Language selection

Government of Canada

Search

Details for: PROBUPHINE

Company: KNIGHT THERAPEUTICS INC.

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02474921PROBUPHINEBUPRENORPHINE HYDROCHLORIDE80 MGIMPLANTSUBCUTANEOUS
Search Reported Side Effects Report a Side Effect

Summary Reports

Summary Basis of Decision
Regulatory Decision Summary

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

PROBUPHINE is:

  • Used to treat adults (18 years and older) who are dependent on opioid drugs.
  • For adults who are currently taking no more than 8 mg of sublingual buprenorphine.
  • A drug program used along with counseling and psychosocial support.
What it does

PROBUPHINE contains buprenorphine. It works in a similar way as other opioid drugs that are used in the treatment of pain. When you stop taking opioid drugs, you can experience withdrawal. PROBUPHINE helps control the symptoms you feel when you are in withdrawal.

When it should not be used

  • Are allergic to buprenorphine or to ethylene vinyl acetate (EVA);
  • Have trouble breathing or other lung problems;
  • Have any conditions that can cause you to have higher than normal carbon dioxide levels in your blood;
  • Have any problems with your heart;
  • Have low levels of potassium, calcium or magnesium in your blood;
  • Have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen;
  • Have serious problems with your liver;
  • Suffer from severe central nervous system depression;
  • Have or had a brain injury or medical condition that can cause growing pressure inside your head;
  • Are at risk for seizures;
  • Suffer from or have a history of alcoholism;
  • Are under 18 years of age.
What the medicinal ingredient is

buprenorphine hydrochloride

What the non-medicinal ingredients are

ethylene vinyl acetate (EVA)

What dosage form it comes in

Subdermal implant: containing 80 mg buprenorphine hydrochloride

Warnings and precautions

Serious Warnings and Precautions

  • Serious complications may happen from the insertion and removal of PROBUPHINE, including:
    • Damage to nerve or blood vessels in your arm
    • Movement of an implant (migration) or pieces of it into blood vessels and your lungs. This could lead to death.
    • Call your healthcare professional right away if:
      • An implant sticks out of the skin or comes out by itself;
      • You have bleeding or symptoms of infection at the site after insertion or removal, including excessive or worsening itching, pain, irritation, redness, or swelling;
      • You have numbness or weakness in your arm or shortness of breath after the insertion or removal procedure.
  • QTc Prolongation: medicines containing buprenorphine have been known to cause problems with how a heart beats (abnormal heart rhythm) in some people. Tell your healthcare professional if you have heart problems.

    • Before you start PROBUPHINE, you should tell your healthcare professional all the medications you are taking as well as changes to or any new medicines you start while you are on PROBUPHINE. Call your healthcare professional right away if you:
    • Have pain or discomfort in your chest that was not there before;
    • Have changes in how your heart beats (it beats too fast, skips a beat);
    • Feel dizzy;
    • Feel lightheaded or feel like you are going to pass out.

    PROBUPHINE contains buprenorphine and belongs to the opioid class of drugs. The warnings and precautions below apply to all medicines in this class including PROBUPHINE.
  • If an implant sticks out or comes out by itself, store it safely to prevent theft and misuse until you can take it to your healthcare professional. Never give your PROBUPHINE to anyone else, because it may harm them or cause death. Selling or giving away PROBUPHINE is against the law. If a child accidently comes into contact with an implant, get emergency help right away.
  • Life-threatening breathing problems can happen while using PROBUPHINE, especially if not used as directed. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
    • If you used PROBUPHINE while you were pregnant, whether for short or long periods of time, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:
      • Has changes in their breathing (such as weak, difficult or fast breathing);
      • Is not feeding well;
      • Is unusually difficult to comfort;
      • Has tremors (shakiness);
      • Has stiffness;
      • Has increased stools or diarrhea;
      • Is sneezing, yawning, vomiting, or has fever.
        • Get medical help right away for your baby.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take PROBUPHINE. Talk about any health conditions or problems you may have, including if you:

