Temozolomide 100 Pill — RED;WHITE CAPSULE, 20mm — Temozolomide

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ImprintTemozolomide / 100
ColourRED;WHITE
ShapeCAPSULE
Size20
StrengthTemozolomide 100 mg
Dosage formCapsule
ManufacturerMayne Pharma Inc.
NDC51862-085
Schedule—
Availability—
IngredientsTemozolomide[Temozolomide]

What does this imprint mean?

The imprint "Temozolomide 100" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Temozolomide

Uses and warnings

BOXED WARNING: Myelosuppression - "Myelosuppression, including pancytopenia, leukopenia...and anemia, some with fatal outcomes, have occurred," with approximately 10% of patients requiring hospitalization or transfusion; blood counts must be monitored, with nadirs typically around day 26-28. Hepatotoxicity - "Fatal and severe hepatotoxicity have been reported" and liver function should be checked at baseline, mid-cycle, and after each cycle. Secondary malignancies, including myelodysplastic syndrome and secondary leukemias, have been observed. Contraindicated in patients with prior serious hypersensitivity to temozolomide or dacarbazine (shared metabolite). Also warns of Pneumocystis pneumonia risk, especially with concurrent steroid use, and embryo-fetal toxicity.

Indicated for adults with "newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment," and for "adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma" as well as "treatment of adults with refractory anaplastic astrocytoma."

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 46492e4f-c3ac-4af2-9fab-9484620a7208.xml