Prograf 5 mg/mL Injection, 1 mL Ampules, 10 Ampules/Pack

Prograf — 5MG/ML, Solution for injection, box of 10 × 1 mL ampules

Prograf (Tacrolimus) is a solution for injection for intravenous use. PROGRAF is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart, or lung transplants, in combination with other immunosuppressants. ( 1.1 ) 1.1 Prophylaxis of Organ Rejection in Kidney, Liver, Heart, or Lung Transplant PROGRAF ® is indicated for the prophylaxis of organ rejection, in adult and pediatric patients receiving allogeneic kidney transplant [see Clinical Studies ( 14.1 )], liver transplant [see Clinical Studies ( 14.2 )], heart transplant [see Clinical Studies ( 14.3 )], or lung transplant [see Clinical Studies ( 14.4 )] in combination with other immunosuppressants.

• Active ingredient or product type: TACROLIMUS
• Strength/concentration: 5MG/ML
• Dosage form and route: Solution for injection, Intravenous
• Exact package presentation: box of 10 × 1 mL ampules
• NDC/item number: 0469-3016-01
• Manufacturer: ASTELLAS USA, INC.
• Storage/handling: Store and Dispense Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
• Status: Rx only

Important safety information: • Not Interchangeable with Extended-Release Tacrolimus Products - Medication Errors: Instruct patients or caregivers to recognize the appearance of PROGRAF capsules. ( 5.3 ) • New Onset Diabetes After Transplant: Monitor blood glucose. ( 5.4 ) • Nephrotoxicity (acute and/or chronic): Reduce the dose; use caution with other nephrotoxic drugs. ( 5.5 ) • Neurotoxicity: Including risk of Posterior Reversible Encephalopathy Syndrome (PRES); monitor for neurologic abnormalities; reduce or discontinue

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.