Dosing & Uses
Dosage Forms & Strengths
capsule
- 5mg
- 20mg
- 100mg
- 140mg
- 180mg
- 250mg
powder for injection
- 100mg/vial
Anaplastic Astrocytoma
Newly diagnosed
- Indicated for adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma
- Begins 4 weeks after end of radiotherapy
- Administer orally in a single dose on days 1-5 of a 28-day cycle for 12 cycles
-
Cycle 1
-
Cycles 2-12
- Days 1-5: 200 mg/m2 PO qDay if patient experienced no or minimal toxicity in Cycle 1
- Note: if dose was not escalated at start of Cycle 2, do not increase dose during Cycles 3-6
Refractory anaplastic astrocytoma
- Indicated for refractory anaplastic astrocytoma (ie, patients with disease progression on a drug regimen containing nitrosourea and procarbazine)
- Initial: 150 mg/m2 PO/IV qDay for 5 days; repeat at 28-day cycles
- Maintenance: May increase/maintain dose at 200 mg/m2 PO/IV qDay for 5 days/28-day cycle if ANC ≥1.5 x 109/L, and platelets ≥100 x 109/L
- Continue until disease progression or unacceptable toxicity
Glioblastoma Multiforme
Indicated for newly diagnosed glioblastoma multiforme (GBM) in adults treated concomitantly with radiotherapy and then as maintenance treatment
Provide Pneumocystis pneumonia (PCP) prophylaxis during concomitant use phase and continue in patients who develop lymphopenia until resolution to Grade ≤1
Concomitant use phase
- 75 mg/m2 PO/IV qDay for 42-49 consecutive days in combination with focal radiotherapy
- Focal radiotherapy includes the tumor bed or resection site with a 2-3 cm margin
- Other administration schedules have been used
- Obtain CBC weekly
Single agent maintenance phase
- Beginning 4 weeks after completing concomitant use phase
- Each cycle is 28 days
- Cycle 1: 150 mg/m2/day PO/IV on Days 1-5
- Cycles 2-6: May increase to 200 mg/m2/day PO/IV on Days 1-5 before starting Cycle 2 if no dosage interruptions or discontinuations are required
- If dose is not escalated at onset of Cycle 2, do not increase the dose for Cycles 3 to 6
- Obtain CBC on Day 22 and then weekly until the ANC >1.5 x 109/L and platelet count >100 x 109/L; do not start next cycle until ANC and platelet count exceed these levels
Dosage Modifications
Dosage modifications for refractory anaplastic anemia
- Obtain CBC on Day 22 and then weekly until ANC >1.5 x 109/L and platelet count >100 x 109/L
- Do not start next cycle until ANC and platelet count exceed these levels
- ANC <1 x 109/L or platelet count <50 x 109/L: Reduce dose for next cycle by 50 mg/m2/day
- Permanently discontinue if unable to tolerate 100 mg/m2/day
Dosage modifications for concomitant phase of GBM
- ANC ≤0.5 x 109/L: Withhold; resume at same dose for next cycle when ANC >1.5 x 109/L; discontinue if ANC <0.5 x 109/L
- Platelet 10 to <100 x 109/L: Withhold; resume at same dose for next cycle when platelet count 100 x 109/L; discontinue if platelet count <10 x 109/L
- Grade 2 nonhematological adverse reactions (except for alopecia, nausea, vomiting): Withhold; resume at same dose for next cycle when resolved to Grade ≤1: discontinue if Grade 3 or 4 adverse reaction occurs
Dosage modifications for newly diagnosed anaplastic astrocytoma and maintenance phase of GBM
- ANC <1 x 109/L: Withhold; resume at reduced dose for next cycle when ANC >1.5 x 109/L
- Platelet <50 x 109/L: Withhold; resume at reduced dose for next cycle when platelet count 100 x 109/L
- Grade 3 nonhematological adverse reactions (except for alopecia, nausea, vomiting): Withhold; resume at reduced dose for next cycle when resolved to Grade ≤1
- Discontinue if recurrent Grade 3 adverse reaction occurs after dose reduction, if Grade 4 adverse reaction occurs, or if unable to tolerate a dose of 100 mg/m2/day
Renal impairment
- Mild-to-moderate (CrCl 36-130 mL/min/m2): No dosage adjustment necessary
- Severe (CrCl <36 mL/min/m2) or end-stage renal disease on dialysis: No dose established
Hepatic impairment
- Mild or moderate (Child Pugh A or B): No dosage adjustment necessary
- Severe (Child Pugh C): No dose established
Dosing Considerations
Monitoring parameters
- Before dosing, withhold until absolute neutrophil count (ANC) ≥1.5 x 109/L and platelet count ≥100 x 109/L
-
For concomitant radiotherapy
- Obtain a complete blood cell count (CBC) before initiating and weekly during treatment
-
For 28-day treatment cycles
- Obtain a CBC before treatment on Day 1 and on Day 22 of each cycle
- IF ANC falls to1.5 x 109/L and platelet count falls <100 x 109/L, perform CBC weekly until recovery
-
For concomitant use with focal radiotherapy
- Obtain a CBC weekly and as clinically indicated
Orphan Designations
Newly diagnosed high grade glioma
- Schering-Plough Research Institute; 2000 Galloping Hill Road; Kenilworth, NJ 07033
Advanced Metastatic Melanoma
- Schering-Plough Research Institute; 2000 Galloping Hill Road; Kenilworth, NJ 0703
Nasopharyngeal carcinoma
- NeOnc Technologies, Inc; 8335 Sunset Blvd., #240; Los Angeles, California 90069
Neuroblastoma
- Orphelia Pharma; 85 Blvd Saint-Michel; Paris, France
Glioblastoma Multiforme (Orphan)
