Patient Information Leaflet

Caverject ® Powder for Injection 40 micrograms
alprostadil

PHARMACIA

This leaflet is a summary of information about Caverject Powder for Injection. Please read it before you start using the injection. If you have any questions after you have read it, speak to your doctor or pharmacist. Keep the leaflet safely as you may need it again.

Caverject is a powder for solution for injection.

What is in your Caverject box?

In the Caverject blue box you will find 6 items.

1 One glass vial containing Caverject 40micrograms

The active ingredient in Caverject is 'alprostadil'. Each vial contains 40micrograms of alprostadil. It also contains the inactive ingredients lactose, sodium citrate, hydrochloric acid and sodium hydroxide.

Caverject Powder is made by Pharmacia NV/SA Puurs, Belgium

2 One glass syringe containing 1mL of a clear solution - Bacteriostatic water for injections.

The syringe contains benzyl alcohol and water for injections. Pharmacia NV/SA Puurs, Belgium and Vetter Pharma-Fertigung GmbH & Co. KG Ravensburg Germany

are manufacturers of the solution in the syringe.

3 One larger 22 gauge needle - 1½ inches long with a grey plastic end.

4 One small 30 gauge needle - 0.5 inch long with a yellow plastic end.

5 Two antiseptic pads (Medi-Swab skin cleansing wipes)

The antiseptic pads are soaked in isopropyl alcohol.

6 One red plastic plug

How does Caverject work?

The alprostadil in Caverject is similar to the natural substance in your body called prostaglandin E1. It widens blood vessels so that blood can flow in your penis more easily. This makes it easier for you to have an erection.

What is Caverject for?

Caverject is for 'erectile dysfunction' including weak erections or impotence. Your doctor may also use it to help find the exact cause of your erectile dysfunction along with other tests.

Before you use Caverject

Is Caverject suitable for you?

You should not use this injection if you have:

• ever had a bad reaction to Caverject, or any other medicines containing alprostadil or any of the other ingredients listed above.
• sickle cell disease, leukaemia, multiple myeloma (bone cancer) or any other problem which means that you get 'priapism'. This is when your erection lasts for a long time.
• an implant in your penis.
• a condition (such as very severe heart disease) in which sexual activity should be avoided
• a penis which is scarred or not straight.
• a tight foreskin.

Do not use any Caverject until your doctor says that it is right for you.

Are you taking any other medicines?

Do not use other medicines for erectile dysfunction at the same time as Caverject. Ask your doctor or pharmacist for advice if you are taking 'anticoagulants' to thin your blood. You might bleed abnormally when you do the injection. Make sure that your doctor knows about any other medicines you are taking, including ones you have bought for yourself at the chemist, BEFORE you start using Caverject.

Important information

Pregnancy

Caverject can be used by couples wishing to conceive and with a partner who is pregnant or breastfeeding. It will not protect your partner from pregnancy, so you should use a reliable contraceptive if appropriate.

Sexually transmitted diseases

Caverject will not protect you or your partner from sexually transmitted diseases like AIDS, herpes and gonorrhoea. Injection of Caverject can start a small amount of bleeding where the needle enters. This could increase the risk of transmission of such diseases. Condoms can protect against sexually transmitted diseases. If you need advice about contraception or 'safe sex' speak to your doctor or contact your local Family Planning Clinic.

Using Caverject

A doctor or nurse will show you how to do the injection for AT LEAST the first time. Do not try to do it yourself until you have learnt the correct way or if you can't remember what to do, see your trainer again. These instructions are a reminder only. Keep Medi-Swab away from the eyes.

How much Caverject should you inject?

Different people need different amounts of Caverject to treat erectile dysfunction. The starting dose is 1.25 - 2.5 micrograms. Most men find that a dose of 5 - 20 micrograms is right for them, however, some men may require a higher dose. You should never use more than 60 micrograms in one injection. If Caverject is being used to find the reason for your erectile dysfunction, the dose will be 5 - 20 micrograms.

If the dose that has been prescribed for you does not work well enough, tell your doctor. Do not change your dose unless your doctor tells you to. If you forget how much to use, read the label on the pack or speak to your doctor.

How do you use Caverject?

These instructions are intended as a guide only; you should follow your prescriber's advice where it differs from this leaflet.

You and your partner

You may like your partner to be involved in preparing and/or giving the injection. If so, you should speak to your doctor about training for your partner. Wash your hands. Dry them on a clean towel. If your partner wishes to be involved in preparing or giving the injection, they should wash their hands too.

 

1. Check your pack

Make sure that the vial is the correct strength and the expiry date is still valid. The vial, syringe and needles all have protective covers. The flip-off cap on the vial can rotate; this is normal. Check that all the covers are on firmly and if they are not on properly, do not use them - take the whole pack back to your pharmacist. There are two needles in the pack:

• The larger 22 gauge needle with the grey end is used to mix the solution and Caverject Powder.
• The smaller and finer 30 gauge needle with the yellow end is used to inject the mixture into your penis.

