Temolon 250 Capsule

Description of Temolon 250 (Temozolomide 250 mg) capsule

Temolon 250 capsule, which contains Temozolomide is an oral antineoplastic agent which falls under the category of alkylating agents. It is mainly used in the treatment of tumours of the central-spinal cord because of its expertise in crossing the blood-brain barrier. The drug works by causing DNA damage in the fast growing neoplastic cells hence blocking their growth and proliferation. It is widely used in diseases like glioblastoma and other malignant gliomas such as in combination with radiotherapy as monotherapy.

Indications of Temolon 250 (Temozolomide 250 mg) capsule

Temozolomide should be used to treat Glioblastoma multiforme and Anaplastic astrocytoma . Depending on the stage of the illness, it is often used at the same time as radiotherapy or as a maintenance drug.

Mechanism of action of Temolon 250 (Temozolomide 250 mg) capsule

Temozolomide is converted to its active metabolite at physiological pH and hence it methylates DNA at specific loci. This is an interfering process of methylation that interferes with DNA architecture and thus replication and transcription of malignant cells. This leads to the fact that the cells cannot divide and they eventually undergo apoptosis. This process is quite effective at the divide of tumoral cells.

How to consume Temolon 250 (Temozolomide 250 mg) capsule

Temozolomide is given in a capsular orally, normally on an empty stomach so as to reduce nausea. Dose is determined as a proportion of body surface area and administration in cyclic doses is done often with radiotherapy. The patients are expected to stick strictly to the schedule prescribed.

Side Effects of Temolon 250 (Temozolomide 250 mg) capsule

1. Common side effects

• Nausea
• Vomiting
• Fatigue
• Constipation
• Headache

2. Serious side effects

• Bone marrow suppression
• Neutropenia
• Thrombocytopenia
• Severe infections

3. Rare side effects

• Hepatotoxicity
• Secondary malignancies
• Hypersensitivity reactions

Safety Advice for Temolon 250 (Temozolomide 250 mg) capsule

Patients taking Temozolomide have to be systematically monitored with hematologic indices since the drug may significantly drop the leukocyte counts, thus predisposing patients to infection. Evaluations of liver functioning are also recommended during the treatment.

Breastfeeding: Temozolomide should be contraindicated during breastfeeding, as the chemotherapeutic agent can be deposited into the breast milk and cause side effects to the growing cells of the infant.

Pregnancy: The drug is contraindicated in the period of gestation, as it can destroy the fetal DNA and cause serious defects in its development.

Alcohol: The drinking of alcohol is to be limited, as it can increase the hepatic load and aggravate such side effects as nausea and fatigue.

Liver: Patients with hepatic impairment are to be closely monitored because the impaired metabolism can increase the risk of drug toxicity.

Lungs: Any symptoms including persistent cough, dyspnea, or fever also have to be reported in a timely manner, as immunosuppression may increase the susceptibility to pulmonary infection.

Kidney: Despite hepatic as the main metabolic site, the renal functioning must be also controlled, especially in patients with already known renal disease.

Driving: Due to the fatigue, dizziness or weakness, a patient can feel weak and therefore, driving is not recommended when this occurs.

Interaction of Temolon 250 (Temozolomide 250 mg) capsule

• Drug–Drug Interaction

Valproic acid × Temozolomide 

Valproic acid can also reduce the excretion of Temozolomide, resulting in increased plasma levels and increased toxicity.

Corticosteroids × Temozolomide

Any simultaneous use of corticosteroids can additionally weaken the immune system, thus increasing the risk of infection.

Other myelosuppressive medications × Temozolomide

The interaction with other myelosuppressive agents may significantly augment bone marrow suppression leading to severe neutropenia and risks of infections.

Antiemetics × Temozolomide 

Although antiemetics are commonly used to correct nausea, some of these drugs can modify the pharmacodynamics of drugs and require a change in dose.

Live vaccines × Temozolomide 

Live vaccines should not be used in the course of Temozolomide therapy, since immunosuppression can increase the risk of infection.

• Drug–Food Interaction 

Temozolomide should be taken preferably on an empty stomach because concomitant food intake may slow down the absorption rate and exacerbate gastrointestinal side effects, including nausea.

• Drug–Disease Interaction 

Suppression of bone marrow:

Temozolomide is capable of significantly reducing hematopoietic production thereby increasing the risk of infections, anaemia and bleeding. Close attention should be given to the patients having pre-existing bone marrow disorders.

Liver disease:

Since the medication is hepatocellularly metabolised, hepatic malfunction will increase the toxicity of the drug. Thus, liver enzyme serial measurements should be encouraged.

Infections:

The drug lowers the immune system of patients, making them susceptible to infection. Preexisting infections are likely to deteriorate during treatment.

Renal impairment:

The impaired renal functioning affects the drug clearance and can increase the adverse effects; therefore, the renal functioning needs to be monitored regularly.

Contraindication of Temolon 250 (Temozolomide 250 mg) capsule

Temozolomide should not be used in patients who have hypersensitivity to the drug, to dacarbazine or in pregnancy.

Dosage of Temolon 250 (Temozolomide 250 mg) capsule

The dosage is dependent on the anatomical location of delivery. Treatment is presented in cycles and it is often used with radiation.

Storage of Temolon 250 (Temozolomide 250 mg) capsule

Store the drug in a cool and dry place at room temperature and not accessible to children.

Missed Dose of Temolon 250 (Temozolomide 250 mg) capsule

In case a dose is missed, he/she should skip it and take the next dosage; he/she is not supposed to take two doses.

Other General Information of Temolon 250 (Temozolomide 250 mg) capsule

Patients need to have proper hydration and nutrition in therapy. Frequent follow up should be done to track on the therapeutic response and adverse effects. Fever or unusual bleeding, severe fatigue, etc. are the symptoms that should be reported at once.

FAQs of Temolon 250 (Temozolomide 250 mg) capsule

1. What is the effectiveness of Temozolomide in brain tumours?

It has the ability to penetrate the blood brain barrier thus providing direct response to tumour cells in the central nervous system.

2. Is Temozolomide infection causing?

Yes, it may lower the levels of leukocytes and put patients at a risk of infections.

3. Why not eat it when you have nothing in your stomach?

When taken without food, the absorption is enhanced and nausea is counteracted.

4. Is it compatible with other interventions?

Yes, it is usually administered together with radiotherapy or any other chemotherapeutic agent to improve the outcomes.

5. What is the reason why regular monitoring is required?

Surveillance enables prompt identification of bone marrow suppression and hepatic toxicity, which is the safe treatment.

Fact Box of Temolon 250 (Temozolomide 250 mg) capsule

References

• FDA Prescribing Information – Temodar (Temozolomide)
  https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021029s033lbl.pdf
• European Medicines Agency (EMA) – Temodal Product Information
  https://www.ema.europa.eu/en/documents/product-information/temodal-epar-product-information_en.pdf
• DrugBank – Temozolomide
  https://go.drugbank.com/drugs/DB00853
• National Cancer Institute (NCI) – Temozolomide
  https://www.cancer.gov/about-cancer/treatment/drugs/temozolomide