Temozolomide Teva: Uses, Dosage & Side Effects
A generic oral alkylating chemotherapy agent containing temozolomide, used to treat glioblastoma multiforme and other malignant brain tumors (gliomas) in adults and children over 3 years of age
Temozolomide Teva is a generic version of the oral alkylating chemotherapy drug containing temozolomide, approved through the European generics pathway as therapeutically equivalent to the originator brand Temodal (Temodar in the U.S.). It is used to treat specific types of malignant brain tumors, including newly diagnosed glioblastoma multiforme (GBM) in adults — where it is given concurrently with radiotherapy and then as maintenance monotherapy — and recurrent or progressive malignant glioma (including glioblastoma and anaplastic astrocytoma) in both adults and children older than 3 years. Because temozolomide crosses the blood-brain barrier effectively, it reaches tumor cells within the central nervous system in therapeutic concentrations. Temozolomide Teva is supplied as hard capsules in multiple strengths and requires a prescription from a specialist physician, typically an oncologist or neuro-oncologist.
Quick Facts: Temozolomide Teva
Key Takeaways
- Temozolomide Teva is a generic equivalent of Temodal (Temodar) and contains the same active substance (temozolomide); it has been demonstrated to be bioequivalent to the originator product and carries the same indications and efficacy profile.
- It is the standard chemotherapy for newly diagnosed glioblastoma multiforme (GBM), given alongside radiotherapy for 42 days and then as maintenance therapy for up to 6 cycles of 28 days each (the Stupp regimen).
- Temozolomide crosses the blood-brain barrier effectively, achieving therapeutic concentrations in the central nervous system at approximately 30–40% of plasma levels, making it uniquely suited for treating brain tumors.
- Myelosuppression (reduced blood cell counts) is the most significant side effect; regular blood tests are mandatory, and prophylaxis against Pneumocystis jirovecii pneumonia (PCP) is required during the concurrent phase with radiotherapy.
- Capsules must be taken on an empty stomach, swallowed whole with water; the dose is calculated based on body surface area (mg/m²), and patients may need to combine multiple capsule strengths to achieve the prescribed dose.
What Is Temozolomide Teva and What Is It Used For?
Temozolomide Teva contains the active substance temozolomide, an imidazotetrazine derivative that functions as a prodrug. It is manufactured by Teva Pharmaceuticals, one of the world's largest generic drug companies, and was authorised in Europe under the centralised generics procedure once the original patents for Temodal expired. Being a generic medicine, Temozolomide Teva has been demonstrated to be bioequivalent to the reference product Temodal, meaning it delivers the same amount of active drug to the bloodstream in the same way and is clinically interchangeable.
After oral administration, temozolomide is rapidly absorbed and spontaneously converts at physiological pH (the normal acidity level of the body) to its active form, MTIC (5-(3-methyltriazen-1-yl)imidazole-4-carboxamide). This conversion does not require enzymatic activation by the liver, which distinguishes temozolomide from many other chemotherapy agents and contributes to its predictable pharmacological activity across patients with varying hepatic enzyme profiles.
Once formed, MTIC acts by adding methyl groups (small chemical tags) to the DNA of cells, a process known as alkylation. The primary target is the O6 position of guanine, one of the four building blocks of DNA. When a methyl group is attached to this position, it causes the DNA to mismatch during replication, leading to futile repair cycles, DNA strand breaks, and ultimately programmed cell death (apoptosis). This mechanism is particularly effective against rapidly dividing tumor cells such as those found in high-grade gliomas.
A critically important factor in the effectiveness of temozolomide is the status of the MGMT (O6-methylguanine-DNA methyltransferase) gene in the tumor. MGMT is a DNA repair enzyme that can remove the methyl groups that temozolomide adds to DNA, essentially undoing the drug's work. In tumors where the MGMT gene promoter is methylated (silenced), the cancer cells produce less of this repair enzyme and are therefore more susceptible to temozolomide. Testing for MGMT promoter methylation status has become a standard part of the diagnostic workup for glioblastoma, as it provides important prognostic information and helps guide treatment decisions.
