Temodar

Last updated on RxList: 12/9/2020
Temodar Side Effects Center

What Is Temodar?

Temodar (temozolomide) is a chemotherapy drug used together with radiation therapy to treat certain types of brain tumor in adults. Temodar is sometimes given after other cancer medications have been tried without successful treatment of the tumor.

What Are Side Effects of Temodar?

Common side effects of Temodar include:

Temporary hair loss may occur. Normal hair growth should return after treatment with Temodar has ended.

Dosage for Temodar

Dose of Temodar is individualized for each patient depending on the condition being treated.

What Drugs, Substances, or Supplements Interact with Temodar?

Temodar may interact with carbamazepine, divalproex sodium, phenytoin, valproic acid, steroids, or sulfa drugs. Tell your doctor all medications you are taking.

Temodar During Pregnancy and Breastfeeding

Temodar is not recommended for use during pregnancy. It may harm a fetus. It is not known if this drug passes into breast milk. Due to the potential risk to the infant, breastfeeding while using this drug is not recommended. Consult your doctor before breastfeeding.

Additional Information

Our Temodar (temozolomide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Temodar Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a seizure (convulsions);
  • sudden chest pain or discomfort, wheezing, dry cough;
  • low blood cell counts--fever, chills, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
  • liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, loss of appetite, constipation;
  • headache, feeling tired;
  • seizure;
  • bruising, purple spots;
  • pain, itching, warmth, redness, swelling, or irritation where the medicine was injected; or
  • hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Temodar (Temozolomide)

Temodar Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Myelosuppression [see WARNINGS AND PRECAUTIONS].
  • Myelodysplastic Syndrome and Secondary Malignancies [see WARNINGS AND PRECAUTIONS].
  • Pneumocystis Pneumonia [see WARNINGS AND PRECAUTIONS].
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Newly Diagnosed Glioblastoma

The safety of TEMODAR was evaluated in Study MK-7365-051 [see Clinical Studies].

Forty-nine percent (49%) of patients treated with TEMODAR reported one or more severe or life-threatening reactions, most commonly fatigue (13%), convulsions (6%), headache (5%), and thrombocytopenia (5%).

The most common adverse reactions (≥20%) across the cumulative TEMODAR experience were alopecia, fatigue, nausea, and vomiting. Table 3 summarizes the adverse reactions in Newly Diagnosed Glioblastoma Trial. Overall, the pattern of reactions during the maintenance phase was consistent with the known safety profile of TEMODAR.

TABLE 3: Adverse Reactions (≥5%) in Patients Receiving TEMODAR in Newly Diagnosed Glioblastoma Trial

Adverse Reactions Concomitant Phase Maintenance Phase
Radiation Therapy and TEMODAR
N=288*
Radiation Therapy Alone
N=285
TEMODAR
N=224
All Grades (%) Grade ≥3 (%) All Grades (%) Grades ≥3 (%) All Grades (%) Grade ≥3 (%)
Skin and Subcutaneous Tissue
Alopecia 69 63 55
Rash 19 1 15 13 1
Dry Skin 2 2 5 <1
Pruritus 4 1 5
Erythema 5 5 1
General
Fatigue 54 7 49 5 61 9
Anorexia 19 1 9 <1 27 1
Fleadache 19 2 17 4 23 4
Weakness 3 2 3 1 7 2
Dizziness 4 1 4 5
Gastrointestinal System
Nausea 36 1 16 <1 49 1
Vomiting 20 <1 6 <1 29 2
Constipation 18 1 6 22
Diarrhea 6 3 10 1
Stomatitis 7 5 <1 9 1
Abdominal Pain 2 <1 1 5 <1
Eye
Vision Blurred 9 1 9 1 8
Injury
Radiation Injury NOS 7 4 <1 2
Central and Peripheral Nervous System
Convulsions 6 3 7 3 11 3
Memory Impairment 3 <1 4 <1 7 1
Confusion 4 1 4 2 5 2
Special Senses Other
Taste Perversion 6 2 5
Respiratory System
Coughing 5 1 1 8 <1
Dyspnea 4 2 3 1 5 <1
Psychiatric
Insomnia 5 3 <1 4
Immune System
Allergic Reaction 5 2 <1 3
Platelet, Bleeding and Clotting
Thrombocytopenia 4 3 1 8 4
Musculoskeletal System
Arthralgia 2 <1 1 6
NOS = not otherwise specified.
Note: Grade 5 (fatal) adverse reactions are included in the Grade ≥3 column.
* One patient who was randomized to radiation therapy-only arm received radiation therapy and TEMODAR.

When laboratory abnormalities and adverse reactions were combined, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of patients, and Grade 3 or Grade 4 platelet abnormalities including thrombocytopenic reactions were observed in 14% of patients.

Refractory Anaplastic Astrocytoma

The safety of TEMODAR was evaluated in Study MK-7365-006 [see Clinical Studies].

