Temozolomide: Package Insert and Label Information (Page 4 of 5)

Temozolomide Capsules, USP

PHARMACIST:

Dispense enclosed Patient Package Insert to each patient.

PHARMACIST INFORMATION SHEET

IMPORTANT DISPENSING INFORMATION

For every patient, dispense temozolomide in a separate vial or in its original package, making sure each container lists the strength per capsule and that patients take the appropriate number of capsules from each package or vial. Please see the dispensing instructions below for more information.

What is temozolomide? [See Full Prescribing Information, Indications and Usage (1).]

Temozolomide is an oral alkylating agent for the treatment of newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma.

How is temozolomide dosed? [See Full Prescribing Information, Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma (2.1), Recommended Dosage and Dosage Modifications for Refractory Anaplastic Astrocytoma (2.2).]

The physician calculates the daily dose of temozolomide capsules for a given patient based on the patient’s body surface area (BSA). Round off the resulting dose to the nearest 5 mg. An example of the dosing may be as follows: the initial daily dose of temozolomide in milligrams is the BSA multiplied by mg/m2 /day (e.g., a patient with a BSA of 1.84 is 1.84 x 75 mg = 138, or 140 mg/day). Adjust the dose for subsequent cycles according to nadir neutrophil and platelet counts in the previous cycle and at the time of initiating the next cycle.

How might the dose of temozolomide be modified for Refractory Anaplastic Astrocytoma? [See Full Prescribing Information, Recommended Dosage and Dosage Modifications for Refractory Anaplastic Astrocytoma (2.2).]

The initial dose is 150 mg/m2 orally once daily for 5 consecutive days per 28-day treatment cycle. Increase the temozolomide dose to 200 mg/m2 /day for 5 consecutive days per 28-day treatment cycle if both the nadir and day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil counts (ANC) are greater than or equal to 1.5 x 109 /L (1500/μL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 x 109 /L (100,000/μL). During treatment, obtain a complete blood count on Day 22 (21 days after the first dose), and weekly until the ANC is above 1.5 x 109 /L (1500/μL) and the platelet count exceeds 100 x 109 /L (100,000/μL). Do not start the next cycle of temozolomide until the ANC and platelet count exceed these levels. If the ANC falls to less than 1.0 x 109 /L (1000/μL) or the platelet count is less than 50 x 109 /L (50,000/μL) during any cycle, reduce the dose for the next cycle by 50 mg/m2. Permanently discontinue temozolomide in patients who are unable to tolerate a dose of 100 mg/m2 per day.

Patients should continue taking temozolomide until their physician determines that their disease has progressed or until unacceptable side effects or toxicities occur. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known. Physicians may alter the treatment regimen for a given patient.

Dosing for Patients with Newly Diagnosed Glioblastoma Multiforme [See Full Prescribing Information, Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma (2.1).]

Concomitant Phase Treatment Schedule

Administer temozolomide orally at 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions), followed by maintenance temozolomide for 6 cycles. No dose reductions are recommended; however, dose interruptions may occur based on patient tolerance. Continue the temozolomide dose throughout the 42-day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count greater than or equal to 1.5 x 109 /L, platelet count greater than or equal to 100 x109 /L, and nonhematological adverse reactions less than or equal to Grade 1 (except for alopecia, nausea and vomiting). During treatment, obtain a complete blood count weekly. Interrupt or discontinue temozolomide dosing during the concomitant phase according to the hematological and nonhematological toxicity criteria [see Table 1 in the Full Prescribing Information, Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma (2.1)]. Pneumocystis pneumonia (PCP) prophylaxis is required during the concomitant administration of temozolomide and radiotherapy, and should be continued in patients who develop lymphocytopenia until resolution to Grade 1 or less.

Maintenance Phase Treatment Schedule

Four weeks after completing the temozolomide and radiotherapy phase, administer temozolomide for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment. At the start of Cycle 2, escalate the dose to 200 mg/m2 , if the nonhematologic adverse reactions for Cycle 1 are Grade less than or equal to 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is greater than or equal to 1.5 x 109 /L, and the platelet count is greater than or equal to 100 x 109 /L. If the dose was not escalated at Cycle 2, do not escalate the dose in subsequent cycles. Maintain the dose at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.

During treatment, obtain a complete blood count on Day 22 (21 days after the first dose) and weekly until the ANC is above 1.5 x 109 /L (1500/μL) and the platelet count exceeds 100 x 109 /L (100,000/μL). Do not start the next cycle of temozolomide until the ANC and platelet count exceed these levels. Base dose reductions during the next cycle on the lowest blood counts and worst nonhematologic adverse reactions during the previous cycle. Apply dose reductions or discontinuations during the maintenance phase [see Table 2 in the Full Prescribing Information, Recommended Dosage and Dosage Modifications for Newly Diagnosed Glioblastoma (2.1)].

How is temozolomide taken? [See Full Prescribing Information, Preparation and Administration, temozolomide capsules (2.3).]

