CIALIS (tadalafil) tablets for Use As Needed, Cialis Once Daily Or As Needed.


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Erectile Dysfunction

CIALIS for use as needed (5 mg, 10 mg, 20 mg)

Improved erectile function 1

CIALIS for use as needed improved Sexual Encounter Profile, question 3 (SEP 3)* values in patients with ED vs placebo

Retrospective analysis of 11 integrated, randomized, double-blind, placebo-controlled trials of 2102 patients stratified by baseline severity (mild, moderate, severe) receiving placebo (N=638), CIALIS 10 mg (N=321), or CIALIS 20 mg (N=1143). Per protocol, patients with “mild” or “mild-moderate” ED were combined into a single category of “mild” ED.

  • Mean SEP 3 scores in all patients 2
    • Endpoint: placebo 31%, CIALIS 10 mg 58%, CIALIS 20 mg 68%
    • Change from baseline: placebo 8%, CIALIS 10 mg 34%, CIALIS 20 mg 46%

* SEP 3 is a yes/no question: “Did your erection last long enough for you to have successful intercourse?” 1

  • CIALIS 20 mg works fast—in as little as 30 minutes in some men 3†
  • Efficacy for up to 36 hours 3‡§

† Individual results may vary. 30-minute onset in 52% of men taking CIALIS 20 mg (N=75) vs 35% taking placebo (N=74); P<.05. Onset defined as the earliest time to a successful erection (at least 1 erection in 4 attempts that led to successful intercourse). 3,4

‡ Individual results may vary. Not studied for multiple attempts per dose.

§ In 2 studies, men were instructed to attempt intercourse at 24 or 36 hours after taking a single dose of CIALIS 20 mg. CIALIS 20 mg was shown to improve, compared to placebo, the ability of men with ED to have a single successful intercourse attempt at each of these time points.

CIALIS for use as needed provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD) 1

Select Important Safety Information Related to Cardiovascular Considerations

  • CIALIS is contraindicated in patients using any form of organic nitrate, either regularly and/or intermittently, as the combination could cause a sudden, unsafe drop in blood pressure.
  • CIALIS is contraindicated in patients using guanylate cyclase (GC) stimulator, such as riociguat. PDE5 inhibitors, including CIALIS, may potentiate the hypotensive effects of GC stimulators.
  • Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Treatments for erectile dysfunction (ED), including CIALIS, 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.
  • CIALIS was not studied in and is not recommended for the following groups of patients: those with myocardial infarction within the last 90 days; unstable angina or angina during sexual intercourse; stroke or heart failure within the last 6 months; uncontrolled arrhythmia; hypotension; uncontrolled hypertension; and hereditary degenerative retinal disorders.
  • Use of CIALIS with alpha-blockers, antihypertensives, or substantial amount of alcohol (≥5 units) may lead to hypotension.

CIALIS for use as needed improved Sexual Encounter Profile, question 3 (SEP 3)* values in patients with ED vs placebo

Retrospective analysis of 11 integrated, randomized, double-blind, placebo-controlled trials of 2102 patients stratified by baseline severity (mild, moderate, severe) receiving placebo (N=638), CIALIS 10 mg (N=321), or CIALIS 20 mg (N=1143). Per protocol, patients with “mild” or “mild-moderate” ED were combined into a single category of “mild” ED.

  • Mean SEP 3 scores in all patients 2
    • Endpoint: placebo 31%, CIALIS 10 mg 58%, CIALIS 20 mg 68%
    • Change from baseline: placebo 8%, CIALIS 10 mg 34%, CIALIS 20 mg 46%

* SEP 3 is a yes/no question: “Did your erection last long enough for you to have successful intercourse?” 1

  • CIALIS 20 mg works fast—in as little as 30 minutes in some men 3†
  • Efficacy for up to 36 hours 3‡§

† Individual results may vary. 30-minute onset in 52% of men taking CIALIS 20 mg (N=75) vs 35% taking placebo (N=74); P<.05. Onset defined as the earliest time to a successful erection (at least 1 erection in 4 attempts that led to successful intercourse). 3,4

‡ Individual results may vary. Not studied for multiple attempts per dose.

