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Temozolomide 100 mg Capsule, 14-count — NDC 73043-0013-14 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Temozolomide 100 mg Capsule, 14-count — NDC 73043-013-14 (Billing 73043-0013-14)

by Devatis, Inc. · 14 CAPSULE in 1 BOTTLE

This is a package of 14 capsules of Temozolomide 100 mg Capsule from Devatis, Inc., marketed since Apr 2017 and currently FDA-listed; retail pharmacies pay about $4.38 per capsule (NADAC).

NDC 73043-0013-14
🏷️ FDA NDC (as labeled) 73043-013-14 billing pads the product segment with a zero
This package
Contains14-count Cost per ea$4.38 NADAC Per package$61.26 / 14 capsules Pack sizes2 compare ↓
Product page 73043-0013-05 Also comes in: 5 capsules 73043-013-05
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Temozolomide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 3, 2026 — Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing (Rising Pharma Holding, Inc.) · FDA recall D-0384-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 73043-013-14
Product NDC 73043-013
11-digit billing NDC 73043001314
NCPDP billing unit EA — each (per item)
RxCUI 313209, 313210, 313211, 317160, 700883, 700885
UNII YF1K15M17Y
Application # ANDA207658
SPL Set ID 6b263fe0-5f06-4889-bf14-4aa185470810
Established class (EPC) Alkylating Drug
Mechanism of action Alkylating Activity
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-04-28
Route ORAL
Dosage form CAPSULE
Substance TEMOZOLOMIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21104070000140
GCN Seq No 043012
GCN 92913
HICL code 020355
Ingredient (HICL) Temozolomide
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1A
Therapeutic class — specific (HIC3) Antineoplastic - Alkylating Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name TEMOZOLOMIDE 100 MG CAPSULE
FDB brand name Temozolomide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 043012
  • GCN: 92913
  • GPI-14 (Medi-Span): 21104070000140
  • HICL (First Databank): 020355
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 313209
Why two NDCs? The FDA registers this code as 73043-013-14 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 73043-0013-14. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Other alkylating agents
How it works Alkylating Activity
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TEMOZOLOMIDE 100 MG CAPSULE Ingredient Temozolomide
📗 Our plain-language guide HelloPharmacist
  • Temozolomide is a chemotherapy used to treat aggressive brain tumors — specifically glioblastoma (a fast-growing brain tumor) and anaplastic astrocytoma. It works by getting into c...
  • What exactly is temozolomide treating, and why do I need it?
  • Yes, it does matter. Swallow the capsules whole with a full glass of water — never open, crush, or chew them. Try to avoid taking them right after a high-fat meal, because fat can...
  • How should I take the capsules — does it matter when I take them or whether I eat first?
📖 Read our full Temozolomide guide →
1
Nutrient depletion considerations

Temozolomide may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Temozolomide nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $4.376 $61.26 / 14 capsules
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · NONE No ASP payment limit on file for NONE this quarter.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $10.327 $4.376
▼ Down 50% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)73043-013-14
11-digit billing NDC73043-0013-14
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeNONE
DescriptorTEMOZOLOMIDE, 100 MG, ORAL
Billing units / pkg1 units
How the units are derivedThis package is 14 EA; the HCPCS unit is 100 MG, so one package = 1 billing unit.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
73043-0013-05 73043-013-05 Main listing 5 CAPSULE in 1 BOTTLE $4.38 / ea $21.88 2025-04-01 — Active
73043-0013-14 You're viewing this 14 CAPSULE in 1 BOTTLE $4.38 / ea $61.26 2025-04-01 — Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($4.38 NADAC).

Pack size FAQ

What quantity is in this package?
This is a 14-count package — 14 capsule in 1 bottle.
How does this package differ from NDC 73043-0013-05?
Both are Temozolomide 100 mg Capsule — the drug itself is identical. This page's package is the 14-count one, while NDC 73043-0013-05 is the 5 capsules package.
What NDC number is used to bill for this package of Temozolomide 100 mg Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Temozolomide 100 mg 16729-0050-53 Accord 5 capsules $4.375 AB Availability likely —
Temozolomide 100 mg 31722-0413-14 Camber 14 capsules $4.375 AB Availability likely —
Temozolomide 100 mg 65162-0803-14 Amneal 14 capsules $4.375 AB Availability likely —
Temozolomide 100 mg 67877-0539-07 Ascend 5 capsules $4.375 AB Availability likely —
Temozolomide 100 mgthis 73043-0013-14 Devatis, 14 capsules $4.375 AB Availability likely —
Temodar 100 mg 00085-1366-03 Merck 5 capsules — — FDA listed —
Temozolomide 100 mg 16571-0818-02 Rising 20 capsules — AB FDA listed —
Temozolomide 100 mg 47335-0892-21 Sun 14 capsules — AB FDA listed —
Temozolomide 100 mg 72162-2661-02 Bryant 5 capsules — AB FDA listed —
temozolomide 100 mg 75834-0143-05 Nivagen 5 capsules — — FDA listed —
Temozolomide 100 mg 82249-0408-05 CivicaScript 5 capsules — AB FDA listed —
Temozolomide 100 mg 70301-2005-01 OPKO 5 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
On the market since
Apr 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White / Green / Yellow / Blue / Orange
ShapeCapsule
Imprint250mg
Size22 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDevatis, Inc.
Application holderDEVA HOLDING AS
FDA applicationANDA207658 (ANDA)
Labeler code73043
First marketedApr 2017
Product typeHuman Prescription Drug
Portfolio16 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 109 words ▾

1. INDICATIONS AND USAGE TEMOZOLOMIDE Capsules are an alkylating drug indicated for the treatment of adult patients 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 )

1.1Newly Diagnosed Glioblastoma TEMOZOLOMIDE Capsules is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment.

