Intracavernous injection

therapy is the process

whereby a small amount
of a chemical is injected
directly into the corpora
cavernosa. These
chemicals are smooth
muscle relaxants and
thus help increase blood
flow into the penis. The
advantage of injection
therapy is that it does
not depend on oral
absorption, as pills do,
and does not depend on
absorption through the
tissues, as with MUSE. The disadvantage is that it requires a small injection. Most men are anxious when
they initially start with injection therapy but find that the procedure itself is usually not that
uncomfortable. In most patients who do not respond to first-line, oral therapy or who are not candidates
for oral therapy, injection therapy provides satisfactory erections.

The only FDA-approved chemicals for intracavernous injection therapy are Caverject (Pharmacia and
Upjohn, Kalamazoo, MI) and Edex (Schwarz Pharma, Monheim, Germany). Both of these agents are
prostaglandin E1. Other agents used alone or in combination are papaverine and phentolamine. All three
prostaglandin E1, papaverine, and phentolamine may be used in combination, and the combination is
referred to as triple P or trimix. Prostaglandin E1 and triple P are the two most common forms of
injection therapy used, and they each have unique advantages and disadvantages.

Who is a candidate for penile injection therapy?

Because the injection requires manual dexterity, it is important that the man be able to perform self-
injection. In some men for whom giving an injection may be difficult or who are anxious about pushing the
needle into the side of their penis, an autoinjector is available that makes this easier. Another option is to
have the mans partner perform the injection. Similarly, if the man is obese and has trouble seeing his
penis, self-injection may be difficult, and he would need to enlist the aid of his partner.

If a man has tried MUSE in the past and has had significant discomfort with it, then using Caverject/Edex
will only cause further discomfort. In this situation, it would be more appropriate to try triple P. In addition,
if the man has a known hypersensitivity or has had a prior reaction to prostaglandins, then Caverject/Edex
would not be appropriate, and depending on the severity of the reaction, he could consider using bimix
(papaverine and phentolamine only).
There are a number of conditions for which injection therapy might cause additional side effects. Men who
are prone to priapism, such as those with sickle cell disease or trait, multiple myeloma, and leukemia, are
at increased risk for priapism if they use this therapy. Men with Peyronies disease should be aware that
during the process of injection, there is local trauma to the tunica albuginea, which could theoretically
cause new plaques to form. Men taking blood thinners, such as warfarin (Coumadin) can use injection
therapy, but should apply pressure to the injection site for a minute or so to prevent a bruise. Men taking
an older type of antidepressant, a monoamine oxidase inhibitor such as Marplan, Nardil, Phenelzine, or
Parnate, should not use this therapy.

How does one perform penile injection therapy?

Before you start to use intracavernous injection therapy at home, you are test dosed in the office. Of all of
the therapies available, intracavernous injection therapy carries the highest risk of priapism, up to 2%.
Most cases of priapism occur with first use, during the test dosing, which is important because if you return
to your urologists office within 3 to 4 hours, the erection can easily be brought back down with just an
injection of another chemical. If your urologist is concerned about priapism, he or she may choose to
terminate your erection by injecting you with a chemical to stop the erection before you head home. Thus,
test dosing minimizes your risk of having a case of priapism at an inopportune time. Secondly, your
urologist can use the test dosing as a time for hands-on instruction, and you can be shown how to inject
and actually perform your first self-injection with guidance in the office. This is very important because the
first time you perform the injection therapy at home, you will be nervous, and remembering that you
performed the injection in the office may help you relax.

The needle that you use to inject is quite small and short. It does not need to pierce deeply into the penis,
just into the corpora on one side, for it to be effective (Figure 8). The syringe used is small also because
the volume that you will be injecting is usually 1 cc or less. After your initial test dose, your urologist will
decide on a dose that you will try initially at home. Do not get discouraged if this initial dose is not
adequate. Most of us would prefer to prescribe a dose that is too small and then increase it as needed in
order to avoid priapism.

