Patient Medication Information: uses, side effects, how to take - Bicnu (Marcan Pharmaceuticals, Powder For Solution)
Serious Warnings and Precautions
See the “Serious side effects and what to do about them” table, below, for more information on these serious side effects. |
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What BiCNU is used for:
BiCNU is used as palliative therapy (to relieve and prevent suffering) by itself or with other anti-cancer drugs in patients with:
Brain cancers:
- astrocytoma, ependymoma, glioblastoma (brain or spinal cord tumors)
- brain stem glioma (brain stem tumor)
- medulloblastoma (cerebellum brain tumor)
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- metastatic brain tumors (tumors that spread outside of the brain)
- Blood cancers:
- Multiple myeloma, with another drug like prednisone.
- Hodgkin's lymphoma, with or without other anti-cancer drugs
- Non-Hodgkin’s lymphoma, with or without other anti-cancer drugs
- Digestive system cancers (gastrointestinal tract tumors)
- A type of skin cancer like Malignant melanoma, with other anti-cancer drugs
How BiCNU works:
BiCNU contains carmustine which is a type of drug of drug called an alkylating agent. Carmustine helps stop cancer cells from dividing which helps slow the growth of cancer cells.
The ingredients in BiCNU are:
Medicinal ingredients: Carmustine
Non-medicinal ingredients (sterile diluent): Propylene glycol or dehydrated alcohol
BiCNU comes in the following dosage forms:
Powder, 100 mg / vial
Do not use BiCNU if:
You are allergic to:
- carmustine or any of the other ingredients in this medicine
- other nitrosourea preparations
You have bone marrow problems causing:
- Low levels of blood platelets (thrombocytes), white blood cells (leukocytes) or red blood cells (erythrocytes)
- You have severe kidney problems.
- You are pregnant or breastfeeding.
- You are less than 18 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BiCNU. Talk about any health conditions or problems you may have, including if you:
- Smoke
- Have or had lung problems
- Have or had serious kidney problems
- Have or had x-ray or CT scan results that are not normal
- Have or had radiation therapy on your chest
- Had chemotherapy in the past
- Are 65 years old or older
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Other warnings you should know about:
- Injection site reaction: BiCNU might leak out while you are receiving it. This might cause swelling, pain, rash, burning and infections around the area. Your healthcare professional will monitor you for signs and symptoms of a leak around the injection site.
- Lung problems: BiCNU can cause pulmonary fibrosis (lung damage). Your healthcare professional will do tests to check on your lung health during treatment. Lung damage can happen up to 17 years after treatment with BiCNU and can cause death.
See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.
Check-ups and testing: You will have regular visits with your healthcare professional before and during your treatment. They will check your blood, liver and kidney health.
Pregnancy and breastfeeding:
Female patients
- Do not take BiCNU if you are pregnant. It may harm your unborn baby.
If you are able to become pregnant:
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during your treatment with BiCNU.
- Do not breastfeed while you are taking BiCNU.
Children: BiCNU should not be used in children due to high risk of lung damage.
Geriatric patients: Your healthcare professional might start you off with a lower dose especially if you have other diseases or are taking other drugs. There also might be a higher risk of liver, kidney, heart problems for elderly patients.
Driving and using machines: BiCNU is mixed with a liquid called propylene glycol. Before you drive or do tasks that require special attention, wait until you know how you respond to BiCNU. Check with your healthcare professional before driving or operating machines since BiCNU can cause dizziness. This may impair your ability to drive or use machines.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with BiCNU:
- A medicine used to lower stomach acid called cimetidine
How to take BiCNU:
- BiCNU will be given to you by a healthcare professional.
- The powder is first mixed into a solution. This solution is then given to you through a vein by a drip over a one to two-hour period.
- The injected area will be monitored during the administration.
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Usual dose:
- The dose you will receive will depend on your disease and will be measured based on your body size. The dosage will also depend on whether BiCNU is given with other anti-cancer drugs.
