Dosing & Getting Patients Started

Dosing recommendations

ED+BPH

5 mg

  • The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity*

Efficacy in ED+BPH

ED

2.5 mg, 5 mg

  • 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*

Efficacy in ED (once daily use)

BPH

5 mg

  • 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

Efficacy in BPH

ED

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*

Efficacy in ED (for use as needed)

*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

Refer to Patient Counseling Information in the Prescribing Information

Instruct patients on proper dosing and treatment expectations:

Rx

1 tablet every day

  • Instruct patients to take CIALIS for once daily use once a day, every day at about the same time1
  • CIALIS may be taken with or without meals1
  • Counsel patients not to drink alcohol in excess with CIALIS1
  • Let patients know that they should avoid skipping doses or splitting tablets as they may not receive an adequate dose1
  • If your patient misses a dose, he may take it when he remembers. However, remind him not to take CIALIS more than once each day1
Week

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 32-4
Month

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 weeks1

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

Food and alcohol consumption1

  • 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 populations1

Renal impairment

Renal impairment

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
Hepatic impairment

Hepatic impairment

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
Geriatric use

Geriatric use

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

Concomitant medications1

Nitrates: Concomitant use of nitrates in any form is contraindicated

Alpha-blockers:

  • 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

CYP3A4 inhibitors:

  • 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.


References

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

  2. 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.

  3. Data on file. Lilly USA, LLC. CIA20110212A.

  4. Data on file. Lilly USA, LLC. CIA20111213A.