Temozolomide 5mg Capsules
Overview
What is this medicine?
How to Use This Medicine
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Take your medication at the same time every day.
You can take your medication with or without food, but be consistent in how you take it each time. If you choose to take it with food, always take it with food. If you choose to take it on an empty stomach, always take it on an empty stomach. Taking it on an empty stomach may help prevent stomach upset.
Consider taking your medication at bedtime, as this may also help minimize stomach upset. However, consult with your doctor before making any changes to your dosage schedule.
Your doctor may prescribe other medications to be taken with this drug to help reduce side effects.
Swallow your medication whole with a full glass of water. Do not chew, break, crush, or dissolve the capsules.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.
Your dosage may consist of two or more different strengths and colors of capsules.
If you vomit after taking your medication, do not take an additional dose.
Handling Your Medication
When handling your medication, take special precautions. Consult with your doctor or pharmacist for guidance on how to handle your medication safely.
Wear gloves when touching your medication.
If a capsule is opened or broken, avoid touching the contents. Do not inhale the contents of the capsule. If you accidentally touch the contents or get them in your eyes, wash your hands or eyes immediately.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Take the capsules on an empty stomach, at least one hour before or two hours after a meal, preferably at bedtime to reduce nausea.
- Swallow capsules whole with a glass of water. Do NOT open, chew, or crush the capsules. If a capsule breaks, avoid contact with skin or mucous membranes. If contact occurs, wash thoroughly with soap and water.
- Wear gloves when handling the capsules.
- Store capsules at room temperature, away from moisture and heat.
- Maintain good hydration unless otherwise instructed by your doctor.
- Avoid live vaccines during treatment.
- Report any signs of infection (fever, chills, sore throat) or unusual bleeding/bruising immediately.
- Use effective contraception during treatment and for at least 6 months after for females, and for at least 3 months after for males.
Available Forms & Alternatives
Available Strengths:
- Temozolomide 100mg Capsules
- Temozolomide 5mg Capsules
- Temozolomide 5mg Capsules
- Temozolomide 250mg Capsules
- Temozolomide 20mg Capsules
- Temozolomide 180mg Capsules
- Temozolomide 140mg Capsules
- Temozolomide 20mg Capsules
- Temozolomide 100mg Capsules
- Temozolomide 140mg Capsules
- Temozolomide 180mg Capsules
- Temozolomide 250mg Capsules
- Temozolomide 250mg Capsules
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or speaking
+ 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 discolored sputum
+ Painful urination
+ 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 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
+ Yellowing of the 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, contact your doctor if they bother you or persist:
Hair loss
Headache
Dizziness, drowsiness, fatigue, or weakness
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Difficulty sleeping
Back, muscle, or joint pain
Dry skin
Changes in taste
Weight gain
Symptoms of a common cold
* 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.
Seek Immediate Medical Attention If You Experience:
- Fever (100.4°F or higher) or chills
- Sore throat or other signs of infection
- Unusual bleeding or bruising
- Severe nausea or vomiting that prevents eating/drinking
- Severe diarrhea
- Extreme fatigue or weakness
- New or worsening headache
- Seizures
- Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Yellowing of skin or eyes (jaundice), dark urine, or severe abdominal pain (signs of liver problems)
Before Using This Medicine
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. It is crucial to avoid breastfeeding while taking this medication and for 1 week after the last dose.
To ensure safe treatment, it is vital to discuss the following with your doctor and pharmacist:
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any existing health problems that may interact with this medication.
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm it is safe to do so.
Precautions & Cautions
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, 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 people who have infections, colds, or flu.
Additionally, you may be at a higher risk of bleeding easily. To minimize this risk, be cautious and avoid injuries. Use a soft-bristled toothbrush and an electric razor for shaving.
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.
It is also important to note that this medication is present in semen. 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 required before starting treatment 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.
Overdose Information
Overdose Symptoms:
- Severe myelosuppression (very low white blood cell count, platelet count)
- Severe nausea and vomiting
- Diarrhea
- Fatigue
What to Do:
There is no known antidote for temozolomide overdose. Treatment is supportive, including close monitoring of blood counts and administration of appropriate blood products or growth factors as needed. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Major Interactions
- Valproic acid: Concomitant administration of valproic acid may decrease the oral clearance of temozolomide by approximately 5%. The clinical significance of this is not fully established, but it could potentially increase temozolomide exposure and toxicity. Monitor for increased myelosuppression.
