Generic Name: Temozolomide Brand Name(s): Generics only. No brands available.

Uses

What is Temozolomide used for?

Temozolomide 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 should I take Temozolomide?

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.

How do I store Temozolomide?

Temozolomide is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Temozolomide in the bathroom or the freezer. There may be different brands of Temozolomide that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Temozolomide down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Temozolomide?

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 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.

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.

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. Men and women should ask about reliable forms of birth control while using this medication. 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 while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Temozolomide during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Temozolomide. Temozolomide is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Temozolomide?

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 ofside 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Temozolomide?

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

Temozolomide may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Temozolomide?

Temozolomide may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Temozolomide?

Temozolomide may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Temozolomide.

What is the dose of Temozolomide for an adult?

Usual Adult Dose for Anaplastic Astrocytoma

Oral:

Initial Dose: 150 mg/m2 orally once a day

Maintenance Dose: 200 mg/m2 orally once a day

Duration of Therapy: 5 consecutive days per 28-day treatment cycle

IV:

Initial Dose: 150 mg/m2 IV over 90 minutes once a day

Maintenance Dose: 200 mg/m2 IV over 90 minutes once a day

Duration of Therapy: 5 consecutive days per 28-day treatment cycle

Comments:

-Dose should only be increased to 200 mg/m2 if both the nadir and day of dosing (Day 29, Day 1 of next cycle), the ANC is greater than or equal to 1.5 x 10(9)/L and platelet count is greater than or equal to 100 x 10(9)/L.

-A complete blood count should be obtained on day 22 or within 48 hours of that day of each cycle and weekly until the ANC is above 1.5 x 10(9)/L and the platelet count is above 100 x 10(9)/L.

-The next cycle should not be started until the ANC and platelet count exceed the above levels.

-In clinical trial, treatment could be continued for a maximum of 2 years. Optimum duration of therapy is not known.

-Treatment with this drug may be continued until disease progression.

Use:

-Refractory anaplastic astrocytoma with disease progression on a drug regimen containing nitrosourea and procarbazine.

Usual Adult Dose for Glioblastoma Multiforme

Concomitant phase with focal radiotherapy:

Oral:

75 mg/m2 orally once a day

Duration of therapy: 42 days

IV:

75 mg/m2 IV over 90 minutes once a day

Duration of therapy: 42 days

Comments:

-No dose reductions are recommended during the concomitant phase.

-Dose interruptions or discontinuation may occur based on toxicity.

-Therapy should continue throughout the 42-day concomitant phase up to 49 days if all of the following conditions are met: ANC greater than or equal to 1.5 x 10(9)/L, platelet count greater than 100 x 10(9)/L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1.

-A complete blood count should be obtained weekly during treatment.

-Pneumocystis pneumonia prophylaxis is required during the concomitant administration of this drug and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery.

Monotherapy Phase:

Cycle 1:

Oral:

150 mg/m2 orally once a day

Duration of therapy: 5 days followed by 23 days without treatment

IV:

150 mg/m2 IV over 90 minutes once a day

Duration of therapy: 5 days followed by 23 days without treatment

Cycles 2-6:

Oral:

200 mg/m2 by mouth once a day

Duration of therapy: First 5 days of each cycle

IV:

200 mg/m2 IV over 90 minutes once a day

Duration of therapy: First 5 days of each cycle

Comments:

-At the start of cycle 2, the dose should be escalated to 200 mg/m2 if: CTC nonhematological toxicity for Cycle 1 is grade less than or equal to 2 (except for alopecia, nausea, and vomiting), ANC is greater than or equal to 1.5 x 10(9)/L, and the platelet count is greater than or equal to 100 x 10(9)/L.

-The dose remains at 200 mg/m2 for cycles 2 through 6 unless toxicity occurs.

-If the dose was not escalated at the beginning of cycle 2, escalation should not be done in subsequent cycles.

-Obtain a complete blood count on day 22 or within 48 hours of that day of each cycle and weekly until the ANC is greater than 1.5 x 10(9)/L and the platelet count is greater than 100 x 10(9)/L. The next cycle should not be started until the ANC and platelet levels exceed these numbers.

-Dose reductions should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle.

Use:

-Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment.

Renal Dose Adjustments

Dose adjustment(s) may be required in patients; however, no specific guidelines have been suggested. Caution is recommended.

Liver Dose Adjustments

Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Caution is recommended.

Dose Adjustments

Glioblastoma Multiforme:

Concomitant Phase:

Interruption of Therapy:

-Absolute Neutrophil Count (ANC) greater than or equal to 0.5 and less than 1.5 x 10(9)/L

-Platelet count greater than or equal to 10 and less than 100 x 10(9)/L

-Common Toxicity Criteria (CTC) Nonhematological Toxicity (except for alopecia, nausea, vomiting) grade 2

Discontinuation of Therapy:

-ANC less than 0.5 x 10(9)/L

-Platelet count less than 10 x 10(9)/L

-CTC Nonhematological Toxicity grade 3 or 4

Maintenance Phase:

Reduce Dose by 1 Dose Level:

-Dose should be reduced to 100 mg/m2 for prior toxicity

-ANC less than 1.0 x 10(9)/L

-Platelet count less than 50 x 10(9)/L

-CTC Nonhematological Toxicity grade 3

Discontinuation of Therapy:

-If dose reduction to less than 100 mg/m2 is required.

