Temodar 180mg Capsules
It is used to treat brain cancer.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antineoplastic agent
Pharmacologic Class
Alkylating agent
Pregnancy Category
Category D
FDA Approved
Aug 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Temozolomide is a chemotherapy medicine used to treat certain types of brain tumors. It works by damaging the DNA of cancer cells, which helps to slow or stop their growth. It is taken by mouth, usually for a few days each month.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription 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 prefer to take it on an empty stomach, always take it that way. Taking your medication on an empty stomach may help prevent stomach upset. Your doctor may also recommend taking it at bedtime.
If you experience stomach upset, talk to your doctor about the best way to take your medication.
In some cases, your doctor may prescribe other medications to help prevent side effects. Be sure to follow their instructions for taking these medications.
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 to feel better.
Your medication 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 Safely
When handling your medication, it's crucial to take special precautions. Consult with your doctor or pharmacist to learn how to handle your medication safely.
Wear gloves when touching your medication to minimize exposure.
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
To maintain the effectiveness of your medication:
Store it at room temperature in a dry place, away from the bathroom.
* If you miss a dose, contact your doctor to determine the best course of action.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription 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 prefer to take it on an empty stomach, always take it that way. Taking your medication on an empty stomach may help prevent stomach upset. Your doctor may also recommend taking it at bedtime.
If you experience stomach upset, talk to your doctor about the best way to take your medication.
In some cases, your doctor may prescribe other medications to help prevent side effects. Be sure to follow their instructions for taking these medications.
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 to feel better.
Your medication 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 Safely
When handling your medication, it's crucial to take special precautions. Consult with your doctor or pharmacist to learn how to handle your medication safely.
Wear gloves when touching your medication to minimize exposure.
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
To maintain the effectiveness of your medication:
Store it at room temperature in a dry place, away from the bathroom.
* If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Take on an empty stomach (at least 1 hour before or 2 hours after a meal) to reduce nausea and vomiting.
- Take at bedtime to help manage nausea and vomiting.
- Swallow capsules whole with a glass of water; do not open, chew, or crush them.
- If a capsule is accidentally opened or damaged, avoid contact with skin or mucous membranes. Wear gloves to clean up any spilled powder.
- Stay well-hydrated.
- Avoid live vaccines during treatment.
- Use effective contraception during treatment and for at least 6 months after for females, and 3 months for males, due to potential harm to a fetus.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and prior treatment. For newly diagnosed Glioblastoma Multiforme (GBM): 75 mg/m² orally once daily for 42 days concurrently with focal radiotherapy, followed by 150-200 mg/m² orally once daily for 5 days every 28 days for 6 cycles. For refractory Anaplastic Astrocytoma (AA): Initial 150 mg/m² orally once daily for 5 days every 28 days; may increase to 200 mg/m² if tolerated.
Dose Range:
75 - 200 mg
Condition-Specific Dosing:
newlyDiagnosedGBM:
75 mg/m² daily for 42 days (concomitant phase), then 150-200 mg/m² daily for 5 days every 28 days (adjuvant phase)
refractoryAA:
Initial 150 mg/m² daily for 5 days every 28 days, escalating to 200 mg/m² if tolerated
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Dosing for pediatric patients (≥3 years) with refractory anaplastic astrocytoma or newly diagnosed GBM has been studied, often using similar mg/m² dosing as adults, but specific recommendations vary and should be guided by clinical protocols.
Adolescent:
Dosing for pediatric patients (≥3 years) with refractory anaplastic astrocytoma or newly diagnosed GBM has been studied, often using similar mg/m² dosing as adults, but specific recommendations vary and should be guided by clinical protocols.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; no specific dose recommendations available. Consider potential for increased toxicity.
Dialysis:
Not available; temozolomide is rapidly hydrolyzed, and dialysis efficacy is unknown.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; no specific dose recommendations available. Consider potential for increased toxicity.
Pharmacology
Mechanism of Action
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. The O6-methylation is the most cytotoxic lesion, leading to DNA mismatch repair and subsequent double-strand breaks, ultimately triggering apoptosis and cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
0.5-1.5 hours (oral)
FoodEffect:
Food decreases the rate and extent of absorption (Cmax decreased by 33%, AUC by 9%). Administer on an empty stomach.
Distribution:
Vd:
0.4 L/kg (similar to total body water)
ProteinBinding:
10-15%
CnssPenetration:
Yes (readily crosses the blood-brain barrier)
Elimination:
HalfLife:
1.8 hours (plasma)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as AIC and unchanged temozolomide)
Unchanged:
Approximately 5-10% (in urine)
Pharmacodynamics
OnsetOfAction:
Not directly applicable for cytotoxic agents; effects are cumulative over treatment cycles.
PeakEffect:
Not directly applicable for cytotoxic agents; effects are cumulative over treatment cycles.
DurationOfAction:
Not directly applicable for cytotoxic agents; effects are cumulative over treatment cycles.
Safety & Warnings
BLACK BOX WARNING
Myelosuppression: Temozolomide causes myelosuppression (thrombocytopenia and neutropenia), which may be severe and result in hospitalization and/or death. Obtain a complete blood count (CBC) on Day 22 (or Day 29) of each 28-day cycle and weekly during the concomitant phase. Do not administer Temodar if ANC is <1.5 x 10^9/L or platelet count is <100 x 10^9/L.
