A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cellcept Indications, Dosage, Storage, Stability - Mycophenolate Mofetil
Cellcept Indications, Dosage, Storage, Stability - Mycophenolate Mofetil
INDICATIONS
Renal and Cardiac Transplant
CellCept is indicated for the prophylaxis of organ rejection in patients
receiving allogeneic renal transplants and in patients receiving allogeneic
cardiac transplants. CellCept should be used concomitantly with cyclosporine
and corticosteroids.
CellCept Intravenous is an alternative dosage form to CellCept capsules,
tablets and oral suspension. CellCept Intravenous should be administered
within 24 hours following transplantation. CellCept Intravenous can be
administered for up to 14 days; patients should be switched to oral CellCept
as soon as they can tolerate oral medication.
DOSAGE AND ADMINISTRATION
Renal Transplantation
A dose of 1.0 g administered orally or intravenously (over 2 hours) twice
a day (daily dose of 2 g) is recommended for use in renal transplant patients.
Although a dose of 1.5 g administered twice daily (daily dose of 3 g)
was used in clinical trials and was shown to be safe and effective, no
efficacy advantage could be established for renal transplant patients.
Patients receiving 2 g/day of CellCept demonstrated an overall better
safety profile than did patients receiving 3 g/day of CellCept.
Cardiac Transplantation
A dose of 1.5 g bid administered intravenously (over NO LESS THAN 2 HOURS)
or 1.5 g bid oral (daily dose of 3 g) is recommended for use in cardiac
transplant patients.
CellCept Capsules, Tablets and Oral Suspension
The initial oral dose of CellCept should be given as soon as possible
following renal or cardiac transplantation. Food had no effect on MPA
AUC, but has been shown to decrease MPA Cmax by 40%. Therefore,
it is recommended that CellCept be administered on an empty stomach. However,
in stable renal transplant patients, CellCept may be administered with
food if necessary.
Note: If required CellCept Oral Suspension can be administered
via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm
interior diameter).
Patients With Hepatic Impairment: No dose adjustments are
recommended for renal patients with severe hepatic parenchymal disease.
However, it is not known whether dose adjustments are needed for hepatic
disease with other etiologies (see CLINICAL
PHARMACOLOGY: Pharmacokinetics).
No data are available for cardiac transplant patients with severe hepatic
parenchymal disease.
Geriatric Use: The recommended dose of 1 g bid for renal transplant patients
and 1.5 g bid for cardiac transplant patients is appropriate for elderly
patients (see PRECAUTIONS: Geriatric
Use).
Preparation of Suspension
It is recommended that CellCept Oral Suspension be constituted by the
pharmacist prior to dispensing to the patient.
CellCept Oral Suspension should not be mixed with any other medication.
Mycophenolate mofetil has demonstrated teratogenic effects in rats and
rabbits. There are no adequate and well-controlled studies in pregnant
women (see WARNINGS, PRECAUTIONS,
ADVERSE REACTIONS, and Handling
and Disposal). Care should be taken to avoid inhalation or direct
contact with skin or mucous membranes of the dry powder or the constituted
suspension. If such contact occurs, wash thoroughly with soap and water;
rinse eyes with water.
- Tap the closed bottle several times to loosen the powder.
- Measure 94 mL of water in a graduated cylinder.
- Add approximately half the total amount of water for constitution
to the bottle and shake the closed bottle well for about 1 minute.
- Add the remainder of water and shake the closed bottle well for about
1 minute.
- Remove the child-resistant cap and push bottle adapter into neck
of bottle.
- Close bottle with child-resistant cap tightly. This will assure the
proper seating of the bottle adapter in the bottle and child-resistant
status of the cap.
Dispense with patient instruction sheet and oral dispensers. It is recommended
to write the date of expiration of the constituted suspension on the bottle
label. (The shelf-life of the constituted suspension is 60 days.)
After constitution the oral suspension contains 200 mg/mL mycophenolate
mofetil. Store constituted suspension at 25° C (77° F); excursions permitted
to 15° to 30° C (59° to 86° F). Storage in a refrigerator at 2° to 8°
C (36° to 46° F) is acceptable. Discard any unused portion 60 days after
constitution.
CellCept Intravenous
CellCept Intravenous is an alternative dosage form to CellCept capsules,
tablets and oral suspension recommended for patients unable to take oral
CellCept. CellCept Intravenous should be administered within 24 hours
following transplantation. CellCept Intravenous can be administered for
up to 14 days; patients should be switched to oral CellCept as soon as
they can tolerate oral medication.
CellCept Intravenous must be reconstituted and diluted to a concentration
of 6 mg/mL using 5% Dextrose Injection USP. CellCept Intravenous is incompatible
with other intravenous infusion solutions. Following reconstitution, CellCept
Intravenous must be administered by slow intravenous infusion over a period
of NO LESS THAN 2 HOURS by either peripheral or central vein.
CAUTION: CELLCEPT INTRAVENOUS SOLUTION SHOULD NEVER BE ADMINISTERED
BY RAPID OR BOLUS INTRAVENOUS INJECTION.
Preparation of Infusion Solution (6 mg/mL)
Caution should be exercised in the handling and preparation of solutions
of CellCept Intravenous. Avoid direct contact of the prepared solution
of CellCept Intravenous with skin or mucous membranes. If such contact
occurs, wash thoroughly with soap and water; rinse eyes with plain water
(see WARNINGS, PRECAUTIONS,
ADVERSE REACTIONS, and Handling
and Disposal).
