If a child puts a PROBUPHINE implant in his or her mouth, call 911 or get emergency help right away,
- Put the implant in a plastic bag. Store the PROBUPHINE implant in a safe place out of the reach of children and where they are protected from theft.
- Contact your health care provider right away, and take the implant to your healthcare provider as soon as possible.
- There are risks of accidental overdose, misuse, and abuse with the use of PROBUPHINE if an implant comes out of the arm and if someone has contact with it.
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What should I avoid while being treated with PROBUPHINE?
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Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how this medication affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few days after insertion.
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You should not drink alcohol during treatment with PROBUPHINE, as this can lead to slowed breathing, drowsiness, slow reaction time, loss of consciousness or even death. You should not take anxiety medicines or benzodiazepines (such as Valium® or Xanax®), sleeping pills, tranquilizers, or sedatives (such as Ambien®) 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. If a healthcare provider is considering prescribing such a medicine for you, remind the healthcare provider that you are being treated with PROBUPHINE.
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What are the possible side effects of PROBUPHINE?
PROBUPHINE can cause serious side effects, including:
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See "What is the most important information I should know about PROBUPHINE?"
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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.
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Opioid withdrawal. If Probuphine comes out of your arm or if you stop treatment, you can have symptoms of opioid withdrawal including: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches. Tell your healthcare provider if you develop any of these symptoms.
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Physical dependency.
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Liver problems. Call your healthcare provider right away if you notice any of these signs of liver problems: your skin or the white part of your eyes turns yellow (jaundice), urine turns dark, stools turn light in color, decreased appetite, stomach (abdominal) pain or nausea. Your healthcare provider may do tests before and during treatment with PROBUPHINE to check your liver.
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Allergic reaction. If you get a rash, hives, itching, swelling of your face, wheezing, low blood pressure, dizziness or decrease in consciousness, call your healthcare provider or get emergency help right away.
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Decrease in blood pressure. You may feel dizzy when you get up from sitting or lying down.
Common side effects of PROBUPHINE include: |
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- Headache
- Depression
- Constipation
- Nausea
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- Vomiting
- Back pain
- Toothache
- Mouth and throat pain
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Common risks with minor surgical procedure include:
- Itching, pain, irritation, redness, swelling, bleeding, or bruising at the insertion or removal site
- Scarring around the insertion site
Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of PROBUPHINE.
Call your doctor for medical advice about side effects. You may also report side effects to the FDA at 1-800-FDA-1088. |
General information about PROBUPHINE
This Medication Guide summarizes important information about PROBUPHINE. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider for information that is written for healthcare professionals. |
What are the ingredients in PROBUPHINE?
Active ingredient: buprenorphine
Inactive ingredient: ethylene vinyl acetate (EVA).
Distributed by Titan Pharmaceuticals, Inc., South San Francisco, CA 94080, USA. PROAW00008-R2 03/21
For more information, go to www.PROBUPHINE.com or call 1-844-859-6341. |