Mycophenolate Mofetil 500mg

Mycophenolate, Cellcept (CDN/US)/Myfortic (US) 

Description: Immunosuppressant Agent 

“Boxed warning

Experienced physician
Only health care providers experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolate. Manage patients receiving the drug in facilities equipped and staffed with adequate laboratory and supportive medical resources. The health care provider responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

Serious infections
Immunosuppression may lead to 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.

Malignancies
Immunosuppression may lead to increased risk of development of lymphoma and other malignancies, particularly of the skin.

Embryo-fetal toxicity
Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Women of reproductive potential must be counseled regarding pregnancy prevention and planning.”

CSA NA – FDA Approved – REMS (Y) – Cannot Ship To US

Mycophenolate is a prodrug that is hydrolyzed in the liver to its active form of mycophenolic acid (MPA) after oral ingestion. It inhibits inosine monophosphate dehydrogenase (IMPDH) thereby preventing guanosine nucleotide synthesis. T and B lymphocytes are dependent on this pathway for proliferation and inhibiting it results in halted production of these cells.

Officially indicated for use in prevention of rejection in some renal, cardiac, or hepatic transplants in combination with other agents.  It is sometimes prescribed off-label for use in prevention of various graft-versus-host diseases, autoimmune hepatitis, lupus nephritis, myasthenia gravis, psoriasis, and scleroderma

Before starting Mycophenolate, Cellcept/Myfortic make sure your physician is aware of any allergies or medications you currently take.  Many dosage forms are not interchangeable.  It can increase your risk of new or reactivated viral infections, neutropenia, pure red cell aplasia, and some GI disorders.  You cannot donate blood while on this medication until 6 weeks after the last dos.  Avoid live vaccines while on this medication.

500-1500mg twice a day

Take with or without food. Delayed-release tablets should be swallowed whole and should not be crushed, cut, or chewed. If a dose is missed, take it soon as it is remembered. If it is close to the next scheduled dose, skip the missed dose and resume at next regularly scheduled time; do not double a dose to make up for a missed dose.

>10%

Cardiovascular

Hypertension (18% to 79%), edema (17% to 68%), hypotension (34%), tachycardia (22% to 23%), lower extremity edema (16%)

Central nervous system

Pain (25% to 79%), headache (11% to 59%), insomnia (24% to 52%), dizziness (34%), depression (20%), chills (3% to <20%), confusion (3% to <20%), drowsiness (3% to <20%), hypertonia (3% to <20%), malaise (3% to <20%), myasthenia (3% to <20%), paresthesia (3% to <20%)

Dermatologic

Skin rash (26%), ecchymoses (20%), cellulitis (3% to <20%)

Endocrine & metabolic

Hyperglycemia (44% to 48%), hypercholesterolemia (46%), hypomagnesemia (20% to 39%), hypokalemia (9% to 37%), hypocalcemia (11% to 30%), increased lactate dehydrogenase (24%), hyperkalemia (22%), acidosis (3% to <20%), weight loss (3% to <20%), hyperuricemia (13%), hyperlipidemia (10% to 12%), hypophosphatemia (9% to 11%)

Gastrointestinal

Abdominal pain (22% to 63%), nausea (27% to 56%), diarrhea (24% to 53%), constipation (38% to 44%), vomiting (20% to 39%), decreased appetite (25%), dyspepsia (19% to 23%), esophagitis (3% to <20%), gastric ulcer (3% to <20%), gastritis (3% to <20%), gastrointestinal hemorrhage (3% to <20%), hernia of abdominal cavity (3% to <20%), intestinal obstruction (3% to <20%), stomatitis (3% to <20%), upper abdominal pain (14%), flatulence (10% to 13%)

Genitourinary

Urinary tract infection (29% to 33%), hematuria (3% to <20%)

Hematologic & oncologic

Leukopenia (19% to 46%), anemia (20% to 45%), leukocytosis (22% to 43%), thrombocytopenia (24% to 38%), benign skin neoplasm (3% to <20%), disorder of hemostatic components of blood (3% to <20%), neoplasm (3% to <20%), pancytopenia (3% to <20%), skin carcinoma (3% to <20%; nonmelanoma; 1% to 12%)

Hepatic

Increased liver enzymes (25%), hepatitis (3% to <20%), increased serum alkaline phosphatase (3% to <20%)

Infection

Bacterial infection (27% to 40%), viral infection (31%), cytomegalovirus disease (4% to 22%), fungal infection (11% to 12%)

Neuromuscular & skeletal

Asthenia (35% to 49%), tremor (12% to 34%), back pain (6% to 12%), arthralgia (7% to 11%)

Renal

Increased serum creatinine (10% to 42%), increased blood urea nitrogen (37%)

Respiratory

Dyspnea (31% to 44%), cough (41%), pleural effusion (34%)

Miscellaneous

Fever (13% to 56%)

Note this is not a complete list of side effects for Mycophenolate, Cellcept/Myfortic only common ones.

1. Why would my physician prescribe a medication with such serious side effects?
   Your physician takes the most recent clinical guidelines to make evidence-based decisions on what medication is appropriate in which situations.  Your current medications, your allergies, age, cost of medication, comorbid conditions and many other factors will further complicate or limit which medications are appropriate.  In most cases this medication is used to prevent organ rejection post transplant, so it is extremely important to take it regularly else risking the health of the transplanted organ.  Furthermore, they will be monitoring your bloodwork and symptoms closely to help prevent many of the serious side effects and may be able to adjust therapy if required.