United Therapeutics Corporation

United Therapeutics Corporation Drugs

• Adcirca
  

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  Adcirca

  

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  2.1 Pulmonary Arterial Hypertension

  The recommended dose of ADCIRCA is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended.

  2.2 Use in Special Populations

  Renal Impairment

  Mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of ADCIRCA because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].

  Hepatic Impairment

  Mild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day. Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of ADCIRCA [see Warnings and Precautions (5.4) and Use in Specific Populations (8.7)].

  Geriatric Patients

  No dose adjustment is required in patients >65 years of age without renal impairment or hepatic impairment.

  2.3 Use with Ritonavir

  Co-administration of ADCIRCA in Patients on Ritonavir

  In patients receiving ritonavir for at least one week, start ADCIRCA at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

  Co-administration of Ritonavir in Patients on ADCIRCA

  Avoid use of ADCIRCA during the initiation of ritonavir. Stop ADCIRCA at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume ADCIRCA at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Warnings and Precautions (5.2), Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

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