1.2Anaplastic Astrocytoma TEMOZOLOMIDE Capsules is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION Administer either orally or intravenously. (2.4) Newly Diagnosed Glioblastoma: 75 mg/m 2 once daily for 42 to 49 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m 2 once daily for Days 1 to 5 of each 28-day cycle for 6 cycles.

May increase maintenance dose to 200 mg/ m 2 for cycles 2 – 6 based on toxicity. ( 2.1 ) Provide Pneumocystis pneumonia (PCP) prophylaxis during concomitant phase and continue in patients who develop lymphopenia until resolution to grade 1 or less. ( 2.1 ) Adjuvant Treatment of Newly Diagnosed Anaplastic Astrocytoma: Beginning 4 weeks after the end of radiotherapy, administer TEMOZOLOMIDE Capsules orally in a single dose on days 1-5 of a 28-day cycle for 12 cycles.

The recommended dosage for Cycle 1 is 150 mg/m 2 per day and for Cycles 2 to 12 is 200 mg/m 2 if patient experienced no or minimal toxicity in Cycle 1. ( 2.2 ) Refractory Anaplastic Astrocytoma : Initial dose of 150 mg/m 2 once daily on Days 1 to 5 of each 28-day cycle. ( 2.2 )

2.1Monitoring to Inform Dosage and Administration Prior to dosing, withhold TEMOZOLOMIDE until patients have an absolute neutrophil count (ANC) of 1.5 x 10 9 /L or greater and a platelet count of 100 x 10 9 /L or greater. For concomitant radiotherapy, obtain a complete blood count prior to initiation of treatment and weekly during treatment. For the 28-day treatment cycles, obtain a complete blood count prior to treatment on Day 1 and on Day 22 of each cycle.

Perform complete blood counts weekly until recovery if the ANC falls below 1.5 x 10 9 /L and the platelet count falls below 100 x 10 9 /L. For concomitant use with focal radiotherapy, obtain a complete blood count weekly and as clinically indicated.

2.2Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma Administer TEMOZOLOMIDE either orally or intravenously once daily for 42 to 49 consecutive days during the concomitant phase with focal radiotherapy and then once daily on Days 1 to 5 of each 28-day cycle for 6 cycles during the maintenance phase. Provide Pneumocystis pneumonia (PCP) prophylaxis during the concomitant phase and continue in patients who develop lymphocytopenia until resolution to grade 1 or less [see Warnings and Precautions ( 5.3 )].

Concomitant Phase The recommended dosage of TEMOZOLOMIDE is 75 mg/m 2 either orally or intravenously once daily for 42 to 49 days in combination with focal radiotherapy. Focal radiotherapy includes the tumor bed or resection site with a 2 to 3 cm margin. Other administration schedules have been used.

Obtain a complete blood count weekly. The recommended dosage modifications due toadverse reactions during concomitant use phase are provided in Table 1 . TABLE 1: Temozolomide Dosage Modifications During Concomitant Phase Adverse Reaction Interruption Discontinuation Absolute Neutrophil Count Withhold TEMOZOLOMIDE if ANC is greater than or equal to 0.5 x 10 9 /L and less than 1.5 x 10 9 /L.

Resume TEMOZOLOMIDE when ANC is greater than or equal to 1.5 x 10 9 /L. Discontinue TEMOZOLOMIDE if platelet count is less than 0.5 x 10 9 /L. Platelet Count Withhold TEMOZOLOMIDE if platelet count is greater than or equal to 10 x 10 9 /L and less than 100 x 10 9 /L.

Resume TEMOZOLOMIDE when platelet count is greater than or equal to 100 x 10 9 /L. Discontinue TEMOZOLOMIDE if platelet count is less than 10 x 10 9 /L. Non-hematological Adverse Reaction (except for alopecia, nausea, vomiting) Withhold TEMOZOLOMIDE if Grade 2 adverse reaction occurs.

Resume TEMOZOLOMIDE when resolution to Grade 1 or less. Discontinue TEMOZOLOMIDE if Grade 3 or 4 adverse reaction occurs. Single Agent Maintenance Use Phase : Beginning 4 weeks after Concomitant Phase completion, administer TEMOZOLOMIDE either orally or intravenously once daily on Days 1 to 5 of each 28-day cycle for 6 cycles.

The recommended dosage of TEMOZOLOMIDE is as follows: Cycle 1: 150 mg/m 2 per day on days 1 to 5. Cycles 2 to 6: May increase… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 137 words ▾

3. DOSAGE FORMS AND STRENGTHS · TEMOZOLOMIDE Capsules, USP for oral administration 5-mg: Capsules have opaque white bodies with opaque green caps. The capsule body is imprinted with the dosage strength.

20-mg: Capsules have opaque white bodies with opaque yellow caps. The capsule body is imprinted with the dosage strength. 100-mg: Capsules have opaque white bodies with opaque flesh caps.

The capsule body is imprinted with the dosage strength. 140-mg: Capsules have opaque white bodies with transparent blue caps. The capsule body is imprinted with the dosage strength.

180-mg: Capsules have opaque white bodies with opaque orange caps. The capsule body is imprinted with the dosage strength. 250-mg: Capsules have opaque white bodies with opaque white caps.

The capsule body is imprinted with the dosage strength. 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg capsules. ( 3 )

⛔ Contraindications 67 words ▾

4. CONTRAINDICATIONS TEMOZOLOMIDE is contraindicated in patients with a history of hypersensitivity reactions to: • temozolomide or any other ingredients in TEMOZOLOMIDE; and • dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. Reactions to TEMOZOLOMIDE have included anaphylaxis [see Adverse Reactions ( 6.2 )].