§ In 2 studies, men were instructed to attempt intercourse at 24 or 36 hours after taking a single dose of CIALIS 20 mg. CIALIS 20 mg was shown to improve, compared to placebo, the ability of men with ED to have a single successful intercourse attempt at each of these time points.

CIALIS for use as needed provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD) 1

Select Important Safety Information Related to Cardiovascular Considerations

  • CIALIS is contraindicated in patients using any form of organic nitrate, either regularly and/or intermittently, as the combination could cause a sudden unsafe drop in blood pressure.
  • CIALIS is contraindicated in patients using guanylate cyclase (GC) stimulator, such as riociguat. PDE5 inhibitors, including CIALIS, may potentiate the hypotensive effects of GC stimulators.
  • Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Treatments for erectile dysfunction (ED), including CIALIS, 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.
  • CIALIS was not studied in and is not recommended for the following groups of patients: those with myocardial infarction within the last 90 days; unstable angina or angina during sexual intercourse; stroke or heart failure within the last 6 months; uncontrolled arrhythmia; hypotension; uncontrolled hypertension; and hereditary degenerative retinal disorders.
  • Use of CIALIS with alpha-blockers, antihypertensives, or substantial amount of alcohol (≥5 units) may lead to hypotension.

CIALIS for use as needed improved Sexual Encounter Profile, question 3 (SEP 3)* values in patients with ED vs placebo

Retrospective analysis of 11 integrated, randomized, double-blind, placebo-controlled trials of 2102 patients stratified by baseline severity (mild, moderate, severe) receiving placebo (N=638), CIALIS 10 mg (N=321), or CIALIS 20 mg (N=1143). Per protocol, patients with “mild” or “mild-moderate” ED were combined into a single category of “mild” ED.

  • Mean SEP 3 scores in all patients 2
    • Endpoint: placebo 31%, CIALIS 10 mg 58%, CIALIS 20 mg 68%
    • Change from baseline: placebo 8%, CIALIS 10 mg 34%, CIALIS 20 mg 46%

* SEP 3 is a yes/no question: “Did your erection last long enough for you to have successful intercourse?” 1

  • CIALIS 20 mg works fast—in as little as 30 minutes in some men 3†
  • Efficacy for up to 36 hours 3‡§

† Individual results may vary. 30-minute onset in 52% of men taking CIALIS 20 mg (N=75) vs 35% taking placebo (N=74); P<.05. Onset defined as the earliest time to a successful erection (at least 1 erection in 4 attempts that led to successful intercourse). 3,4

‡ Individual results may vary. Not studied for multiple attempts per dose.

§ In 2 studies, men were instructed to attempt intercourse at 24 or 36 hours after taking a single dose of CIALIS 20 mg. CIALIS 20 mg was shown to improve, compared to placebo, the ability of men with ED to have a single successful intercourse attempt at each of these time points.

CIALIS for use as needed provided improvement in erectile function for men with ED and controlled hypertension or cardiovascular disease (CVD) 1

Select Important Safety Information Related to Cardiovascular Considerations

  • CIALIS is contraindicated in patients using any form of organic nitrate, either regularly and/or intermittently, as the combination could cause a sudden unsafe drop in blood pressure.
  • CIALIS is contraindicated in patients using guanylate cyclase (GC) stimulator, such as riociguat. PDE5 inhibitors, including CIALIS, may potentiate the hypotensive effects of GC stimulators.
  • Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Treatments for erectile dysfunction (ED), including CIALIS, 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.
  • CIALIS was not studied in and is not recommended for the following groups of patients: those with myocardial infarction within the last 90 days; unstable angina or angina during sexual intercourse; stroke or heart failure within the last 6 months; uncontrolled arrhythmia; hypotension; uncontrolled hypertension; and hereditary degenerative retinal disorders.
  • Use of CIALIS with alpha-blockers, antihypertensives, or substantial amount of alcohol (≥5 units) may lead to hypotension.

