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  • 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 with a known serious hypersensitivity to CIALIS or ADCIRCA® (tadalafil). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.
  • Patients should not use CIALIS if sex is inadvisable due to cardiovascular status. Advise patients to seek immediate medical help if they experience symptoms such as chest pain, dizziness, or nausea during sex.
  • Use of CIALIS with alpha-blockers, antihypertensives, or substantial amounts of alcohol (≥5 units) may lead to hypotension. For the treatment of BPH, CIALIS is not recommended in combination with alpha-blockers. 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 levels, which should be considered when evaluating the potential for interactions.
  • 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.

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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).

EFFICACY INFORMATION

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CIALIS 5 mg, 10 mg, and 20 mg has been approved in the United States for as-needed treatment of erectile dysfunction (ED) since November 2003. With the approval of a low-dose daily treatment option (CIALIS 2.5 mg and 5 mg), you can provide your patients with an ED tablet that can be taken without regard to timing of sexual activity.1

When considering CIALIS, note that the use of CIALIS in patients taking any form of organic nitrate, or those with a known serious hypersensitivity to CIALIS or ADCIRCA® (tadalafil) or any of its ingredients, is contraindicated. Patients should not use CIALIS if sex is inadvisable due to cardiovascular status. Use of CIALIS with alpha-blockers, antihypertensives, or substantial amounts of alcohol (≥5 units) may lead to hypotension. CIALIS for once daily use provides continuous plasma levels, which should be considered when evaluating the potential for drug interactions.1 Review the CIALIS safety profile.

With CIALIS, you can give your patients a choice

In consultation with their patients, physicians have the freedom to choose the dosing regimen that may be appropriate for their patients. For ED patients who want to attempt sex anytime between doses,* consider CIALIS for once daily use. Or, for patients who want up to 36 hours to be ready,*† consider CIALIS for use as needed.

When prescribing CIALIS, it's important to reinforce how to take it in order to help your patients with ED achieve the best results.

  • For your ED patients taking CIALIS for once daily use: Instruct patients to take one dose of CIALIS for once daily use every day at about the same time of day.1 Also, remind your patients that every person is different, and that it may take up to 4 to 5 days before CIALIS for daily use starts working and they are able to have successful intercourse.2,3 Review dosing guidelines >
  • For your ED patients taking CIALIS for use as needed: Instruct patients to try to take CIALIS for use as needed at least 30 minutes before attempting sexual activity.1 Also, remind your patients that every person is different, and that some patients may need to take CIALIS an hour before sexual activity. Review dosing guidelines >

* Individual results may vary. Not studied in 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. CIALIS 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.


Clinical trials

  • The efficacy and safety of CIALIS for once daily use in the treatment of ED has been evaluated in 2 clinical trials of 12 weeks’ duration and 1 clinical trial of 24 weeks’ duration involving a total of 853 patients. CIALIS, when taken once daily, was shown to be effective in improving erectile function in men with ED.1
  • The efficacy and safety of CIALIS for use as needed in the treatment of ED has been evaluated in 22 clinical trials of up to 24 weeks’ duration involving over 4000 patients. CIALIS, when taken as needed up to once daily, was shown to be effective in improving erectile function in men with ED.1


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.

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.

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 Assocation [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: The following events have been reported in men taking PDE5 inhibitors including CIALIS: (1) sudden decrease or loss of vision in one or both eyes; (2) sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. It is not possible to determine whether these events are related directly to the medicines, other health conditions, or to a combination of these. If a patient experiences a sudden decrease or loss in vision or hearing he should stop taking CIALIS, and call a healthcare provider right away. 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.

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.

For more complete information, please see full Prescribing Information and Patient Information.

TD HCP ISI 24JAN2012

References

  • Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2011.
  • Data on file. Lilly USA, LLC: CIA20110212A.
  • Seftel A, Goldfischer E, Kim ED, Dula E, Zeigler H, Burns P. Onset of efficacy of tadalafil once daily in men with erectile dysfunction: a randomized, double-blind, placebo-controlled trial. J Urol. 2011;185:243-248.
  • 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: CIA20051130A.
  • Data on file. Lilly USA, LLC: CIA20110217A.
  • Data on file. Lilly USA, LLC: CIA20111129A.
  • Data on file. Lilly USA, LLC: CIA20080411E.
  • Data on file. Lilly USA, LLC: CIA20120208A.