1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing and Dose Modification Guidelines

The recommended dose for Temozolomide as an intravenous infusion over 90 minutes is the same as the dose for the oral capsule formulation. Bioequivalence has been established only when Temozolomide for Injection was given over 90 minutes [see Clinical Pharmacology (12.3)].

Dosage of Temozolomide must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and the neutrophil and platelet counts at the time of initiating the next cycle. For Temozolomide dosage calculations based on body surface area (BSA) see Table 5. For suggested capsule combinations on a daily dose see Table 6.

Patients with Newly Diagnosed High Grade Glioma:

Concomitant Phase:
Temozolomide is administered 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. Focal RT includes the tumor bed or resection site with a 2- to 3-cm margin. No dose reductions are recommended during the concomitant phase; however, dose interruptions or discontinuation may occur based on toxicity. The Temozolomide dose should be continued 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 x 109/L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, and vomiting). During treatment a complete blood count should be obtained weekly. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in Table 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 recovery from lymphocytopenia (CTC Grade less than or equal to 1).

TABLE 1: Temozolomide Dosing Interruption or Discontinuation During Concomitant Radiotherapy and Temozolomide

Toxicity	TMZ Interruption *	TMZ Discontinuation
* Treatment with concomitant TMZ could be continued when all of the following conditions were met: absolute neutrophil count greater than or equal to 1.5 x 109/L; platelet count greater than or equal to 100 x 109/L; CTC nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, vomiting). TMZ=temozolomide; CTC=Common Toxicity Criteria
Absolute Neutrophil Count	greater than or equal to 0.5 and less than 1.5 x 109/L	less than 0.5 x 109/L
Platelet Count	greater than or equal to 10 and less than 100 x 109/L	less than 10 x 109/L
CTC Nonhematological Toxicity (except for alopecia, nausea, vomiting)	CTC Grade 2	CTC Grade 3 or 4

Maintenance Phase:

Cycle 1:

Four weeks after completing the Temozolomide +RT phase, Temozolomide is administered 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.

Cycles 2-6:

At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the CTC nonhematologic toxicity for Cycle 1 is 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. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.

Dose Reduction or Discontinuation During Maintenance:

Dose reductions during the maintenance phase should be applied according to Tables 2 and 3.

During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose of Temozolomide) or within 48 hours of that day, 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). The next cycle of Temozolomide should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 2and 3.

TABLE 2: Temozolomide Dose Levels for Maintenance Treatment

Dose Level	Dose (mg/m2/day)	Remarks
-1	100	Reduction for prior toxicity
0	150	Dose during Cycle 1
1	200	Dose during Cycles 2-6 in absence of toxicity

TABLE 3: Temozolomide Dose Reduction or Discontinuation During Maintenance Treatment

Toxicity	Reduce TMZ by 1 Dose Level*	Discontinue TMZ
* TMZ dose levels are listed in Table 2. † TMZ is to be discontinued if dose reduction to less than 100 mg/m2 is required or if the same Grade 3 nonhematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction. TMZ=temozolomide; CTC=Common Toxicity Criteria..
Absolute Neutrophil Count	less than 1.0 x 109/L	See footnote†
Platelet Count	less than 50 x 109/L	See footnote†
CTC Nonhematological Toxicity (except for alopecia, nausea, vomiting)	CTC Grade 3	CTC Grade 4†

Patients with Refractory Anaplastic Astrocytoma:

For adults the initial dose is 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle. For adult patients, if both the nadir and day of dosing (Day 29, Day 1 of next cycle) 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 to100 x 109/L (100,000/µL), the Temozolomide dose may be increased to 200 mg/m2/day for 5 consecutive days per 28-day treatment cycle. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, 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). The next cycle of Temozolomide should not be started until the ANC and platelet count exceed these levels. If the ANC falls to less than 1.0 x109/L (1000/µL) or the platelet count is less than 50 x 109/L (50,000/µL) during any cycle, the next cycle should be reduced by 50 mg/m2, but not below 100 mg/m2, the lowest recommended dose (see Table 4). Temozolomide therapy can be continued until disease progression. In the clinical trial, treatment could be continued for a maximum of 2 years, but the optimum duration of therapy is not known.

