Temozolomide: Package Insert and Label Information (Page 3 of 5)
14.2 Refractory Anaplastic Astrocytoma
The efficacy of temozolomide was evaluated in Study MK-7365-006, a single-arm, multicenter trial. Eligible patients had anaplastic astrocytoma at first relapse and a baseline Karnofsky performance status (KPS) of 70 or greater. Patients had previously received radiation therapy and may also have previously received a nitrosourea with or without other chemotherapy. Fifty-four patients had disease progression on prior therapy with both a nitrosourea and procarbazine and their malignancy was considered refractory to chemotherapy (refractory anaplastic astrocytoma population). Temozolomide capsules were given on Days 1 to 5 of each 28-day cycle at a starting dose of 150 mg/m2 /day. If ANC was ≥ 1.5 × 109 /L and platelet count was ≥ 100 × 109 /L at the nadir and on Day 1 of the next cycle, the temozolomide dose was increased to 200 mg/m2 /day. The major efficacy outcome measure was progression-free survival at 6 months and the additional efficacy outcome measures were overall survival and overall response rate.
In the refractory anaplastic astrocytoma population (n=54), the median age was 42 years (range: 19 to 76); 65% were male; and 72% had a KPS of > 80. Sixty-three percent of patients had surgery other than a biopsy at the time of initial diagnosis. Of those patients undergoing resection, 73% underwent a subtotal resection and 27% underwent a gross total resection. Eighteen percent of patients had surgery at the time of first relapse. The median time from initial diagnosis to first relapse was 13.8 months (range: 4.2 months to 6.3 years).
In the refractory anaplastic astrocytoma population, the overall response rate (CR+PR) was 22% (12 of 54 patients) and the complete response rate was 9% (5 of 54 patients). The median duration of all responses was 50 weeks (range: 16 to 114 weeks) and the median duration of complete responses was 64 weeks (range: 52 to 114 weeks). In this population, progression-free survival at 6 months was 45% (95% CI: 31%, 58%) and progression-free survival at 12 months was 29% (95% CI: 16%, 42%). Median progression-free survival was 4.4 months. Overall survival at 6 months was 74% (95% CI: 62%, 86%) and 12-month overall survival was 65% (95% CI: 52%, 78%). Median overall survival was 15.9 months.
15 REFERENCES
1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.
16 HOW SUPPLIED/STORAGE AND HANDLING
Temozolomide is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Temozolomide capsules USP, 5 mg, are supplied as size “3” hard gelatin capsules with green opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “801” with black ink.
They are supplied as follows:
Bottles of 5: NDC 65162-801-51
Bottles of 14: NDC 65162-801-14
Temozolomide capsules USP, 20 mg, are supplied as size “2” hard gelatin capsules with yellow opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “802” with black ink.
They are supplied as follows:
Bottles of 5: NDC 65162-802-51
Bottles of 14: NDC 65162-802-14
Temozolomide capsules USP, 100 mg, are supplied as size “1” hard gelatin capsules with pink opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “803” with black ink.
They are supplied as follows:
Bottles of 5: NDC 65162-803-51
Bottles of 14: NDC 65162-803-14
Temozolomide capsules USP, 140 mg, are supplied as size “0” hard gelatin capsules with blue opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “804” with black ink.
They are supplied as follows:
Bottles of 5: NDC 65162-804-51
Bottles of 14: NDC 65162-804-14
Temozolomide capsules USP, 180 mg, are supplied as size “0” hard gelatin capsules with red opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “805” with black ink.
They are supplied as follows:
Bottles of 5: NDC 65162-805-51
Bottles of 14: NDC 65162-805-14
Temozolomide capsules USP, 250 mg, are supplied as size “0” hard gelatin capsules with white opaque color caps imprinted “AMNEAL” and white opaque color bodies imprinted “806” with black ink.
They are supplied as follows:
Bottles of 5: NDC 65162-806-51
Store temozolomide capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Myelosuppression
Inform patients that temozolomide can cause low blood cell counts and the need for frequent monitoring of blood cell counts. Advise patients to contact their healthcare provider immediately for bleeding, fever, or other signs of infection [see Warnings and Precautions (5.1)].
Myelodysplastic Syndrome and Secondary Malignancies
Advise patients of the increased risk of myelodysplastic syndrome and secondary malignancies [see Warnings and Precautions (5.2)].