One of the most important properties of temozolomide is its ability to cross the blood-brain barrier (BBB). The blood-brain barrier is a highly selective membrane that protects the brain from potentially harmful substances in the bloodstream, but it also prevents many chemotherapy drugs from reaching brain tumors. Temozolomide achieves concentrations in the cerebrospinal fluid (CSF) that are approximately 30–40% of plasma levels, which is exceptionally high for a chemotherapy agent and makes it one of the few truly effective systemic treatments for primary brain tumors.
Temozolomide Teva is approved by the European Medicines Agency (EMA) and other regulatory authorities for the following indications:
- Newly diagnosed glioblastoma multiforme (GBM) in adults: Temozolomide Teva is used first in combination with radiotherapy (the concurrent phase, lasting up to 42–49 days at 75 mg/m² daily) and then alone as maintenance therapy (the monotherapy phase, for up to 6 cycles of 28 days). This protocol, known as the Stupp regimen after the landmark 2005 clinical trial published in the New England Journal of Medicine, demonstrated a significant improvement in overall survival compared with radiotherapy alone and established temozolomide as the standard of care for newly diagnosed GBM.
- Recurrent or progressive malignant glioma in children (older than 3 years) and adults: This includes glioblastoma multiforme and anaplastic astrocytoma that has returned or continued to grow after standard treatment. In this setting, Temozolomide Teva is used as monotherapy in 28-day cycles.
Glioblastoma multiforme is the most aggressive and most common primary malignant brain tumor in adults. It is classified as a grade 4 glioma by the World Health Organization (WHO) and is characterised by rapid growth, extensive infiltration of surrounding brain tissue, and a tendency to recur despite treatment. Even with optimal therapy combining surgery, radiotherapy, and temozolomide chemotherapy, the median overall survival for patients with newly diagnosed GBM remains approximately 14–16 months, underscoring the need for continued research and new therapeutic approaches. Anaplastic astrocytoma is a grade 3 glioma that, while typically less aggressive than GBM, can also be challenging to treat and may progress to GBM over time.
A generic medicine such as Temozolomide Teva contains the same active substance, in the same strength and dosage form, as the originator brand (Temodal). Before a generic can be marketed, the manufacturer must demonstrate bioequivalence — that it releases the active ingredient into the bloodstream at essentially the same rate and to the same extent as the reference product. Generic medicines undergo the same rigorous quality controls for manufacturing, purity, and stability as originator products. The main differences are usually limited to inactive excipients, capsule colour, and cost; the clinical effect is equivalent.
Your doctor may test your tumor for MGMT promoter methylation status. Patients whose tumors have a methylated (silenced) MGMT promoter tend to respond better to temozolomide treatment and generally have better outcomes. However, temozolomide is still offered to patients with unmethylated MGMT promoters, as it remains the standard of care and some benefit is still observed. The MGMT status helps guide expectations and may influence decisions about participating in clinical trials.
What Should You Know Before Taking Temozolomide Teva?
Temozolomide Teva is a cytotoxic chemotherapy medicine and carries many of the same safety considerations as all drugs in the alkylating agent class. It should only be prescribed and supervised by physicians experienced in the oncological treatment of brain tumors. Before starting therapy, your medical team will review your medical history, perform a physical examination, and arrange baseline blood tests, liver function tests, and often a hepatitis B screening to identify any risk factors.
Contraindications
There are specific situations in which Temozolomide Teva must not be used. Understanding these absolute contraindications is essential before starting treatment.
- Hypersensitivity to temozolomide: Do not take Temozolomide Teva if you are allergic to temozolomide or any of the excipients in the capsules (including anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate, tartaric acid, stearic acid, and the capsule shell components).
- Allergy to dacarbazine (DTIC): If you have had an allergic reaction to dacarbazine (another alkylating chemotherapy drug), you should not take Temozolomide Teva, as the two drugs are chemically related and cross-reactivity is possible. Signs of an allergic reaction include itching, difficulty breathing or wheezing, hives, and swelling of the face, lips, tongue, or throat.
- Severe myelosuppression: If your white blood cell counts or platelet counts are severely low before starting treatment, Temozolomide Teva should not be initiated until blood counts recover to acceptable levels. Your doctor will check your blood before prescribing.