TABLE 4: Dosing Modification Table

TABLE 5: Daily Dose Calculations by Body Surface Area (BSA)

Total BSA (m2)	75 mg/m2 (mg daily)	150 mg/m2 (mg daily)	200 mg/m2 (mg daily)
1.0	75	150	200
1.1	82.5	165	220
1.2	90	180	240
1.3	97.5	195	260
1.4	105	210	280
1.5	112.5	225	300
1.6	120	240	320
1.7	127.5	255	340
1.8	135	270	360
1.9	142.5	285	380
2.0	150	300	400
2.1	157.5	315	420
2.2	165	330	440
2.3	172.5	345	460
2.4	180	360	480
2.5	187.5	375	500

TABLE 6: Suggested Capsule Combinations Based on Daily Dose in Adults

Number of Daily Capsules by Strength (mg)
Total Daily Dose (mg)	250 mg	180 mg	140 mg	100 mg	20 mg	5 mg
75	0	0	0	0	3	3
82.5	0	0	0	0	4	0
90	0	0	0	0	4	2
97.5	0	0	0	1	0	0
105	0	0	0	1	0	1
112.5	0	0	0	1	0	2
120	0	0	0	1	1	0
127.5	0	0	0	1	1	1
135	0	0	0	1	1	3
142.5	0	0	1	0	0	0
150	0	0	1	0	0	2
157.5	0	0	1	0	1	0
165	0	0	1	0	1	1
172.5	0	0	1	0	1	2
180	0	1	0	0	0	0
187.5	0	1	0	0	0	1
195	0	1	0	0	0	3
200	0	1	0	0	1	0
210	0	0	0	2	0	2
220	0	0	0	2	1	0
225	0	0	0	2	1	1
240	0	0	1	1	0	0
255	1	0	0	0	0	1
260	1	0	0	0	0	2
270	1	0	0	0	1	0
280	0	0	2	0	0	0
285	0	0	2	0	0	1
300	0	0	0	3	0	0
315	0	0	0	3	0	3
320	0	1	1	0	0	0
330	0	1	1	0	0	2
340	0	1	1	0	1	0
345	0	1	1	0	1	1
360	0	2	0	0	0	0
375	0	2	0	0	0	3
380	0	1	0	2	0	0
400	0	0	0	4	0	0
420	0	0	3	0	0	0
440	0	0	3	0	1	0
460	0	2	0	1	0	0
480	0	1	0	3	0	0
500	2	0	0	0	0	0

3 DOSAGE FORMS AND STRENGTHS

• TEMOZOLOMIDE Capsules for oral administration

  -

  5 mg capsules have opaque white bodies with green caps. The capsule body is imprinted with the dosage strength.

  -

  20 mg capsules have opaque white bodies with yellow caps. The capsule body is imprinted with the dosage strength.

  -

  100 mg capsules have opaque white bodies with pink caps. The capsule body is imprinted with the dosage strength.

  -

  140 mg capsules have opaque white bodies with blue caps. The capsule body is imprinted with the dosage strength.

  -

  180 mg capsules have opaque white bodies with orange caps. The capsule body is imprinted with the dosage strength.

  -

  250 mg capsules have opaque white bodies with white caps. The capsule body is imprinted with the dosage strength.

• Temozolomide is available as 100-mg/vial powder for injection. The lyophilized powder is white to light tan/light pink.

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

6 ADVERSE REACTIONS

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

10 OVERDOSAGE

Doses of 500, 750, 1000, and 1250 mg/m2 (total dose per cycle over 5 days) have been evaluated clinically in patients. Dose- limiting toxicity was hematologic and was reported with any dose but is expected to be more severe at higher doses. An overdose of 2000 mg per day for 5 days was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure, and death. There are reports of patients who have taken more than 5 days of treatment (up to 64 days), with adverse reactions reported including bone marrow suppression, which in some cases was severe and prolonged, and infections and resulted in death. In the event of an overdose, hematologic evaluation is needed. Supportive measures should be provided as necessary.

