Sublocade : Uses, Side Effects, Interactions & More

IMPORTANT WARNING:

Buprenorphine extended-release injection is only available through a special distribution program called Sublocade REMS. Your doctor and pharmacy must be enrolled in this program before you can receive Sublocade. Ask your doctor for more information about this program and how you will receive your medicine.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before and during your treatment to check your body’s response to the Sublocade injection.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with your Sublocade injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Why is this medication prescribed?

Sublocade (Buprenorphine extended-release) injection is used to treat opioid dependence (addiction to opioids, including heroin and narcotic pain relievers) in people who have received oral or sublingual buprenorphine for at least 7 days. Sublocade injection is in a class of medications called opioid partial agonists. It works to prevent withdrawal symptoms when someone stops taking opioid medications by producing effects similar to these medications.

How should this medicine be used?

Extended-release (long-acting) Sublocade (Buprenorphine extended-release) comes as a solution (liquid) that a doctor must inject subcutaneously (just under the skin) into the stomach area. It is usually given once a month with at least 26 days between doses. Each Sublocade slowly releases the medicine into your body over a month.

After receiving a dose of Sublocade injection, you may notice a lump at the injection site for several weeks, but it should decrease in size over time. Do not rub or massage the injection site. Make sure your belt or waistband does not put pressure on the place where the medicine was injected.

Your doctor may increase or decrease your dose depending on how well the medicine works for you and the side effects you experience. Be sure to tell your doctor how you feel during your treatment with Sublocade injection.

If prolonged-release buprenorphine is stopped, your doctor will probably decrease your dose gradually. You may experience withdrawal symptoms including restlessness, watery eyes, sweating, chills, widened pupils (black circles in the middle of the eyes), irritability, anxiety, back pain, weakness, stomach cramps, trouble falling asleep. or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast breathing, or a fast heartbeat. These withdrawal symptoms can occur 1 month or more after your last dose of Sublocade injection.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving Sublocade,

Tell your doctor and pharmacist if you are allergic to buprenorphine, any other medications, or any of the ingredients in Sublocade. Ask your pharmacist or see the Medication Guide for a list of ingredients.
Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antihistamines; benzodiazepines such as alprazolam (Xanax), chlordiazepoxide (Librium, in Librax), clonazepam (Klonopin), diazepam (Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), triazo; carbamazepine (Carbatrol, Tegretol, Teril, others); diuretics (‘water pills’); erythromycin (E.E.S., Eryc, PCE, others); HIV medications such as atazanavir (Reyataz, in Evotaz), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), etravirine (Intelence), indinavir (Crixivan), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); certain medications for irregular heartbeat, including amiodarone (Nexterone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), procainamide (Procanbid), quinidine (in Nuedexta), and sotalol (Betapace, Betapace AF, Sorine); medications for glaucoma, mental illness, dizziness, Parkinson’s disease, ulcers, or urinary problems; ketoconazole, other pain medications; medications for migraines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); muscle relaxants; phenobarbital; phenytoin (Dilantin, Phenytek); rifampicin (Rifadin, Rimactane); sedative sleeping pills; 5HT3 serotonin blockers such as alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); selective serotonin reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as duloxetine (Cymbalta), desvenlafaxine (Khedezla, Pristiq), milnacipran (Savella), and venlafaxine (Effexor); tramadol; trazodone tranquilizers; or tricyclic antidepressants (‘mood elevators’) such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine. Also tell your doctor or pharmacist if you are taking or receiving the following monoamine oxidase (MAO) inhibitors or if you have stopped taking them in the last two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine ( Nardil). , selegiline (Eldepryl, Emsam, Zelapar) or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you closely for side effects. Many other medications can also interact with buprenorphine, so be sure to tell your doctor about all medications you are taking, even those that do not appear on this list.
Tell your doctor if you or a family member drink or have ever drunk large amounts of alcohol, or have or have ever had long QT syndrome (a condition that increases the risk of developing irregular heartbeats that can cause loss of consciousness or sudden death). Also, tell your doctor if you have or have ever had low levels of potassium or magnesium in your blood; heart failure; a slow or irregular heartbeat; chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways); other lung diseases; a head injury; a brain tumor; any condition that increases the amount of pressure on your brain; adrenal problems such as Addison’s disease (condition in which the adrenal gland produces less hormones than normal); benign prostatic hypertrophy (BPH, enlarged prostate gland); difficulty urinating hallucinations (seeing things or hearing voices that are not there); a curve in the spine that makes breathing difficult; or thyroid, gallbladder, or liver disease.
Tell your doctor if you are pregnant or plan to become pregnant. If you receive Sublocade injection regularly during pregnancy, your baby could experience life-threatening withdrawal symptoms after birth. Tell your baby’s doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched crying, uncontrollable shaking of part of the body, vomiting, diarrhea, or lack of weight gain.
Tell your doctor if you are breastfeeding. Tell your baby’s doctor right away if your baby is more sleepy than usual or has trouble breathing while receiving this medicine.
You should know that this medicine can decrease fertility in men and women. Talk to your doctor about the risks of using Sublocade injection.
If you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving Sublocade injection.
You should know that Sublocade injection may make you drowsy. Do not drive a car or operate machinery until you know how this medicine affects you.
You should not drink alcohol or use illegal drugs during your treatment. Drinking alcohol, taking prescription or over-the-counter medications that contain alcohol, or using illegal drugs during your treatment with Sublocade increases the risk that you will experience serious and life-threatening breathing problems.
You should know that buprenorphine can cause dizziness, lightheadedness, and fainting when you get up too quickly from lying down. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
You should know that buprenorphine can cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while using Sublocade.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you miss a scheduled dose of Sublocade injection, you should call your doctor for the dose as soon as possible. Your next dose should be given at least 26 days later.

What side effects can this medication cause?

Sublocade injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

nausea
vomiting
headache
fatigue
pain, itching, swelling, discomfort, redness, bruising, or bumps in the injection site

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately or get emergency medical treatment:

difficulty breathing
agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, slurred speech, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
nausea, vomiting, loss of appetite, weakness, or dizziness
inability to get or keep an erection
irregular menstruation
decreased sexual desire
rash
hives
itching
slurred speech
blurred vision
changes in heartbeat
pain in the upper right part of the stomach
yellowing of the skin or eyes
dark-colored urine
light-colored stools

Sublocade injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

Call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, is having trouble breathing, or is unable to wake up, immediately call 911 for emergency services.

Symptoms of overdose may include the following:

narrowing or widening of the pupils (black circles in the center of the eye)
slowed or difficulty breathing
extreme sleepiness or drowsiness
coma (loss of consciousness for a period of time)
slow heartbeat

What other information should I know?

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using Sublocade.

In the event of an emergency, a family member or caregiver should inform emergency medical personnel that you are physically dependent on an opioid and are receiving Sublocade injection.

Sublocade injection is a controlled substance. Be sure to make regular appointments with your doctor to receive your injections. Ask your pharmacist if you have any questions.

It is important that you keep a written list of all prescription and over-the-counter (over-the-counter) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should take this list with you each time you visit a doctor or if you go into hospital. It is also important information to take with you in case of emergencies.

Brand Names

Sublocade^®

Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.