Pneumocystis Pneumonia
Advise patients of the increased risk of Pneumocystis pneumonia and to contact their healthcare provider immediately for new or worsening pulmonary symptoms. Inform patients that prophylaxis for Pneumocystis pneumonia may be needed [see Dosage and Administration (2.1), Warnings and Precautions (5.3)].
Hepatotoxicity
Advise patients of the increased risk of hepatotoxicity and to contact their healthcare provider immediately for signs or symptoms of hepatoxicity [see Warnings and Precautions (5.4)].
Administration Instructions
Advise patient to not open capsules. If capsules are accidentally opened or damaged, advise patients to take rigorous precautions with capsule contents to avoid inhalation or contact with the skin or mucous membranes. In case of powder contact, the hands should be washed [see Dosage and Administration (2.3)].
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.5), Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with temozolomide and for at least 6 months after the last dose [see Use in Specific Populations (8.3)].
Advise male patients with pregnant partners or female partners of reproductive potential to use condoms during treatment with temozolomide and for at least 3 months after the final dose [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Advise male patients not to donate semen during treatment with temozolomide and for at least 3 months after the final dose [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Lactation
Advise women not to breastfeed during treatment with temozolomide and for at least 1 week after the final dose [see Use in Specific Populations (8.2)].
Infertility
Advise males of reproductive potential that temozolomide may impair fertility [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 01-2022-08
Patient Information
| Temozolomide( tem” oh zol’ oh mide) Capsules, USP | |
| What is the most important information I should know about temozolomide capsules? Temozolomide capsules may cause birth defects. Females and female partners of male patients who take temozolomide capsules:
Males taking temozolomide capsules and have a female partner who is pregnant or who can become pregnant:
See the section “What are the possible side effects of temozolomide capsules?” for more information about side effects. | |
| What is temozolomide capsules? Temozolomide capsules are a prescription medicine used to treat adults with certain brain cancer tumors. It is not known if temozolomide capsules are safe and effective in children. | |
| Who should not take temozolomide capsules? Do not take temozolomide capsules if you:
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| What should I tell my doctor before taking temozolomide capsules? Tell your doctor about all of your medical conditions, including if you:
Do not breastfeed during treatment and for at least 1 week after your last dose of temozolomide capsules. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take a medicine that contains valproic acid. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. | |
| How should I take temozolomide capsules?
Your doctor will decide the best way for you to take temozolomide capsules. Take temozolomide capsules exactly as prescribed by your doctor. There are 2 common dosing schedules for taking temozolomide capsules depending on the type of brain cancer tumor that you have.
You might take temozolomide capsules until your tumor gets worse or for possibly up to 2 years.
Temozolomide capsules:
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| What are the possible side effects of temozolomide capsules? Temozolomide capsules can cause serious side effects, including:
Common side effects of temozolomide capsules include: | |
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| Temozolomide capsules can affect fertility in males and may affect your ability to father a child. Talk with your doctor if fertility is a concern for you. Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects with temozolomide capsules. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
| How should I store temozolomide capsules?
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| General information about the safe and effective use of temozolomide capsules. Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use temozolomide capsules for a condition for which it was not prescribed. Do not give temozolomide capsules to other people, even if they have the same symptoms that you have. It may harm them. This leaflet summarizes the most important information about temozolomide capsules. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about temozolomide capsules that is written for health professionals. For more information, go to www.amneal.com or call 1-877-835-5472. | |
| What are the ingredients in temozolomide capsules? Temozolomide capsules: Active ingredient: temozolomide, USP. Inactive ingredients: colloidal silicon dioxide, ethyl alcohol, lactose anhydrous, sodium starch glycolate, stearic acid and tartaric acid. The body of the capsules is made of gelatin and titanium dioxide and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains alcohol, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, n-butyl alcohol, propylene glycol and shellac. Temozolomide Capsules USP, 5 mg: The green cap contains FD&C Blue #2, gelatin, titanium dioxide and yellow iron oxide. Temozolomide Capsules USP, 20 mg: The yellow cap contains D&C Yellow #10, FD&C Yellow #6, gelatin and titanium dioxide. Temozolomide Capsules USP, 100 mg: The pink cap contains FD&C Blue #1, FD&C Red #3, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 140 mg: The blue cap contains FD&C Blue #1, gelatin and titanium dioxide. Temozolomide Capsules USP, 180 mg: The red cap contains FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. Temozolomide Capsules USP, 250 mg: The white cap contains gelatin and titanium dioxide. *The trademarks depicted herein are owned by their respective companies. Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 01-2022-05 | |
This Patient Information has been approved by the U.S. Food and Drug Administration.
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