11 DESCRIPTION

Temozolomide Capsules contain temozolomide, an imidazotetrazine derivative. The chemical name of temozolomide is 3,4-dihydro-3­methyl-4-oxoimidazo[5,1-d]-as-tetrazine-8-carboxamide. The structural formula is:

The material is a white to light tan/light pink powder with a molecular formula of C6H6N6O2 and a molecular weight of 194.15. The molecule is stable at acidic pH (less than 5) and labile at pH greater than 7; hence Temozolomide can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH.

Temozolomide capsules:

Each capsule for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide.

The inactive ingredients for Temozolomide capsules are as follows:

Temozolomide capsules 5 mg: lactose anhydrous (132.8 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (7.5 mg), tartaric acid (1.5 mg), and stearic acid (3 mg).
Temozolomide capsules 20 mg: lactose anhydrous (182.2 mg), colloidal silicon dioxide (0.2 mg), sodium starch glycolate (11 mg), tartaric acid (2.2 mg), and stearic acid (4.4 mg).
Temozolomide capsules 100 mg: lactose anhydrous (175.7 mg), colloidal silicon dioxide (0.3 mg), sodium starch glycolate (15 mg), tartaric acid (3 mg), and stearic acid (6 mg).
Temozolomide capsules 140 mg: lactose anhydrous (246 mg), colloidal silicon dioxide (0.4 mg), sodium starch glycolate (21 mg), tartaric acid (4.2 mg), and stearic acid (8.4 mg).
Temozolomide capsules 180 mg: lactose anhydrous (316.3 mg), colloidal silicon dioxide (0.5 mg), sodium starch glycolate (27 mg), tartaric acid (5.2 mg), and stearic acid (10.8 mg).
Temozolomide capsules 250 mg: lactose anhydrous (154.3 mg), colloidal silicon dioxide (0.7 mg), sodium starch glycolate (22.5 mg), tartaric acid (9 mg), and stearic acid (13.5 mg).

The body of the capsules is made of gelatin, 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 shellac, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide.

Temozolomide capsules 5 mg: The green cap contains gelatin, titanium dioxide, iron oxide yellow and FD&C Blue #2.
Temozolomide capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and iron oxide yellow.
Temozolomide capsules 100 mg: The pink cap contains gelatin, titanium dioxide and iron oxide red.
Temozolomide capsules 140 mg: The blue cap contains gelatin, titanium dioxide, and FD&C Blue #2.
Temozolomide capsules 180 mg: The orange cap contains gelatin, iron oxide red and titanium dioxide.
Temozolomide capsules 250 mg: The white cap contains gelatin and titanium dioxide.

12 CLINICAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

14.1 Newly Diagnosed Glioblastoma Multiforme

Five hundred and seventy-three patients were randomized to receive either Temozolomide (TMZ)+Radiotherapy (RT) (n=287) or RT alone (n=286). Patients in the Temozolomide +RT arm received concomitant Temozolomide (75 mg/m2) once daily, starting the first day of RT until the last day of RT, for 42 days (with maximum of 49 days). This was followed by 6 cycles of Temozolomide alone (150 or 200 mg/m2) on Days 1 to 5 of every 28-day cycle, starting 4 weeks after the end of RT. Patients in the control arm received RT only. In both arms, focal radiation therapy was delivered as 60 Gy/30 fractions. Focal RT includes the tumor bed or resection site with a 2­ to 3-cm margin. Pneumocystis pneumonia (PCP) prophylaxis was required during the TMZ+RT, regardless of lymphocyte count, and was to continue until recovery of lymphocyte count to less than or equal to Grade 1.

At the time of disease progression, Temozolomide was administered as salvage therapy in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the Temozolomide +RT arm.

