Caverject (Alprostadil)

• Helps with erectile dysfunction
• Produces an erection immediately, even without sexual stimulation
• Self-injectable treatment
• Not to be used more than once a day and no more than three times a week

CAVERJECT contains the active ingredient alprostadil, which belongs to a class of medicines known as prostagladins. Prostagladins are naturally occurring fatty acids in the body. Alprostadil causes the blood vessels to widen and slightly reduces the ability of the blood to clot. CAVERJECT produces an erection when injected into the blood-filled spaces of the penis.

CAVERJECT is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic or psychogenic factors, or due to the combination of them.

Always use this medicine exactly as your doctor or pharmacist has told you. When in doubt, ask your doctor or pharmacist.

Your doctor will determine the appropriate dose of alprostadil. The initial dose of alprostadil is usually around 1.25 to 5 microgram. The amount of medication will be increased until the lowest effective dose is reached.

After an injection, you are likely to have an erection for about an hour. If your erection lasts longer, consult your doctor. Erection should occur within 20 to 30 minutes after injection. Do not exceed the maximum daily dose of 60 mg. CAVERJECT should be used no more than once a day and no more than three times a week.

INSTRUCTIONS FOR PREPARING THE SOLUTION It is important to inject a sterile dose of CAVERJECT. Your doctor will teach you the correct technique for doing this. It is important to follow your doctor's instructions and the instructions provided below.

1. Wash your hands thoroughly and dry them with a clean towel.
2. Remove the plastic top of the cap of the vial with powder. (Do not remove the cap itself!) Wipe the rubbery top with one of the alcohol pads. Discard the pad afterwards.
3. Proceed as follows depending on which CAVERJECT pack you are using.

CAVERJECT pack: vial with powder + ampoule with diluent

• Open the ampoule with diluent as indicated in the figure. (Make sure the tip faces towards you.)
• Place the opened ampoule in a safe, clean place.
• Press the larger needle (22 G 1 1/2 inch) onto the tip of the syringe and remove the needle cover.
• Slowly pull the syringe plunger down to withdraw the full contents of the vial (1 ml).

CAVERJECT pack: vial with powder + pre-filled syringe with diluent

• Remove the larger needle (22 G 1 1/2 inch) from its package, keeping the plastic cover on.
• Break the white seal on the top of the pre-filled syringe.
• Join the needle with cover to the pre-filled syringe.
• Remove the needle cover.

1. Push the needle through the rubbery middle of the vial top. Press the plunger down firmly to squirt all the solution onto the powder.
2. Without pulling the plunger back, gently swirl the vial until all the powder has dissolved.

The solution is now ready to be injected.

INJECTING THE SOLUTION INTO THE PENIS The first injection will be given by your doctor. It is very important that your doctor teaches you the correct technique for administering the injections. Do not try to administer CAVERJECT yourself until you have learned the correct way. The following instructions are a reminder only.

• Withdraw the prescribed dose of solution from the vial by slowly pulling the syringe plunger down.
• Separate the needle from the syringe. (The needle stays in the vial. Do not pull the needle out.)
• Join the shorter injecting needle (30 G 1/2 inch) to the syringe and remove the needle cover.
• Hold the syringe upright for several seconds and slowly push the plunger to squeeze the air
• bubbles out, ensuring that a drop of solution comes out of the needle. Place the syringe on a hard, even surface. Make sure that nothing touches the exposed needle.
• Perform the self-injection procedure whilst sitting in an upright or slightly reclining position.
• If you are right-handed, hold the penis with your left hand, behind the head. If you are uncircumcised the foreskin must be pulled back before you inject the solution.
• Stretch your penis tightly against your thigh so that it does not slip during the procedure. Gently squeeze the penis between your thumb and finger so that the
• injection site bulges out towards the left. The injection will go into this part of the penis (shown as the shaded areas in the figure).
• With your right hand, wipe the skin over this area with the second alcohol pad and let it dry for a few seconds.
• Hold the penis straight with your left hand while injecting the solution. Taking the syringe in your free hand, push the needle straight through the skin all the way into the bulgy part, avoiding veins or other obvious blood vessels or structures.
• Push the plunger firmly and if the solution does not come out fairly easily, move the needle slightly and try again.
• Withdraw the needle from your penis. On the needle mark, press gently with the alcohol pad. Massage the penis to help the solution spread through it.

It is recommended to change the injection site after every injection. The CAVERJECT solution is for single use only. Any unused solution should be discarded. For more information on how to use CAVERJECT, please see the package leaflet.

CAVERJECT should not be used if:

• You are allergic to alprostadil or any of the ingredients in this medicine (see section 'What Caverject contains').
• You have sickle cell anaemia (a blood disease), leukaemia (cancer of the blood), multiple myeloma (bone cancer) or any other problem which increases the risk of getting priapism. This is a painful condition when your penis continues to remain erect.
• You have an anatomical deformation of the penis, such as severe curvature, paraphimosis, cavernosal fibrosis or Peyronie’s disease.
• You have an implant in your penis.
• You have a condition in which sexual activity is not advisable.

CAVERJECT should not be used in women, children and newborns.

When should CAVERJECT be used with caution?

CAVERJECT should be used with caution in men with a history of small temporary strokes (transient ischaemic attacks) or an unstable cardiovascular condition.

Sexual stimulation and intercourse can lead to heart and lung issues in patients with a heart condition, congestive heart failure or a lung disorder. CAVERJECT should therefore be used with caution in these patients.

For more warnings about the use of CAVERJECT, please see the package leaflet.

Other medicines and CAVERJECT

CAVERJECT should not be used in combination with any other treatment or medication for erectile dysfunction.

Medicines that mimic the stimulation of the sympathetic nervous system (sympathomimetics) may reduce the effect of CAVERJECT.

CAVERJECT may enhance the effects of anticoagulants and medicines that decrease blood pressure. People taking medicines to prevent blood clots (anticoagulants such as warfarin or heparin) may have an increased risk of bleeding after the injection.

CAVERJECT may cause side effects. The following are some of the side effects that are known to be associated with this medicine.

• Pain or discomfort in and around the penis.
• Muscle spasms.
• Prolonged erection, abnormal angulations of the erect penis, formation of fibrous tissue within the penis.
• Bruising or clotted blood in penis at site of injection.
• Fungal infection, common cold.
• Feeling faint, impaired or enhanced sense of touch, headache.
• Excessive dilation of the pupil.
• Cardiac arrhythmia.
• Vascular disease, low blood pressure, widening of blood vessels, blood vessel disorders, venous bleeding.
• Nausea, dry mouth.
• Redness, sweating, skin rash, itching.
• Back pain, pelvic pain, or pain in legs and/or stomach.
• Urinary problems.

Injecting CAVERJECT can lead to a prolonged erection that lasts four to six hours. Stop using CAVERJECT and call your doctor at once if you have and erection that lasts four hours or longer.

See the package leaflet for a complete list of side effects. Consult a doctor if the side effects are severe or if you experience side effects that are not listed on the leaflet.

The active ingredient in CAVERJECT is alprostadil. Each vial with powder contains 5, 10, 20 of 40 micrograms of alprostadil.

The other ingredients in CAVERJECT are:

• powder: lactose monohydrate, sodium citrate, hydrochloric acid, sodium hydroxide.
• diluent: benzyl alcohol (9 mg/ml) and water for injections.

The manufacturer of CAVERJECT is:

Pfizer Manufacturing Belgium, Rijksweg 12, 2870 Puurs, Belgium.

Read package leaflet closely before using CAVERJECT.