buprenorphine (injection - Sublocade)

buprenorphine (injection - Sublocade)

Pronunciation: BUE pre NOR feen

Brand: 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?

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 or brain tumor;
  • alcoholism, mental illness;
  • an enlarged prostate and urination problems;
  • liver or kidney 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);
  • curvature of the spine that affects breathing;
  • Addison's disease (adrenal gland disorder); or
  • problems with your gallbladder or thyroid.

If you keep using opioid medicine (oxycodone, morphine, fentanyl, and others) during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Ask a doctor before using Sublocade if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

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.

Tell your doctor if you have a planned surgery.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

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 in case you relapse or keep using opioid medication. 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.

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 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 during sleep;
  • severe drowsiness or dizziness, loss of coordination;
  • pain, redness, itching, or skin changes where the injection was given;
  • 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.

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.

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?

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, blood pressure, motion sickness, irritable bowel, or overactive bladder;
  • other opioid medicines;
  • a benzodiazepine sedative like Valium, Klonopin, or Xanax;
  • sleep medicine, muscle relaxers, or other drugs that make you drowsy; or
  • drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete. Many 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.

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