Warnings and Precautions
During the concurrent phase of treatment (Temozolomide Teva plus radiotherapy for 42 days), you are at increased risk of developing a serious opportunistic infection called Pneumocystis jirovecii pneumonia (PCP). Your doctor will prescribe prophylactic antibiotics (typically trimethoprim/sulfamethoxazole) to prevent this infection. Continue taking this prophylactic medication as directed throughout the concurrent phase and until your lymphocyte counts recover.
Before and during treatment with Temozolomide Teva, inform your doctor if any of the following apply to you:
- Hepatitis B infection: If you have ever had or may currently have hepatitis B virus (HBV) infection, tell your doctor before starting treatment. Temozolomide can cause hepatitis B virus reactivation, which in some cases has been fatal. Your doctor will test you for HBV and monitor you for signs of reactivation throughout treatment and for several months afterwards.
- Blood count abnormalities: If you have low red blood cells (anemia), low white blood cells, or low platelets before starting treatment, or if you develop these during treatment, your doctor may decide to reduce your dose, delay treatment, discontinue it, or prescribe supportive care such as growth factors or transfusions. Blood tests are performed on day 22 (21 days after the first dose) of each cycle, or within 48 hours of that day, and weekly until the absolute neutrophil count (ANC) is above 1.5 × 10&sup9;/L and the platelet count is above 100 × 10&sup9;/L.
- Risk of secondary cancers: There is a small but recognised risk of developing treatment-related blood cancers (including myelodysplastic syndrome and leukemia) as a long-term consequence of temozolomide treatment. This risk must be weighed against the therapeutic benefit for life-threatening brain tumors.
- Nausea and vomiting: These are very common side effects. Your doctor may prescribe anti-emetic medication (such as ondansetron or granisetron) to be taken before and/or after your Temozolomide Teva dose. If you vomit after taking your dose, do not take a second dose on the same day.
- Fever or signs of infection: Contact your doctor immediately if you develop fever, chills, sore throat, cough, or any other symptoms of infection, as this may indicate that your immune system is compromised due to low white blood cell counts.
- Age over 70: Older adults may be more susceptible to infections, bruising, bleeding, and fatigue during temozolomide treatment. Your doctor may choose more conservative dosing and monitoring.
- Liver or kidney problems: If you have impaired liver or kidney function, your dose may need to be adjusted. Liver function should be tested before each treatment cycle, at the midpoint, and at the end of each cycle.
- Prior chemotherapy: If you have previously received chemotherapy, your bone marrow reserve may be reduced and you may be more susceptible to myelosuppression with Temozolomide Teva.
Pregnancy and Breastfeeding
Temozolomide Teva should not be taken during pregnancy unless your doctor has specifically determined that the potential benefit justifies the potential risk to the fetus. Temozolomide has been shown to be teratogenic (can cause birth defects) and embryotoxic in animal studies, and the mechanism of action — DNA alkylation — is inherently damaging to rapidly dividing fetal cells. Women of childbearing potential must use effective contraception during treatment and for at least 6 months after the last dose.
Breastfeeding must be discontinued during treatment with Temozolomide Teva. It is not known whether temozolomide is excreted in human breast milk, but given its mechanism of action, a risk to the breastfed infant cannot be excluded.
Temozolomide can cause permanent infertility in males. Male patients should use effective contraception and should not father a child during treatment or for at least 3 months after the last dose. It is recommended that male patients discuss sperm cryopreservation (freezing) with their doctor before starting treatment, as this offers the best chance of preserving fertility options.
Driving and Operating Machinery
Temozolomide Teva may cause fatigue, drowsiness, and dizziness. If you experience any of these side effects, do not drive, operate machinery, or ride a bicycle until you know how the medication affects you. These effects may be compounded by the underlying brain tumor itself and by concurrent radiotherapy. Concurrent corticosteroid therapy (commonly used in brain tumor patients) can also affect alertness.
Important Information About Ingredients
Temozolomide Teva capsules contain lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to certain sugars (such as lactose intolerance), consult your doctor before taking this medicine. Each capsule also contains less than 1 mmol (23 mg) of sodium, meaning it is essentially sodium-free and suitable for patients on low-sodium diets.