CellCept Intravenous does not contain an antibacterial preservative;
therefore, reconstitution and dilution of the product must be performed
under aseptic conditions.
CellCept Intravenous infusion solution must be prepared in two steps:
the first step is a reconstitution step with 5% Dextrose Injection, USP
and the second step is a dilution step with 5% Dextrose Injection, USP.
A detailed description of the preparation is given below:
Step 1
a. Two (2) vials of CellCept Intravenous are used for preparing
each 1g dose, whereas three (3) vials are needed for each 1.5 g dose.
Reconstitute the contents of each vial by injecting 14 mL of 5% Dextrose
Injection, USP.
b. Gently shake the vial to dissolve the drug.
c. Inspect the resulting slightly yellow solution for particulate
matter and discoloration prior to further dilution. Discard the vial if
particulate matter or discoloration is observed.
Step 2
a. To prepare a 1g dose, further dilute the contents of the two
reconstituted vials (approx. 2 × 15 mL) into 140 mL of 5% Dextrose Injection
USP. To prepare a 1.5 g dose, further dilute the contents of the three
reconstituted vials (approx. 3 × 15 mL) into 210 mL of 5% Dextrose Injection
USP. The final concentration of both solutions is 6 mg mycophenolate mofetil
per mL.
b. Inspect the infusion solution for particulate matter or discoloration.
Discard the infusion solution if particulate matter or discoloration is
observed.
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 25° C (77° F); excursions permitted to 15° to 30° C (59°
to 86° F).
CellCept Intravenous should not be mixed or administered concurrently
via the same infusion catheter with other intravenous drugs or infusion
admixtures.
Dosage Adjustments
In renal transplant patients with severe chronic renal impairment (GFR
<25 mL/min/1.73m² ) outside of the immediate posttransplant period,
doses of CellCept greater than 1 g administered twice a day should be
avoided. These patients should also be carefully observed.
No dose adjustments are needed in renal transplant patients experiencing
delayed graft function postoperatively (see CLINICAL
PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS:
General).
No data are available for cardiac transplant patients with severe chronic
renal impairment. CellCept may be used for cardiac transplant patients
with severe chronic renal impairment if the potential benefits outweigh
the potential risks.
If neutropenia develops (ANC <1.3 × 10³/µL), dosing with CellCept
should be interrupted or the dose reduced, appropriate diagnostic tests
performed, and the patient managed appropriately (see WARNINGS,
ADVERSE REACTIONS, and PRECAUTIONS:
Laboratory Tests).
Handling and Disposal
Mycophenolate mofetil has demonstrated teratogenic effects in rats and
rabbits. CellCept tablets should not be crushed and CellCept capsules
should not be opened or crushed. Avoid inhalation or direct contact with
skin or mucous membranes of the powder contained in CellCept capsules
and CellCept Oral Suspension (before or after constitution). If such contact
occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Should a spill occur wipe up using paper towels wetted with water to remove
spilled powder or suspension. Caution should be exercised in the handling
and preparation of solutions of CellCept Intravenous. Avoid direct contact
of the prepared solution of CellCept Intravenous with skin or mucous membranes.
If such contact occurs, wash thoroughly with soap and water; rinse eyes
with plain water.
HOW SUPPLIED
CellCept (mycophenolate mofetil capsules)
250 mg
Blue-brown, two-piece hard gelatin capsules, printed in black with "CellCept
250" on the blue cap and "Roche" on the brown body. Supplied in the following
presentations:
| NDC Number |
Size |
| NDC 0004-0259-01 |
Bottle of 100 |
| NDC 0004-0259-43 |
Bottle of 500 |
Storage: Store at 25° C (77° F); excursions permitted to
15° to 30° C (59° to 86° F).
CellCept (mycophenolate mofetil tablets)
500 mg
Lavender-colored, caplet-shaped, film-coated tablets printed in black
with "CellCept 500" on one side and "Roche" on the other. Supplied in
the following presentations:
| NDC Number |
Size |
| NDC 0004-0260-01 |
Bottle of 100 |
| NDC 0004-0260-43 |
Bottle of 500 |
Storage and Dispensing Information: Store at 25° C (77°
F); excursions permitted to 15° to 30° C (59° to 86° F). Dispense in light-resistant
containers, such as the manufacturer's original containers.
CellCept Oral Suspension (mycophenolate mofetil for oral suspension)
Supplied as a white to off-white powder blend for constitution to a white
to off-white mixed-fruit flavor suspension. Supplied in the following
presentation:
| NDC Number |
Size |
| NDC 0004-0261-29 |
225 mL bottle with bottle adapter and 2 oral dispensers |
Storage: Store dry powder at 25° C (77° F); excursions
permitted to 15° to 30° C (59° to 86° F). Store constituted suspension
at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F)
for up to 60 days. Storage in a refrigerator at 2° to 8° C (36° to 46°
F) is acceptable. Do not freeze.
CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)
Supplied in a 20 mL, sterile vial containing the equivalent of 500 mg
mycophenolate mofetil as the hydrochloride salt in cartons of 4 vials:
| NDC Number |
|
| NDC 0004-0298-09 |
|
Storage: Store powder and reconstituted/infusion solutions
at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F).
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