The addition of concomitant and maintenance Temozolomide to radiotherapy in the treatment of patients with newly diagnosed GBM showed a statistically significant improvement in overall survival compared to radiotherapy alone (Figure 1). The hazard ratio (HR) for overall survival was 0.63 (95% CI for HR=0.52-0.75) with a log-rank P less than 0.0001 in favor of the Temozolomide arm. The median survival was increased by 2.5 months in the Temozolomide arm.

FIGURE 1: Kaplan-Meier Curves for Overall Survival (ITT Population)

15 REFERENCES

1. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999.
2. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006; 63:1172-1193.
3. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004.  U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.[3]
4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology.

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information).

Temozolomide capsules

PHARMACIST:

Dispense enclosed Patient Package Insert to each patient.

PHARMACIST INFORMATION SHEET

What is Temozolomide?

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

How is Temozolomide dosed?

The daily dose of Temozolomide capsules for a given patient is calculated by the physician, based on the patient's body surface area (BSA). The resulting dose is then rounded off 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, (a patient with a BSA of 1.84 is 1.84 × 75 mg = 138, or 140 mg/day). The dose for subsequent cycles may be adjusted 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?

Dosage of Temozolomide must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and neutrophil and platelet counts at the time of initiating the next cycle. The initial dose is 150 mg/m2 orally once daily 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 × 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 × 109/L (100,000/μL), the Temozolomide dose may be increased to 200 mg/m2/day for 5 consecutive days per 28-day treatment cycle. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109/L (1500/μL) and the platelet count exceeds 100 × 109/L (100,000/μL). The next cycle of Temozolomide should not be started until the ANC and platelet count exceed these levels. If the ANC falls to less than 1.0 × 109/L (1000/μL) or the platelet count is less than 50 × 109/L (50,000/μL) during any cycle, the next cycle should be reduced by 50 mg/m2, but not below 100 mg/m2, the lowest recommended dose (see Table 1 below).

What is the Temozolomide capsules treatment regimen?

Temozolomide is given for 5 consecutive days on a 28-day cycle. Patients should continue taking Temozolomide until their physician determines that their disease has progressed, up to 2 years, or until unacceptable side effects or toxicities occur. Physicians may alter the treatment regimen for a given patient.

Newly Diagnosed Concomitant Phase Treatment Schedule

Temozolomide is administered 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. The Temozolomide dose can be continued 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 × 109/L, platelet count greater than or equal to 100 ×109/L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea and vomiting). During treatment a complete blood count should be obtained weekly. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in Table 2. Pneumocystis pneumonia (PCP) prophylaxis is required during the concomitant administration of Temozolomide and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC grade less than or equal to 1).

Maintenance Phase Treatment Schedule

Four weeks after completing the Temozolomide + RT phase, Temozolomide is administered 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, the dose is escalated to 200 mg/m2, if the CTC nonhematologic toxicity for Cycle 1 is 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 × 109/L, and the platelet count is greater than or equal to 100 × 109/L. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.

During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109/L (1500/μL) and the platelet count exceeds 100 × 109/L (100,000/μL). The next cycle of Temozolomide should not be started until the ANC and platelet count exceed these levels. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 3 and 4.

How is Temozolomide taken?

Patients should take each day's dose with a full glass of water at the same time each day. Taking the medication on an empty stomach or at bedtime may help ease nausea. If patients are also taking antinausea or other medications to relieve the side effects associated with Temozolomide, they should be advised to take these medications 30 minutes before they take Temozolomide. Temozolomide causes the rapid appearance of malignant tumors in rats. Patients SHOULD NOT open or split the capsules. If capsules are accidentally opened or damaged, rigorous precautions should be taken with the capsule contents to avoid inhalation or contact with the skin or mucous membranes. The medication should be kept away from children and pets. The Temozolomide capsules should be swallowed whole and NEVER CHEWED.

What should the patient avoid during treatment with Temozolomide?

