Prograf (Tacrolimus) | EyeKnow O.D.

Warnings & Precautions

Increased risk of serious infection and of lymphoma and other malignancies resulting from immunosuppression. This carries a boxed warning.
Nephrotoxicity is dose-related and common; monitor renal function and trough levels.
Neurotoxicity, including tremor, headache, seizure and posterior reversible encephalopathy syndrome with visual disturbance and cortical blindness, has been reported.
Hyperkalaemia, hypertension and new-onset diabetes after transplant are common.
QT prolongation has been reported; avoid in congenital long QT syndrome.
Therapeutic drug monitoring is required.

Common Side Effects

The most common adverse reactions (≥ 15%) were abnormal renal function, hypertension, diabetes mellitus, fever, CMV infection, tremor, hyperglycemia, leukopenia, infection, anemia, bronchitis, pericardial effusion, urinary tract infection, constipation, diarrhea, headache, abdominal pain, insomnia, paresthesia, peripheral edema, nausea, hyperkalemia, hypomagnesemia, and hyperlipemia.

Pregnancy & Lactation

Pregnancy: Tacrolimus crosses the placenta and is associated with preterm delivery, neonatal hyperkalaemia and renal dysfunction.

Lactation: Tacrolimus is present in human milk; consider the mother's clinical need alongside any potential effect on the infant.

Pediatric Use

Safety and effectiveness have been established in pediatric liver transplant patients. Liver Transplantation Safety and efficacy in pediatric de novo liver transplant patients less than 16 years of age are based on evidence from active controlled studies that included 56 pediatric patients, 31 of which received tacrolimus.