Dosage and Volume Calculations for Injection Therapy

Using Prostaglandin E1 (Caverject, Edex)

Dose Volume

10 g/mL vial 20 g/mL vial 40 g/mL vial

1.0 g/0.10 mL 2.5 g/0.125 mL 10 g/0.25 mL

2.0 g/0.20 mL 5.0 g/0.25 mL 16 g/0.40 mL

2.5 g/0.25 mL 7.5 g/0.375 mL 20 g/0.50 mL

5.0 g/0.50 mL 10.0 g/0.50 mL 24 g/0.6 mL

7.5 g/0.75 mL 15.0 g/0.75 mL 30 g/0.75 mL

10.0 g/1.0 mL 20 g/1.0 mL 40 g/1.0 mL

When using injection therapy at home, you should keep several points in mind:

Look where you are going to inject to make sure that no superficial veins are in the area.
Gently wipe the area with an alcohol swab.
Always inject on the side of the penis toward the base. The needle should be inserted straight into the
penis at a 90-degree angle to the penis.
Apply pressure to the injection site for a minute or two. If there is any bleeding from the injection site,
hold the pressure for about 5 minutes. Men taking blood thinners should apply pressure to the injection
site for about 5 minutes.
Never reinject once you have injected, even if you fear that you have not injected properly.
Alternate sides with each injection.
Do not inject more frequently than every 48 to 72 hours.
If your erection lasts longer than 3 hours, call the urologist on call. Dont wait, it will only make it more
difficult to treat the prolonged erection.
If you are having troubles with performing the injections, talk with your urologist; perhaps getting more
instructions or the autoinjector (PenInject 2.25 autoinjector) or teaching your partner would be helpful.
Remember that with Edex and Caverject, once the medication has been reconstituted (i.e., once the powder
is dissolved in the sterile water), it must be refrigerated. The solutions tend to lose their efficacy after 7
days.
Make sure that the volume of the medication and the dose of medication that you are injecting are
consistent (see calculation tables below).
Do not reuse needles, and carefully dispose of used needles.
Remember that your erection may persist after you climax and ejaculate and will go down when the
medication wears out of your system.

What is the success rate of penile injection therapy?

Intracavernous injection therapy has a success rate ranging from 70% to 94%. It is helpful in erectile
dysfunction of all causes. Injection therapy does not interfere with orgasm or ejaculation. However, its
long-term success requires that the individual be comfortable with the injection therapy. Besides its
overall success rate, another advantage of injection therapy is its quick onset of action, within 5 to 20
minutes of injection.

The dose required to achieve a successful erection varies greatly with the cause of the erectile dysfunction.
Young men with spinal cord injury may only require 1 g of Caverject/Edex, whereas older men with
vascular disease and diabetes may require 40 g of Caverject/Edex.

When compared with other therapies, injection therapy has been shown to be more effective than MUSE
(alprostadil inserted into the urethra) in patients with erectile dysfunction. In addition, patients preferred
injection therapy to MUSE, despite the need for injection, which most likely reflects the superior efficacy of
injection therapy.

Injection therapy does appear to be efficacious in men who have not responded to Viagra therapy. Because
it is not dependent on intact nerves, patients with a neurologic component to their erectile dysfunction
(i.e., those who have undergone non-nerve-sparing radical prostatectomies) often respond to injection
therapy.
What are the risks of penile injection therapy?

Low Compliance

Despite the high efficacy and relatively low side effect profile of injection therapy, there is a high
discontinuation rate. A recent review demonstrated that 15% of men who are offered injection therapy do
not even try it, 40% will discontinue treatment within 3 months, and only 20% to 30% of men will
continue with injection therapy for more than 3 years. Reasons for discontinuation include fear of needles,
the injected volume, adverse effects, partner discontent with therapy, loss of partner r relationship issues,
problems with ability to administer the medication, and return of spontaneous erections.

Pain

Approximately 30% of men have pain with injection therapy. This pain may be injection site pain or, with
Caverject/Edex, it may be a diffuse penile pain. Men who experience penile pain with Caverject/Edex can
be switched to triple P (prostaglandin E1 phentolamine, and papaverine), which has a much lower
incidence of penile pain.

Hematoma

If one does not look closely where one is injecting, it is possible to injure a superficial vein in the penis,
causing a bruise, and, less frequently, a hematoma (a collection of blood). If this occurs, gentle pressure on
the injection site will prevent further bleeding. The bruise or hematoma will resolve with time. Men taking
blood thinners should be cautious when injecting and should always apply pressure after injecting. If there
is significant penile swelling, you should contact your urologist.

