Buprenex Injection

Buprenex is an opioid medicine used to treat moderate to severe pain in adults and children at least 2 years old. An opioid is sometimes called a narcotic.

Buprenex Injection is used to relieve moderate pain that is severe enough to require an opiate pain killer and for which other medicines (e.g., non-opiate pain killers or opiate-containing combination medicines) have not been, or are not expected to be sufficient.

Buprenorphine belongs to a class of medications called opiate partial agonists. Buprenex works by changing the way the body senses pain.

Patients using Buprenex should be checked regularly to see whether they still need this opioid medicine for pain, whether it is helping, and whether they are having side effects or showing signs of misuse, abuse, or addiction.

This medication guide provides information about the Buprenex brand of buprenorphine injection. Sublocade is another brand of buprenorphine injection used to treat opioid addiction.

Buprenex is injected into a muscle or given as an infusion into a vein. A healthcare provider will give you this injection. Buprenex is usually given by injection only if you are unable to take the medicine by mouth or use another form of buprenorphine.

Buprenex is usually given at evenly spaced intervals, up to 6 hours apart. Tell your doctor if Buprenex does not relieve your pain within 1 hour after an injection.

Buprenex can cause irritation if it gets on your skin. If this occurs, remove any clothing the medicine has spilled onto, and rinse your skin with water.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely. You may need other medical tests.

Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Buprenex has boxed warnings for addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; and risks from concomitant use with benzodiazepines or other CNS depressants. A boxed warning is the strongest safety-related warning issued by the FDA.

Buprenex may be habit-forming. Misuse can cause addiction, overdose, or death.

Using Buprenex during pregnancy may cause life-threatening withdrawal symptoms in the newborn (neonatal opioid withdrawal syndrome).

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

You should not use Buprenex if you are allergic to buprenorphine, or if you have:

• severe asthma or breathing problems; or
• a stomach or bowel obstruction (including paralytic ileus).

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

• chronic obstructive pulmonary disease (COPD), sleep apnea, or other breathing disorder;
• a head injury, brain tumor, high pressure inside the skull, or seizures;
• problems with your bile duct, gallbladder, pancreas, thyroid, or adrenal gland;
• heart problems, an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• a drug or alcohol addiction, or mental illness;
• enlarged prostate, urination problems;
• curvature of the spine that affects breathing; or
• liver or kidney disease.

Tell your doctor if you also use stimulant medicine, other opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with buprenorphine could cause a serious condition called serotonin syndrome.

If you use buprenorphine during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Do not breastfeed. Buprenorphine in breast milk can cause life-threatening side effects in a nursing baby.

Get emergency medical help if you have signs of an allergic reaction to Buprenex: hives, 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.

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

• confusion, cold and clammy skin, slow breathing (breathing may stop);
• feeling light-headed;
• fast or uneven heart rate, shortness of breath;
• blue lips or fingernails; or
• severe constipation.

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 breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common Buprenex side effects may include:

• drowsiness, slow breathing;
• nausea, vomiting;
• dizziness, vertigo (spinning sensation);
• pinpoint pupils;
• increased sweating; or
• headache.

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.

Usual Adult Dose of Buprenex for Pain:

Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as needed-A single 0.6 mg IM dose may be given to patients who are not in a high risk category (see Warnings)Maximum single dose: 0.3 mg (IV) or 0.6 mg (IM)

Usual Pediatric Dose of Buprenex for Pain:

2 to 12 years:Initial dose: 2 to 6 mcg/kg IM or slow IV every 4 to 6 hours-Some patients may not need to be remedicated for 6 to 8 hours; fixed interval or round the clock dosing should not be used until the proper inter-dose interval has been establishedOver 12 years:Initial dose: 0.3 mg deep IM or slow IV (over at least 2 minutes); may repeat this dose once after 30 to 60 minutes if needed; then, 0.3 mg IV/IM every 6 hours as neededMaximum single dose: 0.3 mgComments:-Use extra caution with IV administration, especially the first dose.-Monitor closely for respiratory depression, especially within the first 24 to 72 hours.-Use the lowest effective dose for the shortest duration consistent with the individual patient's treatment goals.

• Do not rapidly reduce or abruptly discontinue this medicine in patients who may be physically dependent on opioidsUse: For the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

In a medical setting you are not likely to miss a dose.

In a medical setting an overdose would be treated quickly.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Buprenex will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

You may have a fatal buprenorphine overdose if you start or stop using certain other medicines. Tell your doctor about all your medications.

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; or
• sleep medicine, muscle relaxers, or other drugs that make you drowsy.

This list is not complete and many other drugs may interact with Buprenex. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Distributed by: Indivior Inc., North Chesterfield, VA 23235, USA.