Sublocade Injection (buprenorphine)

Generic name: buprenorphine (BUE pre NOR feen)
Brand name: Sublocade

Sublocade (buprenorphine) is an opioid medication, sometimes called a narcotic.

Sublocade is used to treat opioid addiction. It 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.

Warnings

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

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.

Before taking this medicine

You should not use Sublocade 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.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • a 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.

Some medicines can interact with buprenorphine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

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. Tell your doctor if you are pregnant or plan to become pregnant.

Sublocade can pass into breast milk and may cause drowsiness, and breathing problems in a nursing baby. Tell your doctor if you are breast-feeding.

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 this medicine 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.

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 this medicine 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?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Sublocade will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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 this medicine.

Sublocade side effects

Get emergency medical help if you have signs of an allergic reaction to Sublocade: 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
  • 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 Sublocade 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.

Buprenorphine 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;
  • 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 interact with buprenorphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Alternatives to Sublocade

There are different dosage forms and alternative drugs used to treat opioid use disorder

Talk with your healthcare provider which option would be best suited to you.

Buprenorphine

  • Implant (Probuphine), Sublingual (Subutex)

Buprenorphine and naloxone

  • Sublingual (Bunavail, Suboxone, Zubsolv)

Lofexidine

  • Tablets (Lucemyra)

Methadone

  • Tablets (Dolophine)

Naltrexone

  • IM injection (Vivitrol), Naltrexone tablets

For opioid overdose in an emergency situation:

Naloxone

  • Nasal spray (Narcan, Kloxxado), Naloxone injection

Other related medicines:

Buprenorphine for severe pain:

  • IM injection (Buprenex), Sublingual (Belbuca), Transdermal patch (Butrans)