How Does Temozolomide Teva Interact with Other Drugs?
Temozolomide has a relatively favorable drug interaction profile compared with many other chemotherapy agents. Because it is spontaneously converted to its active form at physiological pH rather than requiring hepatic enzyme activation, it has fewer cytochrome P450-mediated drug interactions than many other anticancer drugs. However, certain interactions are clinically important and should be discussed with your doctor and pharmacist. Always provide a complete list of all medications, herbal supplements, and over-the-counter products you are taking before starting Temozolomide Teva.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Valproic acid (valproate) | Slightly decreased temozolomide clearance; increased risk of thrombocytopenia | Monitor platelet counts closely; dose adjustments may be needed |
| Other myelosuppressive agents (e.g., other cytotoxic chemotherapy) | Additive bone marrow suppression; increased risk of severe neutropenia, thrombocytopenia, anemia | Monitor blood counts more frequently; avoid combination if possible |
| Live attenuated vaccines (MMR, varicella, yellow fever, BCG, nasal influenza, rotavirus) | Risk of vaccine-strain infection due to immunosuppression | Avoid during treatment and for several months after; inactivated vaccines are preferred |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Dexamethasone (corticosteroid) | Commonly co-administered in brain tumor patients; no significant pharmacokinetic interaction | Safe combination; routinely used to manage brain edema |
| Anti-emetics (ondansetron, granisetron, aprepitant) | No significant interaction; used to manage temozolomide-induced nausea and vomiting | Recommended as supportive care |
| Trimethoprim/sulfamethoxazole (co-trimoxazole) | Both may contribute to myelosuppression; PCP prophylaxis is essential during concurrent phase | Required during concurrent phase; monitor blood counts |
| Phenytoin / carbamazepine (enzyme-inducing anticonvulsants) | May reduce temozolomide exposure (limited data); commonly used for seizure management in brain tumor patients | Use with caution; levetiracetam is often preferred as a non-enzyme-inducing alternative |
| Ranitidine, proton pump inhibitors (acid-reducing agents) | No clinically significant effect on temozolomide absorption | May be taken concurrently without dose adjustment |
| Warfarin and other oral anticoagulants | Altered coagulation parameters possible due to thrombocytopenia and hepatic effects | Monitor INR more frequently; dose adjustment of anticoagulant may be needed |
Always inform your oncology team about all medications you are taking, including herbal supplements (St. John's Wort, for example, can affect many drugs), over-the-counter products, and vitamins. While temozolomide itself has limited direct drug interactions, the clinical setting of brain tumor treatment often involves multiple concomitant medications (corticosteroids, anticonvulsants, anti-emetics, prophylactic antibiotics) that may interact with each other and require careful overall management.
What Is the Correct Dosage of Temozolomide Teva?
Your doctor will determine the correct dose of Temozolomide Teva based on your body surface area (calculated from your height and weight), your specific diagnosis, your blood test results, your liver and kidney function, and whether you have previously received chemotherapy. You will usually be prescribed anti-emetic medication to take before and/or after Temozolomide Teva to prevent nausea and vomiting. Dosing is always individualised and may be adjusted between cycles based on tolerability and laboratory values.
Adults
Newly Diagnosed Glioblastoma Multiforme
If you have been newly diagnosed with glioblastoma multiforme, treatment with Temozolomide Teva is divided into two phases:
Concurrent Phase (with Radiotherapy)
Dose: 75 mg/m² once daily
Duration: 42 days continuously (up to 49 days), taken alongside radiotherapy
Administration: Take capsules on an empty stomach, at least 1 hour before breakfast. Swallow whole with water.
Note: PCP prophylaxis (e.g., trimethoprim/sulfamethoxazole) is required throughout this phase. Your doctor may delay or discontinue Temozolomide Teva based on your blood counts and tolerability.
After the concurrent phase is completed and radiotherapy has finished, there is typically a 4-week break to allow your body to recover before starting the monotherapy phase.
Monotherapy Phase (Maintenance)
Cycle 1: 150 mg/m² once daily for 5 days, followed by 23 days without treatment (28-day cycle)
Cycles 2–6: If well tolerated and blood counts are adequate, the dose may be increased to 200 mg/m² once daily for 5 days per 28-day cycle
Duration: Up to 6 cycles total
Note: Blood tests are performed on day 22 of each cycle (or within 48 hours). The dose for the next cycle is determined based on the lowest blood counts recorded (the “nadir”).
