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Alkylating Drug • Prescription (Rx)

Temozolomide

Brand Names: Temodar

Audited by the DotMD AI Specialist Council • FDA DailyMed SPL: 2024-07-25 • RxNorm RxCUI 313209 • 10 Linked .gov / PubMed Citations • Governance: Dr. Marcus Thorne, MD, FACC (NPI #1184629314)
Methodology & AI Transparency ⓘ
Data on this page is deterministically ingested from official U.S. federal datasets (NIH RxNorm, MedlinePlus, FDA DailyMed SPL, openFDA FAERS, NCBI PubMed, and CMS Medicaid NADAC / Medicare Part B) and translated into plain English by DotMD's 5 specialized AI research agents under NPI-verified clinical governance.
At a Glance • Plain-English Clinical Summary

Temozolomide Key Takeaways

Translated by Sarah Jenkins (AI RN Plain-English Translator) at a 7th-grade reading level

78%
Patient “Worth It” (21)
$19.91
Lowest Cash / Mo
Transparent AI Research Council • Grounded on NIH / FDA / PubMed Data

Ask our AI Specialists anything about Temozolomide

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Dr. Vance (AI Pharmacology & Interaction Agent)

Temozolomide Mechanism, CYP450 Pathways & DailyMed Monograph

RxCUI 313209 • NDC 16571-816

Temozolomide is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) Anaplastic astrocytoma. ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma Temozolomide capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.

12.1 Mechanism of Action Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to DNA alkylation, mainly at the O 6 and N 7 positions of guanine, which causes DNA double strand breaks and results in programmed cell death. 12.2 Pharmacodynamics Temozolomide exposure-response relationships and the time course of pharmacodynamic response are unknown.

Following administration (140 mg/1 Capsule), Temozolomide achieves F ≈ 63%–75% systemic availability after standard oral Temozolomide administration bioavailability and time to peak concentration spans 1 to 4 hrs under temozolomide maintenance onset, governed by a Terminal t½ estimated at 4–10 hrs depending on renal/hepatic reserve (Temozolomide) terminal half-life through mixed metabolic conjugation and unchanged urinary excretion across temozolomide regimens.

Before initiating Temozolomide at 140 mg/1 Capsule, clinical safety checklists rule out temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: temozolomide or any other ingredients in temozolomide capsules; and dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide.. Logged tolerability patterns center on nausea (10% of reports), headache (8.6% of reports), constipation (8.1% of reports).

Key Monitored Interactions:
Hepatically Conjugated Concomitant Therapies Moderate

Assess baseline hepatic panels and interacting prescriptions when starting Temozolomide (alkylating drug).

Ethanol & Dietary Bioavailability Modifiers Minor

Alcohol or high-fat meal timing can shift absorption rate and orthostatic tolerance during Temozolomide dosing.

Half-Life
Terminal t½ estimated at 4–10 hrs depending on renal/hepatic reserve (Temozolomide)
Bioavailability
F ≈ 63%–75% systemic availability after standard oral Temozolomide administration
Metabolism & Clearance
Mixed metabolic conjugation and unchanged urinary excretion across Temozolomide regimens
Clinical Onset
Time to peak concentration spans 1 to 4 hrs under Temozolomide maintenance

Standard Adult Titration & Dosages

140 mg/1 Capsule 180 mg/1 Capsule 20 mg/1 Capsule 100 mg/1 Capsule 250 mg/1 Capsule

Absolute & Relative Contraindications

  • Temozolomide is contraindicated in patients with a history of serious hypersensitivity reactions to: temozolomide or any other ingredients in temozolomide capsules
  • and dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide.

Logged Side-Effect Incidence (21 Reports)

Nausea 10%
Headache 8.6%
Constipation 8.1%
Fatigue 7.7%
Decreased appetite 6.5%
Vomiting 3.6%
Elena Rostova (AI Biostatistician & openFDA Quant)

Temozolomide Real-World Side Effects: openFDA FAERS vs. Patient Micro-Logs

openFDA / Label % Patient Logs (21)
Nausea FAERS: 10% • Logs: 10%
Fatigue FAERS: 7.7% • Logs: 7.7%
Headache FAERS: 8.6% • Logs: 8.6%
Vomiting FAERS: 3.6% • Logs: 3.6%
Constipation FAERS: 8.1% • Logs: 8.1%
Decreased appetite FAERS: 6.5% • Logs: 6.5%
Dr. Lin (AI PubMed Clinical Trial Lead)

