Temozar
Generic Name
temozar-250-mg-capsule
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| temozar 250 mg capsule | ৳ 1,250.00 | ৳ 8,750.00 |
Description
Overview of the medicine
Temozar 250 mg Capsule contains Temozolomide, an alkylating agent used to treat certain types of brain cancer. It is primarily used for glioblastoma multiforme and anaplastic astrocytoma. It works by damaging the DNA of cancer cells, leading to their death.
Uses & Indications
Dosage
Adults
For newly diagnosed glioblastoma: Initial phase (concomitant with radiotherapy) 75 mg/m² daily for 42 days. Maintenance phase (after radiotherapy) 150 mg/m² once daily for 5 days, repeated every 28 days for 6 cycles. For refractory anaplastic astrocytoma: Initially 150 mg/m² once daily for 5 days, repeated every 28 days. May increase to 200 mg/m² if tolerated.
Elderly
No specific dose adjustments needed for elderly patients, but monitor carefully for myelosuppression and other adverse effects.
Renal_impairment
Use with caution in patients with severe renal impairment. No specific dose adjustment recommended for mild to moderate renal impairment, but careful monitoring is advised.
How to Take
Take Temozar capsules orally, once daily, usually at bedtime or on an empty stomach, at least one hour before food or two hours after food. Swallow the capsules whole with a glass of water. Do not open, chew, or crush the capsules. Wear gloves if handling damaged capsules.
Mechanism of Action
Temozolomide is a prodrug that is spontaneously hydrolyzed at physiological pH to the active compound 5-(3-methyltriazen-1-yl)imidazole-4-carboxamide (MTIC). MTIC then methylates DNA at various sites, primarily at the N7- and O6-positions of guanine. Methylation at the O6-position is particularly cytotoxic, triggering DNA repair mechanisms which, if unsuccessful, lead to cell cycle arrest and apoptosis of tumor cells.
Pharmacokinetics
Onset
Not typically defined for chemotherapy agents; effects are cumulative over cycles.
Excretion
Primarily excreted renally (5-10% as unchanged drug, the rest as metabolites) within 24 hours. A small amount is eliminated via feces.
Half life
Approximately 1.8 hours (plasma elimination half-life).
Absorption
Rapidly and almost completely absorbed after oral administration, with peak plasma concentrations occurring 0.5-1.5 hours post-dose. Bioavailability is approximately 100%.
Metabolism
Spontaneously hydrolyzed at physiological pH to the active metabolite MTIC, which is then further metabolized.
Side Effects
Contraindications
- Hypersensitivity to Temozolomide or to Dacarbazine (DTIC).
- Severe myelosuppression.
Drug Interactions
Valproic acid
Concomitant use with valproic acid may lead to a small but statistically significant decrease in temozolomide clearance, potentially increasing exposure.
Other myelosuppressive agents
Increased risk of myelosuppression when co-administered with other agents that cause bone marrow suppression.
Storage
Store at room temperature (20°C to 25°C). Protect from moisture and light. Keep out of reach of children. Do not refrigerate.
Overdose
Overdose of temozolomide is expected to result in myelosuppression. Treatment is symptomatic and supportive, including blood transfusions if severe myelosuppression occurs. There is no known antidote.
Pregnancy & Lactation
Pregnancy Category D. Temozolomide is embryotoxic, fetotoxic, and teratogenic in animals. It is contraindicated during pregnancy. Women of childbearing potential should use effective contraception. It is not known whether temozolomide is excreted in human milk, but due to potential serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment.
Side Effects
Contraindications
- Hypersensitivity to Temozolomide or to Dacarbazine (DTIC).
- Severe myelosuppression.
Drug Interactions
Valproic acid
Concomitant use with valproic acid may lead to a small but statistically significant decrease in temozolomide clearance, potentially increasing exposure.
Other myelosuppressive agents
Increased risk of myelosuppression when co-administered with other agents that cause bone marrow suppression.
Storage
Store at room temperature (20°C to 25°C). Protect from moisture and light. Keep out of reach of children. Do not refrigerate.
Overdose
Overdose of temozolomide is expected to result in myelosuppression. Treatment is symptomatic and supportive, including blood transfusions if severe myelosuppression occurs. There is no known antidote.
Pregnancy & Lactation
Pregnancy Category D. Temozolomide is embryotoxic, fetotoxic, and teratogenic in animals. It is contraindicated during pregnancy. Women of childbearing potential should use effective contraception. It is not known whether temozolomide is excreted in human milk, but due to potential serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2 years from the date of manufacture when stored properly.
Availability
Available in pharmacies and hospitals
Approval Status
FDA Approved
Patent Status
Off-patent
Clinical Trials
Temozolomide has been extensively studied in numerous clinical trials, primarily for glioblastoma and anaplastic astrocytoma, demonstrating its efficacy and safety profile. Ongoing research explores its use in combination therapies and other tumor types.
Lab Monitoring
- Complete blood count (CBC) with differential before starting treatment, weekly during the concomitant phase, and before each cycle of maintenance phase.
- Liver function tests (LFTs) periodically.
Doctor Notes
- Emphasize weekly CBC monitoring during the concomitant phase and before each maintenance cycle due to the risk of severe myelosuppression.
- Consider prophylactic antiemetics before each dose, especially during the initial cycles.
- Educate patients on symptoms of myelosuppression and opportunistic infections, and instruct them to report these immediately.
Patient Guidelines
- Take the capsule whole with water on an empty stomach, at least one hour before or two hours after food.
- Do not open, chew, or crush the capsule.
- If you vomit after taking the dose, do not take another dose. Wait until your next scheduled dose.
- Wear gloves if you need to handle damaged capsules.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Temozolomide may cause fatigue or dizziness. Patients should be cautioned about operating machinery or driving if they experience these symptoms.
Lifestyle Advice
- Stay well-hydrated throughout treatment.
- Practice good hand hygiene and avoid crowded places to reduce the risk of infection.
- Report any unusual bleeding, bruising, fever, or signs of infection to your doctor immediately.
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