Orphan designation for treatment of glioblastoma multiforme in pediatric patients
Sponsor
- AmpliPharm Pharmaceuticals, LLC; 970 Peachtree Industrial Boulevard, Suite 100; Suwanee, Georgia 30024
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (14)
- adenovirus types 4 and 7 live, oral
temozolomide decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- axicabtagene ciloleucel
temozolomide, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
temozolomide, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
temozolomide, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- deferiprone
deferiprone, temozolomide. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- etrasimod
etrasimod, temozolomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.
- idecabtagene vicleucel
temozolomide, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, adjuvanted
temozolomide decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
temozolomide decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- lisocabtagene maraleucel
temozolomide, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of temozolomide by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, temozolomide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- tisagenlecleucel
temozolomide, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
temozolomide, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (19)
- acalabrutinib
acalabrutinib, temozolomide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- belatacept
belatacept and temozolomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cholera vaccine
temozolomide decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
temozolomide decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
temozolomide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- fingolimod
temozolomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
temozolomide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- influenza A (H5N1) vaccine
temozolomide decreases effects of influenza A (H5N1) vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- influenza virus vaccine (H5N1), adjuvanted
temozolomide decreases effects of influenza virus vaccine (H5N1), adjuvanted by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- isavuconazonium sulfate
temozolomide and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Use Caution/Monitor.
- meningococcal group B vaccine
temozolomide decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, temozolomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
temozolomide and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- ponesimod
ponesimod and temozolomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- siponimod
siponimod and temozolomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
temozolomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, temozolomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.
- trastuzumab deruxtecan
trastuzumab deruxtecan, temozolomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.
- valproic acid
valproic acid increases levels of temozolomide by decreasing metabolism. Use Caution/Monitor. Cautions is advised.
Minor (1)
- food
food decreases levels of temozolomide by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Absorption is affected by food and consistency of administration with respect to food is recommended.
Adverse Effects
>10%
Alopecia (55-69%)
Lymphopenia (55%)
Nausea (53%)
Vomiting (42%)
Headache (41%)
Fatigue (34%)
Constipation (33%)
Anorexia (9-27%)
Convulsions (23%)
Thrombocytopenia (19%)
Rash (8-19%)
Hemiparesis (18%)
Diarrhea (16%)
Neutropenia (14%)
Fever (13%)
Asthenia (13%)
Dizziness (12%)
Peripheral edema (11%)
Viral infections (11%)
1-10% (selected)
Amnesia (10%)
Insomnia (10%)
Abdominal pain (5-9%)
Ataxia (8%)
Back pain (8%)
Paresis (8%)
URI (8%)
Urinary incontinence (8%)
UTI (8%)
Abnormal vision (5-8%)
Pruritus (5-8%)
Breast pain (6%)
Depression (6%)
Confusion (5%)
Myalgia (5%)
Weight gain (5%)
Anemia (4%)
Erythema (1%)
Postmarketing Reports
Alveolitis
Interstitial pneumonitis
Pulmonary fibrosis
Hepatotoxicity including elevations of liver enzymes, hyperbillirubinemia, cholestasis, and hepatitis
Diabetes insipidus
Reactivation of infections including cytomegalovirus and hepatitis B
Serious opportunistic infections, including some cases with fatal outcomes, can occur with bacterial, viral (primary and reactivated), fungal, and protozoan organisms
Warnings
Contraindications
Hypersensitivity to temozolomide, dacarbazine
Cautions
Severe hepatic/renal impairment, elderly
Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, reported
Prophylaxis for P. jiroveci pneumonia (pneumocystis pneumonia) required for all patients treated with temozolomide and radiation; risk increases with steroid therapy or longer treatment regimens
Fatal and severe hepatotoxicity reported; perform LFTs at baseline, midway through the first cycle, prior to each subsequent cycle, and ~2-4 weeks after the last dose
Causes fetal harm when administered to pregnant women
