Buprenorphine (Intradermal route)
Insertion and removal of the buprenorphine implant are associated with the risk of implant migration, protrusion, and expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion, and expulsion. Because of the risks associated with insertion and removal, the buprenorphine implant is available only through a restricted program called the PROBUPHINE REMS Program. All healthcare providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing buprenorphine implants .
Uses of This Medicine:
Buprenorphine implant is used for the maintenance treatment of opioid (narcotic) dependence in patients who have received other medicines containing buprenorphine (eg, Suboxone®, Subutex®).
When a narcotic medicine is used for a long time, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects if the narcotic is stopped suddenly. Severe withdrawal side effects can usually be prevented when a person is switched to buprenorphine. It acts on the central nervous system (CNS) to help prevent the withdrawal side effects.
This medicine is to be given only by or under the direct supervision of a trained healthcare professional.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of buprenorphine implant in the pediatric population. Safety and efficacy have not been established in children younger than 16 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of buprenorphine implant in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving buprenorphine implant.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Methylene Blue
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Sodium Oxybate
- St John's Wort
- Tolonium Chloride
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison disease (adrenal gland problem) or
- Alcohol abuse, or history of or
- Breathing problems, severe (eg, hypercapnia, hypoxia) or
- Chronic obstructive pulmonary disease (COPD) or
- CNS depression or
- Connective tissue disease (eg, scleroderma), history of or
- Cor pulmonale (serious heart condition) or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Gallbladder disease or
- Head injuries, history of or
- Hypothyroidism (an underactive thyroid) or
- Keloid formation, history of or
- Kyphoscoliosis (curvature of the spine with breathing problems) or
- Mental illness or
- MRSA infection, history of or
- Problems with passing urine Use with caution. May increase risk for more serious side effects.
- Hypotension (low blood pressure) Use with caution. May make this condition worse.
- Liver disease, moderate to severe Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Probuphine® is an implant that is surgically placed and removed under the skin of the upper arm by a trained healthcare provider. The implants are placed in the upper arm for 6 months of treatment and are removed by the end of the sixth month.
Your doctor will treat the arm with numbing medicine and then cut a small incision to insert the implant with a special tool. The incision will be covered with 2 bandages. The top adhesive bandage will be placed over the arm and should be left on for 24 hours. Keep the smaller, bottom bandage clean and dry and in place for 3 to 5 days.
You should apply an ice pack to your arm for 40 minutes every 2 hours for the first 24 hours after placing the implants or as needed.
Your doctor will give you a patient identification card to carry with you.
Do not try to remove the implants by yourself.
If the implant sticks out or comes out: Wash your hands if you touch the implant. Cover the area where the implants were inserted with a clean bandage. Place the implant in a plastic bag, store it in a safe place out of the reach of children, and call your doctor right away.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions While Using This Medicine:
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using this medicine.
Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.
If you have been using this medicine regularly for several days, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects (eg, abdominal or stomach cramps, fever, runny nose, anxiety, or restlessness).
Using too much buprenorphine, or taking too much of another narcotic while using buprenorphine, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Symptoms of an overdose include very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened. Other signs of an overdose may include cold, clammy skin, low blood pressure, pinpoint (small) pupils of the eyes, and a slow heartbeat.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- bleeding, itching, pain, redness, scarring, or swelling at the incision
- dark urine
- darkening of the skin
- difficult or troubled breathing
- difficulty with swallowing
- fast heartbeat
- general tiredness and weakness
- hives, itching, or skin rash
- irregular, fast or slow, or shallow breathing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- mental depression
- noisy breathing
- overactive reflexes
- pale or blue lips, fingernails, or skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- talking or acting with excitement you cannot control
- tightness in the chest
- trembling or shaking
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
- Symptoms of overdose
- Blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- pinpoint pupils
- relaxed and calm
- More common
- Back pain
- difficulty having a bowel movement (stool)
- mouth pain
- runny nose
- stuffy nose
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/15/2016