FDA Drug Safety Communication:
- As part of its ongoing efforts to address the nation's opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
- Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
- Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.
Buprenorphine extended-release injection is only available through a special distribution program called Sublocade REMS. Your doctor and your pharmacy must be enrolled in this program before you can receive buprenorphine injection. Ask your doctor for more information about this program and how you will receive your medication.
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 buprenorphine extended-release injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with buprenorphine extended-release 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?
Buprenorphine extended-release injection is used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers) in people who have received buccal or sublingual buprenorphine for at least 7 days. Buprenorphine extended-release injection is in a class of medications called opiate partial agonists. It works to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
How should this medicine be used?
Buprenorphine extended-release (long-acting) injection comes as a solution (liquid) to be injected subcutaneously (just under the skin) by a health care provider into the stomach area. It is usually given once monthly with at least 26 days in between doses. Each buprenorphine injection slowly releases the drug into your body over a month.
After you receive a dose of buprenorphine extended-release 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. Be sure that your belt or waistband does not put pressure on the place where the medication was injected.
Your doctor may increase or decrease your dose depending on how well the medication works for you, and any side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with buprenorphine extended-release injection.
If buprenorphine extended-release is to be discontinued, your doctor will probably decrease your dose gradually. You may experience withdrawal symptoms including restlessness, teary eyes, sweating, chills, widening of the pupils (black circles in the middle of the eyes), irritability, anxiety, backache, weakness, stomach cramps, difficulty falling asleep or staying asleep, nausea, loss of appetite, vomiting, diarrhea, fast breathing, or fast heartbeat. These withdrawal symptoms may occur 1 month or longer after your last buprenorphine extended-release injection dose.
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 buprenorphine injection,
- tell your doctor and pharmacist if you are allergic to buprenorphine, any other medications, or any of the ingredients in buprenorphine injection. Ask your pharmacist or check the Medication Guide for a list of the 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 such as alprazolam (Xanax), chlordiazepoxide (Librium, in Librax), clonazepam (Klonopin), diazepam (Valium), estazolam, flurazepam, lorazepam (Ativan), oxazepam, temazepam (Restoril), triazolam (Halcion); 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, motion sickness, Parkinson's disease, ulcers, or urinary problems; ketoconazole, other medications for pain; medications for migraine headaches 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); rifampin (Rifadin, Rimactane); sedatives; 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; tranquilizers; trazodone; or tricyclic antidepressants ('mood elevators') such as amitriptyline, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil). 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 within the past 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 carefully for side effects. Many other medications may also interact with buprenorphine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
- tell your doctor if you or a family member drinks or has ever drunk large amounts of alcohol or have or have ever had prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may 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 the 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 in your brain; adrenal problems such as Addison's disease (condition in which the adrenal gland produces less hormone than normal); benign prostatic hypertrophy (BPH, enlargement of the prostate gland); difficulty urinating; hallucinations (seeing things or hearing voices that do not exist); a curve in the spine that makes it hard to breathe; or thyroid, gallbladder, or liver disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you receive buprenorphine extended-release injection regularly during your 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 cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.
- tell your doctor if you are breastfeeding. Tell your baby's doctor right away if your baby is sleepier than usual or has trouble breathing while you are receiving this medication.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using buprenorphine extended-release injection.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving buprenorphine extended-release injection.
- you should know that buprenorphine extended-release injection may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- you should not drink alcohol or use street drugs during your treatment. Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with buprenorphine injection increases the risk that you will experience serious and life-threatening breathing problems.
- you should know that buprenorphine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. 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 may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using buprenorphine injection.
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 buprenorphine extended-release injection dose, you should call your doctor to receive the dose as soon as possible. Your next dose should be given at least 26 days later.
What side effects can this medication cause?
Buprenorphine extended-release injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- 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
- 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
Buprenorphine extended-release injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (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 has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
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 buprenorphine injection.
In the case of an emergency, a family member or caregiver should tell the emergency medical staff that you are physically dependent on an opioid and are receiving treatment with buprenorphine extended-release injection.
Buprenorphine extended-release injection is a controlled substance. Be sure to schedule appointments with your doctor on a regular basis to receive your injections. Ask your pharmacist if you have any questions.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.