- Katie B., Probuphine patient“It’s the first time in 10 years that I don’t have to plan my day around taking my medication.”
“My story started when I was very young, when I got in with the wrong crowd and began using prescription painkillers to get high. I’d sneak them out of my parent’s medicine cabinet.
At one point I had to switch to heroin because I could no longer afford oxycodone.
I was in a very dark place. Stealing from my parents, pawning my mom’s jewelry. If I showed you photos of myself from back then, you wouldn’t recognize me.
Finally, I asked my parents for help, and a nurse friend of my mom told me about a treatment with buprenorphine. I was on it for 10 years, along with diligently participating in a support program and counseling. I was proud of how far I’d come in turning my life around. So, when my doctor told me about Probuphine, and that it was approved, I said “Let’s do it as soon as possible!”
For me, Probuphine was the next step in my treatment.
Now, when I’m out with friends, I don’t have to make excuses to leave early and rush home to take my medication. I don’t get withdrawal symptoms like I used to when I was coming up to dosing time. I can sleep in too…not wake up early to take my first dose, like I had to before!
With Probuphine, my life has changed from when I abused opioids. I can work out and play paintball, which I love. I go competitive bowling with my friends on Sunday nights, and I have a little West Highland terrier, Sophie. She’s old and a brat, but I adore her!
I’ve gone from a deep, dark hole to living a life that I love.”
– Katie B.
Today, Katie works for a non-profit, where she counsels and supports people who are struggling with opioid dependence. She also helps her Mom take care of her Dad.
INDICATION AND IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
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.
WARNING: COMPLICATIONS FROM INSERTION AND REMOVAL OF PROBUPHINE
See full prescribing information for complete Boxed Warning
- 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.
- 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-threating 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 slurred speech |
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· Have mental changes such as confusion |
· Cannot think well or clearly |
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· Have slower breathing than you normally have |
· Have a high body temperature |
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· Have severe sleepiness |
· Have slowed reflexes |
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· Have blurred vision |
· Feel agitated |
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· Have problems with coordination |
· Have stiff muscles · Have trouble walking |
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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 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.
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.
You are encouraged to report side effects of Probuphine. Please contact Titan Pharmaceuticals at 1-844-859-6341 or FDA at 1-800-FDA-1088 www.FDA.gov/medwatch.
Please read Medication Guide and U.S. Full Prescribing Information, including BOXED WARNING.
PRO-18RIB002-08/2018
Please read MEDICATION GUIDE and FULL PRESCRIBING INFORMATION, including BOXED WARNING for Probuphine.
PRO-18PBC001 10/2018