History of hypersensitivity to temozolomide or any other ingredients in TEMOZOLOMIDE capsules and dacarbazine. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS Myelosuppression: Monitor absolute neutrophil count (ANC) and platelet count prior to each cycle and during treatment. Geriatric patients and women have a higher risk of developing myelosuppression.

( 5.1 , 8.5 ) Hepatotoxicity : Fatal and severe hepatotoxicity have been reported. Perform liver tests at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately 2 to 4 weeks after the last dose of TEMOZOLOMIDE ( 5.2 ) Pneumocystis Pneumonia (PCP): Closely monitor all patients, particularly those receiving steroids, for the development of lymphopenia and PCP.( 5.3 ) Secondary Malignancies : Myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed.

( 5.4 ) Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Advise male patients with pregnant partners or female partners of reproductive potential to use condoms.

( 5.5 , 8.1 , 8.3 ) Exposure to Opened Capsules : TEMOZOLOMIDE capsules should not be opened, chewed, or dissolved but should be swallowed whole with a glass of water. ( 5.6 )

5.1Myelosuppression Myelosuppression, including pancytopenia, leukopenia and anemia, some with fatal outcomes, have occurred with TEMOZOLOMIDE [see Adverse Reactions ( 6.1 , 6.2 )] . In MK-7365-006, myelosuppression usually occurred during the first few cycles of therapy and was generally not cumulative. The median nadirs occurred at 26 days for platelets (range: 21 to 40 days) and 28 days for neutrophils (range: 1 to 44 days).

Approximately 10% of patients required hospitalization, blood transfusion, or discontinuation of therapy due to myelosuppression. Geriatric patients and women have been shown in clinical trials to have a higher risk of developing myelosuppression. Obtain a complete blood count and monitor ANC and platelet counts before initiation of treatment and as clinically indicated during treatment.

When TEMOZOLOMIDE is used in combination with radiotherapy, obtain a complete blood count prior to initiation of treatment, weekly during treatment, and as clinically indicated [see Dosage and Administration ( 2.1 , 2.2 , 2.3 )] . For severe myelosuppression, withhold TEMOZOLOMIDE and then resume at same or reduced dose, or permanently discontinue, based on occurrence [see Dosage and Administration ( 2.1 , 2.2 , 2.3 )].

5.2Hepatotoxicity Fatal and severe hepatotoxicity have been reported in patients receiving TEMOZOLOMIDE. Perform liver tests at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately two to four weeks after the last dose of TEMOZOLOMIDE.

5.3Pneumocystis Pneumonia Pneumocystis pneumonia (PCP) can occur in patients receiving TEMOZOLOMIDE. The risk of PCP is increased in patients receiving steroids or with longer treatment regimens of TEMOZOLOMIDE. For patients with newly diagnosed glioblastoma, provide PCP prophylaxis for all patients during the concomitant phase.

Continue in patients who experience lymphopenia until resolution to Grade 1 or less [see Dosage and Administration ( 2.1 )]. Monitor all patients receiving TEMOZOLOMIDE for the development of lymphopenia and PCP.

5.4Secondary Malignancies The incidence of secondary malignancies is increased in patients treated with TEMOZOLOMIDE containing regimens. Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed following TEMOZOLOMIDE administration.

5.5Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, TEMOZOLOMIDE can cause fetal harm when administered to a pregnant woman. Adverse developmental outcomes have been reported in both pregnant patients and pregnant partners of male patients. Oral administration of temozolomide to rats and rabbits during the period of organogenesis resulted in embryolethality and polymalformations at doses less than… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )]. Hepatotoxicity [see Warnings and Precautions ( 5.2 )].

Pneumocystis Pneumonia [see Warnings and Precautions ( 5.3 )]. Secondary Malignancies [see Warnings and Precautions ( 5.4 )]. The most common adverse reactions (≥ 20% incidence) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, and convulsions.

( 6.1 ) The most common Grade 3 to 4 hematologic laboratory abnormalities (≥ 10% incidence) in patients with anaplastic astrocytoma are: decreased lymphocytes, decreased platelets, decreased neutrophils, and decreased leukocytes.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Devatis Inc. at 1-833-534-4406 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or www.devatis.com.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Newly Diagnosed Glioblastoma The safety of TEMOZOLOMIDE was evaluated in Study MK-7365-051 [see Clinical Studies ( 14.1 )]. Severe or life-threatening adverse reactions occurred in 49% of patients treated with TEMOZOLOMIDE; the most common were fatigue (13%), convulsions (6%), headache (5%), and thrombocytopenia (5%).

The most common adverse reactions (≥20%) in patients treated with TEMOZOLOMIDE were alopecia, fatigue, nausea, anorexia, headache, constipation, and vomiting. Table 3 summarizes the adverse reactions in MK-7365-051 TABLE 3: Adverse Reactions (≥10%) in Patients with Newly Diagnosed Glioblastoma Adverse Reactions Concomitant Use Phase Maintenance Use Phase Radiation Therapy and TEMOZOLOMIDE N=288* Radiation Therapy Alone N=285 TEMOZOLOMIDE N=224 All Grades (%) Grade ≥3 (%) All Grades (%) Grades ≥3 (%) All Grades (%) Grade ≥3 (%) Skin and Subcutaneous Tissue Alopecia 69 0 63 0 55 0 Rash 19 1 15 0 13 1 General Fatigue 54 7 49 5 61 9 Anorexia 19 1 9 <1 27 1 Headache 19 2 17 4 23 4 Gastrointestinal System Nausea 36 1 16 <1 49 1 Vomiting 20 <1 6 <1 29 2 Constipation 18 1 6 0 22 0 Diarrhea 6 0 3 0 10 1 Central and Peripheral Nervous System Convulsions 6 3 7 3 11 3 NOS=not otherwise specified.

