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CIALISMD.COM PRESCRIBING INFORMATION PATIENT INFORMATION
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In a moderater-led discussion, a leading urologist and a general practitioner evaluate their experiences with CIALIS for once daily use in patients with both ED and BPH. They cover key topics including efficacy, getting patients started, and cost and coverage.  
 
 
  This is a timely conversation since ED and the symptoms of BPH coexist in many patients. In fact, approximately half of all men with ED may also have symptoms of BPH.1  
 
The data for BPH confirm this finding. A separate study of urologists found that approximately 60% of patients who had symptoms of BPH were also diagnosed with ED.2  
 
Retrospective claims study of comorbid conditions in men with ED (N=301,994). Comorbid BPH symptoms were identified in the 12 months before and 6 months after the ED diagnosis. Cases of ED were defined by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9CM) codes. Cases of BPH symptoms were identified using a combination of ICD-9CM codes, procedure codes based on Current Physician Terminology codes, and National Drug Classification codes for alpha-blockers and 5-alpha reductase inhibitors.
 
Indications
CIALIS for once daily use is indicated for the treatment of erectile dysfunction, or ED (2.5 mg, 5 mg), the signs and symptoms of benign prostatic hyperplasia, or BPH (5 mg), and both ED and the signs and symptoms of BPH, or ED+BPH (5 mg). The recommended starting dose of CIALIS for once daily use for the treatment of ED is 2.5 mg and may be increased to 5 mg, based on individual efficacy and tolerability. If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown.
 
Select Important Safety Information Related to Contraindications
•  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.
 
   Please see additional Important Safety Information below and links to Prescribing Information and Patient Information above.  
 
A prospective, office-based study involving 500 German urologists who evaluated 8563 consecutive patients presenting with urinary symptoms suggestive of BPH. Diagnosis of ED was based on the urologist’s clinical judgment, including the use of the “Cologne assessment of male erectile dysfunction” (KEED) questionnaire.  
 
 
After watching the thought leader video, consider the types of patients in your practice that CIALIS for once daily use may be right for. For example:  

•  Men who are taking an ED medication as needed but want to stop planning their days around bathroom visits
•  Men who are on an alpha-blocker but want to change their treatment plan
•  Men on an alpha-blocker who have trouble maintaining an erection
 
Then, while you are still on cialismd.com, go to the Patient Resources tab to download FREE TRIAL vouchers. For your convenience, you can always download more vouchers whenever you need them.  
 
Sincerely,  
 
 
*Doctor McVary and Doctor Rosenberg are paid consultants of Eli Lilly and Company. Eli Lilly and Company is responsible for the content of this message, with input from these experts.
 
 
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.
 
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: 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 use of PDE5 inhibitors or to other factors. PDE5 inhibitors, including CIALIS, should be used with caution in patients with a history of non-arteritic anterior ischemic optic neuropathy (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. 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. 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 07MAY2014
 
References: 1.Cameron A, Sun P, Lage M. Comorbid conditions in men with ED before and after ED diagnosis: a retrospective database study. Int J Impot Res. 2006;18:375-381. 2. Hoesl CE, Woll EM, Burkart M, Altwein JE. Erectile dysfunction (ED) is prevalent, bothersome, and underdiagnosed in patients consulting urologists for benign prostatic syndrome (BPS). Eur Urol. 2005;47:511-517.  
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CIALIS is a registered trademark of Eli Lilly and Company.
TD95647 03/2015