Temozolomide 250mg Capsules

Temozolomide is an imidazotetrazine derivative that undergoes rapid chemical conversion at physiological pH to the active compound monomethyl triazenoimidazole carboxamide (MTIC). MTIC is the active alkylating agent, which primarily methylates DNA at the O6 and N7 positions of guanine and N3 position of adenine. This methylation leads to DNA damage, triggering apoptosis and inhibiting tumor cell proliferation.

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 or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ 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, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Confusion
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, including:
+ 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 minor 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 or seek medical attention:

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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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.

To ensure safe treatment, it is crucial to discuss the following with your doctor and pharmacist:

All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any existing health problems.
* Potential interactions between this medication and other substances or health conditions.

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so.

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 schedule 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 a decrease in appetite, consult with 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 any questions or concerns, discuss them with your doctor.

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

Be cautious, as this medication can increase the risk of bleeding. To minimize this risk, use a soft toothbrush, an electric razor, and avoid injuries.

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 prone to side effects.

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

This medication is present in semen, so do not donate semen while taking this medication or for 3 months after your last dose.

Women who are pregnant or may become pregnant should not take this medication, as it may harm the unborn baby. A pregnancy test will be performed 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: May decrease temozolomide clearance, potentially increasing myelosuppression. Monitor CBC closely.
• Other myelosuppressive agents (e.g., other chemotherapies, radiation therapy): Increased risk of severe myelosuppression.

• Phenytoin: May alter phenytoin levels (monitor phenytoin levels).

• Signs of myelosuppression (fever, chills, sore throat, unusual bleeding or bruising, fatigue)
• Nausea and vomiting (severity and frequency)
• Headache
• Fatigue
• Constipation or diarrhea
• Rash
• Signs of opportunistic infections (e.g., Pneumocystis jirovecii pneumonia - PCP)
• Signs of hepatotoxicity (jaundice, dark urine, abdominal pain)

Temozolomide is contraindicated in pregnancy (Category D). It can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 6 months after the last dose. Males with female partners of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose.

It is not known whether temozolomide is 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 one week after the last dose.

Safety and effectiveness have been established in pediatric patients 3 years of age and older with refractory anaplastic astrocytoma. Use in children under 3 years is not well established. Dosing is typically based on body surface area and specific protocols for pediatric brain tumors. Myelosuppression is a significant concern.

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 should be taken on an empty stomach to minimize nausea and vomiting, though food does not significantly impact absorption. Consistency in administration (always with or always without food) is key.
• Capsules must be swallowed whole with water. Do not open, crush, or chew them. If a capsule is damaged, avoid contact with skin or mucous membranes; if contact occurs, wash thoroughly.
• Prophylaxis for Pneumocystis jirovecii pneumonia (PCP) is mandatory during the concomitant phase with radiation and should be considered in patients who develop lymphopenia during the adjuvant phase.
• Patients should be educated on signs of myelosuppression (fever, bleeding, bruising) and instructed to report them immediately.
• Dose adjustments are primarily based on nadir blood counts (ANC and platelets) from the previous cycle, not on peak counts.

• Lomustine (CCNU)
• Carmustine (BCNU) wafers (Gliadel)
• Bevacizumab (Avastin)
• Optune (tumor treating fields)
• Other systemic chemotherapies (e.g., procarbazine, vincristine for certain brain tumors)
• Targeted therapies (e.g., BRAF inhibitors for BRAF-mutated gliomas)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.