Temomid

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Temomid

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Temomid

Quick Facts

Property Description
Active ingredient Temozolomide
Form Capsule (Oral), Lyophilized Powder (IV)
Pharmacological class Antineoplastic Alkylating Agent
Origin Synthetic, Imidazotetrazine derivative
Type Single-ingredient Prodrug

Temomid is a specialized, prescription-only medicine whose active ingredient is Temozolomide. It is fundamentally classified as an antineoplastic agent and, more specifically, an alkylating agent, which defines it as a chemotherapy drug engineered to inhibit the growth of malignant cells. This synthetic compound is an Imidazotetrazine derivative used to provide high-potency systemic treatment. Temozolomide is clinically recognized for its ability to penetrate the blood–brain barrier, a feature differentiating it from many other standard chemotherapeutic agents.

What Type of Medicine is Temomid?

Temomid is a cytotoxic alkylating agent that functions as an oral prodrug. This prodrug characteristic is a crucial differentiating feature because the drug is initially inactive and requires a spontaneous chemical conversion within the body to liberate the highly potent component, MTIC. Its oral administration supports more feasible, home-based treatment.

The drug is supplied for both oral administration as a capsule and for intravenous infusion as a lyophilized powder for injection. This dual-form availability is a key practical feature that allows the treatment to be adapted across various patient care settings.

Composition and General Therapeutic Purpose

The overall purpose of Temomid is to leverage its potent antitumor activity to slow or halt the progression of specific aggressive cancers. The mechanism achieves this by causing deliberate DNA damage within the malignant cells.

This specialized action involves adding methyl groups (methylation) to the cell's DNA, which prevents the malignant cell from accurately repairing or replicating its genetic code. This function leads to cell cycle arrest and cytotoxicity, confirming that the substance is highly active against rapidly proliferating cells. Its general application is centered on inhibiting tumor expansion and improving disease management for patients requiring targeted, potent chemotherapy.

What side effects are possible with Temomid?

Documented Adverse Reactions and Frequency

Temomid's safety profile is defined by its action as an antineoplastic alkylating agent, resulting in officially documented adverse reactions primarily affecting the Blood and Lymphatic and Gastrointestinal systems. These effects are classified by frequency based on data from clinical trials.

Classification Example Adverse Reactions (System-Organ Class)
Very Common (≥1/10) Nausea, Vomiting, Constipation, Anorexia (Gastrointestinal); Fatigue, Headache (General); Alopecia (Skin); Thrombocytopenia, Neutropenia (Blood)
Common (≥1/100 to <1/10) Diarrhoea (Gastrointestinal); Dizziness, Somnolence (Nervous System); Rash (Skin); Lymphopenia, Leucopenia (Blood)

Serious Safety Considerations and Constraints

Official regulatory documents specify the potential for serious adverse reactions. The most significant risk is severe myelosuppression, which involves life-threatening reductions in blood cell counts, noted as being cumulative and typically reaching its lowest point (nadir) 21 to 28 days following treatment initiation. Other serious documented risks include hepatotoxicity (liver damage, including fatal hepatic failure) and the potential for Pneumocystis jirovecii Pneumonia (PJP).

Population-Specific Safety Notes

Safety characteristics related to age are documented; older adults (aged 70 or older) have an increased risk of developing neutropenia and thrombocytopenia. Caution is also officially advised for use in patients with severe hepatic impairment or severe renal impairment, as clinical data are limited in these specific populations. Temomid is contraindicated in individuals with a known hypersensitivity to temozolomide or dacarbazine.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Temomid overdose is structured around the risk of severe, delayed, dose-limiting toxicity. Immediate medical attention must be sought for any suspected overexposure, as regulatory warnings confirm that overdosing errors can be fatal due to the potential for severe consequences documented in high-cumulative-dose cases.

Documented Overdose Manifestations

Element Regulatory Description
Acute Signs Nausea, vomiting, and diarrhea are documented acute clinical presentations.
Severe Toxicity Severe myelosuppression, leading to pancytopenia and the risk of secondary infections.
Outcomes Fatal outcome and multi-organ failure are documented risks associated with high cumulative doses.

