Tadalafil (Page 10 of 11)

14.4 Tadalafil 5 mg for Once Daily Use for ED and BPH

The efficacy and safety of tadalafil for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.

In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took tadalafil.

The efficacy results for patients with both ED and BPH, who received either tadalafil 5 mg for once daily use or placebo (N=408) are shown in Tables 21 and 22 and Figure 8.

Tadalafil 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Tadalafil 5 mg for once daily use also resulted in statistically significant improvement in SEP3. Tadalafil 2.5 mg did not result in statistically significant improvement in the total IPSS.

Table 21: Mean IPSS and IIEF EF Domain Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH

Placebo Tadalafil 5 mg p-value
Total Symptom Score (IPSS)
(N=193) (N=206)
Baseline18.218.5
Change from Baseline to Week 12-3.8-6.1<.001
EF Domain Score (IIEF EF)
(N=188) (N=202)
Baseline15.616.5
Endpoint17.622.9
Change from Baseline to Week 121.96.5<.001

Table 22: Mean SEP Question 3 Changes in the Tadalafil 5 mg for Once Daily Use Study in Patients with ED and BPH

Placebo Tadalafil 5 mg
(N=187) (N=199) p-value
Maintenance of Erection (SEP3)
Baseline36%43%
Endpoint48%72%
Change from Baseline to Week 1212%32%<.001

Tadalafil for once daily use resulted in improvement in the IPSS total score at the first scheduled observation (week 2) and throughout the 12 weeks of treatment (see Figure 8).

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(click image for full-size original)

Figure 8: Mean IPSS Changes in ED/BPH Patients by Visit in Study L

In this study, the effect of tadalafil 5 mg once daily on Q max was evaluated as a safety endpoint. Mean Q max increased from baseline in both the treatment and placebo groups (tadalafil 5 mg: 1.6 mL/sec, placebo: 1.2 mL/sec); however, these changes were not significantly different between groups.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tadalafil tablets, USP are supplied as follows:

Four strengths of oval shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes:

2.5 mg tablets: Oval shaped, biconvex, light yellow to yellow colored, film coated tablet, debossed with ‘RDY’ on one side and ’2.5′ on the other side.

5 mg tablets: Oval shaped, biconvex, light yellow to yellow colored, film coated tablet, debossed with, ‘RDY’ on one side and ’5′ on the other side.

NDC 50268-738-13 (10 tablets per card, 3 cards per carton)

10 mg tablets: Oval shaped, biconvex, yellow colored, film coated tablet, debossed with 10 on one side and plain on the other side.

20 mg tablets: Oval shaped, biconvex, yellow colored, film coated tablet, debossed with 20 on one side and plain on the other side.

NDC 50268-739-13 (10 tablets per card, 3 cards per carton).

16.2 Storage

Store at 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature].

Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

“See FDA-approved patient labeling (Patient Information)”

17.1 Nitrates

Physicians should discuss with patients the contraindication of tadalafil with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of tadalafil with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil . In such a patient, who has taken tadalafil, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking tadalafil should seek immediate medical attention [see Contraindications ( 4.1) and Warnings and Precautions ( 5.1)].

17.2 Guanylate Cyclase (GC) Stimulators

Physicians should discuss with patients the contraindication of tadalafil with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of tadalafil with GC stimulators may cause blood pressure to drop to an unsafe level.

17.3 Cardiovascular Considerations

Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions ( 5.1)].

17.4 Concomitant Use with Drugs Which Lower Blood Pressure

Physicians should discuss with patients the potential for tadalafil to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions ( 5.6), Drug Interactions ( 7.1), and Clinical Pharmacology ( 12.2)].

17.5 Potential for Drug Interactions When Taking Tadalafil for Once Daily Use

Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil for once daily use, especially the potential for interactions with medications (e.g., nitrates, alpha-blockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. [see Dosage and Administration ( 2.7), Warnings and Precautions ( 5.6), Drug Interactions ( 7.1, 7.2), Clinical Pharmacology ( 12.2), and Clinical Studies ( 14.2)].

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