There are no dietary restrictions for patients taking Temozolomide. Temozolomide may affect testicular function, so male patients should exercise adequate birth control measures. Temozolomide may cause birth defects. Female patients should avoid becoming pregnant while receiving this drug. Women who are nursing prior to receiving Temozolomide should discontinue nursing. It is not known whether Temozolomide is excreted into breast milk.

Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants and tumorigenicity shown for temozolomide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of Temozolomide to the mother.

What are the side effects of Temozolomide?

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 fatigue, constipation, alopecia, anorexia, and headache.

How is Temozolomide supplied?

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.

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 are Temozolomide capsules dispensed?

Each strength of Temozolomide capsules must be dispensed 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 capsules from each package or vial to equal the total daily dose prescribed by the physician.

How can Temozolomide capsules be ordered?

Temozolomide capsules can be ordered from your wholesaler. It is important to understand if Temozolomide capsules are being used as part of a 42-day regimen or as part of a 5-day course. Remember to order enough Temozolomide capsules 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.

For examples of other dosing regimens, please refer to the full Prescribing Information (Table 6).

Manufactured for:
Chemi Pharma, Austin, TX 78758
Made in Italy  


Rev. 6/15

Patient Information
Temozolomide capsules (TEM-oh-ZOE-loe-mide)

What is the most important information I should know about Temozolomide capsules?

• Temozolomide capsules may cause birth defects. Male and female patients who take Temozolomide capsules should use effective birth control. Female patients and female partners of male patients should avoid becoming pregnant while taking Temozolomide capsules.

See the section "What are the possible side effects of TEMOZOLOMIDE?" for more information about side effects.

What are Temozolomide capsules?

Temozolomide capsules are a prescription medicine used to treat adults with certain brain cancer tumors. Temozolomide capsules blocks cell growth, especially cells that grow fast, such as cancer cells. Temozolomide capsules may decrease the size of certain brain tumors in some patients.

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:

• have had an allergic reaction to dacarbazine (DTIC), another cancer medicine. 
• have had a red itchy rash, or a severe allergic reaction, such as trouble breathing, swelling of the face, throat, or tongue, or severe skin reaction to Temozolomide capsules or any of the ingredients in Temozolomide capsules. If you are not sure, ask your doctor. See the end of the leaflet for a list of ingredients in Temozolomide capsules.

What should I tell my doctor before taking Temozolomide capsules?

Tell your doctor about all your medical conditions, including if you:

• are allergic to dacarbazine (DTIC) or have had a severe allergic reaction to Temozolomide capsules. See "Who should not take Temozolomide capsules? 
• have kidney problems
• have liver problems
• are pregnant. See "What is the most important information I should know about Temozolomide capsules?"
• are breast-feeding. It is not known whether Temozolomide capsules passes into breast milk. You and your doctor should decide if you will breast-feed or take Temozolomide capsules. You should not do both without talking with your doctor

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 (Stavzor®, Depakene®).

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?

Temozolomide capsules may be taken by mouth as a capsule at home. Your doctor will decide the best way for you to take Temozolomide capsules.

There are two common dosing schedules for taking Temozolomide capsules.

•  Some people take Temozolomide capsules for 42 days in a row (possibly 49 days depending on side effects) with radiation treatment. This is one cycle of treatment. After this, you may have "maintenance" treatment. Your doctor may prescribe 6 more cycles of Temozolomide capsules. For each of these cycles, you take Temozolomide capsules one time each day for 5 days in a row and then you stop taking it for the next 23days. This is a 28-day maintenance treatment cycle.
• Another way to take Temozolomide capsules is to take it one time each day for 5 days in a row only, and then you stop taking it for the next 23 days. This is one cycle of treatment (28 days). Your doctor will watch your progress on Temozolomide and decide how long you should take it. You might take Temozolomide capsules until your tumor gets worse or for possibly up to 2 years.
• Your dose is based on your height and weight, and the number of treatment cycles will depend on how you respond to and tolerate this treatment.
• Your doctor may modify your schedule based on how you tolerate the treatment.
• If your doctor prescribes a treatment regimen that is different from the information in this leaflet, make sure you follow the specific instructions given to you by your doctor.

