Probuphine is an opioid medication. An opioid is sometimes called a narcotic.

Probuphine implants are used to treat narcotic addiction in certain people whose addiction has already been treated and controlled with other forms of buprenorphine (such as Subutex or Suboxone). Probuphine implants are for adults and teenagers who are at least 16 years old.

Probuphine implants are available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of using this medicine. The implants are not for use as a pain medication.

Inserting and removing Probuphine implants can cause serious or life-threatening complications.

Talk with your doctor about the risks and benefits of using Probuphine. Read all patient information, medication guides, and instruction sheets provided to you.

A Probuphine implant is a 1-inch rod that is inserted through a needle (under local anesthesia) into the skin of your inside upper arm. You will receive a total of 4 implants.

After the Probuphine implant is inserted, your arm will be covered with 2 bandages. Remove the top bandage after 24 hours, but leave the smaller bandage on for 3 to 5 days. Keep the area clean and dry. Apply an ice pack to the area every 2 hours during the first day, leaving the ice pack on for 40 minutes at a time.

For at least 1 week, check the incision area for warmth, redness, swelling, or other signs of infection.

Call your doctor at once if you notice any of the following symptoms after the implants are inserted:

• an implant sticks out of your skin or comes out by itself;

• you have pain, itching, redness, swelling, bleeding or severe irritation;

• you have numbness or weakness in your arm; or

• you feel short of breath.

Tell your doctor if you cannot feel the Probuphine implant under your skin. Your doctor may perform medical tests or refer you to a surgeon.

Probuphine implants can remain in place for up to 6 months and must be surgically removed. Do not attempt to remove the implants yourself.

If an implant comes out of your arm, keep it in a place where others cannot get to it. As soon as possible, return the implant to your doctor. MISUSE OF A PROBUPHINE IMPLANT CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the implant improperly or without a prescription. Selling or giving away a Probuphine implants is against the law.

Probuphine is only part of a complete treatment program that may also include counseling and other types of addiction support. Tell your doctor if the Probuphine implants are not helping to improve your symptoms of addiction.

Any medical care provider who treats you should know that you are being treated for opioid addiction and using buprenorphine. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.

Usual Adult Dose for Opiate Dependence - Maintenance:

For use in opioid-tolerant patients who meet ALL of the following criteria:
-Achieved and sustained prolonged clinical stability on transmucosal buprenorphine as evidenced by a stable dose for 3 months or longer without any need for supplemental dosing or dose adjustments.
-Currently receiving buprenorphine maintenance (with or without naloxone) at doses of 8 mg/day or less, or equivalent transmucosal product (e.g. Bunavail buprenorphine 4.2 mg/naloxone 0.7 mg per day or less; or Zubsolv buprenorphine 5.7 mg/naloxone 1.4 mg per day or less)
-Patients should not be tapered to a lower dose for the sole purpose of transitioning to the implant.

Insert 1 dose subdermally in the inner side of the upper arm
-Remove at the end of the sixth month

Comments:
-Probuphine implant insertions and removals should be performed by certified healthcare providers.
-Each dose consists of 4 implants; each implant contains 74.2 mg of buprenorphine
-After 1 insertion in each arm, most patients should be transitioned back to transmucosal products for continued treatment as there is no experience with inserting additional implants into other sites in the arm or into a previously-used site.

Uses: For the treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. There is no maximum recommended duration for maintenance therapy as indefinite treatment may be required; when the decision is made to discontinue, doses should be tapered.

You should not use Probuphine implants if you are allergic to buprenorphine.

To make sure Probuphine is safe for you, tell your doctor if you have ever had::

• breathing problems, sleep apnea;

• liver disease;

• problems with your gallbladder or thyroid;

• an enlarged prostate, urination problems;

• Addison's disease (an adrenal gland disorder);

• abnormal curvature of the spine that affects breathing;

• a head injury, brain tumor, or spinal cord problems;

• mental illness or psychosis;

• alcoholism; or

• skin problems such as unusual scars or growths.

If you use buprenorphine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on buprenorphine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Buprenorphine can pass into breast milk and may cause drowsiness or breathing problems in a nursing baby. Ask your doctor about any risks.

Probuphine implants not approved for use by anyone younger than 16 years old.

As Probuphine implants are implanted under your skin, low-level doses of buprenorphine will be continuously delivered into your body for up to 6 months, it is unlikely you will miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of buprenorphine can be fatal.

Overdose symptoms may include severe drowsiness, pinpoint pupils, weak or shallow breathing, or loss of consciousness.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or operating machinery until you know how buprenorphine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid using any opioid pain medicine without approval from your doctor. Opioid pain medicine will not work as well while you are using Probuphine. Talk with your doctor about other options for pain relief.

Get emergency medical help if you have signs of an allergic reaction to Probuphine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Inserting or removing the Probuphine implant can cause serious or life-threatening complications, including damage to nerves or blood vessels. Ask your doctor about these risks.

Call your doctor at once if you have:

• opioid withdrawal symptoms - shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, vomiting;

• confusion, agitation, or other changes in your mental status;

• extreme drowsiness, trouble concentrating;

• a light-headed feeling, like you might pass out;

• weak or shallow breathing, breathing that stops during sleep;

• blurred vision, slurred speech, problems with walking, reflexes, or coordination; or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Probuphine side effects may include:

• pain, itching, redness, swelling, bruising, or bleeding where the implants were inserted;

• headache, depressed mood;

• nausea, vomiting, constipation;

• back pain;

• tooth pain; or

• sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications - opioid pain medicine or prescription cough medicine;

• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.