Advise patients to take each day’s dose with a full glass of water, preferably on an empty stomach or at bedtime. Taking the medication on an empty stomach or at bedtime may help ease nausea. If patients are also taking anti-nausea or other medications to relieve the side effects associated with temozolomide, advise them to take these medications prior to and/or following administration of temozolomide capsules. Advise patients that temozolomide capsules should be swallowed whole and NEVER CHEWED. Advise patients that they SHOULD NOT open or split the capsules. If capsules are accidentally opened or damaged, advise patients to take rigorous precautions with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. In case of powder contact, advise the patients to wash their hands. Advise patients to keep this medication away from children.

What should the patient avoid during treatment with temozolomide? [See Full Prescribing Information, Use in Specific Populations, Pregnancy (8.1), Lactation (8.2), Females and Males of Reproductive Potential (8.3).]

There are no dietary restrictions for patients taking temozolomide. Temozolomide may affect testicular function and may cause birth defects. Advise male patients to exercise adequate birth control measures. Advise female patients to avoid becoming pregnant while receiving this drug. 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 of reproductive potential to use condoms during treatment and for at least 3 months after the last dose. Advise male patients not to donate semen during treatment with temozolomide and for at least 3 months after the final dose. It is not known whether temozolomide is excreted into breast milk. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed while taking temozolomide and for at least 1 week after the last dose.

What are the side effects of temozolomide? [See Full Prescribing Information, Adverse Reactions (6).]

Alopecia, fatigue, nausea, and vomiting are the most common side effects associated with temozolomide. Noncumulative myelosuppression is the dose-limiting toxicity. Patients should be evaluated periodically by their physician to monitor blood counts.

Other commonly reported side effects reported by patients taking temozolomide are headache, constipation, anorexia, and convulsions.

How is temozolomide supplied? [See Full Prescribing Information, How Supplied/Storage and Handling (16).]

Temozolomide capsules are available in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg strengths. The capsules contain a white capsule body with a color cap, and the colors vary based on the dosage strength.

Temozolomide Capsule Strength

Color

5 mg

Green Cap

20 mg

Yellow Cap

100 mg

Pink Cap

140 mg

Blue Cap

180 mg

Red Cap

250 mg

White Cap

The 5 mg, 20 mg, 100 mg, 140 mg, and 180 mg capsule strengths are available in 5 count and 14 count packages. The 250 mg capsule strength is available in a 5 count package.

How is temozolomide dispensed?

Dispense each strength of temozolomide in a separate vial or in its original package (one strength per one container). Follow the instructions below: Based on the dose prescribed, determine the number of each strength of temozolomide capsules needed for the full 42- or 5-day cycle as prescribed by the physician. For example, in a 5-day cycle, 275 mg/day would be dispensed as five 250-mg capsules, five 20-mg capsules and five 5-mg capsules. Label each container with the appropriate number of capsules to be taken each day. Dispense to the patient, making sure each container lists the strength (mg) per capsule and that he or she understands to take the appropriate number of capsules of temozolomide from each package or vial to equal the total daily dose prescribed by the physician.

How can temozolomide be ordered?

Temozolomide can be ordered from your wholesaler. It is important to understand if temozolomide is being used as part of a 42-day regimen or as part of a 5-day course. Remember to order enough temozolomide for the appropriate cycle. For example:

  • a 5-day course of 360 mg/day would require the following to be ordered: two 5-count packages of 180-mg capsules.
  • a 42-day course of 140 mg/day would require the following to be ordered: three 14-count packages of 140-mg capsules.

Temozolomide Product

NDC Number

Bottles:

5 mg capsules (5 count)

65162-801-51

5 mg capsules (14 count)

65162-801-14

20 mg capsules (5 count)

65162-802-51

20 mg capsules (14 count)

65162-802-14

100 mg capsules (5 count)

65162-803-51

100 mg capsules (14 count)

65162-803-14

140 mg capsules (5 count)

65162-804-51

140 mg capsules (14 count)

65162-804-14

180 mg capsules (5 count)

65162-805-51

180 mg capsules (14 count)

65162-805-14

250 mg capsules (5 count)

65162-806-51

References:

“OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.

Distributed by:

Amneal Pharmaceuticals

Bridgewater, NJ 08807

Rev. 01-2022-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 65162-801-51
Temozolomide Capsules USP, 5 mg
Rx only
5 Capsules
Amneal Pharmaceuticals LLC
1
(click image for full-size original)
2
(click image for full-size original)
12

NDC 65162-802-51
Temozolomide Capsules USP, 20 mg
Rx only
5 Capsules
Amneal Pharmaceuticals LLC
3
(click image for full-size original)
4
(click image for full-size original)
34

NDC 65162-803-51
Temozolomide Capsules USP, 100 mg
Rx only
5 Capsules
Amneal Pharmaceuticals LLC
5
(click image for full-size original)
6
(click image for full-size original)
56

NDC 65162-804-51

Temozolomide Capsules USP, 140 mg

Rx only

5 Capsules

Amneal Pharmaceuticals LLC

7
(click image for full-size original)
8
(click image for full-size original)
78

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