Priapism

The risk of priapism with injection therapy is about 2%, and most of these cases occur during the initial
test dosing. Triple P carries a higher risk of priapism than Caverject/Edex. If your erection lasts longer than
3 hours, you should contact your urologist or the urologist on call. Never re-inject after you have injected,
no matter how little you think you received with the first injection. Do not combine therapies for erectile
dysfunction without the prior approval and guidance of your urologist.

Penile Fibrosis

The development of scar tissue within the corpora is a risk of injection therapy, and this risk is higher with
triple P than with Caverject/Edex. Over time, this may be manifested by the need to use a higher dose of
medication to achieve an adequate erection.

Plaque Formation

One of the concerns with injection therapy is that each time the small needle pierces the tunica albuginea
to enter the corpora, it causes minor trauma to the area. Theoretically, this trauma may cause plaques to
form, as occurs in Peyronies disease. Given this potential risk, men should not inject any more frequently
than every 48 hours and should alternate sides. This will evenly distribute the trauma and keep the mans
penis from curving to one side.
Liver Toxicity

The risk of liver injury with injection therapy is low and does not appear to be a concern for men taking
Caverject and Edex. Liver function tests (blood tests obtained to assess how the liver is working) have
shown elevated liver enzyme levels in men with a history of alcohol abuse or liver damage who were using
intracavernous papaverine or papaverine in combination with phentolamine (bimix). Periodic liver function
tests should be considered only in this select patient population.

Intracavernous Injection Therapy

In a study comparing Viagra with injection therapy, of the men who had satisfactory erections with both
Viagra and injection therapy, 73% preferred to use Viagra. In a study of men who had satisfactory erections
using < 20 g of alprostadil injection therapy (Caverject or Edex), 69% of them successfully changed from
injection therapy to Viagra and decided to continue with the Viagra. Although success with injection
therapy was higher in this study, the satisfaction rate was higher for Viagra. In another study looking at use
of triple P injection therapy, the dose of triple P needed to obtain an erection correlated with the
likelihood of response to Viagra. If the dose of triple P was between 0.35 and 0.6 cc, the success rate with
Viagra was 55%; however, if the dose of triple P was >= 0.7 cc, then the success rate with Viagra was 20%.
Other studies have demonstrated that the patients response to prior treatments for erectile dysfunction
was not a predictor of response to Viagra.
Caverject (10, 20, 40g/ml)

Manufacturer
Pfizer

Distributor
Zuellig Pharma

Contents
Alprostadil.

Indications / Uses
Treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic or mixed etiology and may be a useful adjunct to other diagnostic
tests in the diagnosis of erectile dysfunction.

Dosage / Direction for Use

Caverject is administered by direct intracavernosal injection. A -inch, 27- to 30-gauge needle is generally recommended.
The dose of Caverject should be individualized for each patient by careful titration under the supervision of the physician. In clinical studies, patients
were treated with Caverject in doses ranging from 0.2-140 mcg; however, since 99% of patients received doses of 60 mcg, doses of >60 mcg are
not recommended. In general, the lowest possible effective dose should always be employed.
Initial Titration in Physician's Office: The following titration schedule should be followed, depending on erectile response, until the dose that produces
an erection suitable for intercourse and not exceeding a duration of 60 min is reached. If there is no response to the administered dose, then the
next higher dose may be given within 1 hr. If there is a response, then there should be at least a 1-day interval before the next dose is given. The
patient must stay in the physician's office until complete detumescence occurs. (See table.)

