Temozolomide 180mg 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, particularly in rapidly dividing 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 or seek medical attention immediately:

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
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Unexplained bruising or bleeding
Shortness of breath, significant 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
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
Severe and potentially life-threatening liver problems, characterized by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're concerned about any of the following side effects or if they persist, contact your doctor or seek medical attention:

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

This list is not exhaustive. If you have questions or concerns about side effects, 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, such as foods or drugs. 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 or vitamins you are using.
* Your health problems, including any medical conditions or concerns.

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 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 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 individuals who have infections, colds, or flu.

Be cautious, as this medication may increase your risk of bleeding. 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 prone to side effects.

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

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

This medication can cause harm to an unborn baby. A pregnancy test will be conducted 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, leading to increased myelosuppression)
• Myelosuppressive agents (additive myelosuppression)

• Cimetidine (may slightly increase temozolomide exposure, clinical significance uncertain)
• Dexamethasone (commonly co-administered, but may affect temozolomide metabolism, monitor)

• Other agents that affect DNA repair pathways

• Signs of myelosuppression (fever, chills, sore throat, unusual bleeding or bruising, fatigue)
• Gastrointestinal symptoms (nausea, vomiting, constipation, diarrhea)
• Neurological changes (headache, seizures, fatigue, weakness)
• Skin reactions (rash, itching)
• Signs of opportunistic infections (e.g., Pneumocystis jirovecii pneumonia - PJP prophylaxis is often recommended)
• Signs of hepatotoxicity (jaundice, dark urine, abdominal pain)

Temozolomide can cause fetal harm when administered to a pregnant woman. It is classified as Pregnancy Category D. Advise pregnant women of the potential risk to a 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 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 one week after the last dose.

Safety and effectiveness in pediatric patients have not been established. Limited data suggest similar toxicity profiles to adults. Use in children ≥3 years with refractory anaplastic astrocytoma or newly diagnosed GBM is based on extrapolation from adult data, but caution is advised.

No overall differences in safety or effectiveness were observed between elderly patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustments are generally not required based on age alone, but careful monitoring for myelosuppression is important.

• Administer temozolomide on an empty stomach, preferably at bedtime, to minimize nausea and vomiting.
• Prophylaxis for Pneumocystis jirovecii pneumonia (PJP) is mandatory for all patients receiving temozolomide, especially during the concomitant phase with radiation and for patients with lymphopenia.
• Patients should be instructed not to open, chew, or crush capsules. If a capsule is damaged, avoid skin or mucous membrane contact and dispose of properly.
• Myelosuppression, particularly thrombocytopenia and neutropenia, is the dose-limiting toxicity and requires careful monitoring and potential dose adjustments.
• Consider antiemetic prophylaxis, especially for the first few cycles, as nausea and vomiting are common side effects.
• Temozolomide is an oral chemotherapy, which can improve patient convenience, but adherence and proper handling are crucial.

• Radiation therapy (often used in combination)
• Surgery (primary treatment for resectable tumors)
• Other chemotherapeutic agents for brain tumors (e.g., PCV regimen - Procarbazine, Lomustine, Vincristine)
• Tumor Treating Fields (TTFields, Optune)
• Targeted therapies (e.g., BRAF inhibitors for specific mutations)
• Immunotherapy (e.g., checkpoint inhibitors, though less established for primary brain tumors)

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 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.