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CAVERJECT 10MICROGRAMS POWDER FOR SOLUTION FOR INJECTION

Active substance(s): ALPROSTADIL / ALPROSTADIL / ALPROSTADIL

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Patient Information Leaflet

Caverject® 10 micrograms powder for solution for injection
(alprostadil)
Read all of this leaflet carefully before you start using this medicine.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It
may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Caverject 10 micrograms powder for solution for
injection but it will be referred to as Caverject throughout this leaflet.
Please note that this leaflet also contains information about other strengths Caverject
20 micrograms and 40 micrograms powder for solution for injection.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Caverject is and what it is used for
Before you use Caverject
How to use Caverject
Possible side effects
How to store Caverject
Further information

1. What Caverject is and what it is used for

Most men find that a dose of 5 - 20 micrograms is right for them, however, some men
may require a higher dose. To minimise the risk of prolonged painful erection, your
doctor will select the lowest effective dose. You should never use more than
60 micrograms. 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.

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.
If a needle is bent do not use it.
2. To prepare the vial
Flip the plastic cap off the vial. Wipe the rubbery top with one of the wet antiseptic pads.

Caverject contains alprostadil which 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.
Caverject is used 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.

2. Before you use Caverject
Do not use Caverject if you:








are allergic (hypersensitive) to Caverject or any other medicines containing
alprostadil or any of the other ingredients of Caverject.
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.
have an implant in your penis.
have a condition (such as severe heart disease) in which sexual activity should be
avoided.
have a penis which is scarred or not straight.
have a tight foreskin.

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.

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

Take special care with Caverject
Tell your doctor before using Caverject if you:
• have a lung, chest or heart disorder (in these cases you also should engage in
sexual activity with caution)
• have a history of mental illness or addiction
• have had a mini-stroke (transient ischaemic attack)
• have one or more cardiovascular risk factors (these might include high blood
pressure, tobacco use, raised blood glucose, raised blood cholesterol, overweight
and obesity)
• have one or more risk factors for stroke (these might include high blood pressure,
raised blood cholesterol, coronary artery disease, heart arrhythmia, diabetes)

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.

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.

Taking other medicines
Tell your doctor if you are taking any of the following medicines before you start using
Caverject:
• medicines used for treating high blood pressure (antihypertensives)
• medicines used for respiratory and heart disease (sympathomimetics)
• medicines that widen blood vessels (vasodilative agents)
• other medicines for erectile dysfunction such as sildenafil or papaverine
• medicines to thin your blood such as warfarin or heparin, as you might bleed more
when you do the injection.

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.

Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

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

Driving and using machines
Caverject should not affect your ability to drive or use machines.

Important information about some of the ingredients of Caverject
Caverject contains benzyl alcohol which may cause allergic reactions.
This medicine contains less than 1mmol sodium (23mg) per dose and is essentially
‘sodium-free’.

3. How to use 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 the antiseptic swab away from the eyes.

How much Caverject should you inject?
Different people need different amounts of Caverject to treat erectile dysfunction. Your
doctor will advise on the right dose for you and monitor you regularly to check how it is
working. The starting dose is 1.25 - 2.5 micrograms.

6. Changing to the injecting needle
Gently twist the larger needle anticlockwise off the syringe. 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.

(occurring in more than 1 in 10 patients)
• Pain in the penis

How do you do the injection?

(occurring in less than 1 in 100 patients)
• The area injected becomes irritated, inflamed or swollen and may itch or bleed, or
feel numb, warm, tender or painful
• The testes or scrotum could become red, swollen or painful, or develop lumps
called spermatocele, which are cysts containing sperm. The penis could feel numb
• You may get uncomfortable, painful or prolonged erections or none at all, your
ejaculation may change or your foreskin could feel tight or swollen, as well as the
head of your penis
• The desire to pass urine more urgently or frequently than normal or you may have
pain or difficulty in urinating. Some blood may appear in the urine or at the end of
the penis especially if Caverject is injected by mistake into the tube which carries
urine out through the penis (urethra)
• Pelvic pain, weakness, sweating, feeling sick or swollen legs or arms, having a
common cold or dry mouth. You may get a yeast infection (thrush)
• Changes in blood pressure and heart rhythm, faintness, shallow breathing and
collapse could occur because of the injection itself
• Skin itching, redness of the skin at site of injection, rash or skin growth, increased
sweating, eye sensitivity to bright light or excessive dilation of the pupil (blown
pupil), impaired or enhanced sense of touch, leg cramps, cold hands and feet,
venous problems including bleeding (bleeding from vein(s))
• If you have a blood test you may have raised levels of creatinine (a substance
found in your muscles).

