Special Instructions for Use, Handling and Disposal: CellCept oral administration: Mycophenolate mofetil has demonstrated teratogenic effects (see Use in Pregnancy & Lactation), therefore CellCept tablets and capsules should not be crushed or opened. Patients should also avoid inhalation or contact of the skin or mucous membranes with the powder contained in CellCept capsules and oral suspension (before reconstitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
CellCept intravenous administration: Because mycophenolate mofetil has demonstrated teratogenic effects, caution should be exercised in the handling and preparation of solutions of Cellcept i.v. Avoid direct contact of prepared solutions of Cellcept i.v. with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Preparation of infusion solution (6mg/mL): CellCept i.v. does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
CellCept i.v.infusion solution must be prepared in two steps; the first step is a reconstitution step with 5% Dextrose Intravenous Infusion and the second step is a dilution step with 5% Dextrose Intravenous Infusion. A detailed description of the preparation is given as follows: Step 1: Two vials of CellCept i.v. are used for preparing each 1g dose, three vials are needed for each 1.5g dose. Reconstitute the contents of each vial by injecting 14ml of 5% Dextrose Intravenous Infusion.
Gently shake the vial to dissolve the drug yielding a slightly yellow solution.
Inspect the resulting solution for particulate matter and discolouration prior to further dilution. Discard the vial(s) if particulate matter or discolouration is observed.
Step 2: To prepare a 1 g dose, further dilute the contents of the two reconstituted vials (approx. 2 x15 mL) into 140mL of 5% Dextrose Intravenous Infusion. To prepare a 1.5 g dose, further dilute the contents of the three reconstituted vials (approx. 3 x 15 mL) into 210 ml of 5% Dextrose intravenous infusion. The final concentration of both solutions is approximately 6 mg mycophenolate mofetil per mL.
Inspect the infusion solution for particulate matter or discolouration. Discard the infusion solution if particulate matter or discolouration is observed.
Caution: Cellcept i.v. solution must not be administered by rapid or bolus intravenous injection (see Precautions).
If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 4 hours from reconstitution and dilution of the drug product. Keep solutions at 15-30°C.
Any unused product or waste materials should be disposed of in accordance with local requirements.
Incompatibilities: CellCept i.v. is incompatible with i.v. infusion solutions other than Dextrose Intravenous Infusion. CellCept i.v. should not be mixed with or administered concurrently via the same infusion catheter as other i.v. drugs or infusion admixtures.