This medication guide provides information about buprenorphine injection brands used only to treat opioid addiction in adults. These brands are not to be used as pain medication.

Buprenorphine injection is given to people who have started opioid addiction treatment with a form of buprenorphine placed under the tongue or inside the cheek.

Buprenorphine injection is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Buprenorphine injection may also be used for purposes not listed in this medication guide.

You should not be treated with buprenorphine injection if you are allergic to it.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with buprenorphine injection could cause a serious condition called serotonin syndrome.

Tell your doctor if you have or have ever had:

• breathing problems, sleep apnea;
• a head injury or brain problem;
• alcoholism, mental illness;
• an allergy to latex;
• an enlarged prostate;
• urination problems;
• heart problems;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• curvature of the spine that affects breathing;
• Addison's disease (or any other adrenal gland problem);
• problems with your gallbladder or thyroid; or
• liver or kidney disease.

Buprenorphine injection may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

If you use buprenorphine injection during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Tell your doctor if you are breastfeeding. If you are breastfeeding, tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Use Brixadi Monthly (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• weak or shallow breathing, breathing that stops;
• severe drowsiness or dizziness, loss of coordination;
• a light-headed feeling, like you might pass out;
• opioid withdrawal symptoms--shivering, goose bumps, increased sweating, feeling hot or cold, runny nose, watery eyes, diarrhea, vomiting;
• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

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.

Tell your doctor right away if you develop withdrawal symptoms or an allergic reaction even weeks or months after your last dose of buprenorphine injection.

Common side effects may include:

• feeling tired;
• nausea, vomiting, constipation;
• pain, redness, itching, burning, irritation, or skin changes where the injection was given;
• pain and burning when you urinate;
• trouble sleeping;
• headache; or
• abnormal liver function tests.

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.

Avoid driving or hazardous activity until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

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