buprenorphine (injection - Sublocade)

What is the most important information I should know about Sublocade?

Sublocade is available only in a certified healthcare setting under a special program. You will not be able to give yourself this medicine.

What is Sublocade (buprenorphine)?

This medication guide provides information about the Sublocade brand of buprenorphine injection. Buprenex is another brand of buprenorphine injection that is used to treat moderate to severe pain.

Sublocade is used to treat opioid addiction. Sublocade is not for use as a pain medication.

Sublocade is given to people who have started addiction treatment with an oral form of buprenorphine placed under the tongue or inside the cheek (such as Suboxone or Subutex).

Sublocade is available only in a certified healthcare setting under a special program. You will not be able to give yourself this medicine.

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

What should I discuss with my healthcare provider before using Sublocade?

Tell your doctor if you have ever had:

• breathing problem, sleep apnea;
• a head injury, brain tumor, or seizures;
• alcoholism, drug addiction, mental illness;
• an enlarged prostate or urination problems;
• liver disease;
• a heart rhythm disorder (especially if you take medication to treat it);
• long QT syndrome (in you or a family member);
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• abnormal curvature of the spine that affects breathing;
• Addison's disease (adrenal gland disorder); or
• problems with your gallbladder or thyroid.

How is Sublocade given?

Sublocade is injected under the skin once per month. A healthcare provider will give you this injection. You should not give yourself this medicine.

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 lump, or wearing tight clothing over the area.

At least 26 days should pass between each injection of Sublocade.

Sublocade 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 this medicine is not helping to improve your symptoms of addiction.

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

If you need surgery, tell the surgeon ahead of time that you are using Sublocade.

Do not stop receiving Sublocade suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving Sublocade?

What are the possible side effects of Sublocade?

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

• weak or shallow breathing, breathing that stops during sleep;
• 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, upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low cortisol levels -- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious side effects may be more likely in older adults.

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 side effects may include:

• feeling tired;
• nausea, vomiting, constipation;
• itching, pain, or a lump where the medicine was injected;
• 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.

What other drugs will affect Sublocade?

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.

• 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 affect Sublocade, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about buprenorphine injection (Sublocade).