Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Prolonged erection and/or priapism may occur following intracavernosal administration of alprostadil. To minimize the risk, select the lowest effective dose. Patients should be instructed to report immediately to a physician, or if unavailable to seek immediate medical assistance for any erection lasting for a prolonged time period, such as 4 hours.
Treatment of priapism should not be delayed more than 6 hours (please refer to section 4.9) and should be according to established medical practice.

Painful erection is more likely to occur in patients with anatomical deformations of the penis, such as angulation, phimosis, cavernosal fibrosis, Peyronie's disease or plaques.
Penile fibrosis, including angulation, cavernosal fibrosis, fibrotic nodules and Peyronie's disease may occur following the intracavernosal administration of alprostadil. The occurrence of fibrosis may increase with increased duration of use. Regular follow-up of patients, with careful examination of the penis, is strongly recommended to detect signs of penile fibrosis or Peyronie's disease. Treatment with alprostadil should be discontinued in patients who develop penile angulation, cavernosal fibrosis, or Peyronie's disease.

Patients on anticoagulants such as warfarin or heparin may have increased propensity for bleeding after the intracavernosal injection.

Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with alprostadil.


Use of intracavernosal alprostadil offers no protection from the transmission of sexually transmitted diseases. Individuals who use alprostadil should be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV). In some patients, injection of alprostadil can induce a small amount of bleeding at the site of injection. In patients infected with blood-borne diseases, this could increase the transmission of such diseases to their partner.

Alprostadil should be used with caution in patients with cardiovascular and cerebrovascular risk factors.Alprostadil should be used with caution in patients who have experienced transient ischaemic attacks or those with unstable cardiovascular disorders.

Sexual stimulation and intercourse can lead to cardiac and pulmonary events in patients with coronary heart disease, congestive heart failure or pulmonary disease. These patients when using alprostadil should engage in sexual activity with caution.

Alprostadil is not intended for co-administration with any other agent for the treatment of erectile dysfunction (see also 4.5).

The potential for abuse of alprostadil should be considered in patients with a history of psychiatric disorder or addiction.

Caverject uses a superfine needle for administration. As with all superfine needles, the possibility of needle breakage exists.

Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalisation and surgical removal.

Careful patient instruction in proper handling and injection techniques may minimise the potential for needle breakage.

The patient should be instructed that, if the needle is bent, it must not be used; they should also not attempt to straighten a bent needle. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.

Reconstituted solutions of alprostadil are intended for single use only, they should be used immediately and not stored. The syringe and any remaining solution should be properly discarded.

Excipient information

Benzyl alcohol
Caverject contains benzyl alcohol, which may cause hypersensitivity reactions.
The combined daily metabolic load of benzyl alcohol from all sources should be considered, especially in patients with liver or kidney impairment because of the risk of accumulation and toxicity (metabolic acidosis).
This medicine is only indicated for intracavernosal injection. Intravenous administration of the preservative benzyl alcohol has been associated with serious adverse events, and death in paediatric patients including neonates (“gasping syndrome”). The minimum amount of benzyl alcohol at which toxicity may occur is not known.
Premature and low-birth weight infants may be more likely to develop toxicity. Caverject is not indicated for paediatric use.

Sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.

Effects on Driving

4.7      Effects on ability to drive and use machines

Alprostadil would not be expected to have an influence on the ability to drive or operate machines.