oxicity (except for alopecia, nausea, vomiting) CTC Grade 3 CTC Grade 4†
TMZ = temozolomide; CTC = Common Toxicity Criteria.
* TMZ dose levels are listed in Table 3.
† TMZ is to be discontinued if dose reduction to less than 100 mg/m2 is required or if the same Grade 3 nonhematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Absolute Neutrophil Count less than 1.0 × 109 /L See footnote †
Platelet Count less than 50 × 109 /L See footnote †
CTC Nonhematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 3 CTC Grade 4
How is TEMODAR taken?
Patients should take each day's dose with a full glass of water at the same time each day. Taking the medication on an empty stomach or at bedtime may help ease nausea. If patients are also taking antinausea or other medications to relieve the side effects associated with TEMODAR, they should be advised to take these medications 30 minutes before they take TEMODAR. Temozolomide causes the rapid appearance of malignant tumors in rats. Patients SHOULD NOT open or split the capsules. 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. The TEMODAR capsules should be swallowed whole and NEVER CHEWED.
What should the patient avoid during treatment with TEMODAR?
There are no dietary restrictions for patients taking TEMODAR. TEMODAR may affect testicular function, so male patients should exercise adequate birth control measures. TEMODAR may cause birth defects. Female patients should avoid becoming pregnant while receiving this drug. Women who are nursing prior to receiving TEMODAR should discontinue nursing. It is not known whether TEMODAR is excreted into breast milk.
Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants and tumorigenicity shown for temozolomide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of TEMODAR to the mother.
What are the side effects of TEMODAR?
Nausea and vomiting are the most common side effects associated with TEMODAR. Noncumulative myelosuppression is the dose-limiting toxicity. Patients should be eva luated periodically by their physician to monitor blood counts.
Other commonly reported side effects reported by patients taking TEMODAR are fatigue, constipation, alopecia, anorexia, and headache.
How is TEMODAR supplied?
TEMODAR Capsules are available in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths. The capsules contain a white capsule body with a color cap, and the colors vary based on the dosage strength.
TEMODAR Capsule Strength Color
5 mg Green Cap
20 mg Yellow Cap
100 mg Pink Cap
140 mg Blue Cap
180 mg Orange Cap
250 mg White Cap
The 5-mg, 20-mg, 100-mg, 140-mg, and 180-mg capsule strengths are available in 5-count and 14-count packages. The 250-mg capsule strength is available in a 5-count package.
How is TEMODAR dispensed?
Each strength of TEMODAR must be dispensed in a separate vial or in its original package (one strength per one container). Follow the instructions below:
Based on the dose prescribed, determine the number of each strength of TEMODAR capsules needed for the fu |
