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CAVERJECT 20 MICROGRAM POWDER FOR SOLUTION FOR INJECTION

Active substance(s): ALPROSTADIL / ALPROSTADIL

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Patient Information Leaflet

Caverject® 20 microgram 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 20 microgram powder for
solution for injection but will be referred to as Caverject
throughout the remainder of this leaflet.
Your medicine is also available in the following strengths 5
microgram, 10 microgram and 40 microgram.
In this leaflet:
1. What Caverject is and what it is used for
2. Before you use Caverject
3. How to use Caverject
4. Possible side effects
5. How to store Caverject
6. Further information
1. What Caverject is and what it is used for
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.
Do not use any Caverject until your doctor says that it is right for
you.
Take special care with Caverject Dual Chamber
Tell your doctor before using Caverject Dual Chamber 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)

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.
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.

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.

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.

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

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 1 mmol sodium (23 mg) 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.

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.

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.
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.

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.

How do you do the injection?
• 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.

• If recommended by your prescriber wipe the skin over this area

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.

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.

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.

• 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
Ensure that the syringe, vial and needles are disposed of in a
closed, puncture-resistant 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.
How often can you use Caverject?
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.
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.
Very common side effects
(occurring in more than 1 in 10 patients)

Pain in the penis

Uncommon side effects
(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 sight 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).
Not known
(frequency cannot be estimated from available data)

Insufficient blood flow to the heart muscle via the coronary
arteries

Stroke.

5. How to store Caverject
Do not store above 25ºC. Store in the original container.
Keep out of the sight and reach of children.
When you have mixed the Caverject Powder with the solution,
use it straight away. Do not keep it to use later.
For single use only. Any unused Caverject should be discarded.
Do not use Caverject if the injection is cloudy or contains
particles.
Do not use any Caverject after the ‘use-by’ date on the pack. The
expiry date refers to the last day of that month.
If the powder or solution shows any signs of discolouration or
deterioration consult your pharmacist for advice.
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 20 micrograms of alprostadil.
The other ingredients are lactose monohydrate, alphacyclodextrin, sodium citrate, hydrochloric acid, and sodium
hydroxide. The syringe contains benzyl alcohol and water for
injections. The antiseptic pads are soaked in isopropyl alcohol.
What Caverject looks like and contents of the pack
In the Caverject box you will find 5 items
1. One glass syringe containing 1 ml of a clear solution
2. One glass vial with a brown stopper containing 20 micrograms
as an off-white powder with white tamper evident cap.
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 - cleaning wipes
This medicine is manufactured by Pfizer Manufacturing Belgium
N.V./ S.A. Rijksweg 12, B-2870 Puurs, Belgium. Procured from
within the EU. Product Licence Holder: Quadrant
Pharmaceuticals Ltd. Lynstock House, Lynstock Way, Lostock,
Bolton BL6 4SA. Repackaged by Maxearn Ltd. Bolton BL6 4SA.
PL 20774/1248 Caverject 20 microgram powder for solution for
injection
POM

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 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.

Leaflet prepared 25th April 2017
Caverject is a registered trademark of Pharmacia & Upjohn
Company LLC

PP4/1248/V3

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Is this leaflet hard to see or read?
Phone Quadrant Pharmaceuticals
Ltd, Tel: 01204 473081

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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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