Consumer medicine information

1. Why am I using TE-DASATINIB?

TE-DASATINIB contains the active ingredient dasatinib. TE-DASATINIB is used to treat adults and children ages 12 months and older with chronic myeloid leukaemia (CML).
For more information, see Section 1. Why am I using TE-DASATINIB? in the full CMI.

2. What should I know before I use TE-DASATINIB?

Do not use if you have ever had an allergic reaction to TE-DASATINIB 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 TE-DASATINIB? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with TE-DASATINIB and affect how it works.
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 TE-DASATINIB?

• Follow all directions given to you by your doctor or pharmacist carefully.

• The usual starting dose is 100 mg once daily (either as one 100 mg tablet or two 50 mg tablets). The entire dose of 100 mg is to be taken at one time either in the morning or the evening.

• The starting dose for children is determined by body weight. The entire dose prescribed by your doctor should be taken at one time either in the morning or the evening.

5. What should I know while using TE-DASATINIB?

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you or your child do not feel well while you are taking TE-DASATINIB, even if you do not think it is connected with the medicine. This medicine helps most people with chronic myeloid leukaemia (CML), however, like all medicines, TE-DASATINIB can have side effects, although not everybody gets them. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of these 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

Dasatinib.

2 Qualitative and Quantitative Composition

TE-Dasatinib film-coated tablets contain 20, 50, 70 or 100 mg of dasatinib.
Dasatinib is a white to off-white powder.
List of excipients with known effect. TE-Dasatinib film-coated tablets contain sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

TE-Dasatinib film-coated tablets.
The 20 mg tablets are white to off white, round film-coated tablets with bevelled edges and debossed "20" on one side of the tablet.
The 50 mg tablets are white to off white, oval film-coated tablets with bevelled edges and debossed "50" on one side of the tablet.
The 70 mg tablets are white to off white, round film-coated tablets with bevelled edges and debossed "70" on one side of the tablet.
The 100 mg tablets are white to off white, oval film-coated tablets with bevelled edges and debossed "100" on one side of the tablet.

4 Clinical Particulars

4.9 Overdose

Experience with overdose of dasatinib in clinical studies is limited to isolated cases. The highest overdosage of 280 mg per day for one week was reported in two patients and both developed a significant decrease in platelet counts. Since dasatinib is associated with severe myelosuppression, patients who ingest more than the recommended dosage should be closely monitored for myelosuppression and given appropriate supportive treatment.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Dasatinib was not mutagenic when tested in in vitro bacterial cell assays (Ames test) and was not clastogenic in an in vivo rat micronucleus study. Clastogenicity was observed with dasatinib in vitro in assays with Chinese hamster ovary cells in the absence and presence of metabolic activation.
Carcinogenicity. In a two-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day. The highest dose resulted in a plasma drug exposure (AUC) level generally equivalent to or slightly lower than calculated human exposure at the recommended range of starting doses 100 mg or 140 mg daily. A statistically significant increase in the combined incidence of squamous cell carcinomas and papillomas in the uterus and cervix of high-dose female rats and of prostate adenoma in low-dose male rats was noted.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Dasatinib drug substance has the following chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDASATI.gif The chemical name for dasatinib is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1- piperazinyl]-2-methyl-4-pyrimidinyl] amino]-5-thiazolecarboxamide, monohydrate.
The molecular formula is C₂₂H₂₆ClN₇O₂S.H₂O, which corresponds to a formula weight of 506.02 (monohydrate). The anhydrous free base has a molecular weight of 488.01.
The drug substance is insoluble in water (0.008 mg/mL) at 24 ± 4°C. The pH of a saturated solution of dasatinib in water is about 6.0. Two basic ionization constants (pKa) were determined to be 6.8 and 3.1, and one weakly acidic pKa was determined to be 10.8. The solubilities of dasatinib in various solvents at 24 ± 4°C are as follows: slightly soluble in ethanol (USP), methanol, polyethylene glycol 400, and propylene glycol; very slightly soluble in acetone and acetonitrile; and practically insoluble in corn oil.
CAS number. The CAS number for dasatinib monohydrate is 863127-77-9.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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