Very common side effects

Common side effects
(occurring in less than 1 in 10 patients)
• Penis can become bruised, scarred, bent or kinked, particularly after long term use.
Tell your doctor if this happens as you may need to stop Caverject.
• Prolonged erections
• Other problems with your penis
• Swelling and skin discolouration or bruising at site of injection. You may find this
happening the first time you use Caverject but should occur less often with practice
• Muscle spasms.

Uncommon side effects







Get undressed and make yourself comfortable. Take some time to relax yourself
and your partner. If your prescriber has recommended use of the second antiseptic
pad, open it now.
Make sure that the injection needle is not bent. A bent and re-straightened needle
is more likely to break. Needle breakage, with a portion of the needle remaining in
the penis, has been reported and, in some cases, required hospitalisation and
surgical removal. If the needle is bent, do not use it and throw it away. Do not
attempt to straighten it out. Attach a new, unused sterile needle to the syringe.
Take hold of the penis from the front, with the first two fingers underneath close to
the testicles and the thumb on top. Gently squeeze the penis between your thumb
and finger so that the injection site bulges out. If there is a foreskin on the penis,
make sure it is stretched. The injection will go into the part of the penis shown as
the shaded area in diagram A.

Not known
(frequency cannot be estimated from available data)
• Insufficient blood flow to the heart muscle via the coronary arteries
• Stroke.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report any side effects
directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Caverject



If recommended by your prescriber wipe the skin over this area with the second
pad and let it dry.
Keeping a firm grip on the penis and 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. The angle is shown in diagrams B and C. Push the
plunger firmly and if the Caverject does not come out fairly easily, move the needle
slightly and try again. Do not force the Caverject liquid from the syringe.

Keep out of the sight and reach of children.
Do not store above 25°C.
Reconstituted solution should be used immediately and not stored.
Do not keep it to use later on.
For single use only. Any unused solution should be discarded.
If the medicine becomes cloudy or shows any signs of deterioration, seek the advice of
your pharmacist.
Do not use the medicine after the expiry date which is stated on the carton and vial
labels after ‘Exp’. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.

6. Further information
What Caverject contains
The active ingredient in Caverject is alprostadil.
Each vial contains 10micrograms of alprostadil.
The other ingredients are:
Powder contains: lactose monohydrate, alpha cyclodextrin, sodium citrate, hydrochloric
acid and sodium hydroxide.
Syringe contains benzyl alcohol and water for injections. The antiseptic pads are
soaked in isopropyl alcohol.





Pull the needle out. On the needle mark, press gently with the pad or your thumb,
as recommended by your prescriber. Massage the penis to help the Caverject
spread through it.
Do not keep any mixture in the syringe to use for a second injection.

How to throw away the syringe and needle safely

What Caverject looks like and contents of the pack
In each box there are 5 items:
One glass vial containing white lyophilised powder for injections.
One glass syringe containing 1ml of clear solution
One needle-22 gauge (1½ inches long-clear grey needle end)
One needle-27 gauge (half inch long-opaque grey needle end)
Two antiseptic pads
Manufactured by: Pfizer Manufacturing Belgium N.V./S.A., Rijksweg 12, B-2870
Puurs, Belgium.

Ensure that the syringe, vial and needles are disposed of in a closed, punctureresistant container such as a sharps bin. Ask your doctor or pharmacist for instructions
on how to properly dispose of the container after use if you are at all unsure.

Procured from within the EU and repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

How often can you use Caverject?

Leaflet date: 02.05.2017

Do not use Caverject more than once in 24 hours or more than three times in a week.
Change the exact place and side of the penis that you inject Caverject each time you
use it.

Caverject is a registered trademark of Pharmacia & Upjohn Company and LLC.

Your erection after injecting Caverject
It will take a little while for your erection to come on after the injection. With the right
dose of Caverject, your erection should be strong enough for you and your partner to
enjoy lovemaking. Usually, your erection should not last longer than an hour. If you
would like it to last longer, talk to your doctor. If your erection lasts longer than four
hours you should seek medical advice (see the section on side effects below).

What if you use too much Caverject
Tell your doctor straight away as you may need treatment, particularly if you
experience an erection that lasts for longer than four hours.
If you have any further questions on how to use this product, ask your doctor.

4. Possible side effects
Like all medicines, Caverject can cause side effects, although not everybody gets them.

Tell your doctor immediately if
your erection goes on for longer than 4 hours. If you cannot contact your doctor, go to
a hospital casualty department immediately as treatment should be started within
6 hours.

Caverject® 10 micrograms powder for solution for injection; PL 18799/2494
POM

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Is this leaflet hard to see or read?
Call 02085153763 to obtain the leaflet in a
format suitable for you.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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