tadalafil (Rx)

Erectile Dysfunction

Indicated for treatment of erectile dysfunction (ED)

Cialis or generic equivalent only

PRN use: 10 mg PO initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily

Once-daily use: 2.5 mg/day PO in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability

Dosing considerations

• PRN use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (eg, ritonavir, ketoconazole, itraconazole); not to exceed 10 mg/72 hr
• Once-daily use: Decrease dose with concomitant use of potent CYP3A4 inhibitor (eg, ritonavir, ketoconazole, itraconazole); not to exceed 2.5 mg/day

Benign Prostatic Hyperplasia

Indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction

Cialis or generic equivalent only

BPH: 5 mg PO once daily

BPH with ED: 5 mg PO once daily, taken at approximately same time each day without regard to timing of sexual activity

Coadministration with finasteride for BPH: Tadalafil 5 mg plus finasteride 5 mg PO once daily for ≤26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the benefit beyond 26 weeks is unknown

Pulmonary Arterial Hypertension

Indicated for 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%)

Adcirca, Alyq, or generic equivalent only

40 mg PO once daily; dividing dose for more frequent dosing is not recommended

Patients also taking ritonavir: 20 mg PO once daily initially for ≥1 week; may be increased to 40 mg/day on basis of tolerability

Dosing considerations

• If possible, avoid coadministration with CYP3A4 inhibitors; if coadministration is essential, long-term therapy is indicated, or strong CYP3A4 inhibitors are required, modify or hold dose
• Patients already taking strong CYP3A4 inhibitor who require tadalafil: 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability
• Patients already taking tadalafil who require strong CYP3A4 inhibitor: Avoid using tadalafil while starting strong CYP3A4 inhibitor; stop tadalafil ≥24 hours before starting strong CYP3A4 inhibitor; after 1 week, resume tadalafil at 20 mg PO once daily; may be increased to 40 mg/day on basis of tolerability

Dosing Modifications

Renal impairment (ED)

• Cialis (PRN use)

  • Mild (CrCl ≥51 mL/min): No dosage adjustment needed
  • Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr
  • Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr

• Cialis (once daily use)

  • ED (CrCl ≥30 mL/min): No dosage adjustment needed
  • BPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual response
  • ED or BPH (CrCl <30 mL/min:) Not recommended

Renal impairment (PAH)

• Adcirca or Alyq

  • Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability
  • Severe (CrCl <30 mL/min and on hemodialysis): Avoid use

Hepatic impairment (ED)

• Cialis (PRN use)

  • Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once daily
  • Severe (Child-Pugh class C): Not recommended

• Cialis (once daily use)

  • Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advised
  • Severe (Child-Pugh class C): Not recommended

Hepatic impairment (PAH)

• Adcirca or Alyq

  • Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once daily
  • Severe (Child-Pugh class C): Avoid use

Muscular Dystrophy (Orphan)

Orphan designation for Duchenne muscular dystrophy (DMD)

Sponsor

• Eli Lilly and Company; Lilly Corporate Center; Indianapolis, IN 46285

Pulmonary Arterial Hypertension (Orphan)

Orphan designation of a fixed dose combination of macitentan and tadalafil for treatment of pulmonary arterial hypertension

Sponsor

• Actelion Clinical Research, Inc; 1820 Chapel Avenue West, Suite 300; Cherry Hill, New Jersey 08002

Safety and efficacy not established

Erectile Dysfunction

Indicated for treatment of erectile dysfunction (ED)

Cialis or generic equivalent only: No dosage adjustment is warranted solely on basis of age; however, greater sensitivity to medications in some older individuals should be considered

Pulmonary Arterial Hypertension

Indicated for 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%)

Adcirca, Alyq, or generic equivalent only: Lower dose or reduced dosing frequency may be required in elderly because of decreased renal or hepatic clearance