Temodar

Temodar - General Information

Temodar (Temodar and Temodal) is an oral alkylating agent used for the treatment of refractory anaplastic astrocytoma -- a type of cancerous brain tumor. Temodar is not active until it is converted at physiologic pH to the active form, 5-(3-methyltriazen-1-yl)imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is due to alkylation of DNA at the O6 and N7 positions of guanine.

 

Pharmacology of Temodar

Temodar is an antineoplastic agent. It causes death of of rapidly replicating cells, especially malignant cells, leading to regression or slowed tumor growth.

 

Temodar for patients

Nausea and vomiting were among the most frequently occurring adverse events. These were usually either self-limiting or readily controlled with standard antiemetic therapy. Capsules should not be opened. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. The medication should be kept away from children and pets.

IMPORTANT INFORMATION FOR THE PATIENT
Patient Package Insert

TEMODAR (temozolomide) Capsules

What is TEMODAR?

TEMODAR (temozolomide) is used to treat certain cancerous tumors in the brain of adult patients for whom this tumor has recurred. Your doctor has prescribed TEMODAR (temozolomide) as part of your cancer treatment. TEMODAR is a drug you take by mouth that interferes with cell growth, especially in cells that are growing rapidly, such as cancerous cells. TEMODAR has been shown to help slow the growth of certain cancerous tumors. When given to patients with brain cancer, TEMODAR has been shown to reduce the size of the tumor in some patients.

Who should not take TEMODAR?

You should not take TEMODAR Capsules if you have had an allergic reaction to DTIC-Dome (dacarbazine), a different treatment for cancer. If you have had an allergic reaction before to drugs such as DTIC-Dome, be sure to tell your doctor before taking TEMODAR. If you are allergic to drugs similar to TEMODAR, you may also have an allergic reaction to TEMODAR.

How should I take TEMODAR?

Take each dayís dose of capsules at one time, with a full glass of water. DO NOT open or split the capsules. If the capsules are accidentally opened or damaged, you should be extremely careful to avoid inhaling the powder in the capsules or getting it on your skin or mucous membranes (eg, in nose or mouth). Flush the area with water if contact occurs. The medication should be kept away from children and pets. They should be swallowed whole and NEVER CHEWED. If capsules are vomited do not take a second dose. New capsules should not be taken until the next planned dose. The medicine is used best by your body if you take it at the same time every day in relation to a meal. To reduce nausea, try to take TEMODAR on an empty stomach or at bedtime. Your doctor may also have prescribed antinausea or other medications to relieve the side effects associated with TEMODAR. Antinausea medications should be taken as directed by your doctor. It is important that you continue to see your doctor regularly to check your progress. Your doctor can uncover side effects of treatment that you might not notice.

Because TEMODAR (temozolomide) Capsules is a drug you take by mouth, you can take it at home. There are two different dosing schedules for taking TEMODAR.

Be sure you follow the one that your doctor has prescribed for you. One schedule you may be prescribed is,TEMODAR for 42 days (up to 49 days) with radiotherapy.. Another schedule should be taken for 5 consecutive days only, then you must STOP taking TEMODAR for the next 23 days. This total period of 5 days on TEMODAR and 23 days off TEMODAR is called one treatment cycle. Your dose is based on your height and weight, and the number of treatment cycles will depend on how you respond to and tolerate this treatment.

TEMODAR comes in different strength capsules (shown on the outer label in mg). Each strength has a different color band. Depending on the dose of TEMODAR that your doctor prescribes, you may have to take several capsules on each dosing day of a treatment cycle (Day 1 through Day 5, followed by 23 days with no capsules) or the 42 days (up to 49 days) of consecutive treatment schedule with radiotherapy.

· Be sure you understand exactly how many capsules you need to take of each strength. Ask your doctor or pharmacist to write down the number of each strength (include color) that you need to take each dosing day.

· Be sure you know exactly which days are your dosing days.

· Be sure to review the dose with your health care provider each time you start a new cycle. Sometimes the dose or the mix of capsules you need to take will be different from the last cycle.

· Once you take the medicine home, if you are confused or unsure about how to take your dose, contact your doctor or pharmacist immediately.

