Alprostadil, Prostaglandin E1 (PGE1) 10 and 20 micrograms
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about CAVERJECT.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using CAVERJECT against the benefits it is expected to have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What CAVERJECT is used for
What CAVERJECT does
CAVERJECT may be prescribed by your doctor for the treatment of erectile dysfunction (inability to maintain an erection to have sexual intercourse).
CAVERJECT may also be used to help in the diagnosis of erectile dysfunction.
CAVERJECT contains alprostadil. Alprostadil is also known as prostaglandin E1 (PGE1) and is found naturally in many parts of your body.
How CAVERJECT works
CAVERJECT works by increasing the blood flow to the penis. The increased blood flowing into the penis is trapped in the spongy erectile tissue of the penis called the corpora cavernosa. When these chambers fill with blood they swell and your penis becomes erect.
CAVERJECT is injected into a specific area of the penis and should produce an erection in 5 to 20 minutes. The erection should last for about 30 to 60 minutes.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed CAVERJECT for another reason.
This medicine is available only with a doctor's prescription.
Before you are given CAVERJECT
When you must not use it
Do not use CAVERJECT if you have an allergy to:
any medicine containing alprostadil
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Do not use CAVERJECT if you have or have had any of the following medical conditions:
a penis which is scarred or not straight
you have painful erections (Peyronie's disease)
a penile implant
certain illnesses such as leukaemia, multiple myeloma, sickle cell anaemia or any other condition which causes your erection to last for a long time (Priapism)
abnormal thickening of the tissues of your penis
been advised not to have sex.
Do not give this medicine to women.
Do not give CAVERJECT to children or newborns.
CAVERJECT contains an ingredient called benzyl alcohol (see list of ingredients at the end of this leaflet). Benzyl alcohol has been associated with serious side effects which can be fatal in children, especially premature and low weight infants. Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should use this medicine, talk to your doctor.
Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor or your partner's obstetrician if your partner intends to become pregnant.
If you have not told your doctor about any of the above, tell him/her before you start taking CAVERJECT.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including:
all prescription medicines
all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.
Some medicines may be affected by CAVERJECT or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines. Your doctor will advise you.
Tell your doctor or pharmacist if you are taking any of the following:
medicine used to prevent blood clots, e.g., warfarin or heparin.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
The use of CAVERJECT offers no protection from sexually transmitted diseases or those caused by the human immunodeficiency virus (HIV) such as AIDS. Your doctor can give you more information about the type of protection you should use against these diseases.
You may also need to consider using appropriate contraception.
The injection of CAVERJECT can cause a small amount of bleeding at the site of injection. If you have any diseases that can be passed by blood, e.g., hepatitis B, there could be a higher chance of passing them onto your partner.
How to use CAVERJECT
CAVERJECT is a single use device. The syringe device should only be used to administer one dose and then discarded.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions provided at the end of this leaflet, ask your doctor or pharmacist for help.
How much to use
Your doctor will tell you how much CAVERJECT to use. This depends on your condition and whether or not you are taking any other medicines.
You should use CAVERJECT no more than once in a 24 hour period and not more than three times a week.
You should not use more than 3 vials for any one treatment.
You should not change your dosage without first talking to your doctor.
How long to use it
Continue using your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it.
If you use too much (overdose)
Remember to only use the amount of CAVERJECT that your doctor told you to use. If you use more CAVERJECT than your doctor has prescribed, your erection may last longer than is medically safe and may require medical intervention. You should contact your doctor if your erection lasts for more than four (4) hours.
Immediately telephone your doctor, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much CAVERJECT
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using CAVERJECT
Things you must do
Before you start on any new medicine, tell your doctor, pharmacist and dentist that you are using CAVERJECT.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If your partner becomes pregnant while you are using CAVERJECT, tell your doctor or your partner's obstetrician.
If you are about to have any blood tests, tell your doctor that you are using this medicine.
It may interfere with the results of some tests.