  • Have a history of illicit or prescription drug or alcohol abuse;
  • Have problems with how your heart beats (abnormal heart rhythm) or you have a close family member with this problem who is taking medicines to treat it;
  • Have low blood pressure;
  • Have brain problem or recent head injury;
  • Have problems with your gallbladder;
  • Have adrenal gland problems such as Addison’s disease;
  • Have liver disease;
  • Have heart disease;
  • Have trouble breathing, asthma, sleep apnea or other respiratory problems;
  • Have past or current depression and are taking medicines to treat it;
  • Have severe kidney disease or kidney problems;
  • Have severe mental problems or hallucinations (seeing or hearing things that are not really there);
  • Have low thyroid hormone levels (hypothyroidism);
  • Suffer from chronic or severe constipation;
  • Have a curve in your spine that affects your breathing;
  • Have problems urinating;
  • In men: have an enlarged prostate gland;
  • Have a history of keloid formations;
  • Have connective tissue disease (such as scleroderma);
  • Have a history of recurring MRSA (methicillin resistant Staphylococcus aureus) infections;
  • Are going to have a planned surgery;
  • Are taking or have taken a Monoamine Oxidase inhibitor (MAOi) (such as moclobemide or selegiline);
  • Are pregnant or planning to become pregnant*;
  • Are breastfeeding or planning to breastfeed*.

*Pregnancy and breast-feeding: If you are pregnant or planning to become pregnant or you are breastfeeding or planning to breast-feed your baby your doctor will decide if you should use PROBUPHINE. The ingredient in PROBUPHINE can be transferred to your baby through breast milk, or while still in the womb. It can then cause life-threatening breathing problems in your unborn baby or nursing infant. It should only be used if the potential benefit justifies the potential risk to the fetus or baby. It is important that you discuss this with your healthcare professional.

Other warnings you should know about

Driving and operating machinery: Before you do tasks, which may require special attention, you should wait until you know how you react to PROBUPHINE. PROBUPHINE can cause:

  • Drowsiness;
  • Dizziness;
  • Lightheadness.

This can usually occur within the first few days after implant insertion.

Implant breakage: It is unlikely that the PROBUPHINE implants will break after their insertion under the skin. A broken implant should not affect how well PROBUPHINE works. If you think that an implant has broken, you should contact your healthcare professional.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

  • Nausea, vomiting;
  • Feeling tired, weak or dizzy;
  • Decreased appetite.

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you medication, and take you off PROBUPHINE.

Serotonin Syndrome: PROBUPHINE can cause serotonin syndrome, a rare but potentially lifethreatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop serotonin syndrome if you take certain antidepressants or migraine medications while on PROBUPHINE treatment.
Serotonin syndrome symptoms include:

  • Fever, sweating, shivering, diarrhea, nausea, vomiting;
  • Muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
  • Fast heartbeat, changes in blood pressure;
  • Confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sleep Apnea: Opioids can cause sleep-related breathing disorders including sleep apnea (breathing interruptions during sleep) and sleep-related hypoxemia (low level of oxygen in the blood). Your healthcare professional may decide to remove PROBUPHINE implants.

Treatment of short-term pain: When you are on PROBUPHINE treatment, there may be times when you need to take other medicines, including other opioids, to treat short-term pain. Since PROBUPHINE may make it difficult to get full pain relief from other opioids, you should tell your doctor that you are on PROBUPHINE treatment if they are treating you for pain.

