Consumer medicine information

1. Why am I using TEMODAL?

TEMODAL contains the active ingredient temozolomide. TEMODAL belongs to a group of medicines called cytotoxic or chemotherapy medicines. TEMODAL works by killing cancer cells and stopping cancer cells from growing and multiplying.
For more information, see Section 1. Why am I using TEMODAL? in the full CMI.

2. What should I know before I use TEMODAL?

Do not use if you have ever had an allergic reaction to TEMODAL or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use TEMODAL? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TEMODAL and affect how it works. Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use TEMODAL?

• Your doctor has worked out the exact dose of TEMODAL for you according to your individual needs.

• Each time you start a new treatment cycle, be sure you understand exactly how many capsules of each strength you need to take on each day of dosing.

5. What should I know while using TEMODAL?

6. Are there any side effects?

Like all medicines, TEMODAL can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of using TEMODAL. When you get TEMODAL, you can have some serious side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Temozolomide.

2 Qualitative and Quantitative Composition

Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4 mg/mL) and ethanol (0.6 mg/mL).
Each Temodal capsule contains temozolomide (5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg).
List of excipients with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Temodal (temozolomide) 5 mg. Size No. 3 capsule with opaque, green cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, "5 mg", and the Schering-Plough logo.
Temodal (temozolomide) 20 mg. Size No. 2 capsule with yellow cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, "20 mg", and the Schering-Plough logo.
Temodal (temozolomide) 100 mg. Size No. 1 capsule with pink, opaque cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, "100 mg", and the Schering-Plough logo.
Temodal (temozolomide) 140 mg. Size No. 0 capsule with blue, opaque cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, "140 mg", and the Schering-Plough logo.
Temodal (temozolomide) 180 mg. Size No. 0 capsule with orange, opaque cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, "180 mg", and the Schering-Plough logo.
Temodal (temozolomide) 250 mg. Size No. 0 capsule with white, opaque cap and body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, "250 mg", and the Schering-Plough logo.

4 Clinical Particulars

4.9 Overdose

Doses of 500, 750, 1,000 and 1,250 mg/m² (total dose per cycle over 5 days) have been evaluated clinically in patients. Dose limiting toxicity was haematological and was reported at any dose but is expected to be more severe at higher doses. An overdose of 2,000 mg per day for 5 days was taken by one patient and the adverse events reported were pancytopenia, pyrexia, multiorgan failure and death.
There are reports of patients who have taken more than 5 days of treatment (up to 64 days) with adverse events reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death. In the event of an overdose, haematologic evaluation is needed. Supportive measures should be provided as necessary.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Temozolomide was genotoxic in assays for gene mutations (Salmonella typhimurium and Escherichia coli) and chromosomal changes (human blood lymphocytes).
Pathological lesions of necrosis, degeneration, hypospermatogenesis and presence of syncytial cells and immature/abnormal spermatozoa in the testes, epididymis and seminal vesicles have been observed in the mouse, rat and dog at systemic exposure levels to temozolomide well within the anticipated human exposure. Decreased ovarian weight was noted in rats at temozolomide exposure comparable to that anticipated clinically. The reversibility of these changes has not been investigated, but no evidence of recovery was noted during the 23 day nontreatment period.
Carcinogenicity. No long-term carcinogenicity studies have been conducted, but evidence of carcinogenic potential of Temodal was observed in the three and six cycle studies in rats. Neoplasms observed in the rat studies included mammary carcinoma, keratoacanthoma of the skin, basal cell adenoma and a variety of mesenchymal neoplasms. These neoplasms occurred at systemic exposure to temozolomide less than that anticipated clinically. No tumours or preneoplastic changes were observed in the dog studies of up to six cycles. Considering that Temodal is a prodrug of the alkylating agent MTIC, its tumourigenic potential is not unexpected and has been observed with other alkylating agents, including those producing MTIC.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical Name: imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide,3,4-dihydro-3-methyl-4-oxo.
Molecular Formula: C₆H₆N₆O₂.
Molecular Weight: 194.15.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTEMOZO.gif CAS number. 85622-93-1.

7 Medicine Schedule (Poisons Standard)

All states and ACT - Prescription only medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/TEMODAST.gif