Temozolomide capsules: 

• Take Temozolomide capsules exactly as prescribed.
• Temozolomide capsules come in different strengths. Each strength has a different color cap. Your doctor may prescribe more than one strength of Temozolomide capsules for you, so it is important that you understand how to take your medicine the right way. Be sure that you understand exactly how many capsules you need to take on each day of your treatment, and what strengths to take. This maybe different whenever you start a new cycle.
• Talk to your doctor before you take your dose if you are not sure how much to take. This will help to prevent taking too much Temozolomide capsules and decrease your chances of getting serious side effects. 
• Take each day's dose of Temozolomide capsules at one time, with a full glass of water.
• Swallow Temozolomide capsules whole. Do not chew, open, or split the capsules.
• If Temozolomide capsules are accidentally opened or damaged, be careful not to breathe in (inhale) the powder from the capsules or get the powder on your skin or mucous membranes (for example, in your nose or mouth). If contact with any of these areas happens, flush the area with water.
• If you vomit Temozolomide capsules, do not take any more capsules. Wait and take your next planned dose.
• The medicine is used best by your body if you take it at the same time every day in relation to a meal.
• To lessen nausea, try to take Temozolomide capsules on an empty stomach or at bedtime. Your doctor may prescribe medicine to prevent or treat nausea, or other medicines to lessen side effects with Temozolomide capsules.
• See your doctor regularly to check your progress. Your doctor will check you for side effects that you might not notice.
• If you miss a dose of Temozolomide capsules, talk with your doctor for instructions about when to take your next dose of Temozolomide capsules.
• Call your doctor right away if you take more than the prescribed amount of Temozolomide capsules. It is important that you do not take more than the amount of Temozolomide capsules prescribed for you.

What should I avoid while taking Temozolomide capsules?

• Female patients and female partners of male patients should avoid becoming pregnant while taking Temozolomide capsules. See ""What is the most important information I should know about Temozolomide capsules?" 

What are the possible side effects of Temozolomide capsules?

Temozolomide capsules can cause serious side effects.

• See ""What is the most important information I should know about Temozolomide capsules?" 
• Decreased blood cells. TEMOZOLOMIDE affects cells that grow rapidly, including bone marrow cells. This can cause you to have a decrease in blood cells. Your doctor can monitor your blood for these effects.
  • White blood cells are needed to fight infections. Neutrophils are a type of white blood cell that help prevent bacterial infections. Decreased neutrophils can lead to serious infections that can lead to death. Other white blood cells called lymphocytes may also be decreased.
  • Platelets are blood cells needed for normal blood clotting. Low platelet counts can lead to bleeding. Tell your doctor about any unusual bruising or bleeding.

Your doctor will check your blood regularly while you are taking Temozolomide capsules to see if these side effects are happening. Your doctor may need to change the dose of Temozolomide capsules or when you get it depending on your blood cell counts. People who are age 70 or older and women may be more likely to have their blood cells affected.

• Pneumocystis pneumonia (PCP). PCP is an infection that people can get when their immune system is weak. Temozolomide capsules decreases white blood cells, which makes your immune system weaker and can increase your risk of getting PCP. All patients taking Temozolomide capsules will be watched carefully by their doctor for this infection, especially patients who take steroids. Tell your doctor if you have any of the following signs and symptoms of PCP infection: shortness of breath and/or fever, chills, dry cough.
• Secondary cancers. Blood problems such as myelodysplasia syndrome and secondary cancers, such as a certain kind of leukemia, can happen in people who take Temozolomide capsules. Your doctor will watch you for this.
• Convulsions. Convulsions may be severe or life-threatening in people who take Temozolomide capsules.
• Liver side effects have been reported, which very rarely included death.