Prior to dosing, patients must have an ANC of 1.5 x 109/L or greater and a platelet count of 100 x 109/L or greater
For concomitant phase with radiotherapy, obtain complete blood count prior to initiation of treatment and weekly during treatment
All patients, particularly those receiving steroids, should be observed closely for the development of lymphopenia and PCP
As bioequivalence has been established only when given over 90 minutes, infusion over a shorter or longer period of time may result in suboptimal dosing; the possibility of an increase in infusion-related adverse reactions cannot be ruled out
For patients with newly diagnosed glioblastoma, provide PCP prophylaxis for all patients during concomitant phase; continue in patients who experience lymphopenia until resolution to grade 1 or less
Myelosuppression
- Myelosuppression reported, including prolonged pancytopenia, leukopenia, and anemia; may result in aplastic anemia, which in some cases has resulted in a fatal outcome; geriatric patients and women have higher risk of developing myelosuppression
- Obtain a complete blood count and monitor ANC and platelet counts before initiation of treatment and as clinically indicated during treatment; when this drug is used in combination with radiotherapy, obtain a complete blood count prior to initiation of treatment, weekly during treatment, and as clinically indicated
- For severe myelosuppression, withhold therapy and then resume at same or reduced dose, or permanently discontinue, based on occurrence
Pregnancy & Lactation
Pregnancy
Based on mechanism of action and findings from animal studies, therapy can cause fetal harm when administered to a pregnant woman; available postmarketing reports describe cases of spontaneous abortions and congenital malformations, including polymalformations with central nervous system, facial, cardiac, skeletal, and genitourinary system anomalies with exposure to drug during pregnancy; these cases report similar adverse developmental outcomes to those observed in animal studies
Verify pregnancy status in females of reproductive potential prior to initiating therapy
Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after last dose
Because of potential for embryofetal toxicity and genotoxic effects on sperm cells, advise male patients with pregnant partners or female partners of reproductive potential to use condoms during treatment and for at least 3 months after final dose
Advise male patients not to donate semen during treatment and for at least 3 months after final dose
Therapy may impair male fertility; limited data from male patients show changes in sperm parameters during treatment; however, no information is available on duration or reversibility of these changes
Animal data
- Administration of drug to rats and rabbits during period of organogenesis caused numerous external, internal, and skeletal malformations at doses less than maximum human dose based on body surface area; advise pregnant women of potential risk to fetus
Lactation
There are no data on presence of drug or its metabolites in human milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions, including myelosuppression from temozolomide in breastfed children, advise women not to breastfeed during treatment and for at least 1 week after final dose
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Imidazotetrazine derivative prodrug; active metabolite MTIC methylates guanine-rich areas of DNA that initiate transcription, which lead to DNA double strand breaks and apoptosis
Absorption
Rapidly and completely absorbed after oral administration
Peak plasma time: 1 hr (empty stomach); 2.25 hr (high-fat meal)
Bioequivalence: 100%; IV infusion (when administered over 90 min) is bioequivalent to same dose of oral capsule
Mean peak plasma concentration and AUC decreased by 32% and 9%, respectively when administered after a high-fat breakfast
Distribution
Protein bound: 15%
Vd: 0.4 L/kg
Metabolism
Metabolite: Hydrolyzed at physiologic pH to 3-methyl-(triazen-1-yl) imidazole-4-carboxamide (MTIC); MTIC further hydrolyzed to to 5-amino-imidazole-4-carboxamide (AIC), which is known to be an intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species
Elimination
Half-life: 1.8 hr
Clearance: 5.5 L/hr/m²
Excretion: primarily urine (~38%)
Administration
IV Compatibilities
SWI
IV Preparation
Bring the vial to room temp
Reconstitute 100-mg vial with 41 mL SWI to obtain 2.5 mg/mL solution; gently swirl to dissolve (do not shake)
Visually inspect parenteral drug products for particulate matter and discoloration before administering, whenever solution and container permit; discard if particulate matter or discoloration is observed
Do not further dilute reconstituted solution
After reconstitution, store at room temp and use within 14 hr, including infusion time
Using aseptic technique, withdraw up to 40 mL per vial to get required dose and transfer into empty 250 mL PVC infusion bag
IV Administration
Infuse IV using pump over 90 min