Sexual Function/ Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Monitoring and Laboratory Tests: Your doctor may do an electrocardiogram (ECG):

  • Before you start your treatment.
  • After your first dose and at regular intervals during your treatment.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

Serious Drug Interactions

Taking:

  • Other opioid medications (used to treat pain);
  • Benzodiazepines (used to treat anxiety or sleep disorders);
  • Alcohol;
  • Or other central nervous system depressants (including street drugs)

while you are on PROBUPHINE treatment can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

  • Drugs used to treat an irregular heartbeat (such as quinidine, procainamide, disopyramide, flecainide, amiodarone, sotalol, ibutilide, dronedarone and propafenone).
  • General anesthetics (used during surgery).
  • Benzodiazepines or other drugs used to help you sleep or to help reduce anxiety.
  • Drugs used to treat depression and mood disorders (such as nefaxodone, fluosetine, citalopram, amitriptyline, imipramine and maprotiline).
  • Drugs used to treat serious mental or emotional disorders (such as schizophrenia).
  • Antipsychotics (such as chlorpromazine, pimozide, haloperidol, droperidol, ziprasidone and risperidone).
  • Antihistamines (used to treat allergies).
  • Drugs used to treat malaria (such as quinine and chloroquine).
  • Drugs used for the treatment or prevention of vomiting (such as aprepitant, domperidone and ondansetron).
  • Drugs used to treat muscle spasms and back pain (such as muscle relaxants, like cyclobenzaprine).
  • Drugs used to treat viral infections (such as ritonavir, nelfinavir, amprenavir and fosamprenavir).
  • Drugs used to treat fungal infections (such as ketoconazole, itraconzole, voriconazole and fluconazole).
  • Drugs used to treat bacterial infections (such as troleandomycin, clarithromycin, erythromycin, azithromycin, tacrolimus, moxifloxacin, levofloxacin and ciprofloxacin).
  • Drugs used to treat high blood pressure (such as diuretics, also known as “water pills,” verapamil and diltiazem).
  • Drugs used to treat migraines (such as triptans).
  • Warfarin (such as Coumadin) and other anticoagulants (used for the prevention or treatment of blood clots).
  • Monoxidase inhibitors (MAOi) (such as moclobemide or selegiline).
  • Drugs that affect the level of electrolytes in your blood (such as diuretics, laxatives, high doses of corticosteroids and drugs used to reduce the amount of acid made by your stomach).
  • Drugs used to treat certain types of cancer (such as sunitinib, nilotinib, ceritinib, vandetabib, arsenic trioxide and vorinostat).
  • Drugs used to treat asthma or COPD (such as salmeterol and formoterol).
  • Grapefruit juice.

Proper use of this medication

PROBUPHINE is a drug that comes in the form of an implant. 4 implants are inserted just underneath the skin in the inside of your upper arm.

The implants must only be inserted and removed by a certified Healthcare Professional who has received instruction and training.

Insertion of the implants

  • The implants are soft, flexible, and about the size of a matchstick.
  • 4 implants are placed just under the skin on the inside of your upper arm by a minor surgical procedure.
  • Your healthcare professional will cover the site where the implants were inserted with 2 bandages:
    • Leave the top bandage on for 24 hours.
    • Keep the smaller, bottom bandage clean, dry, and in place for 3 to 5 days.
  • You should apply an ice pack to your arm where the implants were inserted, for 40 minutes every 2 hours for the first 24 hours and as you need.
  • Your healthcare professional will fill out and give you a Patient Identification (ID) card. You need to carry this card with you at all times. The implants cannot be seen by x-ray or a CT scan. The card identifies that you are using PROBUPHINE and easily identifies where the implants can be found in your arm. It also shows the date your implants were inserted and the date they are to be removed.
  • Your healthcare professional will decide how long the PROBUPHINE implants will stay in your arm.
  • This card will help you to keep track of the date the implants are to be removed. Schedule an appointment with your healthcare professional to remove the implants on or before the removal date listed on your card.

You should tell your family members that you are using PROBUPHINE to treat your opioid dependence.

Removal of the implants

Do not try to remove the implants yourself. This could lead to infection and you could go into opioid withdrawal. Ask your healthcare professional how to stop PROBUPHINE treatment.

