Prescription Drug Information: Tadalafil

TADALAFIL- tadalafil tablet, film coated
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1 INDICATIONS AND USAGE

1.1 Erectile Dysfunction

Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED).

1.2 Benign Prostatic Hyperplasia

Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia

Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

1.4 Limitation of Use

If tadalafil is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies ( 14.3)].

2 DOSAGE AND ADMINISTRATION

Do not split tadalafil tablets; entire dose should be taken.

2.1 Tadalafil for Use as Needed for Erectile Dysfunction

• The recommended starting dose of tadalafil tablets for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
• The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
• Tadalafil for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of tadalafil, this should be taken into consideration.

2.2 Tadalafil Tablets for Once Daily Use for Erectile Dysfunction

• The recommended starting dose of tadalafil tablets for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
• The tadalafil dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

2.3 Tadalafil Tablets for Once Daily Use for Benign Prostatic Hyperplasia

• The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day. • When therapy for BPH is initiated with tadalafil and finasteride, the recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

2.4 Tadalafil for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia

The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

2.5 Use with Food

Tadalafil tablets may be taken without regard to food.

2.6 Use in Specific Populations

Renal Impairment

Tadalafil for Use as Needed

• Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.

• Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions ( 5.7) and Use in Specific Populations ( 8.7)].

Tadalafil for Once Daily Use

Erectile Dysfunction

• Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil for once daily use is not recommended [see Warnings and Precautions ( 5.7) and Use in Specific Populations ( 8.7)].

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

• Creatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.

• Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil for once daily use is not recommended [see Warnings and Precautions ( 5.7) and Use in Specific Populations ( 8.7)].

Hepatic Impairment

Tadalafil for Use as Needed

• Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of tadalafil once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.

• Severe (Child Pugh Class C): The use of tadalafil is not recommended [see Warnings and Precautions ( 5.8) and Use in Specific Populations ( 8.6)].

Tadalafil for Once Daily Use

• Mild or moderate (Child Pugh Class A or B): Tadalafil for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if tadalafil for once daily use is prescribed to these patients.

• Severe (Child Pugh Class C): The use of tadalafil is not recommended [see Warnings and Precautions ( 5.8) and Use in Specific Populations ( 8.6)].

2.7 Concomitant Medications

Nitrates

Concomitant use of nitrates in any form is contraindicated [see Contraindications ( 4.1)].

Alpha-Blockers

ED — When tadalafil is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and tadalafil should be initiated at the lowest recommended dose [see Warnings and Precautions ( 5.6), Drug Interactions ( 7.1), and Clinical Pharmacology ( 12.2)].

BPH — Tadalafil is not recommended for use in combination with alpha-blockers for the treatment of BPH [see Warnings and Precautions ( 5.6), Drug Interactions ( 7.1), and Clinical Pharmacology ( 12.2)].

CYP3A4 Inhibitors

Tadalafil for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of tadalafil is 10 mg, not to exceed once every 72 hours [see Warnings and Precautions ( 5.10) and Drug Interactions ( 7.2)].

Tadalafil for Once Daily Use — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose is 2.5 mg [see Warnings and Precautions ( 5.10) and Drug Interactions ( 7.2)].

3 DOSAGE FORMS AND STRENGTHS

Four strengths of oval shaped tablets are available in different sizes and different shades of yellow:

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.

10 mg tablets: Oval shaped, biconvex, yellow colored, film-coated tablet, debossed with ‘RDY’ on one side and ’10′ on the other side.

20 mg tablets: Oval shaped, biconvex, yellow colored, film-coated tablet, debossed with ‘RDY’ on one side and ’20′ on the other side.

4 CONTRAINDICATIONS

4.1 Nitrates

Administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology ( 12.2)].

4.2 Hypersensitivity Reactions

Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or ADCIRCA ®). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2)].

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

Do not use tadalafil tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including tadalafil, may potentiate the hypotensive effects of GC stimulators.

5 WARNINGS AND PRECAUTIONS

Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing tadalafil, it is important to note the following:

5.1 Cardiovascular

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including tadalafil, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.

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 Patient Counseling Information ( 17.1)].

Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.

The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for tadalafil, and therefore until further information is available, tadalafil is not recommended for the following groups of patients:

• myocardial infarction within the last 90 days

• unstable angina or angina occurring during sexual intercourse

• New York Heart Association Class 2 or greater heart failure in the last 6 months

• uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension

• stroke within the last 6 months.

As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. In a clinical pharmacology study, tadalafil 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects [see Clinical Pharmacology ( 12.2)]. While this effect should not be of consequence in most patients, prior to prescribing tadalafil tablets, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors.

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