Patient Medication Information: uses, side effects, how to take - Carmustine for Injection USP
What is Carmustine for Injection USP used for?
Carmustine for Injection USP 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)
Serious Warnings and Precautions
- Carmustine for Injection USP should only be prescribed by doctors who are experienced in the use of drugs to treat cancer.
- Your healthcare professional should do some blood tests on you regularly. This will check your liver and kidney health, as well as your blood cell count.
Carmustine for Injection USP may cause the following serious side effects:
- Myelosuppression (a large decrease in the production of blood cells and platelets by the bone marrow). This includes Thrombocytopenia (low blood platelets), leukopenia (low white blood cells) and anemia (low red blood cells). You should not get a dose of Carmustine for Injection USP more often than every 6 weeks. Your healthcare professional will do blood tests for at least 6 weeks after a dose. They will also check your liver, kidney, and lung health.
- Liver problems. High doses of Carmustine for Injection USP might cause liver damage.
- Kidney problems. Decrease in kidney size, kidney damage and failure can happen after high doses and long-term treatment with Carmustine for Injection USP.
- Carmustine for Injection USP should be used in children (less than 18 years old) with extreme caution due to high risk of pulmonary fibrosis (lung damage).
See the Serious side effects and what to do about them table, below, for more information on these serious side effects.
- brain stem glioma (brain stem tumor)
- medulloblastoma (cerebellum brain tumor)
- 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 does Carmustine for Injection USP work?
Carmustine for Injection USP 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.
What are the ingredients in Carmustine for Injection USP?
Medicinal ingredients: Carmustine
Non-medicinal ingredients (sterile diluent): Dehydrated Alcohol Injection USP
Carmustine for Injection USP comes in the following dosage forms:
Lyophilized Powder, 100 mg/vial
Do not use Carmustine for Injection USP if:
- You are allergic to carmustine, other nitrosourea preparations or any of the other ingredients in this medicine.
You have bone marrow problems causing:
o 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 Carmustine for Injection USP. 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
Other warnings you should know about:
- Injection site reaction: Carmustine for Injection USP 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: Carmustine for Injection USP 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 Carmustine for Injection USP 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 Carmustine for Injection USP if you are pregnant. It may harm your unborn baby.
If you are able to become pregnant:
o Tell your healthcare professional right away if you become pregnant or think you may be pregnant during your treatment with Carmustine for Injection USP.
- Do not breastfeed while you are taking Carmustine for Injection USP.
Children: Carmustine for Injection USP 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: Carmustine for Injection USP contains alcohol. Before you drive or do tasks that require special attention, wait until you know how you respond to Carmustine for Injection USP.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
- A medicine used to lower stomach acid called cimetidine
How to take Carmustine for Injection USP:
- Carmustine for Injection USP 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.
- Carmustine for Injection USP is given into a vein by a drip over a one to two-hour period. The injected area will be monitored during the administration.
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 Carmustine for Injection USP is given with other anti-cancer drugs.
- Carmustine for Injection USP 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:
What are possible side effects from using Carmustine for Injection USP?
These are not all the possible side effects you may have when taking Carmustine for Injection USP. 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
If you think you, or a person you are caring for, have taken too much Carmustine for Injection USP, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Serious side effects and what to do about them
| Symptom / effect | 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 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 | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
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, 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 | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
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 | √ | ||
| 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 | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
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.
Storage:
- This drug is stored and disposed of by a healthcare professional.
- Unopened vial: Store in a refrigerator (2-8°C).
- Reconstituted concentrate: Store in a refrigerator (2-8°C) for up to 48 hours.
- Ready-to-use infusion: Store in a refrigerator (2-8°C) for 24 hours, protect from light. If protected from light, it can be stored for another 6 hours, at room temperature (15°C - 25°C).
- Use only clear, colorless to yellowish 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.
If you want more information about Carmustine for Injection USP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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.
- Patient Medication Information by visiting the Drug Product Database: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website http://www.sterimaxinc.com, or by calling
1-800-881-3550.
Last Authorized: October 11, 2022.