Note : Grade 5 (fatal) adverse reactions are included in the Grade ≥3 column. * One patient who was randomized to radiation therapy-only arm received radiation therapy and TEMOZOLOMIDE. Clinically relevant adverse reactions in <10% of patients are presented below: Central & Peripheral Nervous System : memory impairment, confusion Eye : vision blurred Gastrointestinal System : stomatitis, abdominal pain General : weakness, dizziness Immune System : allergic reaction Injury : radiation injury not otherwise specified Musculoskeletal System : arthralgia Platelet, Bleeding, & Clotting : thrombocytopenia Psychiatric : insomnia Respiratory System : coughing, dyspnea Special Senses Other : taste perversion Skin & Subcutaneous Tissue : dry skin, pruritus, erythema When laboratory abnormalities and adverse reactions were combined, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of patients, and Grade 3 or Grade 4 platelet abnormalities including thrombocytopenic reactions, were observed in 14% of patients.

Newly Diagnosed Anaplastic Astrocytoma The safety of TEMOZOLOMIDE for the adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma was derived from published literature [see Clinical Studies ( 14.2 )]. The safety of TEMOZOLOMIDE for the adjuvant treatment of patients with newly diagnosed anaplastic astrocytoma was consistent with the known safety profile of TEMOZOLOMIDE. Refractory Anaplastic Astrocytoma The safety of TEMOZOLOMIDE was evaluated in Study MK-7365-006 [see Clinical Studies ( 14.2 )].… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8. USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] TEMOZOLOMIDE can cause fetal harm when administered to a pregnant woman. Available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to TEMOZOLOMIDE during pregnancy. These cases report similar adverse developmental outcomes to those observed in animal studies.

Administration of TEMOZOLOMIDE to rats and rabbits during the period of organogenesis caused numerous external, internal, and skeletal malformations at doses less than the maximum human dose based on body surface area (see Data) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data Five consecutive days of oral administration of temozolomide at doses of 75 and 150 mg/m 2 (0.38 and 0.75 times the human dose of 200 mg/m 2 ) in rats and rabbits, respectively, during the period of organogenesis (Gestation Days 8-12) caused numerous malformations of the external and internal organs and skeleton in both species. In rabbits, temozolomide at the 150 mg/m 2 dose (0.75 times the human dose of 200 mg/m 2 ) caused embryolethality as indicated by increased resorptions.

8.2Lactation There are no data on the presence of TEMOZOLOMIDE or its metabolites in human milk, the effects on a breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions, including myelosuppression from temozolomide in the breastfed children, advise women not to breastfeed during treatment with TEMOZOLOMIDE and for at least 1 week after the last dose.

8.3Females and Males of Reproductive Potential TEMOZOLOMIDE can cause embryo-fetal harm when administered to a pregnant woman [see Use in Specific Populations ( 8.1 ) ]. Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating TEMOZOLOMIDE [see Use in Specific Populations ( 8.1 )] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with TEMOZOLOMIDE and for at least 6 months after the last dose.

Males Because of the potential for embryofetal toxicity and genotoxic effects on sperm cells, advise male patients with pregnant partners or female partners of reproductive potential to use condoms during treatment with TEMOZOLOMIDE and for at least 3 months after the final dose [see Use in Specific Populations ( 8.1 ), Nonclinical Toxicology ( 13.1 )]. Advise male patients not to donate semen during treatment with TEMOZOLOMIDE and for at least 3 months after the final dose. Infertility TEMOZOLOMIDE may impair male fertility [ see Nonclinical Toxicology ( 13.1 )].

Limited data from male patients show changes in sperm parameters during treatment with TEMOZOLOMIDE; however, no information is available on the duration or reversibility of these changes.

8.4Pediatric Use Safety and effectiveness of TEMOZOLOMIDE have not been established in pediatric patients. Safety and effectiveness of TEMOZOLOMIDE capsules were assessed, but not established, in 2 open-label studies in pediatric patients aged 3 to 18 years. In one study, 29 patients with recurrent brain stem glioma and 34 patients with recurrent high-grade astrocytoma were enrolled.

In a second study conducted by the Children’s Oncology Group (COG), 122 patients were enrolled, including 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 tumors (9). The adverse reaction profile in pediatric… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] TEMOZOLOMIDE can cause fetal harm when administered to a pregnant woman. Available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to TEMOZOLOMIDE during pregnancy. These cases report similar adverse developmental outcomes to those observed in animal studies.

Administration of TEMOZOLOMIDE to rats and rabbits during the period of organogenesis caused numerous external, internal, and skeletal malformations at doses less than the maximum human dose based on body surface area (see Data) . Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data Five consecutive days of oral administration of temozolomide at doses of 75 and 150 mg/m 2 (0.38 and 0.75 times the human dose of 200 mg/m 2 ) in rats and rabbits, respectively, during the period of organogenesis (Gestation Days 8-12) caused numerous malformations of the external and internal organs and skeleton in both species. In rabbits, temozolomide at the 150 mg/m 2 dose (0.75 times the human dose of 200 mg/m 2 ) caused embryolethality as indicated by increased resorptions.

🧒 Pediatric Use 110 words ▾

8.4Pediatric Use Safety and effectiveness of TEMOZOLOMIDE have not been established in pediatric patients. Safety and effectiveness of TEMOZOLOMIDE capsules were assessed, but not established, in 2 open-label studies in pediatric patients aged 3 to 18 years. In one study, 29 patients with recurrent brain stem glioma and 34 patients with recurrent high-grade astrocytoma were enrolled.