Maintenance Therapy: The first injections of Caverject must be done at the physician's office by medically-trained personnel.
Self-injection therapy by the patient can be started only after the patient is properly instructed and well trained in the self-injection technique. The
physician should make a careful assessment of the patient's skills and competence with this procedure. The intracavernosal injection must be done
under sterile conditions. The site of injection is usually along the dorso-lateral aspect of the proximal 3rd of the penis. Visible veins should be
avoided. The side of the penis that is injected and the site of injection must be alternated; the injection site must be cleansed with an alcohol swab.
Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office. The dose that is selected for self-
injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse, and maintained for no longer than 60 min. If
the duration of erection is >60 min, the dose should be reduced. Careful and continuous follow-up of the patient while in the self-injection program
must be exercised. This is especially true for the initial self-injections, since adjustments in the Caverject dose may be needed. Dose adjustment, if
required, should be made only after consultation with the physician, and should be adjusted in accordance with the titration guidelines described
previously. (Up to 57% of patients in 1 clinical study required dose adjustment.) While on self-injection treatment, it is recommended that the patient
visit the prescribing physician every 3 months. At that time, the efficacy and safety of the therapy should be assessed, and the dose of Caverject
should be adjusted, if needed.
The recommended frequency of injection is no more than once daily and no more than 3 times weekly. The reconstituted vial of Caverject is
intended for single use only and should be discarded after use. The user should be instructed in the proper disposal of the syringe, needle and vial.
Once reconstituted, no additional materials should be injected into the vial. When stored in the original container, the reconstituted Caverject solution
is physically, chemically and microbiologically stable for a period of 24 hrs at room temperature. The product should be inspected visually for
particulate matter and discoloration prior to administration. Do not freeze reconstituted solutions.
As an Adjunct to the Diagnosis of Erectile Dysfunction: In the simplest diagnostic test for erectile dysfunction (pharmacologic testing), patients are
monitored for the occurrence of an erection after an intracavernosal injection of Caverject. Extensions of this testing are the use of Caverject as an
adjunct to laboratory investigations, eg duplex or Doppler imaging, 133Xenon washout tests, radioisotope penogram and penile arteriography, to
allow visualization and assessment of penile vasculature. For any of these tests, a single dose of Caverject that induces an erection with firm rigidity
should be used.
Administration: Dilution and Self-Injection Procedure Using the Pre-filled Syringe with Attached Needle: This guide is not meant to substitute for
the advice and counsel of the doctor: Wash hands with soap and water. Remove the plastic cap from the vial. Wipe the rubber stopper of the vial,
using one of the swabs provided (the 2nd swab is needed later). Discard the used swab. Unwrap the larger needle (labeled 22 G 1), keeping its
plastic needle cover in place. Join it to the syringe by slipping the collar of the needle over the neck of the syringe and pushing firmly. Carefully
remove the needle cover. Holding the syringe and the needle pointing upward, push the plunger to the 1-mL mark on the syringe (this will get rid of
any excess water in the syringe). Pierce the needle through the center portion of the rubber stopper of the vial, and then push down the plunger to
inject water into the vial. Carefully holding the syringe and vial as a unit, gently swirl until the powdered medication dissolves completely. Do not use
if the resulting solution is cloudy or coloured, or if it contains particles.
Withdrawing the Medication: To withdraw the medication, turn the vial upside down with the syringe in place. Making sure to keep the tip of the
needle below the level of the fluid, slowly withdraw the plunger of the syringe until the amount of solution is level with the line recommended by the
doctor. If there are air bubbles in the syringe, tap the syringe gently to expel the air, or inject the solution back into the vial and slowly withdraw
again. Remove the needle from the vial and carefully replace the needle cover on the needle. Open the packaging of the smaller needle (labeled 27
G ), without removing the needle, and put it to one side. Remove the large needle and cap from the syringe and discard. Holding the syringe in
one hand, take the smaller needle from its open packet, keeping the plastic needle cover in place, and join it to the syringe in the same way that the
large needle is put.
Self-Injection: Caverject is to be injected into either of 2 areas of the penis called the corpora cavernosa. Perform the self-injection procedure while
sitting in an upright or slightly reclining position. Alternate the injection sites each time Caverject is used. Within either area, the actual point of
injection should be changed each time. Grasp the head of the penis with thumb and forefinger. Stretch penis tautly and hold it firmly against the
thigh so that it does not slip during the procedure. In uncircumcised men, the foreskin must be retracted to assure proper placement of the injection.
Clean the injection area thoroughly with the unused alcohol swab. Put the swab to one side. Hold the syringe between thumb and index finger. Do
not put thumb on the plunger. With a steady, continuous motion, insert the needle at a 90 angle into the injection site as directed by the doctor.
Avoid visible blood vessels. Move the thumb or forefinger to the top of the plunger and press down. Inject the entire contents of the syringe in a slow,
steady motion. Withdraw the needle from the penis. Squeezing both sides of the penis, apply pressure with the alcohol swab to the injection site for
about 3 min. If bleeding occurs, maintain pressure until the bleeding stops. After using the contents of the pack, dispose all materials safely. The
pharmacist may be able to supply a disposal box especially for syringes. If not, the plastic Caverject pack may be used as follows: Put the used
syringe, needles and vial into the plastic Caverject container. Then remove the red plastic locking device from the container and place to one side.
Close the container firmly so that it snaps shut. Remove the perforated center portion of the Caverject label to uncover a keyway. To lock the
container shut, push the red locking device completely into the keyway. Once the locking device is in position, the Caverject container will be
permanently closed and can now be discarded safely. Because it contains the used syringe, needles and vial, it should not be recycled.

