Temozolomide
تموزولوماید
🎗️ Antineoplastic And Immunomodulating AgentsOral alkylating agent
Market / country: 🇺🇸 USA
Temodar (US)
🧮 Dose calculator
Glioblastoma and anaplastic astrocytoma · Regimen source: FDA Temodar · 2.2
- • Only under an oncologist in an equipped centre. Calculator = label mg/m² × BSA (Mosteller); protocol, cycle interval and adjustment for CBC and renal/hepatic function rest with the oncology team. FDA Temodar · 2.2
- • Pneumocystis prophylaxis during the concomitant phase. Start only with ANC ≥1.5 × 10⁹/L and platelets ≥100 × 10⁹/L. FDA Temodar · 2.2FDA Temodar · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ History of serious hypersensitivity to temozolomide or dacarbazine. FDA Temodar · 4
Warnings
- • Myelosuppression; hepatotoxicity; Pneumocystis pneumonia; secondary malignancies; embryo-fetal toxicity; do not open capsules. FDA Temodar · 5
Formulations
- 5 mg capsule — capsule 🇺🇸 USA FDA Temodar · 3
- 20 mg capsule — capsule 🇺🇸 USA FDA Temodar · 3
- 100 mg capsule — capsule 🇺🇸 USA FDA Temodar · 3
- 140 mg capsule — capsule 🇺🇸 USA FDA Temodar · 3
- 180 mg capsule — capsule 🇺🇸 USA FDA Temodar · 3
- 250 mg capsule — capsule 🇺🇸 USA FDA Temodar · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Temodar · 8.1
“Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , TEMODAR can cause fetal harm when administered to a pregnant woman.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Temodar · 8.2
“Because of the potential for serious adverse reactions, including myelosuppression from temozolomide in the breastfed children, advise women not to breastfeed during treatment with TEMODAR and for 1 week after the last dose.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Temodar · 8.4
“Safety and effectiveness of TEMODAR have not been established in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Temodar · 8.5
“… ade 4 thrombocytopenia (20%) in the first cycle of therapy than patients less than 70 years of age [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ] .”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Temodar · 8.3
“Contraception Females Advise females of reproductive potential to use effective contraception during treatment with TEMODAR and for 6 months after the last dose.”
🔗 Reference links
- FDA (approval record)NDA021029
- DailyMed (FDA label)FDA Temodar
- MedlinePlus (NIH)TemozolomideTemozolomide Injection
- WHO ATC/DDDL01AX03
- Darooyab (Iran)Temozolomide
🇮🇷 Registered in Iran Darooyab · G-1072/Temozolomide
Dosage forms with Iranian generic codes, per Darooyab.
- 05949 · TEMOZOLOMIDE 100MG CAP · کپسول تموزولوماید ۱۰۰ میلیگرم
- 19412 · TEMOZOLOMIDE 140MG CAP · کپسول تموزولوماید ۱۴۰ میلیگرم
- 19413 · TEMOZOLOMIDE 180MG CAP · کپسول تموزولوماید ۱۸۰ میلیگرم
- 19416 · TEMOZOLOMIDE 2.5MG/ML VIAL · ویال تموزولوماید ۲٫۵ میلیگرم / میلیلیتر
- 06532 · TEMOZOLOMIDE 20MG CAP · کپسول تموزولوماید ۲۰ میلیگرم
- 07593 · TEMOZOLOMIDE 20MG TAB · قرص تموزولوماید ۲۰ میلیگرم
- 05950 · TEMOZOLOMIDE 250MG CAP · کپسول تموزولوماید ۲۵۰ میلیگرم
- 06100 · TEMOZOLOMIDE 250MG TAB · قرص تموزولوماید ۲۵۰ میلیگرم
- 07384 · TEMOZOLOMIDE 5MG CAP · کپسول تموزولوماید ۵ میلیگرم
- 06637 · TEMOZOLOMIDE 5MG TAB · قرص تموزولوماید ۵ میلیگرم
- 50624 · TEMOZOLOMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 100 mg · پودر تزریقی تموزولوماید ۱۰۰ میلیگرم
- 51888 · TEMOZOLOMIDE CAPSULE ORAL 180 mg · کپسول تموزولوماید ۱۸۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Temodar · 3FDA Temodar · 2.2FDA Temodar · 2.1FDA Temodar · 4FDA Temodar · 5FDA Temodar · 8.1FDA Temodar · 8.2FDA Temodar · 8.4FDA Temodar · 8.5FDA Temodar · 8.3FDA Temodar · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-1072/Temozolomide
- Clinical review⚠ Unverified