Temozolomide

DEA Class; Rx

Common Brand Names; Temodar

• Antineoplastics, Alkylating

Hypersensitivity to temozolomide, dacarbazine

• Alopecia (55-69%)
• Lymphopenia (55%)
• Nausea (53%)
• Vomiting (42%)
• Headache (41%)
• Fatigue (34%)
• Constipation (33%)
• Anorexia (9-27%)
• Convulsions (23%)
• Thrombocytopenia (19%)
• Rash (8-19%)
• Hemiparesis (18%)
• Diarrhea (16%)
• Neutropenia (14%)
• Fever (13%)
• Asthenia (13%)
• Dizziness (12%)
• Peripheral edema (11%)
• Viral infections (11%)

Myelosuppression reported, including prolonged pancytopenia, leukopenia, and anemia; may result in aplastic anemia, which in some cases has resulted in a fatal outcome; geriatric patients and women have higher risk of developing myelosuppression

Severe hepatic/renal impairment, elderly

Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, reported

Prophylaxis for P. jiroveci pneumonia (pneumocystis pneumonia) required for all patients treated with temozolomide and radiation; risk increases with steroid therapy or longer treatment regimens

Obtain CBC prior to treatment on Day 1 and on Day 22 (21 days after the first dose) of each cycle; perform weekly if ANC declines

Fatal and severe hepatotoxicity reported; perform LFTs at baseline, midway through the first cycle, prior to each subsequent cycle, and ~2-4 weeks after the last dose

Causes fetal harm when administered to pregnant women

Prior to dosing, patients must have an ANC of 1.5 x 10⁹/L or greater and a platelet count of 100 x 10⁹/L or greater

For concomitant phase with radiotherapy, obtain complete blood count prior to initiation of treatment and weekly during treatment

All patients, particularly those receiving steroids, should be observed closely for the development of lymphopenia and PCP

As bioequivalence has been established only when given over 90 minutes, infusion over a shorter or longer period of time may result in suboptimal dosing; the possibility of an increase in infusion-related adverse reactions cannot be ruled out

For patients with newly diagnosed glioblastoma, provide PCP prophylaxis for all patients during concomitant phase; continue in patients who experience lymphopenia until resolution to grade 1 or less

Based on mechanism of action, therapy can cause fetal harm when administered to a pregnant woman, including teratogenicity and/or embryo-fetal lethality; product is a genotoxic drug and can cause chromatid or chromosome damage in humans

It is not known whether drug is present in human milk; because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing children from melphalan, breastfeeding is not recommended during treatment and for one week after last dose

Glioblastoma multiforme: 75 mg/m2 PO/IV daily with concomitant radiation therapy for 42 to 49 days; 200 mg/m2 PO/IV daily for 5 days per cycle as maintenance therapy.
Anaplastic astrocytoma: 200 mg/m2 PO/IV daily for 5 days per cycle.

Glioblastoma multiforme: 75 mg/m2 PO/IV daily with concomitant radiation therapy for 42 to 49 days; 200 mg/m2 PO/IV daily for 5 days per cycle as maintenance therapy.
Anaplastic astrocytoma: 200 mg/m2 PO/IV daily for 5 days per cycle.

Safety and efficacy not established.

Safety and efficacy not established.

Safety and efficacy not established.