Overdosage
Symptoms: In man, prolonged erection and/or priapism are known to occur following intracavernosal administration of vasoactive substances,
including alprostadil.
Treatment: The treatment of priapism may include different approaches eg, aspiration, intracavernosal injection of sympathomimetic amines or
surgery. Patients should be instructed to report to a physician any erection lasting for a prolonged period of time eg, 6 hrs.
Contraindications
Patients who have a known hypersensitivity to alprostadil, who have conditions that might predispose them to priapism eg, sickle cell anemia or trait,
multiple myeloma or leukemia, or in patients with anatomical deformation of the penis eg, angulation, cavernosal fibrosis or Peyronie's disease.
Patients with penile implants should not be treated with Caverject.
Caverject should not be used in women or children and is not for use in newborns. It should not be used in men for whom sexual activity is
inadvisable or contraindicated.

Special Precautions
Priapism (erection lasting >6 hrs) is known to occur following intracavernosal administration of vasoactive substances, including Caverject. The
patient should be instructed to immediately report to his physician any erection that persists for >6 hrs. Treatment of priapism should be according to
established medical practice.
Penile fibrosis, including Peyronie's disease, occurred in 1% of patients in clinical studies with Caverject. Regular follow-up of patients, with careful
examination of the penis, is strongly recommended to detect signs of penile fibrosis. Treatment with Caverject should be discontinued in patients
who develop penile angulation, cavernosal fibrosis or Peyronie's disease.
Patients on anticoagulants eg, warfarin or heparin may have increased propensity for bleeding after intracavernosal injection.
Underlying treatable medical causes of erectile dysfunction should be diagnosed prior to initiation of therapy with Caverject.
Use of Caverject offers no protection from the transmission of sexually transmitted diseases. Individuals who use Caverject should be counseled
about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human
immunodeficiency virus (HIV).
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Use in pregnancy & lactation: Not applicable.

Use In Pregnancy & Lactation

Use in pregnancy and lactation is not applicable.

Adverse Reactions
The following adverse reactions information was obtained from clinical studies sponsored by Upjohn involving 1712 patients treated with Caverject.
The most frequent adverse reaction after intracavernosal injection of Caverject is penile pain. In studies, 34% of the patients reported penile pain at
least once, however, this event was associated with only 11% of the administered injections. In the majority of the cases, penile pain was rated mild
or moderate in intensity. 3% of patients discontinued treatment because of penile pain.
Hematoma at the site of injection, which is related to the injection technique rather than to the effects of alprostadil, occurs in 3% of patients.
The frequency of prolonged erection (defined as an erection that lasts for 4-6 hrs) was 2%. The frequency of priapism (defined as an erection that
lasts 6 hrs) was 0.5%. In the majority of cases, spontaneous detumescence occurred.
The following local adverse reactions occurred in 1-1.5% of patients: Injection site ecchymosis, penile rash, penile edema and penile fibrosis. The
following local adverse reactions were reported by 1% of patients: Balanitis, injection site hemorrhage, injection site inflammation, injection site
itching, injection site swelling, urethral bleeding and penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema,
venous leak, painful erection and abnormal ejaculation.
In terms of systemic events, the following were reported for fewer than 1% of patients in clinical studies and were judged to be possibly related to
Caverject use: Testicular pain, testicular swelling, scrotal erythema, pain or tightness, urinary frequency, urinary urgency, impaired urination,
hypotension, vasodilatation, hypertension, supraventricular extrasystole, peripheral vascular disorder, dizziness, hypesthesia, buttock weakness,
localized pain (buttocks pain, leg pain, genital pain, abdominal pain), headache, pelvic pain, back pain, flu syndrome.
Hemodynamic changes, manifested as decreases in blood pressure and increases in pulse rate, were observed during clinical studies, principally at
doses >20 mcg and >30 mcg of Caverject, respectively, and appeared to be dose-dependent. However, these changes were usually clinically
unimportant; only 3 patients (0.2%) discontinued the treatment because of symptomatic hypotension. Caverject had no clinical important effect on
serum or urine laboratory tests.
Click to View ADR Monitoring Website

