From the FDA Drug Label
Tadalafil should be limited to 5 mg not more than once in every 72 hours in patients with creatinine clearance less than 30 mL/min or end-stage renal disease on hemodialysis Tadalafil tablets for once daily use is not recommended in patients with creatinine clearance less than 30 mL/min Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablets for once daily use is not recommended
The recommended dosing of tadalafil for patients with ESRD is:
- For use as needed: 5 mg not more than once in every 72 hours
- For once daily use: not recommended 1, 1
From the Research
For patients with end-stage renal disease (ESRD) requiring Cialis (tadalafil), the recommended initial dose is 5 mg once daily, with a maximum dose of 10 mg not to exceed once every 48 hours. This reduced dosing is necessary because tadalafil clearance is significantly decreased in ESRD patients, leading to approximately doubled drug exposure compared to individuals with normal renal function 2. The most recent and highest quality study, published in 2017, supports the use of low-dose tadalafil in patients undergoing hemodialysis with end-stage renal disease, demonstrating improved erectile and ejaculatory function with acceptable adverse effects 2. Key points to consider when prescribing tadalafil to ESRD patients include:
- Hemodialysis contributes minimally to tadalafil elimination, removing less than 1% of the dose during a dialysis session, so supplemental doses after dialysis are not required
- Patients should take tadalafil at the same time each day when possible for consistent blood levels
- Side effects to monitor include headache, dyspepsia, back pain, and hypotension, particularly if the patient is taking nitrates which are absolutely contraindicated with tadalafil
- The reduced dosing schedule balances therapeutic efficacy for erectile dysfunction while minimizing adverse effects related to drug accumulation in patients with severely impaired kidney function. Other studies, such as those published in 2009 and 2013, also support the use of phosphodiesterase type 5 inhibitors, including tadalafil, in patients with ESRD, but the 2017 study provides the most recent and relevant guidance 3, 4. Additionally, general management of ESRD patients involves controlling blood pressure, monitoring for signs of protein-energy wasting and malnutrition, and providing vaccination against seasonal influenza, tetanus, hepatitis B, human papillomavirus, and Streptococcus pneumoniae 5, 6.