VITAROS

Vitaros is applied to the tip of the penis. Vitaros should be used as needed to achieve an erection. Each Vitaros AccuDose container is for single use only and should be properly discarded after use. The onset of effect is within 5 to 30 minutes after administration.

The duration of effect is approximately 1 to 2 hours. However, the actual duration will vary from patient to patient. Each patient should be instructed by a medical professional on proper technique for administration of Vitaros prior to self-administration.

The maximum frequency of use is no more than 2-3 times per week and only once per 24-hour period. The initial dose should be recommended by a physician. A starting dose with the 300 mcg dose can be considered especially in patients with serious ED, co-morbidity or failure to PDE-5 inhibitors.

Those patients that do not tolerate the 300 mcg dose due to local side effects can be titrated to the lower 200 mcg dose. , dizziness, fainting) and the need to avoid operating machinery until one is aware of their tolerance to the drug.

In the clinical trial there was a higher withdrawal rate in the 300 mcg treated group compared to the 200 mcg group, 30% compared to 20% respectively.

Method of administration:

It is recommended to urinate before applying the drug. After removing the cap, apply all the contents of Vitaros into the opening at the tip of the penis (meatus) 5 to 30 minutes before attempting intercourse by following the instructions below: 1.

Wash your hands before applying Vitaros. Remove the AccuDose container (see Fig. 1) from the sachet by tearing fully down the seal from the middle of the top edge. Save the sachet for discarding the used AccuDose container later. 2. Bring the contents of the single-dose container to room temperature by rolling the container between your hands (see Fig.

2). 4 Special precautions for storage) and the contents have already reached room temperature. 3. Twist the plunger several times to make sure it will glide easily (see Fig. 3). Then remove the cap from the tip of the AccuDose container.

Fig. 1 Fig. 2 Fig. 3 4. Grasp the tip of the penis with one hand and gently squeeze to widen the opening at the tip of the penis, while holding it in an upright vertical position (see Fig 4) (Note, if you are not circumcised, first retract and hold the foreskin back prior to widening the opening at the tip of the penis).

5. Hold the barrel of the AccuDose container between your fingers and without inserting it inside the penis (see Fig. 5), place the tip of the container as close as possible to the opening at the tip of the penis for the cream to go down the urethra (the tube that leads from the bladder and transports and discharges urine and semen outside the body).

Remember to push out all the cream from the AccuDose container. Slowly, but firmly, push down the plunger with your thumb or finger until all the cream is expelled into the opening at the tip of the penis and down the urethra.

Note:

While it is important that all the cream goes down the urethra, take care not to insert the tip of the AccuDose container into the opening at the tip of the penis. 6. Hold the penis in an upright position for approximately 30 seconds in order to allow the cream to penetrate.

There will likely be some cream that does not initially fit into the opening at the tip of the penis. Any excess cream covering the opening at the tip of the penis should be gently moved into the opening with the tip of a finger (see Fig.

6). Do not use a second AccuDose to compensate for cream not expelled into the opening at the tip of the penis. Do not urinate immediately after application, due to the risk that drug could come out before the effect takes place. 7. Remember, each Vitaros dose is suitable for a single administration only.

Replace the cap on the tip of the AccuDose container and place in the opened sachet, fold and discard in accordance with local requirements. 8. Vitaros may be irritating to the eyes. Wash your hands after applying Vitaros.

Tabulated list of adverse reactions The most frequently reported adverse events in treatment with Vitaros are presented in the table below. (Very common ≥ 1/10; Common ≥ 1/100, <1/10; Uncommon ≥1/1000, <1/100; Rare ≥1/10000, <1/1000; Very rare <1/10000) Priapism (an erection lasting longer than 4 hours) is a serious condition that requires prompt treatment by a physician.

4) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

uk/yellowcard.

Local effects:

Prolonged erections lasting > 4 hours (priapism), although rare, were observed with the use of Vitaros. 1%) in the 300 mcg groups. If priapism occurs, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

5%) at the 100, 200 and 300 mcg alprostadil doses, respectively, during dosing in the Phase 3 studies. Patients should be cautioned to avoid activities, such as driving or hazardous tasks, where injury could result if hypotension or syncope occurs after Vitaros administration.

Before initiation of treatment with Vitaros, causes of erectile dysfunction, that are treatable, should be excluded by appropriate diagnostic methods. 3). Clinical studies have not been conducted in patients with a history of neurological disease or spinal injury.

The pharmacokinetics of Vitaros has not been formally studied in patients with hepatic and /or renal insufficiency. The dose may need to be lowered in these populations due to impaired metabolism.

General Precautions:

Vitaros should be applied according to the instructions above. Inadvertent intraurethral exposure may result in penile burning or tingling sensation and pain. Repeated longer term intraurethral exposure of Vitaros is unknown. Patients should be informed that Vitaros offers no protection from the transmission of sexually transmitted diseases.

Patients and partners who use Vitaros need to be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted agents, including the human immunodeficiency virus (HIV). Health care professionals should encourage their patients to inform their sexual partners that they are using Vitaros.

Partners of Vitaros users can experience adverse events, most commonly vaginal irritation. A condom barrier is therefore recommended. The effects of Vitaros on the oral or anal mucosa has not been studied. A condom barrier should be used for oral sex (fellatio) or anal sex.

Vitaros has no contraceptive properties. It is recommended that couples using Vitaros use adequate contraception if the female partner is of childbearing potential There is no information on the effects on early pregnancy of alprostadil at the levels received by the female partners.

A condom barrier should be used for sexual intercourse with women of childbearing age, pregnant or lactating women. Only latex material based condoms have been investigated together with its use and other materials may not exclude possible risk for occurrence of damage to the condom.

This medicine contains 5 mg alcohol (ethanol) in each 100 mg dose which is equivalent to 50 mg/g (5 %w/w). It may cause a burning sensation on damaged skin.

Vitaros should not be used in patients with any of the following: - Underlying disorders such as orthostatic hypotension, myocardial infarction and syncope. - Known hypersensitivity to alprostadil or any of the ingredients in Vitaros.

- Conditions that might predispose them to priapism, such as sickle cell anaemia or trait, thrombocythemia, polycythemia or multiple myeloma or, leukaemia. - Abnormal penile anatomy such as severe hypospadias, in patients with anatomical deformation of the penis, such as curvature, and in patients with urethritis and balanitis (inflammation/infection of the glans of the penis).

Fig. 4 Fig. 5 Fig. 6 - Prone to venous thrombosis or who have a hyperviscosity syndrome and are therefore at increased risk of priapism (rigid erection lasting 4 or more hours). - Vitaros should not be used in patients for whom sexual activity is inadvisable as in men with unstable cardiovascular or unstable cerebrovascular conditions.

- Vitaros should not be used for sexual intercourse with a woman with child-bearing potential unless the couple uses a condom barrier.