Improved erection confidence 5

CIALIS for use as needed improved International Index of Erectile Function question 15 (IIEF 15)* scores in ED patients vs placebo

Results from a retrospective analysis of 17 placebo-controlled studies in the general ED population with a range of ED severity based on responses to the IIEF questionnaire.

*Patient response to IIEF 15: “How do you rate your confidence that you could get and keep an erection?” Percentage based on total cohort population (placebo, N=1002; CIALIS 10 mg, N=527; CIALIS 20 mg, N=1816) as denominator.

  • Mean IIEF 15 scores at baseline and endpoint: placebo, 1.94 and 2.24; CIALIS 10 mg, 1.90 and 3.05; CIALIS 20 mg, 1.98 and 3.44

Treatment-emergent adverse reactions 3

Treatment-emergent adverse reactions reported by ≥2% of patients treated with CIALIS for use as needed (10 mg or 20 mg) and more frequent on drug than placebo in 8 primary, placebo-controlled, phase 3 studies (including a study in patients with diabetes)

  • Overall discontinuation rates in clinical trials were 3.1% for CIALIS 10 mg and 20 mg vs 1.4% for placebo

INDICATIONS: CIALIS is indicated for the treatment of erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and ED and the signs and symptoms of BPH (ED+BPH). If used with finasteride to initiate BPH treatment, it is recommended for up to 26 weeks, as the incremental benefit decreases from 4 to 26 weeks and is unknown beyond that time frame.

Important Safety Information for CIALIS ® (tadalafil) tablets

CONTRAINDICATIONS

Nitrates: CIALIS is contraindicated in patients using any form of organic nitrate, either regularly and/or intermittently, as the combination could cause a sudden, unsafe drop in blood pressure.

Hypersensitivity Reactions: CIALIS is contraindicated in patients with a known serious hypersensitivity to CIALIS or ADCIRCA ® (tadalafil). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.

Guanylate Cyclase (GC) Stimulators: CIALIS is contraindicated in patients using a GC stimulator, such as riociguat. PDE5 inhibitors, including CIALIS, may potentiate the hypotensive effects of GC stimulators.

WARNINGS AND PRECAUTIONS

Cardiovascular: Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Treatments for erectile dysfunction (ED), including CIALIS, 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.

Phosphodiesterase 5 (PDE5) inhibitors, including CIALIS, are mild systemic vasodilators. While this effect should not be of consequence in most patients, physicians should consider this potential when prescribing CIALIS.

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.

CIALIS was not studied and is not recommended in patients who have recently suffered a heart attack (within 90 days) or stroke (within 6 months), or patients with uncontrolled hypertension, hypotension, uncontrolled arrhythmias, heart failure (New York Heart Association [NYHA] ≥Class 2 in last 6 months), unstable angina or angina occurring during sexual activity.

Potential Drug Interactions: CIALIS can potentiate the hypotensive effects of alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units). CIALIS is not recommended in combination with alpha-blockers for the treatment of benign prostatic hyperplasia (BPH) symptoms because efficacy of the combination has not been adequately studied and due to the risk of blood pressure lowering. Caution is advised when CIALIS is used as a treatment for ED in men taking alpha-blockers. CIALIS for once daily use provides continuous plasma tadalafil levels. Physicians should consider this when evaluating the potential for interactions.

Combination with other PDE5 inhibitors: CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Instruct patients not to take CIALIS in combination with ADCIRCA or other PDE5 inhibitors.

Potent inhibitors of CYP3A4: For patients taking potent inhibitors of CYP3A4, dose should be adjusted: CIALIS for use as needed: 10 mg no more than once every 72 hours. CIALIS for once daily use: the maximum recommended dose is 2.5 mg.