Recurrent or Progressive Malignant Glioma
Monotherapy for Recurrent Glioma
Patients not previously treated with chemotherapy: 200 mg/m² once daily for the first 5 days of a 28-day cycle
Patients previously treated with chemotherapy: 150 mg/m² once daily for the first 5 days of a 28-day cycle, with potential increase to 200 mg/m² in subsequent cycles if tolerated
Duration: Treatment continues until disease progression or unacceptable toxicity
Children (Older Than 3 Years)
Temozolomide Teva should not be given to children younger than 3 years of age due to a lack of clinical experience in this age group. In children older than 3 years with recurrent or progressive malignant glioma, the dosing follows the same principles as for adults: 150–200 mg/m² daily for 5 days of each 28-day cycle, based on prior chemotherapy exposure and individual tolerability. Treatment in pediatric patients should be supervised by a specialist in pediatric oncology at a center experienced in the care of children with brain tumors.
Pediatric dosing also considers growth trajectory and long-term consequences of cytotoxic therapy, including potential impact on fertility, neurocognitive development, and the risk of second malignancies. Families will usually be offered detailed counselling about short- and long-term side effects before treatment begins.
Elderly Patients
No specific dose adjustment is required for elderly patients based on age alone. However, patients over 70 years of age may be more susceptible to myelosuppression and infections. Your doctor will monitor your blood counts closely and may adjust the dose or timing of treatment as needed. Landmark clinical trials such as the Stupp trial included patients up to 70 years of age, and subsequent studies — including the Perry trial (2017) — have confirmed the benefit of temozolomide in elderly patients, particularly those with MGMT-methylated tumors. In selected elderly patients, a hypofractionated short-course radiotherapy regimen with temozolomide may be offered as an alternative to the full 6-week concurrent schedule.
Missed Dose
If you forget to take Temozolomide Teva, take the missed dose as soon as possible on the same day. If a full day has passed, contact your doctor or specialist nurse for guidance — do not simply double up the next day. Do not take a double dose to make up for a missed dose unless your doctor specifically instructs you to do so. If you vomit after taking your dose, do not take a second dose on the same day; notify your medical team at the next scheduled contact.
Overdose
If you or someone else accidentally takes more capsules than prescribed, contact your doctor, pharmacist, or emergency services immediately. Overdose of temozolomide is likely to cause more severe and prolonged myelosuppression (reduction in all blood cell lines) and intensified gastrointestinal side effects. Doses of up to 2,000 mg/m² over 5 days have been reported in clinical settings with significant, sometimes fatal, myelosuppression. There is no specific antidote; treatment is supportive with close monitoring of blood counts, transfusions, growth factors, and management of infections as needed.
How to Take Temozolomide Teva Capsules
Take your prescribed dose of Temozolomide Teva once daily, ideally at the same time each day to establish a routine. Take the capsules on an empty stomach — at least one hour before eating breakfast, or at bedtime at least 2 hours after your last meal. Swallow the capsules whole with a glass of water. Do not open, crush, chew, or divide the capsules. If a capsule is accidentally damaged, avoid getting the powder on your skin, in your eyes, or in your nose; if accidental contact occurs, flush the area thoroughly with water for at least 15 minutes and seek medical advice.
Depending on your prescribed dose, you may need to take several capsules at once, potentially of different strengths. To minimise dosing errors, ask your pharmacist to write out exactly how many capsules of each strength you should take. Review your dose with your doctor at the start of each new treatment cycle, as the dose may differ from the previous cycle based on your blood test results.
Temozolomide Teva capsules contain a cytotoxic (cell-killing) substance. Handle them carefully. If a capsule is broken or leaking, avoid contact of the powder with your skin, eyes, or nose, and inform your pharmacist. Accidental ingestion by children can be fatal — store capsules out of sight and reach of children, preferably in a locked cabinet. Do not dispose of unused or expired capsules in household waste or flush them down the toilet; return them to your pharmacy for safe disposal to protect the environment.