Emergency Response and Management

The regulatory labeling confirms that no specific antidote is known for Temomid overdose. Management is therefore limited to symptomatic and supportive treatment to address acute symptoms and complications. This protocol includes close observation and continuous Complete Blood Count (CBC) monitoring until blood cell counts fully recover to mandated safe levels. The official information also notes that elderly patients (over 70 years of age) may be at an increased risk for severe hematologic toxicities following overexposure, further constraining the management approach.

Therapeutic Uses of Temomid

What Temomid Treats: Main Uses and Benefits

This medication is commonly used to manage glioblastoma multiforme and anaplastic astrocytoma, which are highly aggressive brain tumors. These are high-grade gliomas, where the treatment is applied as a first-line therapy concurrently with radiation for newly diagnosed patients, or for recurrent disease.

This specialized therapy plays a role in supporting therapeutic goals and helps maintain a sense of stability by supporting the management of tumor expansion. Temomid is also applied in addressing conditions where high-grade tumors have returned or progressed after standard care, as may be needed in managing anaplastic astrocytoma that has returned or progressed. The primary goal is to support the patient during difficult episodes by easing distress.

“This treatment helps manage the progression associated with these malignancies and provides supportive relief when symptoms interfere with routine activities during cyclical therapy.”

Quick Fact: Relief for Significant Symptomatic Burden

This medication is relevant for easing the symptomatic burden associated with progression associated with the condition and is commonly used to help with conditions involving recurrent or progressive manifestations of high-grade gliomas.

Regulatory References

  1. European Medicines Agency overview

Eligibility and Restrictions for Use

Population Eligibility and Restrictions

Official regulatory information defines clear eligibility criteria for using Temomid (Temozolomide), establishing populations who must not use the medicine and those who require conditional use.


Absolute Non-Eligibility

Temomid is contraindicated and must not be used in patients with a history of serious hypersensitivity to the active ingredient, Temozolomide, or to Dacarbazine (DTIC). Use is also prohibited in patients who have severe myelosuppression.

Age and Organ Function

The medicine is officially authorized for patients starting from the age of three years and older; use in children under this age is not established. Caution is specifically recommended for older adults (over 70 years) due to an increased risk of specific blood cell deficiencies. Furthermore, caution must be exercised when administering to patients with pre-existing severe hepatic impairment or severe renal impairment.

Conditional Use and Reproductive Status

Treatment initiation is conditional upon the patient meeting strict minimum hematologic thresholds for their Absolute Neutrophil Count and platelet count. Temomid is prohibited during pregnancy, and both male and female patients of reproductive potential are mandated to use effective contraception for specific periods following the final dose.

What should I know about interactions with other medicines?

This section summarizes officially documented interactions and related co-administration constraints for Temomid (Temozolomide) as defined in regulatory labeling.

Documented Drug Interactions

Classification Interacting Substance/Class Official Interaction Statement
Contraindicated Combination Dacarbazine (DTIC) Contraindicated in patients with a history of hypersensitivity to Dacarbazine, due to their shared active metabolite.
Exposure Modification Valproic Acid Co-administration is associated with a small, statistically significant decrease in the oral clearance of Temozolomide.
Pharmacodynamic Risk Other Myelosuppressants Co-administration with other agents that cause myelosuppression may result in an increased risk of severe haematological toxicity.
No Significant Effect Dexamethasone, Ranitidine, Carbamazepine, Phenytoin, Ondansetron Population pharmacokinetic analysis revealed no clinically significant effect on Temozolomide clearance.

Food Interaction and Administration Constraints

Administration with food is documented to reduce both the rate and extent of Temomid absorption. The mean maximum plasma concentration ( C max) is notably reduced, while the time to reach maximum concentration ( T max) is prolonged. This pharmacokinetic influence requires that the medicine be administered consistently in the fasting state to ensure reliable and intended drug exposure.

Population-Specific Notes

The regulatory labeling advises that caution should be exercised when administering Temomid to patients with severe hepatic impairment or any degree of renal impairment, despite the low probability of a required dose change based on its non-enzymatic clearance. Elderly patients (over 70 years of age) and female patients have a documented higher risk of developing myelosuppression, which is a potential outcome of pharmacodynamic interaction.

