Temodar 100mg Injection, 1 Vial

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 cells like cancer 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, difficulty 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
Signs of severe and potentially life-threatening liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Irritation or swelling at the injection site
Pain at the injection site

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 notice any of the following side effects or any other symptoms that bother you or don't go away, 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
Sleep disturbances
Back, muscle, or joint pain
Dry skin
Changes in taste
Weight gain
Symptoms of a common cold
* Mouth irritation or mouth sores

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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, tell your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have.

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 any concerns or questions you have with your doctor.

Before receiving any vaccinations, consult with your doctor, as some 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, talk to 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 any concerns you have 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 while taking this medication 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 by 5%, not considered clinically significant in most cases, but monitor for increased myelosuppression)
• Other myelosuppressive agents (e.g., other chemotherapy, radiation therapy) - increased risk of bone marrow suppression.

• 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)
• Signs of opportunistic infections (e.g., Pneumocystis jirovecii pneumonia - PJP prophylaxis is often recommended)
• Signs of liver dysfunction (jaundice, dark urine, abdominal pain)

Temozolomide can cause fetal harm when administered to a pregnant woman. It is teratogenic and embryotoxic in animals. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential should 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, advise women not to breastfeed during treatment with temozolomide.

Safety and effectiveness in pediatric patients have not been established for newly diagnosed glioblastoma multiforme or refractory anaplastic astrocytoma. However, temozolomide has been studied and used in pediatric patients with other brain tumors (e.g., high-grade glioma, medulloblastoma) in clinical trials or off-label, with varying efficacy and toxicity profiles. Myelosuppression is a significant concern.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients in clinical trials, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk of myelosuppression and other adverse events, requiring careful monitoring.

• Temozolomide IV is bioequivalent to the oral formulation; IV can be used when oral administration is not feasible.
• Pneumocystis jirovecii pneumonia (PJP) prophylaxis is strongly recommended for all patients receiving temozolomide with concomitant radiation therapy, and should be continued during the adjuvant phase for patients who develop lymphopenia.
• Administer antiemetics prior to and during temozolomide treatment to manage nausea and vomiting.
• Dose adjustments are primarily based on nadir blood counts (ANC and platelets) from the previous cycle.
• Patients should be well-hydrated before and during administration to prevent renal complications, although direct nephrotoxicity is not a primary concern.
• Infusion time is typically 90 minutes. Do not administer as a rapid IV push or bolus.

• Carmustine (BCNU)
• Lomustine (CCNU)
• Bevacizumab (Avastin) - for recurrent GBM
• Radiation therapy
• Surgery
• Tumor Treating Fields (TTFields, Optune)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for the recommended disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Your pharmacist may be aware of local drug take-back programs that can assist with safe disposal. Some medications may have additional patient information leaflets available; consult with your pharmacist if you have questions. If you have concerns or questions about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred to ensure prompt and effective treatment.