temozolomide

This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

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5 Capsules, 250 mg

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About temozolomide

Overview

This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.

How to use

Read the Patient Information Leaflet if available from your pharmacist before you start taking temozolomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once a day on a treatment schedule. Swallow the capsules whole with a full glass of water (8 ounces or 240 milliliters). Do not crush, chew, or open the capsules. If you vomit after taking your dose, do not take any more medication. Wait and take your next dose at the regular time. To reduce nausea and vomiting, take temozolomide on an empty stomach or at bedtime. For the best effect, take this medication at the same time every day in relation to a meal (for example, 1 hour before or 3 hours after a meal).

The dosage and treatment schedule are based on your medical condition, height, weight, and response to treatment. Carefully follow your doctor's directions for taking this medication. To help you remember, mark your calendar to keep track of when to take the next dose.

Your doctor may also prescribe other medications (such as antibiotics) to help prevent infection or side effects. Follow your doctor's directions for taking all your medications.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

If the capsules are accidentally opened or damaged, avoid inhaling the medication or getting it on your skin. If contact occurs, flush the area with water. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Side effects

Nausea, vomiting, loss of appetite, mouth sores, changes in taste, constipation, tiredness, dizziness, trouble sleeping, or headache may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may 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.

Although temozolomide is used to treat cancer, it may rarely increase your risk of getting other cancers. Also, temozolomide decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.

Tell your doctor right away if you have any serious side effects, such as: symptoms of liver damage (such as stomach/abdominal pain, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, such as: seizure.

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, such as: 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 or at www.fda.gov/medwatch.

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

Warnings & Precautions

Before taking temozolomide, tell your doctor or pharmacist if you are allergic to it; or to dacarbazine; 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: kidney problems, liver problems, bleeding/blood problems.

Temozolomide can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

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

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).

Women and older adults may be more sensitive to the side effects of this drug, especially increased risk of infection and easy bruising/bleeding.

Men should not donate sperm while using temozolomide and for 3 months after stopping this drug.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using temozolomide. Temozolomide may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after stopping treatment. Men using this medication who have a partner that is pregnant or who can become pregnant should use a condom for birth control during treatment and for 3 months after stopping treatment. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for at least 1 week after stopping treatment. Consult your doctor before breast-feeding.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: nalidixic acid.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Missed Doses:

For the best possible benefit, it is important to take each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Notes:

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, liver function, brain scan) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

Selected from the Licensed Solutions data included with permission and copyrighted by FDB, inc., 2014. This copyrighted material has been downloaded and Licensed data provider and is not for distribution in professional healthcare settings. This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment. 

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