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

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

Brixadi Monthly is available only under a special program. You must be registered in the program and understand the risks and benefits of Brixadi Monthly.

Brixadi Monthly may also be used for purposes not listed in this medication guide.

Fatal side effects may occur if you also drink alcohol or use other drugs that cause drowsiness or slow breathing.

Using opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Brixadi Monthly is available only under a special program. You must be registered in the program and understand the risks and benefits of Brixadi Monthly.

Brixadi Monthly is injected under the skin. A healthcare provider will give you this injection.

After each injection, you may see or feel a small lump under your skin where the medicine was injected. This could last for several weeks but the lump should eventually get smaller. Avoid rubbing or massaging the skin where an injection was given and wearing tight clothing over the area.

Your doctor will determine how often you will receive Brixadi Monthly.

You will need frequent blood tests to check your liver function.

Brixadi Monthly is only part of a complete treatment program that may also include counseling and other types of addiction support. Tell your doctor if you feel that Brixadi Monthly is not helping to improve your symptoms of addiction.

In an emergency, your family or caregivers should tell medical personnel that you are using Brixadi Monthly. Make sure any follow-up doctor knows you use this medicine.

Do not stop using Brixadi Monthly suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings).

You should not be treated with Brixadi Monthly 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 Brixadi Monthly 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.

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

If you use Brixadi Monthly 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.

Call your doctor for instructions if you miss an appointment for your Brixadi Monthly.

In a medical setting an overdose would be treated quickly.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Avoid driving or hazardous activity until you know how Brixadi Monthly 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.

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.

Brixadi Monthly may cause serious side effects. 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 of Brixadi Monthly 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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. Tell your doctor if you also use an antibiotic, antifungal medication, seizure medication, or medicine to treat HIV or hepatitis C.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

• medicine for allergies, asthma, heart problems, motion sickness, irritable bowel, or overactive bladder;

• other opioid medicines;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• sleep medicine, muscle relaxers, or other medications that make you drowsy; or

• medications that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete and many other drugs may affect Brixadi Monthly. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.