Your doctor may have prescribed a treatment regimen that is different from the one discussed in this information sheet. If so, make sure you follow the specific instructions given to you by your doctor. You should talk to your doctor about what to do if you miss a day. If you take more than the prescribed amount of medicine, contact your doctor right away. It is important that you understand your dosage regimen, it is also important that you do not take more than the amount of TEMODAR prescribed for you. Overdoses can lead to serious outcomes including severe low blood counts and possible death.

How is TEMODAR supplied?

TEMODARâ (temozolomide) Capsules are white with color-coded printing according to strength, each a different size. The capsules are available in four different strengths.

TEMODAR Capsule Strength	Color
5mg	Green Imprint
20mg	Brown Imprint
100mg	Blue Imprint
250mg	Black Imprint

What should I avoid while taking TEMODAR?

There are no limitations on what you may eat or drink while taking TEMODAR. However, to ease nausea, try to take TEMODAR on an empty stomach.

TEMODAR may cause birth defects. Therefore, male or female patients who take TEMODAR should use effective birth control. Female patients should avoid becoming pregnant while receiving this drug. You should not breast-feed an infant while taking TEMODAR. It is not known whether TEMODAR passes into breast milk. Because many drugs do pass into breast milk, there is the possibility of serious harm to nursing infants.

What are the possible or reasonably likely side effects of TEMODAR?

Nausea and vomiting are the most common side effects associated with TEMODAR. Your doctor can prescribe medicines that may help reduce some of these. Other common side effects include headache, feeling tired, and constipation.

TEMODAR also can reduce the number of certain types of blood cells, which can have serious effects. White blood cells are needed to fight infections. Lowering of white blood cells could result in a serious infection with a potential outcome of death. Platelets are needed in the normal course of blood clotting. Lowering of platelets does not allow your blood to clot normally, which can result in bleeding episodes. Therefore, it is important that your doctor check your blood periodically while you are taking TEMODAR to see if these side effects are occurring. Patients age 70 or older, women, and patients who have had chemotherapy or radiation therapy may be more likely to have their blood cells affected.

There are other side effects associated with TEMODAR. They are included in a longer, more technical information leaflet written for health care providers that you can get from your doctor or pharmacist.

General information about the use of prescription drug products.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Package Insert. You should contact your health care professional regarding any concerns you may have about using TEMODAR. TEMODAR should not be used for a condition for which it was not prescribed, and it should not be given to other persons.

Copyright ©2004, Schering Corporation, Kenilworth, NJ 07033. All rights reserved. 22571613 Rev. 08/04

 

Temodar Interactions

Administration of valproic acid decreases oral clearance of temozolomide by about 5%. The clinical implication of this effect is not known.

Patients with Severe Hepatic or Renal Impairment

Caution should be exercised when TEMODAR Capsules are administered to patients with severe hepatic or renal impairment.

 

Temodar Contraindications

TEMODAR (temozolomide) Capsules are contraindicated in patients who have a history of hypersensitivity reaction to any of its components. TEMODAR is also contraindicated in patients who have a history of hypersensitivity to DTIC, since both drugs are metabolized to MTIC.

 

Additional information about Temodar

Temodar Indication: For the treatment of adult patients diagnosed with anaplastic astrocytoma who have relapsed following chemotherapy
Mechanism Of Action: Temodar is not active until it is converted at physiologic pH to the active form, 5-(3-methyltriazen-1-yl)imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is due to alkylation of DNA at the O6 and N7 positions of guanine.
Drug Interactions: Not Available
Food Interactions: Not Available
Generic Name: Temozolomide
Synonyms: Temozolodida [Spanish]; Temozolomidum [Latin]; Temozolamide; Methazolastone
Drug Category: Antineoplastic Agents
Drug Type: Small Molecule; Approved; Investigational

Other Brand Names containing Temozolomide: Temodal; Temodar;
Absorption: Rapid and complete absorption in the gastrointestinal tract
Toxicity (Overdose): Not Available
Protein Binding: 15%
Biotransformation: Not Available
Half Life: Approximately 1.8 hours.
Dosage Forms of Temodar: Capsule Oral
Chemical IUPAC Name: 3-methyl-4-oxoimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide
Chemical Formula: C6H6N6O2
Temozolomide on Wikipedia: https://en.wikipedia.org/wiki/Temozolomide
Organisms Affected: Humans and other mammals