What Are the Side Effects of Temozolomide Teva?
Like all medicines, Temozolomide Teva can cause side effects, although not everyone experiences them. The side-effect profile is consistent with that of the originator product Temodal and with the temozolomide drug class in general. The pattern may differ depending on whether you are receiving Temozolomide Teva concurrently with radiotherapy (where fatigue, nausea, and hair loss tend to dominate) or as monotherapy (where myelosuppression and gastrointestinal effects become more prominent). Your medical team will monitor you closely and proactively manage side effects.
Contact your doctor or seek emergency care immediately if you experience: a severe allergic reaction (hives, wheezing, swelling of face/lips/tongue/throat), uncontrolled bleeding, unusual bruising, seizures (convulsions), fever or chills, or a severe or new-pattern headache that does not resolve. These may be signs of serious adverse events requiring prompt intervention.
Temozolomide treatment can cause a reduction in certain blood cells. This may mean you bruise or bleed more easily, develop anemia (shortage of red blood cells causing fatigue and shortness of breath), or have reduced resistance to infections due to low white blood cells. The reduced blood cell count is usually temporary and recovers between treatment cycles. In a small proportion of patients, it can become prolonged and lead to a very serious form of anemia (aplastic anemia) or treatment-related myelodysplastic syndrome or leukemia. Your doctor will perform regular blood tests to detect any changes early and determine whether dose reduction, treatment delay, transfusion support, or growth factor injections are required.
Very Common
May affect more than 1 in 10 people
- Loss of appetite (anorexia)
- Headache
- Nausea and vomiting
- Diarrhea
- Constipation
- Skin rash
- Hair loss (alopecia)
- Fatigue and tiredness
- Speech difficulties (during concurrent phase)
Common
May affect up to 1 in 10 people
- Infections, including oral thrush (candida)
- Decreased blood cell counts (neutropenia, lymphopenia, thrombocytopenia)
- Allergic reactions
- Elevated blood sugar (hyperglycemia)
- Memory impairment, depression, anxiety, confusion, insomnia
- Impaired coordination and balance, difficulty concentrating
- Dizziness, altered sensation, tingling (paresthesia), tremor, taste changes
- Partial vision loss, abnormal vision, double vision, eye pain
- Hearing loss, tinnitus (ringing in ears), ear pain
- Blood clots in lungs (pulmonary embolism) or legs (deep vein thrombosis), high blood pressure
- Pneumonia, shortness of breath, bronchitis, cough, sinus infection
- Stomach or abdominal pain, heartburn, difficulty swallowing (dysphagia)
- Dry skin, itching (pruritus)
- Muscle damage, muscle weakness, muscle pain (myalgia)
- Joint pain (arthralgia), back pain
- Frequent urination, urinary incontinence
- Fever, flu-like symptoms, feeling generally unwell
- Fluid retention, leg swelling (peripheral edema)
- Elevated liver enzymes (ALT, AST)
- Weight loss or weight gain
- Radiation injury at the treatment site
Uncommon
May affect up to 1 in 100 people
- Brain infections (including herpes meningoencephalitis), which can be fatal
- Wound infections
- New or reactivated cytomegalovirus (CMV) infections
- Reactivated hepatitis B virus infections
- Secondary cancers including myelodysplastic syndrome (MDS) and leukemia
- Pancytopenia (reduction in all blood cell lines), severe anemia, leukopenia
- Petechiae (red pinpoint spots under the skin)
- Diabetes insipidus (increased urination and thirst), low potassium levels (hypokalemia)
- Mood swings, hallucinations
- Partial paralysis (hemiparesis), changes in sense of smell
- Hearing impairment, middle ear infections
- Palpitations, hot flashes
- Abdominal bloating, difficulty controlling bowel movements, hemorrhoids, dry mouth
- Liver inflammation (hepatitis), liver damage (including fatal liver failure), cholestasis, elevated bilirubin
- Blisters on body or in mouth, skin peeling, painful skin redness, severe rash with skin swelling affecting palms and soles
- Increased sun sensitivity (photosensitivity), hives (urticaria), increased sweating, skin color changes
- Difficulty urinating
- Vaginal bleeding, vaginal irritation, absent or heavy periods, breast pain, sexual impotence
- Tremors, facial swelling, tongue discoloration, thirst, dental problems
- Dry eyes
Rare
May affect fewer than 1 in 1,000 people
- Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) — potentially life-threatening
- Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
- Interstitial pneumonitis (inflammation of the lungs)
- Pulmonary fibrosis (scarring of lung tissue)
- Tumor lysis syndrome (metabolic emergency due to rapid tumor cell death)
- Severe aplastic anemia (failure of the bone marrow)
If you experience any side effects, including any possible side effects not listed in this article, talk to your doctor, pharmacist, or specialist nurse. Reporting suspected side effects to the relevant national reporting system (such as the Yellow Card scheme in the UK, FDA MedWatch in the U.S., or EudraVigilance in the EU) helps provide more information on the safety profile of the medicine.