Flush lines before and after infusion
Do not infuse other medications simultaneously thru same infusion line
Oral Administration
Take capsule consistently either with or without food; preferably take on empty stomach HS to avoid N/V
Swallow capsules whole with water; do not open, chew, or dissolve contents of capsules
May consider antiemetics before/after
Storage
Capsules: Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Vials: Refrigerate at 2-8ºC (36-46ºF)
Reconstituted solution: Store at room temp and use within 14 hr, including infusion time
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Temodar intravenous - | 100 mg vial |  | |
| temozolomide oral - | 250 mg capsule |  | |
| temozolomide oral - | 180 mg capsule |  | |
| temozolomide oral - | 100 mg capsule |  | |
| temozolomide oral - | 180 mg capsule |  | |
| temozolomide oral - | 140 mg capsule |  | |
| temozolomide oral - | 20 mg capsule |  | |
| temozolomide oral - | 5 mg capsule |  | |
| temozolomide oral - | 250 mg capsule |  | |
| temozolomide oral - | 140 mg capsule |  | |
| temozolomide oral - | 250 mg capsule |  | |
| temozolomide oral - | 20 mg capsule |  | |
| temozolomide oral - | 5 mg capsule |  | |
| temozolomide oral - | 140 mg capsule |  | |
| temozolomide oral - | 20 mg capsule |  | |
| temozolomide oral - | 100 mg capsule |  | |
| temozolomide oral - | 180 mg capsule |  | |
| temozolomide oral - | 100 mg capsule |  | |
| temozolomide oral - | 5 mg capsule |  | |
| temozolomide oral - | 100 mg capsule |  | |
| temozolomide oral - | 20 mg capsule |  | |
| temozolomide oral - | 5 mg capsule |  | |
| temozolomide oral - | 140 mg capsule |  | |
| temozolomide oral - | 180 mg capsule |  | |
| temozolomide oral - | 100 mg capsule |  | |
| temozolomide oral - | 250 mg capsule |  | |
| temozolomide oral - | 250 mg capsule |  | |
| temozolomide oral - | 180 mg capsule |  | |
| temozolomide oral - | 250 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
temozolomide intravenous
TEMOZOLOMIDE - INJECTION
(TEM-oh-ZOL-oh-mide)
COMMON BRAND NAME(S): Temodar
USES: This medication is used to treat certain types of brain cancer. Temozolomide belongs to a class of drugs known as alkylating agents. It works by slowing or stopping the growth of cancer cells.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using temozolomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein as directed by your doctor. It is given by a health care professional, usually over 90 minutes.The dosage and treatment schedule are based on your medical condition, height, weight, and response to treatment. To get the most benefit, carefully follow the dosing schedule as directed by your doctor. To help you remember, mark your calendar to keep track of when to receive the next dose.Your doctor may also prescribe other medications (such as antibiotics) to help prevent infection or side effects. Follow your doctor's directions for taking all your medications.
SIDE EFFECTS: Nausea, vomiting, loss of appetite, mouth sores, changes in taste, constipation, tiredness, dizziness, trouble sleeping, headache, or pain/redness/swelling at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Although temozolomide is used to treat cancer, it may rarely increase your risk of getting other cancers. Also, temozolomide decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn't go away, fever, chills), easy bruising/bleeding.Tell your doctor right away if you have any serious side effects, such as: symptoms of liver damage (such as stomach/abdominal pain, yellowing eyes/skin, dark urine).Get medical help right away if you have any very serious side effects, such as: seizure.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, such as: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before receiving temozolomide, tell your doctor or pharmacist if you are allergic to it; or to dacarbazine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, bleeding/blood problems.Temozolomide can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using temozolomide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (such as prescription drugs, nonprescription drugs, and herbal products).Women and older adults may be more sensitive to the side effects of this drug, especially increased risk of infection and easy bruising/bleeding.Men should not donate sperm while using temozolomide and for 3 months after stopping this drug.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using temozolomide. Temozolomide may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication who have a partner that is pregnant or who can become pregnant should use condoms for birth control during treatment and for some time after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for 1 week after the last dose. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Lab and/or medical tests (such as complete blood count, liver function, brain scan) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised October 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