Side Effects
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
+ 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, 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
Swallowing difficulties
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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you're concerned about any of these symptoms or if they persist, contact your doctor:
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 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.
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
+ 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, 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
Swallowing difficulties
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
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects. If you're concerned about any of these symptoms or if they persist, contact your doctor:
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 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 (especially >100.4°F or 38°C) or chills (signs of infection)
- Unusual bleeding or bruising (nosebleeds, bleeding gums, petechiae)
- Severe or persistent nausea, vomiting, or diarrhea
- Extreme tiredness or weakness
- Yellowing of skin or eyes, dark urine, or abdominal pain (signs of liver problems)
- New or worsening headache, seizures, or changes in mental status
- Severe skin rash or blistering
Before Using This Medicine
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 (OTC) 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 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 (OTC) 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.
Precautions & Cautions
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 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 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, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.
Be cautious, as this medication may 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.
The medication is present in semen, so do not donate semen while taking this medication or for 3 months after the last dose.
This medication can harm an unborn baby. A pregnancy test will be conducted before starting the 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 pregnancy occurs, notify your doctor immediately.
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 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, wash your hands frequently and avoid close contact with people who have infections, colds, or flu.
Be cautious, as this medication may 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.
The medication is present in semen, so do not donate semen while taking this medication or for 3 months after the last dose.
This medication can harm an unborn baby. A pregnancy test will be conducted before starting the 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 pregnancy occurs, 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. Management is supportive, including close monitoring of blood counts and appropriate medical interventions for myelosuppression and other toxicities. Call 1-800-222-1222 (Poison Control) immediately.
Drug Interactions
Major Interactions
- Valproic acid (may decrease temozolomide clearance, requiring dose reduction of temozolomide)
- Myelosuppressive agents (additive myelosuppression)
Moderate Interactions
- Other antineoplastic agents (potential for additive toxicity)
- Phenytoin (potential for altered temozolomide levels, though not consistently reported)
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelets
Rationale: To establish baseline hematologic parameters due to risk of myelosuppression.
Timing: Prior to initiation of treatment.
Liver Function Tests (LFTs) - AST, ALT, bilirubin
Rationale: To assess baseline hepatic function, as liver toxicity can occur.
Timing: Prior to initiation of treatment.
Renal Function Tests (RFTs) - BUN, creatinine
Rationale: To assess baseline renal function.
Timing: Prior to initiation of treatment.
Routine Monitoring
Complete Blood Count (CBC) with differential and platelets
Frequency: Weekly during concomitant phase; prior to each cycle (Day 1) and on Day 22 (or Day 29) of each 28-day adjuvant cycle.
Target: Absolute Neutrophil Count (ANC) ≥1.5 x 10^9/L, Platelets ≥100 x 10^9/L (for dose continuation/escalation).
Action Threshold: ANC <1.5 x 10^9/L or Platelets <100 x 10^9/L (requires dose reduction or delay).
Liver Function Tests (LFTs)
Frequency: Prior to each cycle.
Target: Within normal limits or acceptable baseline.
Action Threshold: Significant elevations (e.g., >3-5x ULN) may require dose modification or discontinuation.
Symptom Monitoring
- Signs of infection (fever, chills, sore throat)
- Unusual bleeding or bruising
- Severe nausea or vomiting
- Persistent fatigue or weakness
- Headache
- Seizures
- Allergic reactions (rash, itching, swelling)
- Signs of liver problems (yellowing of skin/eyes, dark urine, abdominal pain)
Special Patient Groups
Pregnancy
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 the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.
Trimester-Specific Risks:
First Trimester:
High risk of major birth defects and miscarriage due to rapid cell division and organogenesis.
Second Trimester:
Risk of fetal growth restriction, myelosuppression, and other organ toxicities.
Third Trimester:
Risk of fetal growth restriction, myelosuppression, and other organ toxicities; potential for premature birth.
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, advise women not to breastfeed during treatment with temozolomide.
Infant Risk:
High (potential for serious adverse reactions, including myelosuppression and other toxicities)
Pediatric Use
Safety and effectiveness in pediatric patients under 3 years of age have not been established. In patients 3 years and older, dosing is often based on body surface area, similar to adults, but specific protocols should be followed. Pediatric patients may be more susceptible to certain toxicities.
Geriatric Use
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. Dose adjustments are generally not required based on age alone, but careful monitoring for myelosuppression and other toxicities is important.
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.
- Consider administering at bedtime to help manage gastrointestinal side effects.
- Prophylaxis for Pneumocystis jirovecii pneumonia (PJP) is recommended for all patients receiving temozolomide with concomitant radiation therapy, and for patients in the adjuvant phase who develop lymphopenia.
- Patients should be monitored closely for myelosuppression, especially neutropenia and thrombocytopenia, which are dose-limiting toxicities.
- Capsules should be swallowed whole. If a capsule is opened or damaged, avoid contact with skin or mucous membranes, and wear gloves for cleanup.
- Temozolomide is an oral alkylating agent that readily crosses the blood-brain barrier, making it effective for brain tumors.
Alternative Therapies
- Lomustine (CCNU)
- Carmustine (BCNU)
- Bevacizumab (for recurrent GBM)
- Radiation therapy
- Surgery
Cost & Coverage
Average Cost:
Price varies widely by dose and pharmacy. For 180mg capsules, it can range from $1,000 to $3,000+ per capsule. per capsule
Generic Available:
Yes
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
General Drug Facts
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.