When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to temozolomide or dacarbazine (DTIC), or if you are pregnant.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• To help prevent nausea or vomiting, you may try taking this medicine at bedtime on an empty stomach.
• Swallow the capsule whole with a glass of water. Do not crush, break, chew, or open it.
• If a capsule breaks open, be careful not to breathe in any medicine or get it on your skin. Wash your skin right away with soap and water if any medicine gets on it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor for instructions. If you vomit right after you take the medicine, do not take more medicine. Wait until your next scheduled dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how temozolomide works. Tell your doctor if you are also using any of the following:
  
  • Carbamazepine
  • Phenytoin
  • Sulfamethoxazole/trimethoprim
  • Valproic acid

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, liver disease, anemia or any blood cell problems, or any type of infection.
• This medicine may cause the following problems:
  
  • Higher risk of pneumonia
  • Higher risk of other cancers
  • Liver problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fever, chills, cough, sore throat, body aches
• Seizures
• Severe nausea or vomiting
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Hair loss
• Headache
• Mild nausea or vomiting, constipation, diarrhea
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088