How Should You Store Temozolomide Teva?
Proper storage of Temozolomide Teva is essential both for maintaining the drug's effectiveness and for safety, particularly in households with children. Accidental ingestion by a child can be fatal.
- Temperature: Store at or below 30°C (86°F). Do not freeze. Avoid storing in bathrooms or other areas with high humidity or temperature fluctuations.
- Child safety: Keep out of sight and reach of children, preferably in a locked cabinet. Accidental ingestion can be fatal for children. Never transfer capsules to unlabelled containers.
- Packaging: Each capsule is individually sealed in a dose sachet within its carton. Keep capsules in their original packaging until immediately before use to protect from moisture and light.
- Expiration: Do not use Temozolomide Teva after the expiration date printed on the dose sachet and carton. The expiration date refers to the last day of that month.
- Inspection: If you notice any change in the appearance of the capsules (cracks, discolouration, broken shells), inform your pharmacist and do not use them.
- Disposal: Do not dispose of capsules in household waste or flush them down the drain. Return unused or expired capsules to your pharmacy for safe cytotoxic waste disposal. These measures help protect the environment and prevent accidental exposure to others.
What Does Temozolomide Teva Contain?
Each Temozolomide Teva capsule contains temozolomide as the active substance. The capsules are available in six different strengths to allow flexible dosing based on body surface area, and patients may combine capsules of different strengths to achieve the prescribed daily dose.
Active Ingredient
- Temozolomide 5 mg — hard capsule
- Temozolomide 20 mg — hard capsule
- Temozolomide 100 mg — hard capsule
- Temozolomide 140 mg — hard capsule
- Temozolomide 180 mg — hard capsule
- Temozolomide 250 mg — hard capsule
Inactive Ingredients (Excipients)
The excipients typically found in the capsule contents are: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, and stearic acid. The capsule shells are made of gelatin, titanium dioxide (E 171), and sodium lauryl sulfate, with different iron oxide colorants (yellow, red, and/or black iron oxide — E 172) depending on the strength. The printing ink on the capsule shell typically contains shellac, propylene glycol (E 1520), purified water, ammonium hydroxide, potassium hydroxide, and black iron oxide (E 172). The exact composition of excipients may vary slightly from the originator product but remains within the approved bioequivalence specifications.
Temozolomide Teva capsules are packaged in cartons containing 5 or 20 capsules, each individually sealed in a dose sachet. Not all pack sizes may be marketed in every country.
Similar Generic Alternatives
Temozolomide is available from multiple manufacturers as generic medicines. Other generic brands of temozolomide include Temozolomide Accord, Temozolomide SUN, Temozolomide Hospira, Temozolomid STADA, Temomedac, and Temozolomide Sandoz. All meet the same European and international regulatory standards for bioequivalence with the originator Temodal (Temodar). Your oncology team or pharmacy will dispense the brand available through your national healthcare or insurance system, but the active substance and clinical effect are the same across generics.
Frequently Asked Questions About Temozolomide Teva
Yes. Temozolomide Teva has been approved as a generic medicine on the basis of bioequivalence studies with the originator Temodal (Temodar). Bioequivalence means the two products deliver the same amount of active substance into the bloodstream at the same rate, within strict regulatory limits. The clinical effect, dosing, and side-effect profile are therefore expected to be the same. Regulatory authorities in Europe (EMA) and other regions require generics to meet rigorous quality and manufacturing standards identical to those applied to originator products.