Interactions
No known interactions. Caverject is not intended for co-administration with any other agent for the treatment of erectile dysfunction.
Incompatibilities: Caverject is not intended to be mixed or co-administered with any other products. The presence of benzyl alcohol in the
reconstitution vehicle decreases the degree of binding to package surfaces. Therefore, a more consistent product delivery is produced when
bacteriostatic water for injection containing benzyl alcohol is used.
Storage
Store at controlled room temperature (20-25C).

Description
Each vial also contains lactose, sodium citrate, hydrochloric acid and sodium hydroxide.
Each 1-mL diluent syringe contains benzyl alcohol 9 mg and water for injection.

Mechanism of Action
Pharmacology: Alprostadil is present in various mammalian tissues and fluids. It has a diverse pharmacologic profile, among which some of its
more important effects are vasodilation, inhibition of platelet aggregation, inhibition of gastric secretion, and stimulation of intestinal and uterine
smooth muscle. The pharmacologic effect of alprostadil in the treatment of erectile dysfunction is presumed to be mediated by inhibition of 1-
adrenergic activity in penile tissue and by its relaxing effect on cavernosal smooth muscle.
Pharmacokinetics: The pharmacokinetics of IV administered alprostadil have been extensively studied. When administered IV to man, alprostadil is
rapidly transformed to relatively inactive metabolites. In healthy men, 70-90% of alprostadil is extensively extracted and metabolized in a single pass
through the lungs, resulting in a metabolic half-life of <1 min. After intracavernosal administration, levels of alprostadil and its primary metabolite 15-
oxo-13,14,-dihydro-PGE1 are elevated in the cavernosa. No intact alprostadil is detected in the peripheral circulation, and levels of the 15-
oxo-13,14,-dihydro-PGE1 metabolite are not significantly elevated in the peripheral circulation after intracavernosal administration.

MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders

ATC Classification
G04BE01 - alprostadil ; Belongs to the class of drugs used in erectile dysfunction.

Regulatory Classification
B

Presentation / Packing
Inj 20 mcg (sterile powd in vial) + pre-filled syringe (diluent) x 1's.

O NAS PRODUKTY LISTY REFUNDACYJNE PIELGNIARKI WIEDZA RECEPTA KONTAKT

Prostavasin 60 P: proszek do sporz.

(Rp)
Alprostadil roztw. do inf. 100%
D: 60 g 2 578
LEK
O: 10 amp.

Prostin VR P: roztw. do wstrz.

