Consumer medicine information

1. Why am I using MYCOTEX?

MYCOTEX contains the active ingredient mycophenolate sodium. MYCOTEX is used in adult patients: 1) to prevent the body from rejecting a transplanted kidney; 2) It is also used to treat inflammatory kidney disease associated with chronic autoimmune disorder known as systemic lupus erythematosis (also called lupus or SLE). MYCOTEX is used in combination with other medicines. For more information, see Section 1. Why am I using MYCOTEX? in the full CMI.

2. What should I know before I use MYCOTEX?

Do not use if you have ever had an allergic reaction to mycophenolate sodium 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 MYCOTEX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with MYCOTEX 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 MYCOTEX?

• The usual dose is 1,440 mg, taken as 720 mg twice a day.

• Doctor may prescribe a different dose, particularly for the initial treatment of inflammatory kidney disease.

5. What should I know while using MYCOTEX?

6. Are there any side effects?

Less serious side effects: diarrhoea, constipation, indigestion, flatulence, loose stools, nausea (feeling sick), or vomiting, pain in the stomach, pain or swelling in the joints, weakness.
Serious side effects: symptoms of infection including fever, chills, sweating, feelings of tiredness, drowsiness, or lack of energy. 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

Mycophenolate sodium.

2 Qualitative and Quantitative Composition

Each enteric coated 360 mg tablet contains Mycophenolic acid 360 mg (as sodium).
Excipients with known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Mycotex 360 mg. Pale orange-red colored, oval shaped, biconvex, film-coated tablets imprinted "MA 360" with black ink on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. There has been no reported experience of overdosage of Mycotex in humans.
Treatment. Although dialysis may be used to remove the inactive metabolite MPAG, it would not be expected to remove clinically significant amounts of the active moiety, MPA. This is in large part due to the very high plasma protein binding of MPA. By interfering with enterohepatic circulation of MPA, bile acid sequestrants such as cholestyramine may reduce the systemic exposure of MPA.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Mycophenolate sodium and mycophenolate mofetil were genotoxic in the mouse lymphoma/thymidine kinase assay, the micronucleus test in V79 Chinese hamster cells in vitro and in the in vivo mouse micronucleus assay. They were not genotoxic in the bacterial mutation assay. Mycophenolate sodium showed weak evidence of genotoxicity in the chromosome aberration assay in human lymphocytes. There were no relevant qualitative or quantitative differences in the genotoxic potential of mycophenolate sodium and mycophenolate mofetil. The genotoxic activity of MPA may be due to a shift in the relative abundance of the nucleotides in the cellular pool used for DNA synthesis.
Carcinogenicity. In a 104-week oral carcinogenicity study in rats, mycophenolate sodium at daily doses up to 9 mg/kg was not tumorigenic. The highest dose tested resulted in approximately 0.6-1.2 times the systemic exposure observed in renal transplant patients at the recommended dose of 1.44 g/day. Similar results were observed in a parallel study in rats performed with mycophenolate mofetil. In a 26 week oral carcinogenicity assay in a P53^± (heterozygous) transgenic mouse model, mycophenolate sodium at daily doses up to 200 mg/kg was not tumorigenic. The highest dose tested resulted in approximately 5 times the systemic exposure (plasma AUC) observed in renal transplant patients taking 1.44 g/day. The results of this study, however, remain equivocal because of the lack of a response to the positive control compound, benzene.
In a 2-year carcinogenicity study in rats, administration of oral doses of 6 and 9 mg/kg/day mycophenolate sodium resulted in an increase in the incidence of benign thymomas in the thymus in females. Systemic exposure (plasma AUC) at these respective doses was about 0.5 and 1 times that observed in renal transplant patients taking 1.44 g/day.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Mycophenolate sodium is the sodium salt of the active moiety, mycophenolic acid, and is a white to off-white, fine crystalline powder.
Mycophenolate sodium is freely soluble in aqueous media at physiological pH, as in the upper intestine, but practically insoluble in 0.1 M HCl.
Chemical name: (E)-6-(4- Hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4methyl-hex-4-enoic acid sodium salt.
Empirical formula: C₁₇H₁₉O₆Na.
Molecular weight: 342.32.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSMYCSOD.gif CAS number. 37415-62-6.

7 Medicine Schedule (Poisons Standard)

Schedule 4.

Summary Table of Changes

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