Common side effects with Temozolomide capsules include:

• nausea and vomiting. Your doctor can prescribe medicines that may help reduce these symptoms. 
• headache
• feeling tired
• loss of appetite
• hair loss
• constipation
• bruising
• rash
• paralysis on one side of the body
• diarrhea
• weakness
• fever
• dizziness
• coordination problems
• viral infection
• sleep problems
• memory loss
• bruising or small red or purple spots under the skin

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?

• Store Temozolomide capsules at 77°F (controlled room temperature). Storage at 59°F to 86°F (15°Cto 30°C) is permitted occasionally. 
• Keep Temozolomide capsules out of the reach of children and pets.

General information about 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.

How are Temozolomide capsules supplied?

Temozolomide capsules contain a white capsule body with a color cap and the colors vary based on the dosage strength. The capsules are available in six different strengths.

What are the ingredients in Temozolomide capsules?

Temozolomide capsules:

Active ingredient: temozolomide.
Inactive ingredients: lactose anhydrous, colloidal silicon dioxide, sodium starch glycolate, tartaric acid, stearic acid.

The body of the capsules is made of gelatin, 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 shellac, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide.

Temozolomide capsules 5 mg: The green cap contains gelatin, titanium dioxide, iron oxide yellow and FD&C Blue #2.
Temozolomide capsules 20 mg: The yellow cap contains gelatin, titanium dioxide, and iron oxide yellow.
Temozolomide capsules 100 mg: The pink cap contains gelatin, titanium dioxide and iron oxide red.
Temozolomide capsules 140 mg: The blue cap contains gelatin, titanium dioxide, and FD&C Blue #2.
Temozolomide capsules 180 mg: The orange cap contains gelatin, iron oxide red and titanium dioxide.
Temozolomide capsules 250 mg: The white cap contains gelatin and titanium dioxide.

Manufactured for:
ChemiPharma, Austin, TX 78758
Made in Italy  

Rev. 6/15

PACKAGE LABEL

NDC 42737-101-05
5 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 5 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
5 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-101-05 
5 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 5 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 5 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-101-14

5 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 14 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains:
5 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strenghts in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-101-14

5 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 14 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 5 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-102-05

20 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 5 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
20 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-102-05

20 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 5 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 20 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-102-14

20 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 14 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
20 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-102-14 

20 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 14 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 20 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-103-05

100 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 5 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
100 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-103-05 

100 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 5 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 100 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-103-14

100 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 14 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
100 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-103-14 

100 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 14 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 100 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-104-05

140 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 5 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
140 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-104-05 

140 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 5 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 140 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-104-14

140 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 14 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
140 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-104-14 
140 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 14 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 140 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-105-05

180 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 5 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
180 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-105-05 

180 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 5 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 180 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-105-14
180 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 14 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
180 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-105-14 
180 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 14 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 180 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.

NDC 42737-106-05

250 mg per capsule

Temozolomide
Capsules

For Oral Administration
Rx only

THIS PACKAGE CONTAINS 5 CAPSULES

ATTENTION PHARMACIST: SPECIAL DISPENSING INFORMATION INCLUDED.
Please review carefully.

CHEMI PHARMA

For Oral Administration

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Each capsule contains: 
250 mg temozolomide.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Read accompanying directions carefully.

Cytotoxic: Do not open the capsules, Swallow whole.
If a capsule is damaged, avoid contact with your skin, eyes, or nose.

Manufactured for:
Chemi Pharma
Austin, TX 78758
Made in Italy

Rev. 6/15

LOT

EXP.

NDC 42737-106-05 

250 mg per capsule

Temozolomide
Capsules

THIS PACKAGE CONTAINS 5 CAPSULES

For Oral Administration
Rx only

Cytotoxic
Read accompanying directions carefully

Dispense in tight, light-resistant containers as defined in USP/NF.

Usual Dose: See package insert for recommendations regarding the use of varying capsule strengths in establishing a daily regimen.

Each capsule contains: 250 mg temozolomide.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

CHEMI PHARMA

Manufactured for: Chemi Pharma
Austin, TX 78758 - Made in Italy

Rev. 4/15

Lot

Exp.