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?
You should not use this medicine if you are allergic to buprenorphine. You will not receive Sublocade unless you have already been using oral buprenorphine for at least 7 days in a row.
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.
If you use Sublocade 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 habit-forming medicine may need medical treatment for several weeks.
Sublocade can pass into breast milk and may cause drowsiness, and breathing problems in a nursing baby. Ask your doctor about any risk.
Sublocade is not approved for use by anyone younger than 18 years old.
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.
Sublocade should never be injected into a vein or a muscle. This medicine is for injection only under the skin. Sublocade forms a solid mass when it comes into contact with a bodily fluid such as blood. Injecting Sublocade into a vein or muscle could result in damage to the skin or underlying tissues, as well as a blood clot that could travel to the lungs and cause death.
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.
Any medical care provider who treats you should know that you are being treated for opioid addiction and that you are receiving Sublocade. Make sure your family members know how to provide this information in case they need to speak for you during an emergency.
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?
Call your doctor for instructions if you miss an appointment for your Sublocade injection.
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?
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid using any opioid pain medicine without approval from the doctor who is treating you with Sublocade. Opioid pain medicine will not work as well while you are receiving Sublocade. Talk with your doctor about other options for pain relief while you are using Sublocade.
What are the possible side effects of Sublocade?
Get emergency medical help if you have signs of an allergic reaction: hives, itching; severe dizziness; wheezing, 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 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 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
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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.
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.
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;
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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).
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2020 Cerner Multum, Inc. Version: 2.03. Revision date: 10/14/2019.