-If the same Grade 3 CTC nonhematological toxicity recurs after dose reduction.

-CTC Nonhematological Toxicity grade 4

Anaplastic Astrocytoma:

Dose Reduction:

-If the ANC falls below 1.0 x 10(9)/L or the platelet count is less than 50 x 10(9)/L during any cycle, the next cycle should be reduced by 50 mg/m2 but not below 100 mg/m2.

Other Comments

Administration advice:

Oral Capsules:

-Swallow capsules whole with a glass of water.

-Consistency of administration with respect to food is recommended.

-To reduce nausea and vomiting, take this drug on an empty stomach.

-If vomiting occurs after administration, a second dose should not be administered that day.

-Bedtime administration may be advised.

IV Injection:

-Withdraw volume necessary for dose and transfer into an empty 250 mL infusion bag.

-Infuse IV over 90 minute using pump.

-Flush lines before and after each infusion. Infuse only via IV.

-May be administered in the same IV line with 0.9% Sodium Chloride injection only.

Storage requirements:

IV Injection:

-Prior to reconstitution, store in refrigerator.

-After reconstitution, store product at room temperature. Reconstituted product must be used within 14 hours including infusion time.

Reconstitution/preparation techniques:

IV Injection:

-Bring vial to room temperature prior to reconstitution.

-Reconstitute with 41 mL of Sterile Water for Injection and gently swirl vial. Do not shake.

-Inspect vial for visible particular matter. If particulates are present, do not use.

-Do not further dilute reconstituted product.

Patient advice:

-Antiemetic therapy may be administered prior to and/or following administration.

-If capsules are open or damaged, precautions should be taken to avoid inhalation or contact with the skin or mucous membranes.

What is the dose of Temozolomide for a child?

Usual Pediatric Dose for Anaplastic Astrocytoma

Less than 3 years: Safety and efficacy have not been established

3 years or older:

Previously Untreated with Chemotherapy:

200 mg/m2 orally once a day

Duration of therapy: 5 days followed by 23 days without treatment

Previously Treated with Chemotherapy:

Initial Dose: 150 mg/m2 orally once a day

Maintenance Dose: 200 mg/m2 orally once a day

Duration of therapy: First 5 days of each treatment cycle

Comments:

-Dose in cycle 2 for patients previously treated with chemotherapy should be increased if there is no haematological toxicity.

-If the nadir on day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil counts (ANC) are greater than or equal to 1.5 × 10(9)/L and platelet counts are greater than or equal to 100 × 10(9)/L, the dose may be increased to 200 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle.

-During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 10(9)/L and the platelet count exceeds 100 × 10(9)/L. The next cycle should not be started until the ANC and platelet count exceed these levels.

-If the ANC falls to less than 1.0 × 10(9)/L or the platelet count is less than 50 × 10(9)/L during any cycle, the next cycle should be reduced by 50 mg/m2 , but not below 100 mg/m2 , the lowest recommended dose.

-Treatment may be continued until disease progression or a maximum of 2 years.

Use:

-Recurrent or progressive malignant glioblastoma multiforme or anaplastic astrocytoma

Usual Pediatric Dose for Glioblastoma Multiforme

Less than 3 years: Safety and efficacy have not been established

3 years or older:

Previously Untreated with Chemotherapy:

200 mg/m2 orally once a day

Duration of therapy: 5 days followed by 23 days without treatment

Previously Treated with Chemotherapy:

Initial Dose: 150 mg/m2 orally once a day

Maintenance Dose: 200 mg/m2 orally once a day

Duration of therapy: First 5 days of each treatment cycle

Comments:

-Dose in cycle 2 for patients previously treated with chemotherapy should be increased if there is no haematological toxicity.

-If the nadir on day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil counts (ANC) are greater than or equal to 1.5 × 10(9)/L and platelet counts are greater than or equal to 100 × 10(9)/L, the dose may be increased to 200 mg/m2 orally once daily for 5 consecutive days per 28 day treatment cycle.

-During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 10(9)/L and the platelet count exceeds 100 × 10(9)/L. The next cycle should not be started until the ANC and platelet count exceed these levels.

-If the ANC falls to less than 1.0 × 10(9)/L or the platelet count is less than 50 × 10(9)/L during any cycle, the next cycle should be reduced by 50 mg/m2 , but not below 100 mg/m2 , the lowest recommended dose.

-Treatment may be continued until disease progression or a maximum of 2 years.

Use:

-Recurrent or progressive malignant glioblastoma multiforme or anaplastic astrocytoma

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

How is Temozolomide available?

Temozolomide is available in the following dosage forms and strengths:

  • Oral capsule,
  • Intravenous powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Temozolomide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: June 2, 2018 | Last Modified: June 2, 2018

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