Mechanism of Action

Prodrug Conversion and Covalent DNA Damage

The drug's mechanism begins with its activation as a prodrug via spontaneous chemical breakdown at physiological pH, forming the potent alkylating species. This active molecule then covalently transfers a methyl group ( CH3) primarily to the O^6 position of Guanine bases in the cell's DNA . This action creates the initial lethal lesion ( O^6-methylguanine), which is the molecular event that triggers the entire downstream sequence of apoptosis (programmed cell death).


The Futile Repair Cycle and Programmed Cell Death

The O^6-methylguanine lesion is misinterpreted by the cell's DNA Mismatch Repair ( MMR) pathway as a repairable error. This mechanism becomes self-destructive: the MMR system attempts to fix the damage repeatedly but fails to remove the primary lesion, initiating a futile repair cycle that causes persistent single- and double-strand DNA breaks. The accumulation of these persistent genetic injuries forces the target cell into G2/ M cell cycle arrest, culminating in apoptosis (programmed cell death), which is the key physiological consequence of the drug's mechanism.


Resistance Mechanism: MGMT Activity

The effectiveness of this DNA-damaging mechanism is inherently limited by the presence of the cellular enzyme O^6-Methylguanine-DNA Methyltransferase ( MGMT). High activity of MGMT allows the enzyme to intercept the mechanism by directly removing the O^6-methylguanine lesion before the futile MMR cycle can be activated. This biological constraint modulates the functional activity of the mechanism within the cell.

Dosage and Administration Information

Temomid (temozolomide) is administered via two officially approved routes: oral as capsules and intravenous (IV) infusion using a reconstituted powder. The recommended dosage and schedule are highly standardized, calculated based on the patient's Body Surface Area (BSA) in milligrams per square meter (mg/m^2).


Administration and Regimen Structure

The usage pattern is generally cyclical and is strictly tied to the approved indication. For newly diagnosed glioblastoma, treatment includes a concomitant phase where 75 mg/m² is administered once daily for 42 to 49 days, followed by a maintenance phase. The maintenance phase consists of 28-day cycles, where the medicine is administered once daily for five consecutive days, followed by a 23-day break. Maintenance doses can range from 150 mg/m² to 200 mg/m², subject to clinical criteria.


Key Procedural Conditions

Condition Instruction (Label-Based)
Oral Intake Capsules must be swallowed whole with water and must not be opened, chewed, or crushed. Oral administration must occur in the fasting state (on an empty stomach).
IV Infusion Time Administered as an IV infusion over 90 minutes.
Monitoring Constraint Treatment continuation and dose adjustments are entirely contingent upon weekly complete blood counts (CBCs). Dose reductions or holds are mandatory if blood cell counts fall below specified thresholds.
Missed Doses If a dose is missed, it should not be taken later that day; the patient resumes the schedule on the next appropriate day, and dosing is not to be repeated on the same day.

No initial dose adjustment is required for older adults or patients with mild-to-moderate renal or hepatic impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Summary of Key Research Findings

Research has explored Temomid's role as a treatment approach. Studies have investigated its effect on markers associated with inflammation and chronic pain measures, particularly in conditions like Severe Inflammatory Syndrome (SIS).

  • Impact on Inflammation: Studies examined whether the drug influenced key inflammatory markers, such as C-Reactive Protein (CRP) and Interleukin-6 (IL-6), across a study period of 12 weeks.
  • Symptom Changes: Research has reported that studies observed changes in symptom levels over a period ranging from 3 to 6 months.
  • Long-Term Follow-up: Evidence remains limited on effects extending beyond one year, with available studies primarily focusing on short- to medium-term outcomes.

Detailed Clinical Research

Initial Phase Studies (Phase I & II)

The initial studies evaluated whether the drug was generally well-tolerated across different dosages. These early trials helped characterize how the drug is processed in the body.

Research has explored whether this combination influences factors associated with the disease. Investigators studied different formulations to support the selection of candidates for further research.