Temozolomide Teva is used to treat specific types of brain tumors. It is the standard chemotherapy for newly diagnosed glioblastoma multiforme (GBM) in adults, used first alongside radiotherapy and then as maintenance therapy. It is also used for recurrent or progressive malignant glioma (including GBM and anaplastic astrocytoma) in children older than 3 years and adults. It is not used for other cancer types outside these indications unless as part of a clinical trial.
Temozolomide is a prodrug that spontaneously converts to an active alkylating compound (MTIC) at the body's normal pH. MTIC adds methyl groups to DNA, primarily at the O6 position of guanine, causing DNA mismatches during replication. This triggers failed DNA repair attempts, strand breaks, and ultimately programmed cell death (apoptosis). Its key advantage is its ability to cross the blood-brain barrier, reaching therapeutic concentrations in the brain tissue where the tumor is located.
No, Temozolomide Teva should be taken on an empty stomach, at least one hour before eating breakfast. Food can reduce the rate of drug absorption. The capsules should be swallowed whole with a glass of water — do not open, crush, or chew them. Take them at the same time each day for consistency. If you experience significant nausea on an empty stomach, discuss antiemetic options and timing strategies with your oncology team rather than taking the medicine with food.
MGMT (O6-methylguanine-DNA methyltransferase) is a DNA repair enzyme that can reverse the damage temozolomide causes to cancer cell DNA. When the MGMT gene promoter is methylated (silenced), tumors produce less of this repair enzyme and are more sensitive to temozolomide. Patients with MGMT-methylated tumors generally have better response rates and improved survival. Your doctor may test your tumor for this biomarker to help guide treatment decisions and discussions about prognosis.
Yes, hair loss (alopecia) is listed as a very common side effect, occurring in more than 1 in 10 patients. However, the hair loss associated with temozolomide is generally less severe than that seen with many other chemotherapy agents. Many patients experience thinning rather than complete hair loss, and hair typically regrows after treatment is completed. Concurrent radiotherapy to the head often contributes to more pronounced hair loss in the irradiated treatment field; this regrowth may be slower and patchy.
For newly diagnosed GBM, the total treatment duration is typically 10–12 months: 6 weeks of daily temozolomide during the concurrent phase with radiotherapy, followed by a 4-week break, and then up to 6 cycles of 28 days each during the maintenance phase. Some protocols extend beyond 6 cycles in selected patients. For recurrent glioma, treatment continues until disease progression or unacceptable side effects. Your doctor will regularly evaluate whether continuing treatment is appropriate based on MRI scans and clinical response.
If you forget to take Temozolomide Teva, take the missed dose as soon as possible on the same day. If a full day has passed, contact your doctor or specialist nurse for guidance rather than doubling up the next day. Never take two doses on the same day to compensate unless specifically told to do so. If you vomited after taking a dose, do not take another dose on the same day. Keep a medication diary and note any missed or vomited doses to share with your oncology team at the next visit.
References
- European Medicines Agency (EMA). Temozolomide Teva — Summary of Product Characteristics. Last updated 2025. Available at: https://www.ema.europa.eu
- Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. New England Journal of Medicine. 2005;352(10):987-996. doi:10.1056/NEJMoa043330
- Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncology. 2009;10(5):459-466.
- U.S. Food and Drug Administration (FDA). Temozolomide — Prescribing Information. Last updated 2024.
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Central Nervous System Cancers. Version 2.2025.
- Weller M, van den Bent M, Preusser M, et al. EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood. Nature Reviews Clinical Oncology. 2024;21:29-49.
- Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma. New England Journal of Medicine. 2005;352(10):997-1003.
- World Health Organization (WHO). WHO Classification of Tumours: Central Nervous System Tumours. 5th edition. 2021.
- Perry JR, Laperriere N, O'Callaghan CJ, et al. Short-Course Radiation plus Temozolomide in Elderly Patients with Glioblastoma. New England Journal of Medicine. 2017;376(11):1027-1037.
- British National Formulary (BNF). Temozolomide monograph. London: BMJ Group and Pharmaceutical Press; 2025.
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