Tembrox
Generic Name
Temozolomide
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tembrox 15 mg syrup | ৳ 47.00 | N/A |
Description
Overview of the medicine
Tembrox (Temozolomide) is an anti-cancer medication used to treat certain types of brain tumors, specifically glioblastoma multiforme and anaplastic astrocytoma. It works by damaging the DNA of cancer cells, thereby preventing their growth and spread.
Uses & Indications
Dosage
Adults
For newly diagnosed glioblastoma multiforme: 75 mg/m² orally once daily for 42 days (concomitant phase), then 150-200 mg/m² for 5 days every 28 days (adjuvant phase). For anaplastic astrocytoma: Initially 150 mg/m² orally once daily for 5 days, repeated every 28 days. May increase to 200 mg/m² if tolerated.
Elderly
No specific dose adjustments needed based solely on age, but caution is advised due to potential for increased myelosuppression. Dosage based on body surface area.
Renal_impairment
No specific dose adjustment recommendations for mild to moderate renal impairment. Data for severe impairment is limited; use with caution.
How to Take
Take orally on an empty stomach, at least one hour before food or at bedtime, to minimize nausea and vomiting. Swallow capsules whole with water; do not open, chew, or crush. If capsules are accidentally opened, avoid contact with skin and mucous membranes.
Mechanism of Action
Temozolomide is an alkylating agent that methylates DNA, causing DNA damage. This damage triggers apoptosis (programmed cell death) in rapidly dividing cancer cells.
Pharmacokinetics
Onset
Peak plasma levels reached within 0.5-1.5 hours.
Excretion
Primarily excreted in urine (about 38% of the dose within 24 hours), with a small portion excreted in feces.
Half life
Approximately 1.8 hours.
Absorption
Rapidly absorbed after oral administration with high bioavailability (approximately 100%). Peak plasma concentrations are achieved within 0.5-1.5 hours.
Metabolism
Spontaneously and rapidly hydrolyzed at physiological pH to the active metabolite, 5-(3-methyltriazen-1-yl)imidazole-4-carboxamide (MTIC), which is further metabolized.
Side Effects
Contraindications
- Hypersensitivity to temozolomide or dacarbazine (since MTIC is the active metabolite of both drugs).
- Severe myelosuppression.
Drug Interactions
Valproic acid
Concomitant use with valproic acid may decrease temozolomide clearance, potentially leading to increased systemic exposure and myelosuppression. Dose adjustment of temozolomide may be necessary.
Other myelosuppressants
Concurrent use with other agents that cause myelosuppression (e.g., other chemotherapy drugs, radiation) may increase the risk and severity of hematologic toxicities.
Storage
Store at controlled room temperature (20°C to 25°C). Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose may result in severe myelosuppression (bone marrow depression), including prolonged pancytopenia, which can be life-threatening. Management involves supportive care, including blood transfusions and growth factors as needed.
Pregnancy & Lactation
Pregnancy Category D: Temozolomide can cause fetal harm when administered to a pregnant woman. It is recommended to avoid pregnancy during treatment and for at least 6 months after. Lactation: It is unknown whether temozolomide is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment.
Side Effects
Contraindications
- Hypersensitivity to temozolomide or dacarbazine (since MTIC is the active metabolite of both drugs).
- Severe myelosuppression.
Drug Interactions
Valproic acid
Concomitant use with valproic acid may decrease temozolomide clearance, potentially leading to increased systemic exposure and myelosuppression. Dose adjustment of temozolomide may be necessary.
Other myelosuppressants
Concurrent use with other agents that cause myelosuppression (e.g., other chemotherapy drugs, radiation) may increase the risk and severity of hematologic toxicities.
Storage
Store at controlled room temperature (20°C to 25°C). Protect from light and moisture. Keep out of reach of children.
Overdose
Overdose may result in severe myelosuppression (bone marrow depression), including prolonged pancytopenia, which can be life-threatening. Management involves supportive care, including blood transfusions and growth factors as needed.
Pregnancy & Lactation
Pregnancy Category D: Temozolomide can cause fetal harm when administered to a pregnant woman. It is recommended to avoid pregnancy during treatment and for at least 6 months after. Lactation: It is unknown whether temozolomide is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months
Availability
Available in pharmacies and hospitals
Approval Status
Approved (DGDA)
Patent Status
Generic versions available
Clinical Trials
Temozolomide has been extensively studied in clinical trials for glioblastoma multiforme and anaplastic astrocytoma. Ongoing research explores its use in other cancers and in combination therapies.
Lab Monitoring
- Complete Blood Count (CBC) with differential must be performed frequently, especially before each cycle and weekly during the concomitant phase. Liver Function Tests (LFTs) should also be monitored regularly.
Doctor Notes
- Emphasize frequent hematological monitoring due to myelosuppression risk.
- Counsel patients on potential side effects and when to seek immediate medical attention.
- Ensure patients understand the strict dosing regimen and administration instructions.
Patient Guidelines
- Take Tembrox exactly as prescribed by your doctor.
- Do not open, chew, or crush the capsules. Swallow them whole.
- Report any signs of infection (fever, chills) or unusual bleeding/bruising immediately to your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember on the same day. If it is almost time for your next dose, 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
Tembrox may cause fatigue, dizziness, or somnolence. Patients should be advised to exercise caution when driving or operating machinery until they know how the drug affects them.
Lifestyle Advice
- Maintain good hydration by drinking plenty of fluids.
- Practice good oral hygiene to prevent mouth sores.
- Avoid live vaccines during treatment.
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