  • The 4 implants are removed by a minor surgical procedure.
  • When the implants are removed, the insertion site will be closed with stitches.
  • Your healthcare professional will cover the site where the implants were removed with 2 bandages:
    • Leave the top bandage on for 24 hours.
    • Keep the smaller, bottom bandage clean, dry, and in place for 3 to 5 days.
  • You should apply an ice pack to your arm where the implants were inserted, for 40 minutes every 2 hours for the first 24 hours and as you need.
  • Schedule an appointment with your healthcare professional to remove the stitches.

Interrupting or stopping your treatment: If the implants are not replaced with new ones at the same time they are removed, your doctor will prescribe the same dose of sublingual buprenorphine you were taking before you started PROBUPHINE treatment. Take it until you can start your treatment again. If you are stopping your treatment, your doctor should monitor you for withdrawal. Your doctor may change your dose of sublingual buprenorphine if needed.

What should I do if PROBUPHINE implant sticks out of my skin or comes out by itself?

IMPORTANT:

  • Never give or allow others to touch or use the implant. It contains buprenorphine and it can be dangerous.

If a PROBUPHINE implant comes out by itself or sticks out of your skin:

  • Remove the implant and put it in a plastic bag. Try not to touch it with your bare hands. If you do, wash your hands right away.
  • Cover the area where the implants were inserted with a clean bandage.
  • Store it:
    • Safely out of the reach and sight of children. If a child accidently comes into contact with an implant get emergency help right away.
    • In a safe place where it cannot be stolen.
  • Contact your healthcare professional right away and take the implant to them as soon as possible.

Usual Dose

4 implants inserted just under the skin on the inside of your upper arm for up to 6 months.

Overdose

PROBUPHINE will be implanted by your healthcare professional. It is unlikely that overdose could occur. However, if you notice:

  • Your lips turning blue;
  • Constriction of the pupils of your eyes (getting smaller);
  • You are feeling sleepy or drowsy;
  • You have trouble breathing;
  • You have a slow heart beat.

Get medical help right away.

If you think you have taken too much PROBUPHINE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking PROBUPHINE. If you experience any side effects not listed here, contact your healthcare professional.

Side effects of PROBUPHINE include:

  • Nausea;
  • Vomiting;
  • Abdominal pain;
  • Constipation;
  • Cold and flu like symptoms;
  • Urinary tract infection;
  • Bronchitis;
  • Sinus infections;
  • Feeling tired;
  • Back pain;
  • Headache;
  • Toothache;
  • Mouth and throat pain;
  • Feeling depressed;
  • Feeling anxious;
  • Decreased sex drive (libido);
  • Mild sweating;
  • Bruising at the insertion or removal site;
  • Scarring around the insertion site.
Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Get immediate medical help
COMMON
Infection at the insertion or removal site   ✔  
RARE
Respiratory depression: slow, shallow or weak breathing     ✔
Allergic reactions: rash, hives, swelling of face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Opioid withdrawal (if PROBUPHINE comes out of your arm or if you stop treatment): shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting and muscle aches.   ✔  
Liver problems: your skin or the white part of your eyes turns yellow (jaundice), urine turns dark, stools turn light in color, stomach (abdominal) pain or nausea.   ✔  
Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, floppy muscle/low muscle tone, cold and clammy skin.     ✔
Complication of the insertion procedure: weakness or numbness in your arm, or shortness of breath     ✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

PROBUPHINE will be stored by your healthcare professional.

Keep any implant that has accidently come out and been removed from your arm in a plastic bag safely away from the reach and sight of children and in a safe place where it cannot be stolen.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

  • Talk to your healthcare professional.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpdbdpp/index-eng.jsp); the manufacturer’s website, by emailing medinfo@gudknight.com, or by calling 1- 844-483-5636.

This leaflet was prepared by Knight Therapeutics Inc.

Last Revision: May 20, 2020

Date modified: