Temozolomide capsules

What is this medication?

TEMOZOLOMIDE (te moe ZOE loe mide) is a chemotherapy drug. It is used to treat some kinds of brain cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): TEMODAR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• kidney disease
• liver disease
• an unusual or allergic reaction to temozolomide, dacarbazine (DTIC), other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a full glass of water. Do not chew, crush or open the capsules. You can take this medicine with or without food. However, you should always take it the same way each time. Taking this medicine on an empty stomach may reduce nausea. Taking this medicine at bedtime may also reduce nausea. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, talk with your health care professional about when to take your next dose. Do not take double or extra doses. If you vomit after a dose, do not take another until your next planned dose.

What may interact with this medication?

• vaccines
• valproic acid

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

You may need blood work done while you are taking this medicine.

Call your doctor or health care provider for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Call if you get diarrhea. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care provider if you notice any unusual bleeding.

Do not open the capsules of this medicine. Breathing in or touching the powder in the capsule may be harmful. If the powder accidentally gets on your skin, wash the area thoroughly. If you have difficulty swallowing, contact your doctor or health care provider.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

Do not become pregnant while taking this medicine or for at least 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care provider or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 1 week after stopping it.

Men should not father a child while taking this medicine or for at least 3 months after stopping it. Contact your doctor right away if your partner becomes pregnant. Do not donate sperm while taking this medicine and for at least 3 months after you stop taking it.

This medicine may make it more difficult to father a child. Talk to your health care provider if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• low blood counts - this medicine may decrease the number of white blood cells, red blood cells, and platelets. You may be at increased risk for infections and bleeding.
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine
• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• seizures

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• hair loss
• headache
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.