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Temorel (20mg / 100mg / 250mg) - Temozolomide Capsules

Temorel contains Temozolomide, an oral chemotherapy agent used primarily for treating certain types of brain tumors. It works by inhibiting cancer cell growth and promoting cell death, particularly in glioblastomas and other malignant gliomas.

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General Information:
Generic Name: Temozolomide
Brand Name: Temorel
Packing: 5 Capsules
Strengths: 20mg, 100mg, 250mg
Manufacturer: Reliance Life Sciences Pvt Ltd
Form: Capsules
Category: Antineoplastic, Alkylating agent
Prescription Status: Rx-only
Product Introduction:
Temorel is an alkylating agent used for the treatment of brain tumors, including glioblastoma multiforme (GBM) and anaplastic astrocytoma. It is commonly used in combination with radiation therapy or as a single agent in recurrent cases.

Uses:
Temorel (Temozolomide) is used for:
  1. Glioblastoma Multiforme (GBM) – as first-line treatment in combination with radiotherapy
  2. Anaplastic Astrocytoma – as adjuvant therapy post-surgery or radiation
  3. Recurrent Malignant Gliomas – in cases where other therapies have failed
  4. Other Brain Tumors – off-label use as per physician discretion
  5. CNS (Central Nervous System) Lymphoma – in certain circumstances
  6. Supportive care in brain cancer – alongside other cancer treatments

Storage Instructions:
  1. Store at room temperature, below 25°C
  2. Keep the bottle tightly closed and protect from moisture and heat
  3. Keep out of reach of children and pets
  4. Do not use after the expiry date printed on the packaging

How It Works (Mechanism of Action):
Temozolomide is an alkylating agent that works by adding alkyl groups to the DNA of cancer cells, causing DNA damage and preventing cell division. This action leads to cell death, specifically targeting rapidly dividing cancer cells, including those found in glioblastomas and other malignant brain tumors.

Side Effects:
Common side effects:
  1. Nausea and vomiting
  2. Fatigue
  3. Loss of appetite
  4. Headache
  5. Dizziness
  6. Diarrhea or constipation
Severe side effects:
  1. Bone marrow suppression (leading to low white blood cells, red blood cells, or platelets)
  2. Increased risk of infection
  3. Liver toxicity
  4. Severe nausea/vomiting
  5. Pneumonitis (lung inflammation)
  6. Severe allergic reactions (rash, swelling, difficulty breathing)

Dosage (Typical Recommended Dose):
  1. For Glioblastoma Multiforme (GBM): 75 mg/m²/day, taken orally for 42 days followed by a 28-day rest period, in combination with radiation therapy
  2. For Anaplastic Astrocytoma: 150 mg/m²/day for 5 days every 28-day cycle, followed by rest periods
  3. For Recurrent Gliomas: Starting dose of 200 mg/m²/day, adjusted as needed based on response and tolerability
  4. Dosage adjustments may be necessary for patients with severe bone marrow suppression or liver issues

Method of Administration:
  1. Take orally, once daily, preferably with or without food
  2. Swallow the capsules whole with water; do not crush or chew
  3. Administer the medication at the same time each day
  4. If a dose is missed, take it as soon as possible, unless it's close to the time of the next dose—do not take two doses at the same time

Precautions:
  1. Monitor blood counts regularly for signs of bone marrow suppression (low blood cells)
  2. Liver function should be assessed before and during treatment
  3. Patients may need to avoid pregnancy during treatment and for some time after, as the drug can harm the fetus
  4. May cause nausea and vomiting – antiemetics should be given if necessary
  5. Caution in patients with existing infections or weakened immune systems

Drug Interactions:
  1. Use caution when combined with other chemotherapy drugs, especially those that suppress the bone marrow
  2. Avoid using with strong CYP450 enzyme inducers or inhibitors as it may affect drug metabolism
  3. Co-administration with warfarin or other blood thinners should be done with caution due to increased bleeding risk
  4. Avoid live vaccines during chemotherapy treatment

Allergies:
  1. Contraindicated in patients with hypersensitivity to temozolomide or any excipients of the formulation
  2. Seek medical attention for allergic reactions such as rash, swelling, difficulty breathing, or severe dizziness

Overdose Information:
  1. Overdose symptoms may include severe nausea, vomiting, and bone marrow suppression
  2. If overdose occurs, immediate medical attention is required
  3. Supportive treatment such as fluids, electrolyte balance, and blood cell support may be necessary

Missed Dose Instructions:
  1. If a dose is missed, take it as soon as you remember unless it’s close to the time for the next dose
  2. Do not double up on doses to make up for a missed one
  3. If vomiting occurs after taking the dose, do not retake the dose until the next scheduled dose

Additional Notes:
  1. Avoid live vaccines while on treatment
  2. Hydration is important, as chemotherapy can cause dehydration and electrolyte imbalance
  3. Patients should be monitored for infections, especially during periods of bone marrow suppression
  4. Close monitoring of liver function, white blood cell counts, and platelet counts is necessary during treatment
  5. Fertility risks: Patients may experience infertility with long-term use; discuss fertility preservation options before starting treatment if needed

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