(Lz)
Alprostadil D: 500 g/ml 100%
1 975
O: 5 amp. 1 ml LEK
CAVERJECT
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.
CAVERJECT
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.
Published by MIMS/myDr April 2014
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.
1
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.
CAVERJECT
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.
Published by MIMS/myDr April 2014
Immediately telephone your
doctor, or Poisons Information
Centre (telephone Australia 13 11
26 or New Zealand 0800 POISON
or 0800 764 766) for advice, 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.
2
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:
CAVERJECT
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.
Published by MIMS/myDr April 2014
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 25C. 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 2C -
8C (Refrigerate. Do not freeze.) for
not more than 24 hours after
dissolving.
Care should be taken to avoid storing
the product at temperatures above
25C even when you travel.
3
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.
CAVERJECT
The diluent in CAVERJECT contains
Water for Injections and benzyl
alcohol.
This medicine does not contain
sucrose, gluten, tartrazine or any
other azo dyes.
Supplier
CAVERJECT is supplied in
Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Australia
Toll Free number: 1800 675 229.
It is supplied in New Zealand by:
Pfizer New Zealand Ltd
PO Box 3998
Auckland, New Zealand
Toll Free number: 0800 736 363.
Australian registration
numbers
CAVERJECT 10 micrograms,
AUST R 202518.
CAVERJECT 20 micrograms,
AUST R 202519.
Date of preparation
This leaflet was prepared in January
2014.
Registered trademark of Pfizer Inc.
Pfizer Australia Pty Ltd 2014.
INSTRUCTIONS ON
HOW TO USE
CAVERJECT
My prescribed dose is
______microgram =_______ mL.
Before you use Caverject
Wash and dry your hands before
using Caverject. If your partner
wishes to be involved in
preparing or giving the injection,
they should also wash and dry
their hands.
Published by MIMS/myDr April 2014
The remaining solution in the
Caverject vial should be
discarded after the dose is
withdrawn.
It is important that you follow the
instructions carefully to prepare
and inject Caverject.
It is important that you also read
the Consumer Medicine
Information leaflet available from
your pharmacist or at
www.pfizer.com.au and follow
your doctor's advice.
PART I Preparing the syringe
Prepare your syringe just before use.
If storage is necessary, store at 2C -
8C (Refrigerate. Do not freeze.) for
not more than 24 hours after
dissolving.
There are two needles in the pack
The larger 22 gauge needle is
used for adding diluent to
dissolve the Caverject powder.
The smaller and finer 27 or 30
gauge needle is used to inject the
dissolved solution into your
penis.
1. Prepare the vial
Flip the plastic cap off the vial.
Wipe the rubber top with one of
the alcohol swabs. Discard this
alcohol swab.
2. Fitting the needle
Hold the syringe, break the seal
and remove by rocking the cap up
and down and pulling.
Twist the base of the cover on the
larger needle (22 gauge) and
remove.
Keep the cover on the needle.
Join the needle to the syringe by
turning the needle clockwise
tightly onto the syringe.
DO NOT TWIST TOO
TIGHTLY.
Remove the needle cover by
pushing it away from the syringe
with your thumb and forefinger.
Do not touch the exposed needle.
3. Dissolving the powder with the
supplied diluent
4
 Push the needle through the
rubber middle of the vial top.
Press the plunger down firmly to
squirt all the solution onto the
powder.
The reconstituted solution may
appear cloudy at first.
Without removing the syringe
from the vial, gently shake the
vial until all the powder has
dissolved.
If the solution 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.
4. Filling the syringe
With the needle still inserted, turn
the vial upside down. Make sure
the needle tip is underneath the
level of the liquid. If the plunger
has moved whilst turning the vial
upside down, push back into its
original position.
Gently pull the plunger to draw
all the mixture into the syringe.
Make sure the gap in the rubber
stopper in the vial is facing you
so you can check the position of
the needle tip so that all liquid
can be withdrawn from the vial.
5. Changing the 22 gauge needle
to the 27 or 30 gauge needle
Hold the sides of the syringe (not
the plunger or the white cap) and
remove the needle from the
syringe by twisting it in an
anticlockwise direction. The
needle stays in the vial.
DO NOT pull the needle out of
the vial.
Remove the smaller injecting
needle (27 or 30 gauge) 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.
6. Setting the dose
Tap the syringe gently to send
any air bubbles to the top.
CAVERJECT
Push the plunger to squeeze the Withdraw the needle from your
air bubbles out, ensuring that a penis. Apply pressure to the
drop of solution comes out of the injection site for at least 5
needle. minutes with the alcohol swab or
7. Check your dose until the bleeding stops.
Continue pushing until the Safely dispose of the used
plunger is exactly at the right syringe, vial and needles as
mark for your dose. Your doctor instructed by your doctor or
will have shown you where this pharmacist.
is.
PART II Injecting the Caverject
solution
The prepared Caverject solution is
injected into either side of the penis
shaded below (corpora cavernosa).
Alternate the injection site each time
you use Caverject; choose one side of
your penis for this injection, use the
other side next time and so on.
Within each area, the actual point of
injection should also be changed
each time.
8. Injecting the Caverject solution
DO NOT USE THE NEEDLE
IF IT IS BENT.
Perform the self-injection
procedure whilst sitting in an
upright, slightly reclining or
standing position.
Hold the head of your penis with
your thumb and forefinger and
squeeze gently. The injection site
will then bulge out.
Stretch your penis tightly against
your thigh so that it does not slip
during the procedure. If you are
uncircumcised the foreskin must
be pulled back before you inject
the solution.
Clean the injection area with an
alcohol swab. Put swab on one
side.
Hold the syringe between your
thumb and index finger. Do not
press on the plunger. Gently rest
the needle on the penis.
With a steady, continuous
motion, insert the entire length of
the needle at a 90 degree angle
into the injection site.
Published by MIMS/myDr April 2014 5