April 2003

Jane S. Ricciuti, RPh, MS

April 22, 2003

Antineoplastic Agents

Temodar

(Temozolomide) Capsules

Manufacturer: Schering Corporation

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 03/11/03)

Adverse Effects: Temodar (temozolomide) was studied in 2 open-label phase 2 studies in pediatric patients. The FDA has approved the addition of safety information to the Temodar labeling. The FDA has not approved Temodar for use in pediatric patients. Efficacy of Temodar in pediatric patients has not been established.

Temozolomide was studied in patients' aged 3-18 years at a dosage of 160-200 mg/m² daily for 5 days every 28 days. The safety of temozolomide was assessed in a study involving 29 patients with recurrent brain stem glioma and 34 patients with recurrent high grade astrocytoma. The second study, by the Children's Oncology Group, enrolled 122 patients with medulloblastoma/PNET (29), high-grade astrocytoma (23), low-grade astrocytoma (22), brain stem glioma (16), ependymoma (14), other CNS tumors (9), and non-CNS. Pediatric adverse events from these phase 2 trials are listed in Table 2 .

Temodar (Temozolomide) Capsules Labeling

Temodar (Temozolomide) Capsules

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Cite this: April 2003 - Medscape - Apr 23, 2003.

Table 1. Moxifloxacin Efficacy in the Treatment of Penicillin-Resistant *Streptococcus pneumoniae* CAP
Pathogen	Moxifloxacin		Comparators
Pathogen	n/N	%	n/N	%
All S pneumoniae	230/244	94	138/162	85
S pneumoniae bacteremia	53/58	91	35/41	85
S pneumoniae with penicillin MIC penicillin ≥ 2 mcg/mL	21/21	100	5/5	100
S pneumoniae bacteremia with penicillin MIC penicillin ≥ 2 mcg/mL	7/7	100	2/2	100

Table 2. Adverse Events Reported in Pediatric Cooperative Group Trial
	*No. (%) of Temodar* Patients (N = 122)**
Body System/Organ Class Adverse Event (AE)	All Events	Grade 3/4
Subjects reporting an AE body as a whole	107 (88)	69 (57)
Central and Peripheral Nervous System
Central cerebral CNS cortex	22 (18)	13 (11)
Gastrointestinal System
Nausea	56 (46)	5 (4)
Vomiting	62 (51)	4 (3)
Platelet, Bleeding, and Clotting
Thrombocytopenia	71 (58)	31 (25)
Red Blood Cell Disorders
Decreased hemoglobin	62 (51)	7 (6)
White Cell and RES Disorders
Decreased WBC	71 (58)	21 (17)
Lymphopenia	73 (60)	48 (39)
Neutropenia	62 (51)	24 (20)

Table 3. Outcomes of Randomized Treatment at Week 24 (Pooled Studies T20-301 and T20-302)
Outcomes	Fuzeon + Background Regimen 90 mg Twice Daily	Background Regimen
	N = 661	N = 334
HIV-1 RNA log change from baseline (log₁₀ copies/mL)	-1.52	-0.73
CD4+ cell count change from baseline (cells/mm²)	+71	+35
HIV RNA ≥ 1 log below baseline	342 (52%)	86 (26%)
HIV RNA < 400 copies/mL	247 (37%)	54 (16%)
HIV RNA < 50 copies/mL	151 (23%)	30 (9%)
Discontinued due to adverse reactions/labs*	40 (6%)	12 (4%)
Discontinued due to injection site reactions*	20 (3%)	N/A
Discontinued due to other reactions*	36 (5%)	14 (4%)

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April 2003

Antineoplastic Agents

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