If you are being treated with warfarin or heparin (medicines that are used to stop your blood from clotting) you need to be aware of an increased chance of bleeding after injection.
An injection with CAVERJECT should produce an erection that lasts for 30 - 60 minutes and enables you to have sex.
Tell your doctor if your erection lasts for more than 60 minutes. Your dose may need to be reduced.
Keep all of your doctor's appointments so that your progress can be checked.
From time to time your doctor will need to examine the injection site to detect any abnormal thickening of the tissues of the penis. If this happens, your treatment with CAVERJECT will be stopped.
Always discuss with your doctor any problems or difficulties during or after using CAVERJECT.
Things you must not do
Do not use CAVERJECT to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop using your medicine or lower the dosage without checking with your doctor.
Do not use any mixture left in the syringe or vial for a second injection.
Do not use the needle to inject if it is bent (refer to notes at the end of this leaflet under the subheading "Injecting the Caverject solution").
Side effects
Check with your doctor as soon as possible if you have any problems while using CAVERJECT, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like many medicines, CAVERJECT may cause side effects. If they occur, they are likely to be minor and temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
These are common side effects of CAVERJECT. Mostly these are mild and short lived:
pain in the penis during erection
bruising at the site of injection.
Tell your doctor if you experience the following uncommon or rare side effects:
redness, swelling, bleeding and itching at the site of injection
localised pain (buttocks, leg, genital, back or pelvis)
leg cramps
numbness
increased sweating
increased feeling of pain or sensitivity, especially in the skin
yeast infection
inflammation of the head of the penis
tight foreskin
hardened areas developing at the site of injection. This can result in curvature of the penis
prolonged erection (lasting 4 to 6 hours). Additional instructions of what you can do if this happens are provided below.
abnormal ejaculation or painful erection
swelling, redness, pain of the scrotum
disorder of the testis (pain, warmth, swelling, thickening)
changes in your heartbeat or palpitations
changes in blood pressure
dizziness and headache
fainting
nausea, dry mouth
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 (urethra), some blood may appear in the urine or at the end of the penis
skin rash, redness, sensitivity, irritation, itchiness
dilated pupil.
Your doctor will check regularly that CAVERJECT is not causing abnormal thickening of the tissues of the penis. If this happens, your treatment with CAVERJECT will be stopped.
If your erection lasts for more than 1 hour, you should tell your doctor as your dose may need to be reduced.
If your erection lasts for more than 2 hours, try walking around, especially up and down stairs, emptying your bladder, or taking a hot or cold shower. You should avoid any further sexual activity.
Contact your doctor immediately if your erection lasts for 4 hours or more. This can be painful and may require medical treatment.
Other side effects not listed above may occur in some patients.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
After using CAVERJECT
Storage
Keep your unused packs of CAVERJECT vials in a cool dry place where the temperature stays below 25°C. Do not freeze. After dissolving the CAVERJECT powder, the solution of CAVERJECT should be used as soon as possible. If storage is necessary, store at 2°C - 8°C (Refrigerate. Do not freeze.) for not more than 24 hours after dissolving.
Care should be taken to avoid storing the product at temperatures above 25°C even when you travel.
Do not store CAVERJECT in checked luggage during air travel.
Do not store CAVERJECT or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
After using CAVERJECT, put all the injection material back into its original box and ask your pharmacist to dispose them safely. If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
CAVERJECT 10 microgram or CAVERJECT 20 microgram is available as a sterile freeze-dried powder. It is supplied in a clear glass vial. CAVERJECT is available in packs containing 1, 5 or 10.
*Not all pack sizes are available.
Ingredients
CAVERJECT powder for injection contains either 10 micrograms or 20 micrograms of the active ingredient, alprostadil (prostaglandin E1; PGE1).
The other ingredients are lactose, alfadex, sodium citrate, hydrochloric acid, sodium hydroxide.
The diluent in CAVERJECT contains Water for Injections and benzyl alcohol.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
