BiCNU

DRUG DESCRIPTION

BiCNU® (carmustine for injection) is one of the nitrosoureas used in the treatment of certain neoplastic diseases. It is 1,3-bis (2-chloroethyl)-1-nitrosourea. It is sterile lyophilized pale yellow flakes or congealed mass with a molecular weight of 214.06. It is highly soluble in alcohol and lipids, and poorly soluble in water. BiCNU (carmustine) is administered by intravenous infusion after reconstitution as recommended.

The structural formula is:

BiCNU (carmustine) Structural Formula Illustration

BiCNU (carmustine) is available in 100 mg single dose vials of lyophilized material. Sterile diluent for constitution of BiCNU (carmustine) is co-packaged with the active drug product for use in constitution of the lyophile. The diluent is supplied in an ampule containing 3 mL of Dehydrated Alcohol Injection, USP.

What are the possible side effects of carmustine (BiCNU, Gliadel)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • redness of your eyes or skin and severe warmth or tingling under your skin (within 2 to 4 hours after your carmustine injection);
  • signs of infection such as fever, chills, sore throat, mouth sores;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or...

Read All Potential Side Effects and See Pictures of BiCNU »

What are the precautions when taking carmustine (BiCNU)?

Before using carmustine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders, liver disease, lung disease, kidney disease, recent/current infection.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to...

Read All Potential Precautions of BiCNU »


BiCNU Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, headache, flushing, or pain at injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: dark urine, yellowing eyes/skin, severe stomach/abdominal pain, change in the amount of urine, vision changes, fast heartbeat, dizziness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using carmustine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders, liver disease, lung disease, kidney disease, recent/current infection.

Before having surgery, tell your doctor or dentist that you are using this medication.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

Caution is advised when using this drug in children. Serious lung problems have developed years later in people who received this medication as children.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


BiCNU Patient Information Including Side Effects

Brand Names: BiCNU, Gliadel

Generic Name: carmustine (Pronunciation: kar MUS teen)

  • What is carmustine (BiCNU)?
  • What are the possible side effects of carmustine (BiCNU)?
  • What is the most important information I should know about carmustine (BiCNU)?
  • What should I discuss with my healthcare provider before receiving carmustine (BiCNU)?
  • How is carmustine given (BiCNU)?
  • What happens if I miss a dose (BiCNU)?
  • What happens if I overdose (BiCNU)?
  • What should I avoid while receiving carmustine (BiCNU)?
  • What other drugs will affect carmustine (BiCNU)?
  • Where can I get more information?

What is carmustine (BiCNU)?

Carmustine is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Carmustine is used to treat brain tumors, Hodgkin's disease, multiple myeloma, and non-Hodgkin's lymphoma.

Carmustine is sometimes given with other cancer medications.

Carmustine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of carmustine (BiCNU)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • redness of your eyes or skin and severe warmth or tingling under your skin (within 2 to 4 hours after your carmustine injection);
  • signs of infection such as fever, chills, sore throat, mouth sores;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • wheezing, rapid breathing, feeling short of breath;
  • chest pain, dry cough, fever, feeling ill;
  • urinating less than usual or not at all;
  • confusion, mood changes, increased thirst;
  • swelling in your ankles or feet; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include darkened skin color where the IV needle was placed.

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.

What is the most important information I should know about carmustine (BiCNU)?

Do not use carmustine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You should not use this medication if you are allergic to carmustine.

Before receiving carmustine, tell your doctor if you have bone marrow suppression, liver or kidney disease, or a history of lung or breathing problems.

Carmustine is usually given once every 6 weeks. You may be given either a single injection or multiple injections over a 2-day period. Follow your doctor's dosing instructions very carefully.

Carmustine can cause nausea and vomiting that may last up to 6 hours after your injection.

To be sure this medication is not causing harmful effects, your blood will need to be tested weekly for at least 6 weeks after you receive a dose of carmustine. Your kidneys, liver, and lung function may also need to be tested. Do not miss any follow-up visits to your doctor.

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