Pulmonary Arterial Hypertension

ADCIRCA (tadalafil tablets) ® is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Pulmonary Arterial Hypertension

The recommended dose of ADCIRCA (tadalafil tablets) 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.

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 and Use In Specific Populations].

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 and Use In Specific Populations].

Geriatric Patients

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

Use with Ritonavir

Co-administration of ADCIRCA (tadalafil tablets) in Patients on Ritonavir

In patients receiving ritonavir for at least one week, start ADCIRCA (tadalafil tablets) at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Co-administration of Ritonavir in Patients on ADCIRCA (tadalafil tablets)

Avoid use of ADCIRCA (tadalafil tablets) during the initiation of ritonavir. Stop ADCIRCA (tadalafil tablets) at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume ADCIRCA (tadalafil tablets) at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Dosage Forms And Strengths

20 mg, orange, film-coated, almond-shaped tablets (not scored) debossed with “4467”.

Storage And Handling

ADCIRCA (tadalafil) is supplied as follows: 20 mg orange, film–coated, almond–shaped tablets (not scored), debossed with “4467”

Bottles of 60 NDC 66302-467-60

Storage

Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

Eli Lilly and Company, Indianapolis, IN 46285, USA. Marketed by : United Therapeutics Corporation. Revised: 2/2011

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.