- Other myelosuppressive agents: Concurrent use with other agents that cause myelosuppression (e.g., other chemotherapeutic agents, radiation therapy) can lead to additive bone marrow suppression, increasing the risk of severe neutropenia and thrombocytopenia.
Moderate Interactions
- Phenytoin: May alter temozolomide metabolism, though specific data are limited. Monitor for altered efficacy or toxicity.
- Dexamethasone: Commonly co-administered, but may interact with other drugs. No direct significant interaction with temozolomide reported.
Monitoring
Baseline Monitoring
Rationale: To establish baseline hematologic parameters and assess for pre-existing myelosuppression, which is a common and dose-limiting toxicity.
Timing: Prior to initiation of treatment.
Rationale: To assess baseline hepatic function, as temozolomide is metabolized in the liver and hepatic impairment may affect drug clearance.
Timing: Prior to initiation of treatment.
Rationale: To assess baseline renal function, as temozolomide and its metabolites are primarily renally excreted.
Timing: Prior to initiation of treatment.
Rationale: Patients receiving temozolomide with concomitant radiation therapy are at increased risk of PCP. Prophylaxis is recommended.
Timing: Prior to initiation of concomitant phase.
Routine Monitoring
Frequency: Weekly during concomitant phase with radiation therapy; prior to each cycle (Day 1) during adjuvant phase; on Day 22 (or 21 days after first dose) of each cycle.
Target: ANC ≥1.5 x 10^9/L and platelet count ≥100 x 10^9/L for dose escalation or continuation.
Action Threshold: Dose reduction or delay if ANC <1.5 x 10^9/L or platelet count <100 x 10^9/L. Hold dose if ANC <1.0 x 10^9/L or platelet count <50 x 10^9/L.
Frequency: Periodically, especially if abnormalities are noted or symptoms of hepatic dysfunction occur.
Target: Within normal limits or stable.
Action Threshold: Consider dose modification or discontinuation if significant elevations occur.
Frequency: Periodically, especially if abnormalities are noted.
Target: Within normal limits or stable.
Action Threshold: Consider dose modification or discontinuation if significant deterioration occurs.
Symptom Monitoring
- Signs of myelosuppression (fever, chills, sore throat, unusual bleeding or bruising, fatigue)
- Gastrointestinal symptoms (nausea, vomiting, constipation, diarrhea)
- Neurological changes (headache, seizures, confusion, weakness)
- Skin reactions (rash, itching)
- Fatigue
- Hair loss
Special Patient Groups
Pregnancy
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.
Trimester-Specific Risks:
Lactation
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 one week after the last dose.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established for all indications. For newly diagnosed GBM, efficacy has been demonstrated in children ≥3 years. For refractory/recurrent high-grade glioma, use is often off-label and individualized. Children may be at increased risk of myelosuppression and other toxicities. Close monitoring of blood counts is essential.
Geriatric Use
Elderly patients (≥70 years) may be at increased risk of myelosuppression (neutropenia and thrombocytopenia) compared to younger patients. Close monitoring of blood counts is recommended. No specific dose adjustment is required based on age alone, but individual patient tolerance and comorbidities should be considered.
Clinical Information
Clinical Pearls
- Administer temozolomide on an empty stomach (at least 1 hour before or 2 hours after a meal) to minimize nausea and vomiting, although food does not significantly affect absorption.
- Consider administering the dose at bedtime to help manage nausea and vomiting.
- Antiemetics (e.g., ondansetron) should be prescribed and taken as directed, especially during the first few cycles.
- Pneumocystis jirovecii pneumonia (PCP) prophylaxis (e.g., with trimethoprim/sulfamethoxazole) is strongly recommended for all patients receiving temozolomide with concomitant radiation therapy, and for patients receiving temozolomide monotherapy if lymphopenia is prolonged.
- Capsules must be swallowed whole. If a capsule is accidentally opened or damaged, avoid contact with skin or mucous membranes. If contact occurs, wash thoroughly with soap and water.
- Patients should be educated on the signs and symptoms of myelosuppression and instructed to report them immediately.
- Dose adjustments are primarily based on hematologic toxicity (ANC and platelet counts).
Alternative Therapies
- Radiation therapy (often used in combination with temozolomide)
- Surgery (resection of tumor)
- Targeted therapies (e.g., bevacizumab for recurrent glioblastoma)
- Tumor Treating Fields (TTFields, e.g., Optune)
- Immunotherapy (e.g., checkpoint inhibitors, though limited efficacy in glioblastoma)