Temozolomide 140mg Capsules

Temozolomide is an imidazotetrazine derivative that undergoes rapid chemical conversion at physiological pH to the active compound monomethyl triazenoimidazole carboxamide (MTIC). MTIC is an alkylating agent that primarily methylates DNA at the O6 and N7 positions of guanine. This methylation leads to DNA damage, triggering cell cycle arrest and apoptosis, thereby exerting its cytotoxic effects on tumor cells.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever or chills
+ Severe sore throat, ear or sinus pain, or cough
+ Increased or discolored sputum
+ Painful urination or mouth sores
+ Wounds that won't heal
Unexplained bruising or bleeding
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Confusion or mood changes
Difficulty swallowing
Loss of bladder control
Memory problems or loss
Abnormal burning, numbness, or tingling sensations
Seizures
Changes in vision
Pinpoint red spots on the skin
Breast pain
Signs of severe and potentially life-threatening liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Hair loss
Headache
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Sleep disturbances
Back, muscle, or joint pain
Dry skin
Changes in taste
Weight gain
Common cold symptoms
Mouth irritation or mouth sores

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A known allergy to dacarbazine.
If you have a low white blood cell count (leukopenia) or a low platelet count (thrombocytopenia).
If you are breastfeeding. You should not breastfeed while taking this medication and for 1 week after your last dose.

Potential Interactions with Other Medications or Health Conditions

This medication may interact with other drugs or health problems. To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products, vitamins, or supplements you are using.
* Any existing health problems or conditions.

It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss your test results with your doctor.

Before receiving any vaccinations, consult with your doctor, as certain vaccines may not be effective or may increase the risk of infection when taken with this medication.

If you experience stomach upset, vomiting, diarrhea, or loss of appetite, consult your doctor, as there may be ways to minimize these side effects.

This medication can cause low blood cell counts, which may lead to bleeding problems, infections, or anemia. In severe cases, low blood cell counts can be life-threatening and may require hospitalization or blood transfusions. If you have concerns, discuss them with your doctor.

You may be more susceptible to infections due to this medication. To reduce the risk of infection, practice good hygiene by washing your hands frequently and avoid close contact with people who have infections, colds, or flu.

Additionally, you may be more prone to bleeding easily. Take precautions to avoid injury, and use a soft toothbrush and an electric razor to minimize the risk of bleeding.

Rare but serious side effects of this medication include bone marrow problems and the development of secondary cancers. Discuss these risks with your doctor.

If you are 70 years or older, use this medication with caution, as you may be more likely to experience side effects.

This medication may affect fertility in men. Discuss this potential side effect with your doctor.

It is also important to note that this medication can be present in semen. Do not donate semen while taking this medication or for 3 months after your last dose.

Women of childbearing age should be aware that this medication can harm an unborn baby. A pregnancy test will be required before starting this medication to confirm that you are not pregnant. If you or your partner may become pregnant, use effective birth control during treatment and for a period after the last dose, as advised by your doctor. If you or your partner becomes pregnant, notify your doctor immediately.

• Valproic acid (decreases temozolomide clearance, potentially increasing myelosuppression)
• Other myelosuppressive agents (additive myelosuppression)

• Phenytoin (potential for altered temozolomide levels, monitor)
• Dexamethasone (commonly co-administered, but monitor for additive side effects)

• Nausea
• Vomiting
• Fatigue
• Headache
• Constipation
• Rash
• Hair loss
• Fever (sign of infection due to myelosuppression)
• Bleeding/bruising (sign of thrombocytopenia)
• Signs of opportunistic infections (e.g., Pneumocystis jirovecii pneumonia - PJP)

Temozolomide is classified as Pregnancy Category D. It can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during treatment and for at least 6 months after the last dose. Men with female partners of childbearing potential should use effective contraception during treatment and for at least 3 months after the last dose.

It is not known whether temozolomide or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated during treatment with temozolomide and for at least 1 week after the last dose.

Temozolomide has been studied and is used in pediatric patients with certain brain tumors (e.g., high-grade glioma, recurrent medulloblastoma). Dosing is typically based on body surface area, similar to adults, but requires careful monitoring due to potential for increased toxicity and long-term effects on development.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be more susceptible to myelosuppression and should be monitored closely.

• Temozolomide capsules must be swallowed whole with a glass of water. Do not open, chew, or crush them. If capsules are accidentally opened or damaged, avoid contact with skin or mucous membranes. If contact occurs, wash thoroughly with water.
• Administer on an empty stomach, preferably at bedtime, to minimize nausea and vomiting. Prophylactic antiemetics are highly recommended.
• Pneumocystis jirovecii pneumonia (PJP) prophylaxis is required for all patients receiving temozolomide with concomitant radiotherapy for newly diagnosed glioblastoma, and should be continued throughout the concomitant phase and for 28 days after. Consider prophylaxis for other patients at risk.
• Dose adjustments are primarily based on nadir blood counts (ANC and platelets) from the previous cycle.
• Patients should be advised about the potential for severe myelosuppression and instructed to report any signs of infection or bleeding immediately.
• Temozolomide can cause fatigue; advise patients to plan activities accordingly and rest when needed.

• Lomustine (CCNU)
• Carmustine (BCNU) wafers (Gliadel)
• Procarbazine
• Vincristine
• Radiation therapy
• Surgical resection
• Tumor Treating Fields (TTFields, Optune)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.