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Temodar Indications, Dosage, Storage, Stability - Temozolomide

Temodar Indications, Dosage, Storage, Stability - Temozolomide

INDICATIONS

TEMODAR (temozolomide) Capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine.

This indication is based on the response rate in the indicated population. No results are available from randomized controlled trials in recurrent anaplastic astrocytoma that demonstrate a clinical benefit resulting from treatment, such as improvement in disease- related symptoms, delayed disease progression, or improved survival.

DOSAGE AND ADMINISTRATION

Dosage of TEMODAR 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) ³1.5 x 109 /L (1,500/µL) and both the nadir and day 29, Day 1 of the next cycle platelet counts are ³100 x 109/L (100,000/µL), the TEMODAR dose may be increased to 200 mg/m2/day for 5 consecutive days per 28 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 (1,500/µL) and the platelet count exceeds 100 x 109/L (100,000/µL). The next cycle of TEMADOR should not be started until the ANC and the platelet count, exceeds these levels. If the ANC falls to > 1.0 x 109 /L (1,000/µL) or the platelet count the TEMODAR dose may be increased to 200 mg/m2/day for 5 consecutive days per 28 day treatment cycle. If the ANC falls to <1.0 x 109/L (1,000/µL) or the platelet count is < 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 3). (See WARNINGS).

TEMODAR 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. For TEMODAR dosage calculations based on body surface area (BSA), see table 4. For suggested capsule combinations based on daily dose, see table 5.

Table 3
Dosing Modification
150 mg/m2/d x 5d
(Starting Dose)
or
200 mg/m2/d x 5d

 ¯

Measure Day 22 ANC and
platelets

¯

Measure ANC
and platelets on Day 29 (Day 1 of next cycle)

¯

Based on lowest counts at either Day 22 or Day 29

¯

¯

  

  ¯

  

 ¯
ANC <1,000/mL or
platelets <50,000/mL
 
ANC 1,000/mL - 1,500/mL
or platelets
50,000/mL - 100,000/mL
 
ANC >1,500/mL and
platelets >100,000/mL

¯

¯

  

  ¯

  

 ¯
Postpone therapy until
ANC >1,500/mL and
platelets >100,000/mL;
reduce dose by 50
mg/m2/d for subsequent
cycle
 
Postpone therapy until
ANC >1,500/mL and
platelets >100,000/mL;
maintain initial dose
 
Increase dose to, or
maintain dose at,
200/mg/m2/d x 5d for
subsequent cycle


Table 4. Daily Dose Calculations by Body Surface Area (BSA) for 5 consecutive days per 28 day treatment cycle for the initial chemotherapy cycle (150 mg/m2) and for subsequent chemotherapy cycles (200 mg/m2) for patients whose nadir and day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil count (ANC) is >1.5 x 109/L (1,500/µL) and whose nadir and day 29, Day 1 of next cycle platelet count is >100 x 109/L (100,000/µL).

Total BSA
150 mg/m2
200 mg/m2
(m)2
(mg daily)
(mg daily)
0.5
75
100
0.6
90
120
0.7
105
140
0.8
120
160
0.9
135
180
1.0
150
200
1.1
165
220
1.2
180
240
1.3
195
260
1.4
210
280
1.5
225
300
1.6
240
320
1.7
255
340
1.8
270
360
1.9
285
380
2.0
300
400
2.1
315
420
2.2
330
440
2.3
345
460
2.4
360
480
2.5
375
500


Table 5. Suggested Capsule Combinations Based on Daily Dose

 
Number of Daily Capsules by
Strength (mg)
Total Daily Dose (mg)
250
100
20
5
200
0
2
0
0
205
0
2
0
1
210
0
2
0
2
215
0
2
0
3
220
0
2
1
0
225
0
2
1
1
230
0
2
1
2
235
0
2
1
3
240
0
2
2
0
245
0
2
2
1
250
1
0
0
0
255
1
0
0
1
260
1
0
0
2
265
1
0
0
3
270
1
0
1
0
275
1
0
1
1
280
1
0
1
2
285
1
0
1
3
290
1
0
2
0
295
1
0
2
1
300
0
3
0
0
305
0
3
0
1
310
0
3
0
2
315
0
3
0
3
320
0
3
1
0
325
0
3
1
1
330
1
0
4
0
335
1
0
4
1
340
0
3
2
0
345
0
3
2
1
350
1
1
0
0
355
1
1
0
1
360
1
1
0
2
365
1
1
0
3
370
1
1
1
0
375
1
1
1
1
380
1
1
1
2
385
1
1
1
3
390
1
1
2
0
395
1
1
2
1
400
0
4
0
0
405
0
4
0
1
410
0
4
0
2
415
0
4
0
3
420
0
4
1
0
425
0
4
1
1
430
1
1
4
0
435
0
4
1
3
440
0
4
2
0
445
0
4
2
1
450
1
2
0
0
455
1
2
0
1
460
1
2
0
2
465
1
2
0
3
470
1
2
1
0
475
1
2
1
1
480
1
2
1
2
485
1
2
1
3
490
1
2
2
0
495
1
2
2
1
500
2
0
0
0


In the clinical trial, TEMODAR was administered under both fasting and non-fasting conditions; however, absorption is affected by food (see CLINICAL PHARMACOLOGY) and consistency of administration with respect to food is recommended. There are no dietary restrictions with temozolomide. To reduce nausea and vomiting, temozolomide should be taken on an empty stomach. Bedtime administration may be advised. Antiemetic therapy may be administered prior to and/or following administration of TEMODAR.

TEMODAR (temozolomide) CAPSULES should not be opened or chewed. They should be swallowed whole with a glass of water.

HOW SUPPLIED

TEMODAR (temozolomide) Capsules are supplied in amber glass bottles with child-resistant polypropylene caps containing the following capsule strengths:

TEMODAR (temozolomide) Capsules 5 mg:

TEMODAR (temozolomide) Capsules 20 mg:

TEMODAR (temozolomide) Capsules 100 mg:

TEMODAR (temozolomide) Capsules 250 mg:

Store at 25° (77° F); excursions to 15°-30° C (59°-86° F).

[See USP Controlled Room Temperature]

Handling and Disposal

Temozolomide causes the rapid appearance of malignant tumors in rats. Capsules should not be opened. 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. Procedures for proper handling and disposal of anticancer drugs should be considered 1-7. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

REFERENCES

  1. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs, NIH Publication No. 83- 2621. For sale by the Superintendent of Documents, U. S. Government Printing office, Washington, DC 20402.
  2. AMA Council Report, Guidelines for Handling Parenteral Antineoplastics. JAMA, 1985; 2.53( 11): 1590- 1592.
  3. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
  4. Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia, 1983; 1: 426- 428.
  5. Jones RB, et al: Safe Handling Of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA - A Cancer Journal for Clinicians, 1983; (Sept/ Oct) 258- 263.
  6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J. Hosp Pharm, 1990; 47: 1033-- 1049.
  7. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work- Practice Guidelines), Am J Health- Syst Pharm, 1996; 53: 1669- 1685.

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