Consumer medicine information

1. Why am I using MYCOPHENOLIC ACID ARX?

MYCOPHENOLIC ACID ARX contains the active ingredient mycophenolic acid (as sodium). MYCOPHENOLIC ACID ARX is used for people who have had a kidney transplant, to prevent the body from rejecting the new kidney.
For more information, see Section 1. Why am I using MYCOPHENOLIC ACID ARX? in the full CMI.

2. What should I know before I use MYCOPHENOLIC ACID ARX?

Do not use if you have ever had an allergic reaction to MYCOPHENOLIC ACID ARX 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 MYCOPHENOLIC ACID ARX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with MYCOPHENOLIC ACID ARX 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 MYCOPHENOLIC ACID ARX?

• Keep your tablets in the foil blister pack until it is time to take them. If you take the tablets out of the blister pack, they will not keep well.

• Store the pack in a cool dry place where the temperature stays below 25°C.

5. What should I know while using MYCOPHENOLIC ACID ARX?

6. Are there any side effects?

The common side effects include diarrhea, indigestion, bloating, muscle pain, weakness, pain in joint, pain in stomach.
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

Mycophenolic acid as sodium salt.

2 Qualitative and Quantitative Composition

Mycophenolic Acid ARX enteric coated tablets are available in 180 mg and 360 mg. Mycophenolic Acid ARX enteric coated tablets contain the active mycophenolic acid (as sodium salt), equivalent to 192.4 mg and 384.7 mg mycophenolate sodium, respectively.
Excipients with known effects. Sodium. Each 180 mg and 360 mg tablet contains 15 mg and 360 mg of elemental sodium respectively.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Mycophenolic Acid ARX enteric coated tablets 180 mg are lime green, round shaped, biconvex bevelled edged enteric-coated tablets imprinted with M1 on one side with black ink and plain on the other side.
Mycophenolic Acid ARX enteric coated tablets 360 mg are peach, round shaped, biconvex enteric-coated tablets imprinted with M2 on one side with black ink and plain on the other side.

4 Clinical Particulars

4.9 Overdose

Signs and symptoms. There has been no reported experience of overdosage of mycophenolic acid 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

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

7 Medicine Schedule (Poisons Standard)

Prescription only medicine - S4.

Summary Table of Changes

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