	2. To prepare the vial.
	Flip the plastic cap off the vial. Wipe the rubbery top with one of the wet antiseptic pads.
	3. Fitting the needle to the syringe
	Hold the syringe and twist the white tamper evident cap to break the seal. Take the foil off the larger needle, (22 gauge) with the grey end, keeping the cover on. Join the needle to the syringe by turning the needle clockwise tightly onto the syringe, then remove the needle cover by pushing it away from the syringe with your thumb and forefinger.
	4. Mixing the solution with the powder.
	Push the needle through the rubbery middle of the vial top. Press the plunger down firmly to squirt all the solution onto the powder. Gently swirl the vial until all the powder has dissolved. If the mixture is cloudy or does not dissolve completely, do not use it. Never use tap water or any liquid other than the one supplied in the syringe. If you do not intend to use your injection immediately, replace the cover on the needle and put the vial and the syringe in the box provided. Store in a safe place at room temperature for up to 6 hours.
	5. Filling the syringe
	With the needle still inserted, turn the vial upside down. The needle should support the vial unaided. Make sure the needle tip is underneath the level of the liquid. Gently pull the plunger to draw all the mixture into the syringe. Pull the needle out of the vial.
	6. Changing to the injecting needle.
	Gently twist the larger needle anti-clockwise off the syringe. Put this and the empty vial in the blue box. Remove the smaller injecting needle, (30 gauge) with the yellow end, from its package, keeping the cover on. Twist the needle clockwise tightly onto the syringe, then remove the needle cover by pushing it away from the syringe with your thumb and forefinger.

7. Setting the dose

Tap the syringe gently to send any air bubbles to the top, then push the plunger to squeeze the air bubbles out, ensuring that at least one drop of solution comes out of the needle. Continue pushing until the plunger is exactly at the right mark for your dose. Your doctor will have shown you where this is.

Does Caverject have side effects?

When you first start using Caverject, you may find the injection leaves a small bruise. This should happen less often with practice.

IF ANY OF THE FOLLOWING SIDE EFFECTS BOTHER YOU OR YOU NOTICE ANY OTHER UNPLEASANT EFFECTS, TELL YOUR DOCTOR OR PHARMACIST BEFORE YOU USE CAVERJECT AGAIN.

2-4% of patients have found the following:

• Scarring or bending of the penis
• Headache or pain in the buttocks, tummy and between or in the legs
• Flu-like symptoms including blocked noses, painful sinuses, flu-like syndrome and breathing problems

1% or less of users have found the following side effects with Caverject:

• The area injected becomes inflamed or swollen and may itch, have a rash or bleed.
• The penis, testes or scrotum could be red, swollen or painful, or the penis could feel numb, your ejaculation may change or your foreskin could feel tight.
• The desire to pass urine more frequently than normal or difficulty in urinating. If Caverject is injected by mistake into the tube which carries urine out through the penis, some blood may appear in the urine or at the end of the penis.
• Dizziness, back or pelvic pain, general weakness, sickness, dry mouth.
• Changes in blood pressure and heart rhythm, faintness, shallow breathing and collapse could occur because of the injection itself.
• Skin itching or rash, increased sweating, eye sensitivity to bright light, impaired sense of touch, cold hands and feet.

If your erection goes on for longer than 4 hours, speak to the doctor who prescribed Caverect for you straight away. This may have been a doctor in a clinic or hospital, or your GP. If you cannot contact this doctor, go to a hospital casualty department, and show them the section below 'How to treat prolonged erection or priapism'.

How do you store Caverject?

• Do not store above 25°C.
• Keep the syringe and needles in a safe place where children cannot reach them.
• When you have mixed the Caverject Powder with the solution, you can keep it for up to 6 hours at room temperature (below 25°C). Do not refrigerate or freeze.
• For single use only. As soon as you have used any of the Caverject, wash the rest away down the sink.
• Do not use any Caverject after the 'use-by' date on the pack.

Important information

• Caverject can only be prescribed by a doctor. Do not let anyone else use your Caverject even if they have the same problem as you.
• Never let anyone else use your needles. Always put them in the blue box after use, and seal the box.

Note for doctors only

Instructions for doctors on treating prolonged erection or priapism

The treatment of priapism (prolonged erection) should not be delayed more than 6 hours. Initial therapy should be by penile aspiration. Using aseptic technique, insert a 19 - 21 gauge butterfly needle into the corpus cavernosum and aspirate 20-50mL of blood. This may detumesce the penis. If necessary, the procedure may be repeated on the opposite side of the penis until a total of up to 100mL blood has been aspirated. If still unsuccessful, intracavernous injection of alpha-adrenergic medication is recommended. Although the usual contra-indication to intrapenile administration of a vasoconstrictor does not apply in treatment of priapism, caution is advised when this option is exercised. Blood pressure and pulse should be continuously monitored during the procedure. Extreme caution is required in patients with coronary heart disease, uncontrolled hypertension, cerebral ischaemia and in subjects taking monoamine oxidase inhibitors. In the latter case, facilities should be available to manage a hypertensive crisis. A 200microgram/mL solution of phenylephrine should be prepared and 0.5 to 1.0mL of the solution injected every 5 to 10 minutes. Alternatively, a 20microgram/mL solution of epinephrine should be used. If necessary, this may be followed by further aspiration of blood through the same butterfly needle. The maximum dose of phenylephrine should be 1mg, or epinephrine 100micrograms (5mL of the solution).

As an alternative, metaraminol may be used, but it should be noted that fatal hypertensive crises have been reported. If this still fails to resolve the priapism, urgent surgical referral for further management, which may include a shunt procedure, is required.