In a second study conducted by the Children’s Oncology Group (COG), 122 patients were enrolled, including 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 tumors (9). The adverse reaction profile in pediatric patients was similar to adults.

🧓 Geriatric Use 219 words ▾

8.5Geriatric Use In MK-7365-051, 15% of patients with newly diagnosed glioblastoma were 65 years and older. This study did not include sufficient numbers of patients aged 65 years and older to determine differences in effectiveness from younger patients. No overall differences in safety were observed between patients ≥65 years and younger patients.

The CATNON trial did not include sufficient numbers of patients aged 65 years and older to determine differences in safety or effectiveness when compared to younger patients. In MK-7365-006, 4% of patients with refractory anaplastic astrocytoma were 70 years and older. This study did not include sufficient numbers of patients aged 70 years and older to determine differences in effectiveness from younger patients.

Patients 70 years and older had a higher incidence of Grade 4 neutropenia (25%) and Grade 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 )] . In the entire safety database for which hematologic data exist (N=932), 7% (4/61) and 10% (6/63) of patients >70 years experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. For patients ≤70 years, 7% (62/871) and 6% (48/879) experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively.

Pancytopenia, leukopenia, and anemia also occurred.

🆘 Overdosage 103 words ▾

10. OVERDOSAGE Dose-limiting toxicity was myelosuppression and was reported with any dose but is expected to be more severe at higher doses. An overdose of 2000 mg per day for 5 days was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure, and death.

There are reports of patients who have taken more than 5 days of treatment (up to 64 days), with adverse reactions reported including myelosuppression, which in some cases was severe and prolonged, and infections and resulted in death. In the event of an overdose, monitor complete blood count and provide supportive measures as necessary.

🧬 Clinical Pharmacology ~2 min read ▾

12. CLINICAL PHARMACOLOGY

12.1Mechanism 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 alkylation of DNA. Alkylation (methylation) occurs mainly at the O 6 and N 7 positions of guanine.

12.2Pharmacodynamics Temozolomide exposure-response relationships and the time course of pharmacodynamic response are unknown.

12.3Pharmacokinetics Following a single oral dose of 150 mg/m 2 , the mean C max is 7.5 mcg/mL for temozolomide and 282 ng/mL for MTIC. The mean AUC is 23.4 mcg·hr/mL for temozolomide and 864 ng·hr/mL for MTIC. Following a single 90-minute intravenous infusion of 150 mg/m 2 , the mean C max is 7.3 mcg/mL for temozolomide and 276 ng/mL for MTIC.

The mean AUC is 24.6 mcg·hr/mL for temozolomide and 891 ng·hr/mL for MTIC. Temozolomide exhibits linear kinetics over the therapeutic dosing range of 75 mg/m 2 /day to 250 mg/m 2 /day. Absorption The median T max is 1 hour.

Effect of Food The mean temozolomide C max and AUC decreased by 32% and 9%, respectively, and median T max increased by 2-fold (from 1 to 2.25 hours) when TEMOZOLOMIDE capsules were administered after a modified high-fat breakfast (587 calories comprised of 1 fried egg, 2 strips of bacon, 2 slices of toast, 2 pats of butter, and 8 oz whole milk). Distribution Temozolomide has a mean (CV%) apparent volume of distribution of

0.4L/kg (13%). The mean percent bound of drug-related total radioactivity is 15%. Elimination Clearance of temozolomide is approximately

5.5L/hr/m 2 and the mean elimination half-life is 1.8 hours. Metabolism Temozolomide is spontaneously hydrolyzed at physiologic pH to the active species, MTIC and to temozolomide acid metabolite. MTIC is further hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), which is known to be an intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.

Cytochrome P450 enzymes play a minor role in the metabolism of temozolomide and MTIC. Relative to the AUC of temozolomide, the exposure to MTIC and AIC is 2.4% and 23%, respectively. Excretion Approximately 38% of the administered temozolomide total radioactive dose is recovered over 7 days: 38% in urine and 0.8% in feces.

The majority of the recovered radioactivity in urine is unchanged temozolomide (6%), AIC (12%), temozolomide acid metabolite (2.3%), and unidentified polar metabolite(s) (17%). Specific Populations No clinically significant differences in the pharmacokinetics of temozolomide were observed based on age (range: 19-78 years), gender, smoking status (smoker vs. non-smoker), creatinine clearance (CLcr) of 36 to 130 mL/min/m 2 , or mild to moderate hepatic impairment (Child Pugh class A and B). The pharmacokinetics of temozolomide has not been studied in patients with CLcr < 36 mL/min/m 2 , end-stage renal disease on dialysis, or severe hepatic impairment (Child-Pugh class C).

Drug Interaction Studies Clinical Studies and Model-Informed Approaches No clinically significant differences in the pharmacokinetics of temozolomide or MTIC were observed when co-administered with ranitidine. No clinically significant differences in the clearance of temozolomide or MTIC were predicted when co-administered with the following drugs: valproic acid, dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, histamine-2-receptor antagonists, or phenobarbital.

🧬 Mechanism of Action 51 words ▾

12.1Mechanism 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 alkylation of DNA. Alkylation (methylation) occurs mainly at the O 6 and N 7 positions of guanine.

📦 How Supplied / Storage and Handling ~1 min read ▾

16. HOW SUPPLIED/STORAGE AND HANDLING TEMOZOLOMIDE is a hazardous drug. Follow applicable special handling and disposal procedures.

1 TEMOZOLOMIDE Capsules, USP TEMOZOLOMIDE Capsules, USP are supplied in amber glass bottles, with child-resistant polypropylene caps (not supplied in sachets) containing the following capsule strengths: TEMOZOLOMIDE Capsules USP, 5 mg: Have opaque white bodies with opaque green caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 73043-011-05 14-count – NDC 73043-011-14 TEMOZOLOMIDE Capsules USP, 20 mg: Have opaque white bodies with opaque yellow caps.

