Mycophenolate Mofetil

MYCOPHENOLATE MOFETIL- mycophenolate mofetil injection, powder, lyophilized, for solution
Mylan Institutional LLC

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES AND SERIOUS INFECTIONS

Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1), Use in Special Populations (8.1, 8.3)].
Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2)].
Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3)].

1 INDICATIONS AND USAGE

Mycophenolate mofetil for injection is indicated for the prophylaxis of organ rejection, in recipients of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Mycophenolate mofetil for injection should not be used without the supervision of a physician with experience in immunosuppressive therapy.

Mycophenolate Mofetil for Injection

Mycophenolate mofetil for injection is recommended for patients unable to take oral mycophenolate mofetil. Mycophenolate mofetil for injection should be administered within 24 hours following transplant. Mycophenolate mofetil for injection can be administered for up to 14 days; however, patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication.

Mycophenolate mofetil for injection must be reconstituted before use [see Dosage and Administration (2.6)]. Mycophenolate mofetil for injection is incompatible with other intravenous infusion solutions and should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.

Mycophenolate mofetil for injection must not be administered as a bolus. Following reconstitution, mycophenolate mofetil for injection must be administered by slow intravenous infusion over a period of no less than 2 hours by either peripheral or central vein, as rapid infusion increases the risk of local adverse reactions such as phlebitis and thrombosis [see Adverse Reactions (6.1)].

2.2 Dosing for Kidney Transplant Patients: Adults and Pediatrics

Adults

The recommended dosage for adult kidney transplant patients is 1 g orally or intravenously infused over no less than 2 hours, twice daily (daily dose of 2 g).

Pediatrics (3 months and older)

Pediatric dosing is based on body surface area (BSA). The recommended dosage of mycophenolate oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m2 , administered twice daily (maximum daily dose of 2 g or 10 mL of the oral suspension). Pediatric patients with BSA ≥ 1.25 m2 may be dosed with capsules or tablets as follows:

Table 1 Pediatric Dosing Using Capsules or Tablets for Pediatric Kidney Transplant

Body Surface Area

Dosing

1.25 m2 to <1.5 m2

Mycophenolate capsule 750 mg twice daily (1.5 g daily dose)

≥ 1.5 m2

Mycophenolate capsules or tablets 1 g twice daily (2 g daily dose)

2.3 Dosing for Heart Transplant Patients: Adults

The recommended dosage of mycophenolate mofetil for injection for adult heart transplant patients is 1.5 g orally or intravenously infused over no less than 2 hours administered twice daily (daily dose of 3 g).

2.4 Dosing for Liver Transplant Patients: Adults

The recommended dosage of mycophenolate mofetil for injection for adult liver transplant patients is 1.5 g administered orally twice daily (daily dose of 3 g) or 1 g infused intravenously over no less than 2 hours, twice daily (daily dose of 2 g).

2.5 Dosing Adjustments: Patients with Renal Impairment, Neutropenia

Renal Impairment

No dose adjustments are needed in kidney transplant patients with delayed graft function postoperatively [see Clinical Pharmacology (12.3)]. In kidney transplant patients with severe chronic impairment of the graft (GFR <25 mL/min/1.73 m2), do not administer doses of mycophenolate mofetil for injection greater than 1 g twice a day. These patients should be carefully monitored [see Clinical Pharmacology (12.3)].

Neutropenia

If neutropenia develops (ANC <1.3 x 103 /mcL), dosing with mycophenolate mofetil for injection should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].

2.6 Preparation Instructions of Intravenous for Pharmacists

General Preparation Instructions Before Handling the Formulation

Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans. Follow applicable special handling and disposal procedures.1 [see Warnings and Precautions (5.1), Adverse Reactions (6.2), Use in Specific Populations (8.1, 8.3), How Supplied/Storage and Handling (16.1)]

Care should be taken to avoid inhalation or direct contact with skin or mucous membranes of the dry powder because MMF has demonstrated teratogenic effects in humans. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap. If such contact occurs, wash hands thoroughly with soap and water; rinse eyes with water.

Alert patients that they and others should also avoid inhalation or contact of the skin or mucous membranes with the oral suspension. Advise them to wash the area thoroughly with soap and water if such contact occurs; if ocular contact occurs, rinse eyes with plain water.

Mycophenolate Mofetil For Injection

Before proceeding with the preparation steps for mycophenolate mofetil for injection read the general preparation instructions [see General Preparation Instructions Before Handling the Formulations] and note the following:

Mycophenolate mofetil for injection does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
This product is sealed under vacuum and should retain a vacuum throughout its shelf life. If a lack of vacuum in the vial is noted while adding the diluent, the vial should not be used.

Mycophenolate mofetil for injection must be reconstituted and further diluted. A detailed description of the preparation is given below.

Table 2 Preparation Instructions of Mycophenolate Mofetil for Injection for Pharmacists

Preparation of the 1 g dose

1.
Reconstitute two (2) vials of Mycophenolate Mofetil for Injection by injecting 14 mL of 5% Dextrose Injection USP into each vial.
2.
Gently shake the vial to dissolve the drug.
3.
Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution. Discard the vials if particulate matter or discoloration is observed.
4.
Dilute the contents of the two reconstituted vials (approximately 2 x 15 mL) into 140 mL of 5% Dextrose Injection USP.
5.
Inspect the resulting infusion solution and discard if particulate matter or discoloration is observed.

Preparation of the 1.5 g dose

1.
Reconstitute three (3) vials of Mycophenolate Mofetil for Injection by injecting 14 mL of 5% Dextrose Injection USP into each vial.
2.
Gently shake the vial to dissolve the drug.
3.
Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution. Discard the vials if particulate matter or discoloration is observed.
4.
Dilute the contents of the three reconstituted vials (approximately 3 x 15 mL) into 210 mL of 5% Dextrose Injection USP.
5.
Inspect the resulting infusion solution and discard if particulate matter or discoloration is observed.

The administration of the infusion should be initiated within 4 hours of reconstitution and dilution of the drug product. Keep solutions at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Discard unused portion of the reconstituted solutions.

Mycophenolate mofetil for injection should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.

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