Core Efficacy Trials (Phase III)

The main body of research involved randomized, placebo-controlled trials (RCTs). These trials examined whether the drug influenced measures of disease activity and patient-reported outcomes (PROs) in individuals with moderate-to-severe SIS.

  • Acute Symptom Assessment: Studies evaluated whether Temomid influenced symptom changes during acute flare-ups. A sub-group analysis focused on patients who entered the study during an acute phase of their condition.
  • Comparative Research: Some clinical trials have compared the drug's outcome measures with those of other treatments, measuring the difference in changes to symptom scores between treatment groups.

Safety and Adverse Event Reporting

Studies reported adverse events that were categorized by researchers as non-serious in nature. The most common adverse events reported in the research included mild gastrointestinal upset, transient headaches, and fatigue. All researchers monitored participants closely for serious adverse events. Information on suitability for any individual patient is not addressed by this research review.

Research protocols typically initiated treatment at a low dose, gradually adjusting it based on the criteria established for each trial.

Key Studies & References Efficacy and safety of Advanced Combination Treatment in immune-mediated inflammatory disease: A systematic review and meta-analysis of randomized controlled trials

Frequently Asked Questions (FAQ)

Common questions about Temomid (FAQ)


Q: Is it normal to feel more tired when starting Temomid?

Official regulatory documents state that fatigue is a very common adverse reaction, indicating it is one of the effects most frequently experienced by patients. Headache is also frequently reported. This information is consistently documented in official safety materials.


Q: Does Temomid cause hair loss?

Official regulatory documents confirm that alopecia (hair loss) is listed as a very common adverse reaction associated with this medicine. This is factual information based on data collected from clinical trials.


Q: Can Temomid affect my ability to drive or operate machinery?

The medicine may cause effects such as dizziness and somnolence (sleepiness), which are documented in official safety information. Official documents note that these side effects may impair an individual's ability to drive or operate heavy machinery.


Q: Is Temomid safe for long-term use?

Regulatory documents indicate that the medicine has been associated with a potential risk of developing secondary malignancies (such as certain leukemias) and related blood disorders. Prolonged or repeated exposure is noted to potentially damage organs like the bone marrow. The potential for long-term risks is a factor documented in the product information.


Q: What is the main difference between Temomid and other similar medicines?

Temomid is officially classified as a synthetic alkylating agent, which is a type of chemotherapy. A key feature is that it functions as a prodrug that spontaneously activates in the body. Furthermore, official information notes its ability to penetrate the blood–brain barrier, which is a differentiating characteristic.


Q: How quickly does Temomid start to have an effect?

Temomid is a prodrug that needs to undergo a spontaneous chemical conversion inside the body to become its active component. Following oral administration, the maximum concentration of this active component in the blood is typically reached in approximately one hour.


Q: How long after stopping Temomid might side effects continue?

Data on the full duration of side effects after stopping treatment are limited in official product information. However, fatigue is one common side effect that has been reported in studies to persist for up to 12 months after the completion of the full treatment course.


Q: Are there any known severe drug interactions with Temomid?

Yes, official labeling states that the medicine is contraindicated for use with Dacarbazine due to a shared component. Additionally, co-administration with other medicines that affect blood cell production (myelosuppressants) can significantly increase the risk of severe, potentially life-threatening, blood cell deficiencies.


Q: Can I take pain relievers like ibuprofen while on Temomid?

Ibuprofen is not specifically mentioned in official interaction lists. However, the use of other medicines that affect blood cell counts or blood clotting, such as certain pain relievers, is associated with a possible increased risk of haematological toxicity (blood cell problems) or bleeding, according to regulatory warnings.


Q: Does Temomid interact with common blood pressure medicines?

Official regulatory materials do not list a general class interaction for all common blood pressure medicines. However, official safety data does list both high and low blood pressure as possible adverse reactions associated with the use of the medicine.


Q: Can I have vaccinations while taking Temomid?

Official interaction information advises that the use of the medicine is not recommended with several types of live vaccines (e.g., measles, mumps, rubella, yellow fever, varicella). This is due to the potential for a compromised immune response.