- BiCNU is usually given at least every 6 weeks. Your healthcare professional will do blood tests to check your blood health during treatment.
- Your healthcare professional may lower your dose, stop your treatment for a period of time or recommend that you stop treatment completely. This may happen if you experience serious side effects.
Overdose:
| If you think you, or a person you are caring for, have taken too much BiCNU, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms. |
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Missed dose:
BiCNU needs to be given on a fixed schedule. Talk to your healthcare professional if you have missed a treatment.
Possible side effects from using BiCNU:
These are not all the possible side effects you may have when taking BiCNU. If you experience any side effects not listed here, tell your healthcare professional.
- Headache
- Severe nausea and vomiting
- Rash, itchy skin (when used on the skin)
- Darkening of an area of skin or nails with accidental skin contact
- Breast growth in males
- Muscle pain
- Tissue damage due to leakage in injection area
- Fast heartbeat, chest pain
Serious side effects and what to do about them
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Eye disorders: blurred vision, loss of vision in eye, increased sensitivity of the eyes to light, eye pain or redness, swelling and itching of the eyelids, decreased | √ | ||
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| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| sharpness of vision, eye irritation, blocked eye veins | |||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | √ | ||
| Lung problems including Interstitial lung disease, pneumonitis, pulmonary fibrosis (diseases that inflame or scar lung tissue): shortness of breath when rest that gets worse with exertion, dry cough, wheezing, cough and chest tightness accompanied by fever and more phlegm, persistent weakness / tiredness | √ | ||
| Myelosuppression including leukopenia, thrombocytopenia (a large decrease in the production of blood cells and platelets by the bone marrow): bleeding, bruising, chills, fatigue, fever, infections, weakness, shortness of breath or other signs of infection | √ | ||
| Thrombophlebitis, Phlebitis (swelling of a vein): pain, tenderness, redness or swelling | √ | ||
| COMMON | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | √ | ||
| Bone marrow dysplasia or Acute Leukaemia (a group of diseases in which the body produces large numbers of abnormal blood cells, | √ | ||
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| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| blood cancer): Fever, infection, bruising or bleeding easily, breathlessness, blood in urine or stool, bleeding gums, bone pain, frequent or severe nosebleeds, lumps due to swollen lymph nodes in and around the neck, forearm, abdomen, or groin, pale skin, shortness of breath, weakness, fatigue, or general lack of energy; | |||
| Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness | √ | ||
| Injection Site Reactions: blistering, itching, pain, redness, swelling, discoloration, severe skin damage, tenderness, burning/warmth in the area around the injection | √ | ||
| RARE | |||
| Encephalopathy (brain disorder): muscle weakness in one area, poor decision-making or concentration, involuntary twitching, trembling, difficulty speaking or swallowing, seizures | √ | ||
| Kidney problems (damage to the kidneys): back and abdominal pain, change in the colour of urine (pale or dark) decrease in amount of urine produced, pain or discomfort when urinating, swelling of the legs and ankles. | √ | ||
| Neuroretinitis (eye disorder): painless decrease in vision, decreased color vision | √ | ||
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| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNKNOWN | |||
| Hypersensitivity (allergic reaction): fever, skin rash, hives, itching, swelling, shortness of breath, wheezing, runny nose, itchy, watery eyes | √ | ||
| Infection: fever and chills, nausea, vomiting, diarrhea, generally feeling unwell | √ | ||
| Neutropenic enterocolitis (inflammation of the intestines): abdominal pain, diarrhea, results in nausea, vomiting | √ | ||
| Secondary malignancies (cancers caused by radiation or chemotherapy) | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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. |
Storage:
- Your healthcare professional will store and throw away this drug (unopened vial reconstituted and reconstituted diluted solutions)
- Do not use this drug after the expiry date which is stated on the label and carton after expiry. The expiration date refers to the last day of that month.
- Keep out of reach and sight of children.
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If you want more information about BiCNU:
- 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://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.marcanpharma.com, or by calling 1-855-627-2261.