Actual product appearance may differ slightly.
The only way to obtain buprenorphine extended-release injectable is through Sublocade REMS, a unique distribution scheme. Before you can receive a buprenorphine injection, both your doctor and your pharmacist must be signed up for this programme. For additional information about this programme and how you will receive your medication, speak with your doctor.
Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to the buprenorphine extended-release injection, your doctor may prescribe specific tests both before and after your therapy.
The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start buprenorphine extended-release injection therapy and each time you get a new prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the Food and Drug Administration (FDA) website.
Why is this medication prescribed?
Those who have taken buccal or sublingual buprenorphine for at least 7 days are treated for opioid dependence (addiction to opioid medications, including heroin and narcotic painkillers) with buprenorphine extended-release injection. The drug buprenorphine extended-release injectable belongs to the group of drugs known as opiate partial agonists. It functions by creating effects that are comparable to those of opioid medicines, preventing withdrawal symptoms when someone stops using them.
How should this medicine be used?
A healthcare professional will inject buprenorphine extended-release (long-acting) injection subcutaneously (just beneath the skin) into the stomach area. It is typically administered once each month, with a minimum gap of 26 days between doses. Each injection of buprenorphine gradually delivers the medicine into your bloodstream over the course of a month.
After receiving a dose of buprenorphine extended-release injection, you might experience some swelling for a few weeks, but it should eventually go away. Avoid massaging or rubbing the injection site. Make sure your belt or waistband is not pressing against the injection site for the medication.
Depending on how well the drug works for you and any adverse effects you encounter, your doctor may raise or decrease your dose. When receiving a buprenorphine extended-release injection as part of your treatment, be careful to let your doctor know how you are feeling.
Your doctor will most likely gradually reduce your dose if buprenorphine extended-release needs to be stopped. Restlessness, teary eyes, sweating, chills, widening of the pupils (black circles in the middle of the eyes), irritability, anxiety, backache, weakness, stomach cramps, trouble falling or staying asleep, nausea, loss of appetite, vomiting, diarrhoea, fast breathing, or rapid heartbeat are just a few withdrawal symptoms you might experience. One month or more after your last dosage of buprenorphine extended-release injection, you may experience these withdrawal symptoms.
Other uses for this medicine
Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.
What special precautions should I follow?
Before receiving buprenorphine injection,
- If you have an allergy to buprenorphine, any other drugs, or any of the chemicals in buprenorphine injection, let your doctor and pharmacist know right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
- Inform your doctor and pharmacist about any additional prescription and over-the-counter medications, vitamins, herbal items, nutritional supplements, and any drugs you are now taking or intend to take. Any of the following should be mentioned: antihistamines; benzodiazepines such as triazolam (Halcion), lorazepam (Ativan), oxazepam (Restoril), chlordiazepoxide (Librium, in Librax), estazolam (Xanax), flurazepam (Klonopin), and flurazepam (Librium); HIV drugs such as atazanavir (Reyataz, in Evotaz), delavirdine (Rescriptor), efavirenz (Sustiva, in Atripla), indinavir (Crixivan), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); diuretics (‘water pills’); erythromycin (E.E.S., Eryc, PCE, others); medications for glaucoma, mental illness, motion sickness, Parkinson’s disease, ulcers, or urinary problems; ketoconazole; other painkillers; medications for irregular heartbeat, such as amiodarone (Nexterone, Pacerone), disopyramide (Norpace), procainamide (Procanbid), quinidine (in Nuedexta), and sotalol (Betapace, Betapace AF, Sorine); such as zolmitriptan (Amig), sumatriptan (Imitrex, in Treximet), naratriptan (Amerge), eletriptan (Relpax), frovatriptan (Frova), and zolmitriptan (Axert); muscle relaxants; phenobarbital; phenytoin (Dilantin, Phenytek); 5HT3 serotonin blockers such alosetron (Lotronex), dolasetron (Anzemet), granisetron (Kytril), ondansetron (Zofran, Zuplenz), or palonosetron (Aloxi); rifampin (Rifadin, Rimactane); sedatives; sleeping medications; selective serotonin-reuptake inhibitors like duloxetine; serotonin and norepinephrine reuptake inhibitors like citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline ( (Cymbalta), tramadol, tranquillizers, trazodone, or tricyclic antidepressants (often known as “mood lifters”) including amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine are examples of these (Surmontil).Also let your physician or pharmacist know if you are receiving any of the following monoamine oxidase (MAO) inhibitors, or if you have stopped taking them within the previous two weeks: methylene blue, isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). The dosage of your drugs may need to be adjusted, and your health may need to be closely watched for any negative effects. Buprenorphine and numerous other drugs may interact, so be sure to let your doctor know about all the drugs you’re taking, even if they’re not on this list.
- Inform your doctor if you or a member of your family consumes significant amounts of alcohol or has ever experienced prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness or sudden death). A slow or irregular heartbeat, heart failure, chronic obstructive pulmonary disease (COPD), a set of illnesses that affect the lungs and airways, heart failure, low levels of potassium or magnesium in the blood, or if you previously had any of these conditions, should also be mentioned to your doctor. Addison’s disease, which causes the adrenal gland to produce less hormone than normal, benign prostatic hypertrophy (BPH), enlargement of the prostate gland, difficulty urinating, hallucinations (seeing things or hearing voices that are not there), a curve in the spine that makes it difficult to breathe, thyroid, gallbladder, or any condition that increases the amount of pressure in your brain
- If you are pregnant or plan to become pregnant, let your doctor know. Regular extended-release injections of buprenorphine during pregnancy may put your unborn child at danger of experiencing life-threatening withdrawal symptoms. If your infant exhibits any of the following symptoms, contact your doctor straight away: irritability, hyperactivity, disturbed sleep, high-pitched crying, excessive shaking of a body part, vomiting, diarrhoea, or failure to gain weight.
- If you are breastfeeding, let your doctor know. If your infant seems more lethargic than usual or experiences breathing difficulties while you are taking this medicine, call your doctor straight away.
- You should be aware that this medicine may lower both male and female fertility. The dangers of using buprenorphine extended-release injectable should be discussed with your doctor.
- Inform the surgeon or dentist that you are receiving an extended-release injection of buprenorphine if you are having surgery, including dental surgery.
- You should be aware that the extended-release injection of buprenorphine may cause you to feel sleepy. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
- During your treatment, you shouldn’t consume alcohol or use illegal substances. You have a higher risk of developing severe and perhaps fatal respiratory issues while receiving therapy with buprenorphine injection if you consume alcohol, take prescription or over-the-counter meds that include alcohol, or use illicit substances.
- You should be aware that taking buprenorphine can make you feel weak, lightheaded, and dizzy if you stand up too rapidly from a reclining position. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
- The possibility of constipation with buprenorphine should be noted. While using buprenorphine injection, discuss with your doctor whether you should alter your diet or take additional medications to prevent or cure constipation.
What special dietary instructions should I follow?
Keep eating normally unless your doctor instructs you otherwise.
What should I do if I forget a dose?
Buprenorphine extended-release injectable doses are scheduled, so if you forget to take one, call your doctor right once to get the next dose. At least 26 days should pass before you take your next dose.
What side effects can this medication cause?
The extended-release injection of buprenorphine may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:
- Injection site discomfort, itchiness, pain, swelling, redness, bruising, or lumps
Some adverse effects can be very harmful. Call your doctor right away if you encounter any of these symptoms, or seek emergency care:
- Having trouble breathing
- Agitation, hallucinations (hearing voices or seeing things that aren’t there), fever, sweating, confusion, shakiness, slurred speech, extremely rigid or twitching muscles, loss of coordination, fever, nausea, diarrhoea, or vomiting
- Nausea, vomiting, weight loss, anorexia, or lightheadedness
- Failure to achieve or maintain erection
- Irregular periods of time
- Less sexual arousal
- Muddled speech
- Fuzzy vision
- Alterations in heartbeat
- Stomach ache in the top right corner
- Eyes or skin that have a yellow tint
- Urine with a dark colour
- Stools with a light colour
Other negative effects could be brought on by buprenorphine extended-release injection. If you have any strange side effects while taking this medicine, call your doctor right away.
You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).
In case of emergency/overdose
Call 1-800-222-1222 to reach the poison control helpline. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.
Symptoms of overdose may include the following:
- Pupil dilation or dilation of the pupils (black circles in the centre of the eye)
- Sluggish or challenging breathing
- Excessive tiredness or sleepiness
- Coma (loss of consciousness for a period of time)
- Sluggish heartbeat
What other information should I know?
Inform your doctor and the lab staff that you are using buprenorphine injection prior to any laboratory test (particularly those involving methylene blue).
You should be treated with buprenorphine extended-release injection if you are physically dependent on an opioid, and a family member or carer should inform emergency medical personnel of this if necessary.
Extended-release buprenorphine injection is a prohibited drug. To receive your injections, make sure to arrange regular appointments with your doctor. If you have any inquiries, go to your pharmacist.
You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.