Dosing & Getting Patients Started

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

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

5 mg, 10 mg, 20 mg

The recommended starting dose of CIALIS 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*

*Counsel patients not to take CIALIS more than once each day.

Getting patients started

Discuss the potential benefits and risks of CIALIS for once daily use

Instruct patients on proper dosing and treatment expectations:

1 tablet every day

Instruct patients to take CIALIS for once daily use once a day, every day at about the same time 1
CIALIS may be taken with or without meals 1
Counsel patients not to drink alcohol in excess with CIALIS 1
Let patients know that they should avoid skipping doses or splitting tablets as they may not receive an adequate dose 1
If your patient misses a dose, he may take it when he remembers. However, remind him not to take CIALIS more than once each day 1

1 week to help improve ED

Men may respond differently. Your patients may be able to have successful intercourse within 4 to 5 days, or they may see results earlier, based on studies using the Sexual Encounter Profile question 3 2-4

1 month to help improve BPH symptoms

After beginning treatment, symptoms (as measured by the total International Prostate Symptom Score) may improve in as early as 2 weeks, although it could take about 4 weeks 1

Important information to share with patients (for more complete safety guidance direct patients to the Patient Information)

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 a guanylate cyclase (GC) stimulator, such as riociguat. PDE5 inhibitors, including CIALIS, may potentiate the hypotensive effects of GC stimulators.

Patients should stop sexual activity and get medical help right away if they experience symptoms such as chest pain, dizziness, or nausea during sex.

The most common side effects with CIALIS are headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Back pain and muscle aches usually go away within 2 days.

Important considerations

Food and alcohol consumption 1

CIALIS may be taken without regard to food
Both alcohol and CIALIS, a phosphodiesterase 5 (PDE5) inhibitor, act as mild vasodilators
When mild vasodilators are taken in combination, the blood pressure lowering effects of each individual compound may be increased
Substantial consumption of alcohol (eg, ≥5 units) in combination with CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache
CIALIS did not affect alcohol plasma concentrations and alcohol did not affect CIALIS plasma concentrations

Use in specific populations 1

CIALIS for once daily use

For ED
- Creatinine clearance <30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended
For BPH and ED+BPH
- 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 <30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended

CIALIS for use as needed for ED

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 <30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours

CIALIS for once daily use

Mild or moderate (Child-Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients
Severe (Child-Pugh Class C): The use of CIALIS is not recommended

CIALIS 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 CIALIS 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 CIALIS is not recommended

No dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered.

Select Important Safety Information Related to Geriatric Use

In placebo-controlled studies with CIALIS for use as needed for ED, diarrhea was reported more frequently (2.5%) in patients 65 years of age and older.

Concomitant medications 1

Nitrates: Concomitant use of nitrates in any form is contraindicated

ED: When CIALIS 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 CIALIS should be initiated at the lowest recommended dose
BPH: CIALIS is not recommended for use in combination with alpha-blockers for the treatment of BPH

CIALIS for use as needed: For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CIALIS is 10 mg, not to exceed once every 72 hours
CIALIS 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

For additional details on dosing and administration of CIALIS, see the full Prescribing Information.

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.

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.

Data on file. Lilly USA, LLC. CIA20110212A.

Data on file. Lilly USA, LLC. CIA20111213A.

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