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Cialis Daily Bph

Symptoms of Benign Prostatic Hyperplasia.
CIALIS 5 mg for once daily use.
Significant reduction in urinary symptom severity 1.
Mean changes in total International Prostate Symptom Score (IPSS)* by visit in patients with BPH in Study J 1.
Total IPSS at baseline: placebo (N=205): 17.1; CIALIS 5 mg (N=205): 17.3 1 CIALIS 5 mg for once daily use resulted in a statistically significant improvement in total IPSS at week 12 compared to placebo 1.
* The IPSS is a 4-week recall questionnaire administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. It assesses the severity of irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with scores ranging from 0 to 35. Higher numeric scores represent greater severity. 1 Total IPSS ranges from ≤7 for mild symptoms, 8 to 19 for moderate symptoms, and 20 to 35 for severe symptoms. 3.
Select Important Safety Information Related to 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.
Mean changes in total IPSS* by visit in patients with BPH in Study K 1.
Total IPSS at baseline: placebo (N=164): 16.6; CIALIS 5 mg (N=160): 17.1 1 CIALIS 5 mg for once daily use resulted in a decrease in mean total IPSS starting at week 1 and throughout the 12 weeks of treatment 1.
* The IPSS is a 4-week recall questionnaire administered at the beginning and end of a placebo run-in period and subsequently at follow-up visits after randomization. It assesses the severity 1 of irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with scores ranging from 0 to 35. Higher numeric scores represent greater severity 1 . Total IPSS ranges from ≤7 for mild symptoms, 8 to 19 for moderate symptoms, and 20 to 35 for severe symptoms. 3.
Select Important Safety Information Related to Warnings and Precautions.
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.
Mean changes in total IPSS* by visit in patients with moderate to severe BPH symptoms and enlarged prostate (>30 cc) in Study LVIW 1,2.
Total IPSS at baseline: placebo + finasteride (N=350): 17.4; CIALIS 5 mg + finasteride 5 mg (N=345): 17.1 1 CIALIS 5 mg for once daily use + finasteride resulted in improvement in total IPSS compared to placebo + finasteride at all time points measured 1.
* The IPSS is a 4-week recall questionnaire. It assesses the severity of irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with scores ranging from 0 to 35. Higher scores represent greater severity. 1 Total IPSS ranges from ≤7 for mild symptoms, 8 to 19 for moderate symptoms, and 20 to 35 for severe symptoms. 3.
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.
Treatment-emergent adverse reactions.
Studies J, K, and L 1.
Treatment-emergent adverse reactions reported by ≥1% of patients treated with CIALIS 5 mg for once daily use and more frequent on drug than placebo.
Data from studies J, K, and L: 3 placebo-controlled clinical studies of 12 weeks’ duration (2 studies for BPH and 1 study for ED+BPH)
The discontinuation rate due to adverse reactions in patients treated with CIALIS for once daily use was 3.6% compared with 1.6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with CIALIS included headache, upper abdominal pain, and myalgia.
Study LVIW 4.
Treatment-emergent adverse reactions reported by ≥1% of patients treated with CIALIS 5 mg for once daily use + finasteride 5 mg or placebo + finasteride 5 mg.
Data from Study LVIW: a placebo-controlled clinical study of 26 weeks’ duration in men with BPH and enlarged prostate (>30 cc)
The discontinuation rate due to adverse reactions in patients treated with CIALIS 5 mg for once daily use + finasteride 5 mg was 1.2% compared with 2.9% in patients treated with placebo + finasteride 5 mg.
Limitation of use:
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.
BPH clinical trial designs.
Studies J and K 1,5,6.
Two placebo-controlled, double-blind, parallel-design, 12-week studies assessed the efficacy and safety of CIALIS 5 mg for once daily use in men with BPH.
Patients with BPH (N=410 in Study J and N=325 in Study K) received either CIALIS 5 mg for once daily use or placebo Patients had moderate to severe BPH symptoms and mean age was 63.2 years (range 44 to 87)
*Study K had an additional visit at week 1.
Eligibility criteria:
Patients (N=410 in Study J and N=325 in Study K) were ≥45 years of age Clinical diagnosis of BPH >6 months BPH symptom severity ranged from moderate to severe (IPSS ≥13 at start of placebo lead-in period) † Maximum urinary flow rate (Q max ) 4-15 mL/sec at start of placebo lead-in period.
Efficacy parameter:
Total IPSS (primary endpoint)
Safety measures:
Analyzed treatment-emergent adverse reactions, laboratory measures, postvoid residual volume, and Q max.
† Moderate BPH symptoms are defined as total IPSS ≥8 to <20; severe symptoms as total IPSS ≥20.
Study LVIW 1,2.
A placebo-controlled, double-blind, parallel-design, 26-week study that assessed the efficacy and safety of CIALIS 5 mg with finasteride 5 mg vs placebo with finasteride 5 mg in men with moderate to severe BPH symptoms.
696 patients with symptoms of BPH and an enlarged prostate (>30 cc) were randomized to receive either CIALIS 5 mg for once daily use + finasteride 5 mg or placebo + finasteride 5 mg.
Eligibility criteria:
Patients (N=696) were ≥45 years of age Clinical diagnosis of BPH >6 months BPH symptom severity ranged from moderate to severe (IPSS ≥13 at start of placebo lead-in period)* Q max 4-15 mL/sec Enlarged prostate (>30 cc) Patients were naive to 5-alpha reductase inhibitor therapy, such as finasteride.
Efficacy parameters:
Total IPSS at week 12 (primary endpoint) Total IPSS at week 4 and week 26 (key secondary endpoints) Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF) † at 4, 12, and 26 weeks in 404 men with erectile dysfunction at baseline (key secondary endpoint)
Safety measures:
Treatment-emergent adverse reactions, vital signs, and clinical laboratory values.
Limitation of use:
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.
* Moderate BPH symptoms are defined as total IPSS ≥8 to <20; severe symptoms as total IPSS ≥20.
† The IIEF is a 4-week recall questionnaire. The EF domain of the IIEF score ranges from 0 to 30. Higher IIEF-EF scores reflect better erectile function. 1.
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.
Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
Casabé A, Roehrborn CG, Da Pozzo LF, et al. Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. J Urol. 2014;191:727-733.
Barry MJ, Fowler FJ Jr, O’Leary MP, et al; and The Measurement Committee of the American Urological Association. The American Urological Association symptom index for benign prostatic hyperplasia. J Urol. 1992;148:1549-1557.
Data on file. Lilly USA, LLC. CIA20131017A.
Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol. 2008;180:1228-1234.
Porst H, Kim ED, Casabé AR, et al. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol. 2011;60:1105-1113.
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