Cytarabine Lipid Complex Injection

IMPORTANT WARNING:

Cytarabine lipid complex injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

Cytarabine lipid complex injection may cause a serious or life threatening reaction. Your doctor will give you a medication to prevent this reaction and will monitor you carefully after you receive a dose of cytarabine lipid complex. If you experience the following symptoms, tell your doctor immediately: nausea, vomiting, headache, and fever.

IMPORTANT NOTICE:

Cytarabine lipid complex injection is no longer available in the U.S.

WHY is this medicine prescribed?

Cytarabine lipid complex is used to treat lymphomatous meningitis (a type of cancer in the covering of the spinal cord and brain). Cytarabine lipid complex is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Cytarabine lipid complex comes as a liquid to be injected intrathecally (into the fluid-filled space of the spinal canal) over 1 to 5 minutes by a doctor or nurse in a medical facility. At first, cytarabine lipid complex is given as five doses spaced 2 weeks apart (at weeks 1, 3, 5, 7, and 9); then 4 weeks later, five more doses are given spaced 4 weeks apart (at weeks 13, 17, 21, 25, and 29). You will have to lay flat for 1 hour after you receive a dose of cytarabine lipid complex injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving cytarabine lipid complex injection,

• tell your doctor and pharmacist if you are allergic to cytarabine or any of the ingredients in cytarabine lipid complex injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have meningitis. Your doctor will probably not want you to receive cytarabine lipid complex.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are receiving cytarabine lipid complex injection. If you become pregnant while receiving cytarabine lipid complex, call your doctor. Cytarabine lipid complex may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Cytarabine lipid complex may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• constipation
• stomach pain
• tiredness
• weakness
• muscle or joint pain
• trouble falling or staying asleep

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• sudden change or loss of vision or hearing
• dizziness
• fainting
• confusion or memory loss
• seizure
• numbness, burning, or tingling in the hands, arms, feet, or legs
• loss of bowel or bladder control
• loss of feeling or movement on one side of the body
• difficulty walking or unsteady walking
• sudden fever, severe headache, and stiff neck
• difficulty breathing or swallowing
• rash
• hives
• itching
• unusual bleeding or bruising
• fever, sore throat, ongoing cough and congestion, or other signs of infection

Cytarabine lipid complex may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cytarabine lipid complex.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.