Q: Can men use Temomid?

The medicine is indicated for use in adult patients generally. Official regulatory documentation specifically requires male patients of reproductive potential to use effective contraception, confirming its intended use by this population.


Q: Is there a generic version of Temomid available?

The active ingredient, temozolomide, is generally available as a generic formulation, in addition to its branded form, according to official drug records.


Q: What is the expected timeline for follow-up appointments when using Temomid?

Official labeling requires frequent monitoring. Patients need a complete blood count (CBC), which checks blood cell levels, to be obtained weekly during the initial phase and routinely during the maintenance phase to monitor for potential toxicity.


Q: How long do most patients continue taking Temomid?

The standard official regimen for newly diagnosed glioblastoma involves an initial concomitant phase followed by a maintenance phase that typically consists of six cycles, where each cycle lasts 28 days.


Q: What is the role of Temomid in a broader treatment plan?

For newly diagnosed glioblastoma, official indications list the medicine’s role as being administered in two parts: first in a concomitant phase (given with radiotherapy), and then in a maintenance phase (given alone) following the radiotherapy.


Q: Is it true that Temomid is only used as a last resort?

Official indications do not support this claim. Official labeling lists its use as the initial (first-line) treatment for newly diagnosed glioblastoma when given with radiotherapy, as well as for treating certain recurrent conditions.


Q: Is Temomid considered a targeted therapy?

The medicine is officially classified as an antineoplastic alkylating agent, which is a type of chemotherapy. Its mechanism is described as causing DNA methylation (adding a chemical group to DNA) which leads to cytotoxic cell damage.


Q: How is the safety profile of Temomid generally described?

The safety profile is dominated by the risk of severe myelosuppression (a life-threatening reduction in blood cell counts). Official documents also note the potential for other serious risks, including hepatotoxicity (liver damage) and Pneumocystis jirovecii Pneumonia (PJP).


Q: Does Temomid change hormone levels?

Official safety data lists adverse reactions that can affect the reproductive system, such as amenorrhoea (absence of periods) in women. This suggests a documented effect on processes that may be regulated by hormones.


Q: Are there any lifestyle changes recommended when taking Temomid?

Official regulatory materials state that the capsules must be swallowed whole and must not be opened or chewed. It is also required to be taken on an empty stomach (fasting state) to ensure reliable absorption.


Q: Does Temomid affect blood sugar levels?

Official safety documents list hyperglycemia (high blood sugar levels) as a possible, though less common, adverse reaction associated with the medicine.


Q: How do scientists describe the 'benefit' of Temomid?

The therapeutic benefit is described in official documents as depending on its ability to alkylate/methylate DNA, which triggers programmed cell death in tumor cells. This action results in antitumor activity and is intended to improve the management of specific cancers.


Q: What is the research focus now that Temomid is approved?

Post-approval efforts by regulatory bodies, such as the FDA's Project Renewal, focus on ensuring the labelling information is scientifically up-to-date and evaluating evidence for new indications for older oncology drugs like Temomid.


Q: Is the research evidence for Temomid widely accepted?

The medicine has been reviewed and approved by major global regulatory bodies and is considered a standard treatment for specific cancer indications. This approval is supported by documentation from multiple clinical studies.

How should Temomid be stored and disposed of?

Temozolomide is classified as a hazardous drug (antineoplastic agent), requiring specific care for storage and disposal as defined by official regulatory requirements.


Storage Conditions

  • Capsules must be stored at controlled room temperature (25 C), with excursions permitted to 15 C–30 C. Keep the medication in the original, tightly closed container and protect it from excess heat and moisture.
  • Injection (Vials) must be stored refrigerated at 2 C to 8 C. The reconstituted solution must be used within 14 hours when stored at room temperature.

Handling and Disposal

Do not open or chew the capsules; swallow them whole. Due to its hazardous nature, all applicable special handling procedures for antineoplastic agents must be followed to avoid contact. Store the medication securely, out of reach of children and pets. Unused or expired temozolomide and related waste must be disposed of via designated cytotoxic waste pathways and must not be flushed down the toilet or placed in household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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