The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 73043-012-05 14-count – NDC 73043-012-14 TEMOZOLOMIDE Capsules USP, 100 mg: Have opaque white bodies with opaque flesh caps. The capsule body is imprinted with the dosage strength.

They are supplied as follows: Bottles: 5-count – NDC 73043-013-05 14-count – NDC 73043-013-14 TEMOZOLOMIDE Capsules USP, 140 mg: Have opaque white bodies with transparent blue caps. The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 73043-014-05 14-count – NDC 73043-014-14 TEMOZOLOMIDE Capsules USP, 180 mg: Have opaque white bodies with opaque orange caps.

The capsule body is imprinted with the dosage strength. They are supplied as follows: Bottles: 5-count – NDC 73043-015-05 14-count – NDC 73043-015-14 TEMOZOLOMIDE Capsules USP, 250 mg: Have opaque white bodies with opaque white caps. The capsule body is imprinted with the dosage strength.

They are supplied as follows: Bottles: 5-count – NDC 73043-016-05 Store TEMOZOLOMIDE Capsules, USP at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description ~2 min read ▾

11. DESCRIPTION Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as -tetrazine-8-carboxamide.

The structural formula of temozolomide is: The material is a white to light tan/light pink powder with a molecular formula of C 6 H 6 N 6 O 2 and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence TEMOZOLOMIDE can be administered orally and intravenously. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH.

TEMOZOLOMIDE Capsules, USP: TEMOZOLOMIDE Capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide. The inactive ingredients are as follows: TEMOZOLOMIDE Capsules, USP 5 mg : lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3.0 mg). TEMOZOLOMIDE Capsules, USP 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg).

TEMOZOLOMIDE Capsules, USP 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3.0 mg), and stearic acid (6.0 mg). TEMOZOLOMIDE Capsules, USP 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg). TEMOZOLOMIDE Capsules, USP 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.4 mg), and stearic acid (10.8 mg).

TEMOZOLOMIDE Capsules, USP 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9.0 mg), and stearic acid (13.5 mg). The body of the capsules is made of gelatin and titanium dioxide and is opaque white. The cap is also made of gelatin and the colors may vary based on the dosage strength.

The capsule body and cap are imprinted with pharmaceutical branding ink, which contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide, and ferric oxide. T EMOZOLOMIDE Capsules, USP 5 mg: The opaque green cap contains gelatin, titanium dioxide, iron oxide yellow and FD&C Blue 2. TEMOZOLOMIDE Capsules, USP 20 mg: The opaque yellow cap contains gelatin, titanium dioxide and iron oxide yellow.

TEMOZOLOMIDE Capsules, USP 100 mg: The opaque flesh cap contains gelatin, titanium dioxide and iron oxide red. TEMOZOLOMIDE Capsules, USP 140 mg: The transparent blue cap contains gelatin, FD&C Blue #2, and titanium dioxide. TEMOZOLOMIDE Capsules, USP 180 mg: The opaque orange cap contains gelatin, titanium dioxide and iron oxide red.

TEMOZOLOMIDE Capsules, USP 250 mg: The opaque white cap contains gelatin and titanium dioxide. FDA approved dissolution test specifications differ from USP chemical-structure

💬 Information for Patients ~2 min read ▾

17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Myelosuppression Inform patients that TEMOZOLOMIDE can cause low blood cell counts and the need for frequent monitoring of blood cell counts.

Advise patients to contact their healthcare provider immediately for bleeding, fever, or other signs of infection [see Warnings and Precautions ( 5.1 )]. Myelodysplastic Syndrome and Secondary Malignancies Advise patients of the increased risk of myelodysplastic syndrome and secondary malignancies [see Warnings and Precautions ( 5.2 )]. Pneumocystis Pneumonia Advise patients of the increased risk of Pneumocystis pneumonia and to contact their healthcare provided immediately for new or worsening pulmonary symptoms.

Inform patients that prophylaxis for Pneumocystis pneumonia may be needed [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.3 )]. Hepatotoxicity Advise patients of the increased risk of hepatotoxicity and to contact their healthcare provider immediately for signs or symptoms of hepatoxicity [see Warnings and Precautions ( 5.4 )]. Administration Instructions Advise patient to not open capsules.

If capsules are accidentally opened or damaged, advise patients to take rigorous precautions with capsule contents to avoid inhalation or contact with the skin or mucous membranes [see Warnings and Precautions ( 5.6 )]. In case of powder contact, the hands should be washed. [see Dosage and Administration ( 2.4 )]. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential to use effective contraception during treatment with TEMOZOLOMIDE and for at least 6 months after the last dose [see Use in Specific Populations ( 8.3 )]. Advise male patients with pregnant partners or female partners of reproductive potential to use condoms during treatment with TEMOZOLOMIDE and for at least 3 months after the final dose [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )].

Advise male patients not to donate semen during treatment with TEMOZOLOMIDE and for at least 3 months after the final dose [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )]. Lactation Advise women not to breastfeed during treatment with TEMOZOLOMIDE and for at least 1 week after the final dose [see Use in Specific Populations ( 8.2 )]. Infertility Advise males of reproductive potential that TEMOZOLOMIDE may impair fertility [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )].

Made in Turkey Distributed by: Devatis, Inc. San Clemente, CA 92672 Revised: 11/2024

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Following a single oral dose of 150 mg/m 2 , the mean C max is 7.5 mcg/mL for temozolomide and 282 ng/mL for MTIC. The mean AUC is 23.4 mcg·hr/mL for temozolomide and 864 ng·hr/mL for MTIC. Following a single 90-minute intravenous infusion of 150 mg/m 2 , the mean C max is 7.3 mcg/mL for temozolomide and 276 ng/mL for MTIC.

The mean AUC is 24.6 mcg·hr/mL for temozolomide and 891 ng·hr/mL for MTIC. Temozolomide exhibits linear kinetics over the therapeutic dosing range of 75 mg/m 2 /day to 250 mg/m 2 /day. Absorption The median T max is 1 hour.

Effect of Food The mean temozolomide C max and AUC decreased by 32% and 9%, respectively, and median T max increased by 2-fold (from 1 to 2.25 hours) when TEMOZOLOMIDE capsules were administered after a modified high-fat breakfast (587 calories comprised of 1 fried egg, 2 strips of bacon, 2 slices of toast, 2 pats of butter, and 8 oz whole milk). Distribution Temozolomide has a mean (CV%) apparent volume of distribution of

0.4L/kg (13%). The mean percent bound of drug-related total radioactivity is 15%. Elimination Clearance of temozolomide is approximately

5.5L/hr/m 2 and the mean elimination half-life is 1.8 hours. Metabolism Temozolomide is spontaneously hydrolyzed at physiologic pH to the active species, MTIC and to temozolomide acid metabolite. MTIC is further hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), which is known to be an intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.

Cytochrome P450 enzymes play a minor role in the metabolism of temozolomide and MTIC. Relative to the AUC of temozolomide, the exposure to MTIC and AIC is 2.4% and 23%, respectively. Excretion Approximately 38% of the administered temozolomide total radioactive dose is recovered over 7 days: 38% in urine and 0.8% in feces.

The majority of the recovered radioactivity in urine is unchanged temozolomide (6%), AIC (12%), temozolomide acid metabolite (2.3%), and unidentified polar metabolite(s) (17%). Specific Populations No clinically significant differences in the pharmacokinetics of temozolomide were observed based on age (range: 19-78 years), gender, smoking status (smoker vs. non-smoker), creatinine clearance (CLcr) of 36 to 130 mL/min/m 2 , or mild to moderate hepatic impairment (Child Pugh class A and B). The pharmacokinetics of temozolomide has not been studied in patients with CLcr < 36 mL/min/m 2 , end-stage renal disease on dialysis, or severe hepatic impairment (Child-Pugh class C).

Drug Interaction Studies Clinical Studies and Model-Informed Approaches No clinically significant differences in the pharmacokinetics of temozolomide or MTIC were observed when co-administered with ranitidine. No clinically significant differences in the clearance of temozolomide or MTIC were predicted when co-administered with the following drugs: valproic acid, dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, histamine-2-receptor antagonists, or phenobarbital.

🔬 Clinical Studies ~3 min read ▾

14. CLINICAL STUDIES

14.1Newly Diagnosed Glioblastoma The efficacy of TEMOZOLOMIDE was evaluated in MK-7365-051 (NCT00006353), a randomized (1:1), multicenter, open-label trial. Eligible patients were required to have newly diagnosed glioblastoma. Patients were randomized to receive either radiation therapy alone or concomitant TEMOZOLOMIDE 75 mg/m 2 once daily starting the first day of radiation therapy and continuing until the last day of radiation therapy for 42 days (with a maximum of 49 days), followed by TEMOZOLOMIDE 150 mg/m 2 or 200 mg/m 2 once daily on Days 1 to 5 of each 28-day cycle, starting 4 weeks after the end of radiation therapy and continuing for 6 cycles.

In both arms, focal radiation therapy was delivered as 60 Gy/30 fractions and included radiation to the tumor bed or resection site with a 2- to 3-cm margin. PCP prophylaxis was required during the concomitant phase, regardless of lymphocyte count and continued until recovery of lymphocyte count to Grade 1 or less. The major efficacy outcome measure was overall survival.

A total of 573 patients were randomized, 287 to TEMOZOLOMIDE and radiation therapy and 286 to radiation therapy alone. At the time of disease progression, TEMOZOLOMIDE was administered as salvage therapy in 161 patients of the 282 (57%) in the radiation therapy alone arm and 62 patients of the 277 (22%) in the TEMOZOLOMIDE and radiation therapy arm. The addition of concomitant and maintenance TEMOZOLOMIDE to radiation therapy for the treatment of patients with newly diagnosed glioblastoma showed a statistically significant improvement in overall survival compared to radiotherapy alone ( Figure 1 ).

The hazard ratio (HR) for overall survival was 0.63 (95% CI: 0.52, 0.75) with a log-rank P <0.0001 in favor of the TEMOZOLOMIDE arm. The median overall survival was 14.6 months in the TEMOZOLOMIDE arm and 12.1 months for radiation therapy alone arm. FIGURE 1: Kaplan-Meier Curves for Overall Survival (ITT Population) in Newly Diagnosed Glioblastoma Trial in MK-7365-051 Kaplan-Meier Curves

14.2Refractory Anaplastic Astrocytoma Newly Diagnosed Anaplastic Astrocytoma The efficacy of TEMOZOLOMIDE for the adjuvant treatment of newly diagnosed anaplastic astrocytoma was derived from studies of TEMOZOLOMIDE in the published literature. TEMOZOLOMIDE was evaluated in CATNON (NCT00626990), a randomized, open-label, multicenter trial, where the major efficacy outcome measure was overall survival. Refractory Anaplastic Astrocytoma The efficacy of TEMOZOLOMIDE was evaluated in Study MK-7365-006, a single-arm, multicenter trial.