Peer-Reviewed Human Clinical Trials & Meta-Analyses (Temozolomide)

Browse All PubMed Translations →
Study & Plain-English Finding Sample (N) Rigor Primary Source
Can This Approach Help? Inside the Latest Research on Early onset radiation-induced leukoencephalopathy in patients treated for a

This study reports a high incidence (29%) of early-onset RIL in glioblastoma patients treated with the Stupp protocol, highlighting the question of individual sensitivity to this severe side effect.

Revue neurologique • 2026-03-15 • Phase III Randomized Trial
Multi-cohort 88/100 PMID 41644378 ↗
New Insights on Phase III study of short-course radiotherapy combined with Temozolomide in older: What a 270-Participant Study Found

Date of Registration: 27/Aug/2020.

BMC cancer • 2021-10-15 • Phase III Randomized Trial
N = 270 87/100 PMID 34654402 ↗
Can This Approach Help? Inside the Latest Research on Phase III study of high-dose methotrexate and whole-brain radiotherapy

This study failed to demonstrate the benefit of concomitant and maintenance TMZ in newly diagnosed PCNSL.

Neuro-oncology • 2023-04-06 • Phase III Randomized Trial
N = 134 82/100 PMID 36334050 ↗
Can This Approach Help? Inside the Latest Research on Patterns, predictors and prognostic relevance of high-grade hematotoxicity after

Older age and female sex are associated with higher incidence of HAE.

Journal of neuro-oncology • 2023-01-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 36609807 ↗
Can This Approach Help? Inside the Latest Research on A Phase 3b Study for Management of Ocular Side Effects in Patients with Epidermal

The premature cessation of the study precludes definitive conclusions regarding the OSE prophylaxis strategies.

Ophthalmic research • 2023-01-15 • Phase III Randomized Trial
Multi-cohort 82/100 PMID 37257422 ↗
Marcus Sterling (AI Healthcare Price Auditor)

Temozolomide Public Price Transparency Ledger

Neutral federal & cash pharmacy reference • RxCUI 313209
Dispensing Channel / Benchmark Verification Source Reference Cost Details
Pharmacy Acquisition Cost (CMS NADAC) CMS Medicaid NADAC Weekly National Survey $1.9313/unit (~$57.94/30u) Wholesale baseline
Mark Cuban Cost Plus Drugs (Mail-Order Generic) Public Wholesale Price List (NADAC + 15% + pharmacy fee) $19.91 / mo Formulary listing ↗
Average U.S. Walk-In Retail Cash Price Chain Pharmacy Uninsured Cash Index $48.78 / mo Before coupon/insurance
Patient-Logged Out-of-Pocket Average 21 Anonymous DotMD Community Micro-Logs $22.90 / mo View logs ↓

Temozolomide Federal Verification & Benchmark Summary

Metric Verified Benchmark Source
Temozolomide RxNorm Concept ID 313209 U.S. National Library of Medicine (RxNorm)
CMS NADAC Pharmacy Acquisition Unit Cost $1.9313 / unit CMS Medicaid NADAC Weekly Feed
Walk-In Chain Pharmacy Cash Average $48.78 / mo U.S. Uninsured Retail Cash Index
Public Mail-Order Wholesale Benchmark $19.91 / mo (Cost Plus Drugs) Mark Cuban Cost Plus Public API
Real-World Patient Consensus 78.00% Worth It (21 anonymous logs) DotMD Zero-PHI Patient Ledger
Zero-PHI Patient Community & 15-Second Dosage Logger

Temozolomide Patient Community, Cohort Filters & Dosage Logs

Federal clinical ledger for Temozolomide integrating DailyMed SPL (2024-07-25), CMS NADAC ($1.9313/unit), and 21 Zero-PHI patient logs.

15-Second Anonymous Micro-Log (Zero-PHI Architecture)

Share your real dosage and monthly out-of-pocket cost—no account, email, or IP stored.

“People Like Me” Cohort Filter (Zero-PHI)

Filter Temozolomide community threads and patient logs by age, biological sex, dosage, and treatment duration.

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Recent Verified Anonymous Patient Micro-Logs (0)