Welcome to the Vitaros® for healthcare professionals

Vitaros® is a topical alprostadil formulation delivered in a drop of just 100µl and applied to the tip of the penis (meatus). It is indicated for the treatment of men ≥18 years of age with erectile dysfunction.1

Spot on

Vitaros® is spot on

Unlike other options, Vitaros® involves no pills, pellets or needles.2-8 It is simply a locally applied, rapidly acting, discreet drop of cream.1

  • Vitaros® combines 300μg of alprostadil with NexACT®-DDAIP1
  • Vitaros® is applied in moments, absorbed in seconds and active within 5 to 30 minutes1
  • Vitaros® may be appropriate for many patients, including those in whom oral therapies are not1-5
  • Vitaros® has no known interactions with food, alcohol or other medications1

All common adverse events are localised to the application site, are generally mild and of short duration​.1

How it works.

Vitaros® is applied to the tip of the penis (meatus), in moments, absorbed in seconds and gives an erection in 5 to 30 minutes.1 This happens because the permeation enhancer, NexACT®-DDAIP, allows alprostadil to get to work quickly.1

Application and action

A simple method of application

​No pills, no pellets, no needles. Simple and discreet, Vitaros® is spot on for ED.1

Topically applied, fast and effective. Vitaros® is spot on for ED.1

View the Mode of Action video here

Efficacy that’s spot on

Overall, 52% of men who used Vitaros® 300 μg over 12 weeks reported an improved erection vs. 20% using placebo (n=821).10 This is based on the Global Assessment Questionnaire (GAQ), where the patient either answers Yes or No to the question: “When using the study medication, did you feel your erections improved? 10,16

This improvement is similar in those patients with comorbidities such as diabetes mellitus, cardiovascular disease, hypertension, a prostatectomy, or even severe ED, compared to the general population.10,16

Primary endpoints were change in IIEF-EF and final visit responses to SEP2 (penetration success) and SEP3 (ejaculation success) at 12 weeks, each of which significantly improved vs. placebo (p<0.001).16

Safety information

The non-systemic application of Vitaros® means it has no known drug-drug interactions and they are considered unlikely. It is not known to be affected by food, alcohol or other medication (e.g. nitrates).1​-5

All common (>1/100, <1/10) side effects of Vitaros® 300µg treatment are localised to the application site and are generally mild and of short duration1,17​

In males

  • Rash
  • Urethral pain
  • Penile burning
  • Penile erythema
  • Genital pain
  • Genital discomfort
  • Genital erythema
  • Erection increased
  • Prurits genital
  • Penile oedema
  • Balanitis
  • Penile tingling
  • Penile throbbing
  • Penile numbness

Partners

  • Vulvovaginal burning sensation

 

The use of a latex condom is recommended to reduce the risk of partner side effect1

Vitaros® should not be used in:

Patients with underlying disorders such as orthostatic hypotension, myocardial infarction (within ≤6 months)16 and syncope or in patients with unstable cardiovascular or unstable cerebrovascular disease for whom sexual activity is inadvisable.1

Patients who have any known conditions that may predispose them to priapism, which is a serious condition that requires prompt treatment by a physician.1

References & Definitions

References

  1. Vitaros® Summary of Product Characteristics. Accessed via www.medicines.org.uk
  2. Sildenafil (Viagra®) Summary of Product Characteristics. Accessed via www.medicines.org.uk
  3. Tadalafil (Cialis®) Summary of Product Characteristics. Accessed via www.medicines.org.uk
  4. Vardenafil (Levitra®) Summary of Product Characteristics. Accessed via www.medicines.org.uk
  5. Avanafil (Spedra) Summary of Product Characteristics. Accessed via www.medicines.org.uk
  6. Alprostadil (Caverject®) Summary of Product Characteristics. Accessed via www.medicines.org.uk
  7. Alprostadil (Viridal Duo®) Summary of Product Characteristics. Accessed via www.medicines.org.uk
  8. Costa P and Potempa A-J. Drugs 2012; 72(17): 2243-54.
  9. Padma-Nathan H and Yeager JL. Urology 2006; 68: 386-391.
  10. Rooney M et al. J Sex Med 2009; 6: 520–534.
  11. Wolka AM et al. International Journal of Pharmaceutics 2004; 271: 5–10.
  12. Meier-Davis SR. J Pharm Drug Deliv Res 2012; 1: 1.
  13. Nunes KP and Webb RC. Erectile Dysfunction – Disease-Associated Mechanisms and Novel Insights into Therapy. InTech 2012. Chapter 1. DOI: 10.5772/1195.
  14. Buyuktimkin S et al. Pharmaceutical Research 1993; 10: 1632–37.

Definitions

IIEF: International index of erectile function
A 15-question investigation used in the clinical assessment of ED and treatment outcomes in clinical trials. A score of 0-5 is awarded to each question that examines the 4 main domains of male sexual function: erectile function (EF), orgasmic function, sexual desire and intercourse satisfaction. Severe ED (score = 6–10), moderate ED (score = 11–16), mild-to-moderate ED (score = 17–21), or mild ED (score = 22–25).

SEP2: Sexual encounter profile question 2, “Were you able to insert your penis into your partner’s vagina? (Yes or No).”

SEP3: Sexual encounter profile question 3, “Did your erection last long enough for you to complete intercourse with ejaculation? (Yes or No).”

GAQ: Global Assessment Questionnaire (GAQ), “When using the study medication, did you feel your erections improved? (Yes or No).”