Eligible patients had anaplastic astrocytoma at first relapse and a baseline Karnofsky performance status (KPS) of 70 or greater. Patients had previously received radiation therapy and may also have previously received a nitrosourea with or without other chemotherapy. Fifty-four patients had disease progression on prior therapy with both a nitrosourea and procarbazine and their malignancy was considered refractory to chemotherapy (refractory anaplastic astrocytoma population).

TEMOZOLOMIDE capsules were given on Days 1 to 5 of each 28-day cycle at a starting dose of 150 mg/m 2 /day. If ANC was ≥1.5 x 10 9 /L and platelet count was ≥100 x 10 9 /L at the nadir and on Day 1 of the next cycle, the TEMOZOLOMIDE dose was increased to 200 mg/m 2 /day. The major efficacy outcome measure was progression-free survival at 6 months and the additional efficacy outcome measures were overall survival and overall response rate.

In the refractory anaplastic astrocytoma population (n=54), the median age was 42 years (range: 19 to 76); 65% were male; and 72% had a KPS of >80. Sixty-three percent of patients had surgery other than a biopsy at the time of initial diagnosis. Of those patients undergoing resection, 73% underwent a subtotal resection and 27% underwent a gross total resection.

Eighteen percent of patients had surgery at the time of first relapse. The median time from initial diagnosis to firs… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13. NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Temozolomide is carcinogenic in rats at doses less than the maximum recommended human dose. Temozolomide induced mammary carcinomas in both males and females at doses 0.13 to 0.63 times the maximum human dose (25 - 125 mg/ m 2 ) when administered orally on 5 consecutive days every 28-days for 6 cycles. Temozolomide also induced fibrosarcomas of the heart, eye, seminal vesicles, salivary glands, abdominal cavity, uterus, and prostate, carcinomas of the seminal vesicles, schwannomas of the heart, optic nerve, and harderian gland, and adenomas of the skin, lung, pituitary, and thyroid at doses 0.5 times the maximum daily dose.

Mammary tumors were also induced following 3 cycles of temozolomide at the maximum recommended daily dose. Temozolomide is a mutagen and a clastogen. In a reverse bacterial mutagenesis assay (Ames assay), temozolomide increased revertant frequency in the absence and presence of metabolic activation.

Temozolomide was clastogenic in human lymphocytes in the presence and absence of metabolic activation. Temozolomide impairs male fertility. Temozolomide caused syncytial cells/immature sperm formation at doses of 50 and 125 mg/m 2 (0.25 and 0.63 times the human dose of 200 mg/m 2 ) in rats and dogs, respectively, and testicular atrophy in dogs at 125 mg/m 2 .

13.2Animal Toxicology and/or Pharmacology Toxicology studies in rats and dogs identified a low incidence of hemorrhage, degeneration, and necrosis of the retina at temozolomide doses equal to or greater than 125 mg/m2 (0.63 times the human dose of 200 mg/m 2 ). These changes were most commonly seen at doses where mortality was observed.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 208 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Temozolomide is carcinogenic in rats at doses less than the maximum recommended human dose. Temozolomide induced mammary carcinomas in both males and females at doses 0.13 to 0.63 times the maximum human dose (25 - 125 mg/ m 2 ) when administered orally on 5 consecutive days every 28-days for 6 cycles. Temozolomide also induced fibrosarcomas of the heart, eye, seminal vesicles, salivary glands, abdominal cavity, uterus, and prostate, carcinomas of the seminal vesicles, schwannomas of the heart, optic nerve, and harderian gland, and adenomas of the skin, lung, pituitary, and thyroid at doses 0.5 times the maximum daily dose.

Mammary tumors were also induced following 3 cycles of temozolomide at the maximum recommended daily dose. Temozolomide is a mutagen and a clastogen. In a reverse bacterial mutagenesis assay (Ames assay), temozolomide increased revertant frequency in the absence and presence of metabolic activation.

Temozolomide was clastogenic in human lymphocytes in the presence and absence of metabolic activation. Temozolomide impairs male fertility. Temozolomide caused syncytial cells/immature sperm formation at doses of 50 and 125 mg/m 2 (0.25 and 0.63 times the human dose of 200 mg/m 2 ) in rats and dogs, respectively, and testicular atrophy in dogs at 125 mg/m 2 .

📚 References 8 words ▾

15. REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardous-drugs

📄 Package Label / Principal Display Panel 143 words ▾

PACKAGE LABEL PRINCIPAL DISPLAY PANEL NDC 73043- 011 -05 5 mg per capsules Temozolomide Capsules, USP For Oral Administration Rx Only THIS PACKAGE CONTAINS 5 CAPSULES Devatis NDC 73043- 012 -05 20 mg per capsules Temozolomide Capsules, USP For Oral Administration Rx Only THIS PACKAGE CONTAINS 5 CAPSULES Devatis NDC 73043- 013 -05 100 mg per capsules Temozolomide Capsules, USP For Oral Administration Rx Only THIS PACKAGE CONTAINS 5 CAPSULES Devatis NDC 73043- 014 -05 140 mg per capsules Temozolomide Capsules, USP For Oral Administration Rx Only THIS PACKAGE CONTAINS 5 CAPSULES Devatis NDC 73043- 015 -05 180 mg per capsules Temozolomide Capsules, USP For Oral Administration Rx Only THIS PACKAGE CONTAINS 5 CAPSULES Devatis NDC 73043- 016 -05 250 mg per capsules Temozolomide Capsules, USP For Oral Administration Rx Only THIS PACKAGE CONTAINS 5 CAPSULES Devatis temo-5mg-5s temo-20mg-5s temo-100mg-5s temo-140mg-5s temo-180mg-5s temo-250mg-5s

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Temozolomide — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Temozolomide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$40.5K
Claims incl. refills
54
Beneficiaries
11
Spend / beneficiary
$3,680.61
Spend / claim
$749.75
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.