Myelosuppression (thrombocytopenia and neutropenia) was the dose-limiting adverse reaction. It usually occurred within the first few cycles of therapy and was not cumulative. Myelosuppression occurred late in the treatment cycle and returned to normal, on average, within 14 days of nadir counts. The median nadirs occurred at 26 days for platelets (range: 21 to 40 days) and 28 days for neutrophils (range: 1 to 44 days). Only 14% (22/158) of patients had a neutrophil nadir and 20% (32/158) of patients had a platelet nadir, which may have delayed the start of the next cycle. Less than 10% of patients required hospitalization, blood transfusion, or discontinuation of therapy due to myelosuppression.

The most common adverse reactions (≥20%) were nausea, vomiting, headache, fatigue, constipation, and convulsions.

Tables 4 and 5 summarize the adverse reactions and hematological laboratory abnormalities in Refractory Anaplastic Astrocytoma Trial.

TABLE 4: Adverse Reactions (≥5%) in Patients Receiving TEMODAR in Refractory Anaplastic Astrocytoma Trial

Adverse Reactions TEMODAR
N=158
All Reactions (%) Grades 3-4 (%)
Gastrointestinal System
Nausea 53 10
Vomiting 42 6
Constipation 33 1
Diarrhea 16 2
Abdominal pain 9 1
Anorexia 9 1
General
Headache 41 6
Fatigue 34 4
Asthenia 13 6
Fever 13 2
Back pain 8 3
Central and Peripheral Nervous System
Convulsions 23 5
Hemiparesis 18 6
Dizziness 12 1
Coordination abnormal 11 1
Amnesia 10 4
Insomnia 10
Paresthesia 9 1
Somnolence 9 3
Paresis 8 3
Urinary incontinence 8 2
Ataxia 8 2
Dysphasia 7 1
Convulsions local 6
Gait abnormal 6 1
Confusion 5
Cardiovascular
Edema peripheral 11 1
Resistance Mechanism
Infection viral 11
Endocrine
Adrenal hypercorticism 8
Respiratory System
Upper respiratory tract infection 8
Pharyngitis 8
Sinusitis 6
Coughing 5
Skin and Appendages
Rash 8
Pruritus 8 1
Urinary System
Urinary tract infection 8
Micturition increased frequency 6
Psychiatric
Anxiety 7 1
Depression 6
Reproductive Disorders
Breast pain, female 6
Metabolic
Weight increase 5
Musculoskeletal System
Myalgia 5
Vision
Diplopia 5
Vision abnormal* 5
* This term includes blurred vision; visual deficit; vision changes; and vision troubles.

TABLE 5: Grade 3 to 4 Adverse Hematologic Laboratory Abnormalities in Refractory Anaplastic Astrocytoma Trial

TEMODAR* †
Decreased lymphocytes 55%
Decreased platelets 19%
Decreased neutrophils 14%
Decreased leukocytes 11%
Decreased hemoglobin 4%
*Change from Grade 0 to 2 at baseline to Grade 3 or 4 during treatment.
†Denominator range= 142, 158

Hematological Toxicities For Advanced Gliomas

In clinical trial experience with 110 to 111 females and 169 to 174 males (depending on measurements), females experienced higher rates of Grade 4 neutropenia (ANC <0.5 x 109/L) and thrombocytopenia (<20 x 109/L) than males in the first cycle of therapy (12% vs. 5% and 9% vs. 3%, respectively).

In the entire safety database for which hematologic data exist (N=932), 7% (4/61) and 9.5% (6/63) of patients >70 years experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. For patients ≤70 years, 7% (62/871) and 5.5% (48/879) experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. Pancytopenia, leukopenia, and anemia also occurred.

Adverse Reactions With TEMODAR For Injection

Adverse reactions that were reported in 35 patients who received TEMODAR for injection that were not reported in patients who received TEMODAR capsules were pain, irritation, pruritus, warmth, swelling, and erythema at infusion site; petechiae; and hematoma.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of TEMODAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug exposure.

Dermatologic: Toxic epidermal necrolysis and Stevens-Johnson syndrome

Immune System: Hypersensitivity reactions, including anaphylaxis. Erythema multiforme, which resolved after discontinuation of TEMODAR and, in some cases, recurred upon rechallenge.

Hematopoietic: Prolonged pancytopenia, which may result in aplastic anemia and fatal outcomes.

Hepatobiliary: Fatal and severe hepatotoxicity, elevation of liver enzymes, hyperbilirubinemia, cholestasis, and hepatitis.

Infections: Serious opportunistic infections, including some cases with fatal outcomes, with bacterial, viral (primary and reactivated), fungal, and protozoan organisms.

Pulmonary: Interstitial pneumonitis, pneumonitis, alveolitis, and pulmonary fibrosis.

Endocrine: Diabetes insipidus

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Temodar (Temozolomide)

© Temodar Patient Information is supplied by Cerner Multum, Inc. and Temodar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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