Prolonged Erection: There have been rare reports of priapism with this class of compounds. Patients should be advised to seek immediate medical attention should this occur. Use CIALIS with caution in patients who have conditions that might predispose them to priapism.

Vision/Hearing: Sudden decrease or loss of vision in one or both eyes has been reported in men taking PDE5 inhibitors, including CIALIS. Neither the postmarketing reports nor observational studies substantiated a causal relationship between PDE5 inhibitor use and non‑arteritic anterior ischemic optic neuropathy (NAION). PDE5 inhibitors, including CIALIS, should be used with caution in patients with a history of NAION, and only when the anticipated benefits outweigh the risks. Patients with a “crowded” optic disc may also be at an increased risk of NAION. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Sudden decrease or loss in hearing, sometimes with ringing in the ears and dizziness has also been reported in men taking PDE5 inhibitors, including CIALIS. It is not possible to determine whether these hearing events are related directly to the use of PDE5 inhibitors or to other factors.

If a patient experiences a sudden decrease or loss of vision or hearing, he should stop taking CIALIS and call a healthcare provider right away.

Specific Populations: Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for daily use is not recommended; CIALIS for use as needed—5 mg not more than once every 72 hours. Creatinine clearance 30 to 50 mL/min: For CIALIS for daily use treatment of BPH or ED/BPH, start dosing at 2.5 mg and increase to 5 mg based upon individual response. CIALIS for use as needed—5 mg not more than once per day with maximum dose 10 mg not more than once every 48 hours. Severe hepatic impairment: Use of CIALIS is not recommended. Mild or moderate hepatic impairment: CIALIS has not been extensively evaluated in patients with mild or moderate hepatic impairment; caution is advised if CIALIS is prescribed to these patients. With CIALIS for use as needed, dose should not exceed 10 mg. Additional dose adjustments may be required for patients with other concomitant medications. See full Prescribing Information for complete dosing instructions.

Sexually Transmitted Diseases: The use of CIALIS offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH: Prior to initiating treatment with CIALIS for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.

ADVERSE REACTIONS

Most common adverse reactions (≥2%) with CIALIS for once daily use vs placebo, respectively, include:

In ED (2.5 and 5 mg): headache (3% and 6% vs 5%), dyspepsia (4% and 5% vs 2%), nasal congestion (2% and 2% vs 0%), flushing (1% and 3% vs 1%), and pain in extremity (1% and 2% vs 0%). Back pain (3% and 3% vs 1%) and myalgia (2% and 2% vs 1%) were also reported, sometimes with delayed onset.

In BPH and ED/BPH (5 mg): headache (4.1% vs 2.3%), dyspepsia (2.4% vs 0.2%), nasopharyngitis (2.1% vs 1.6%). Back pain (2.4% vs 1.4%) was also reported, sometimes with delayed onset.

Most common adverse reactions (≥2%) with CIALIS for use as needed in ED (5 mg, 10 mg, and 20 mg) vs placebo, respectively, include: headache (11%, 11%, and 15% vs 5%), dyspepsia (4%, 8%, and 10% vs 1%), nasal congestion (2%, 3%, and 3% vs 1%), flushing (2%, 3%, and 3% vs 1%), and pain in limb (1%, 3%, and 3% vs 1%). Back pain (3%, 5%, and 6% vs 3%) and myalgia (1%, 4%, and 3% vs 1%) were also reported, sometimes with delayed onset.

TD HCP ISI 16MAY2017

References

Lewis RW, Sadovsky R, Eardley I, et al. The efficacy of tadalafil in clinical populations. J Sex Med. 2005;2:517-531.

Carson CC, Rajfer J, Eardley I, et al. The efficacy and safety of tadalafil: an update. BJU Int. 2004;93:1276-1281.

Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.

Rosen RC, Padma-Nathan H, Shabsigh R, Saikali K, Watkins V, Pullman W. Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20 mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study. J Sex Med. 2004;1:193-200.

Data on file. Lilly USA, LLC. CIA20110217A.

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