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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 How CAVERJECT works Do not use CAVERJECT if you
have or have had any of the
CAVERJECT works by increasing following medical conditions:
This leaflet answers some common
the blood flow to the penis. The
questions about CAVERJECT. a penis which is scarred or not
increased blood flowing into the
straight
It does not contain all the available penis is trapped in the spongy erectile
information. It does not take the you have painful erections
tissue of the penis called the corpora
place of talking to your doctor or (Peyronie's disease)
cavernosa. When these chambers fill
pharmacist. with blood they swell and your penis a penile implant
All medicines have risks and becomes erect. certain illnesses such as
benefits. Your doctor has weighed leukaemia, multiple myeloma,
CAVERJECT is injected into a
the risks of you using CAVERJECT sickle cell anaemia or any other
specific area of the penis and should
against the benefits it is expected to condition which causes your
produce an erection in 5 to 20
have for you. erection to last for a long time
minutes. The erection should last for
(Priapism)
If you have any concerns about about 30 to 60 minutes.
abnormal thickening of the
taking this medicine, ask your Ask your doctor if you have any tissues of your penis
doctor or pharmacist. questions about why this medicine
been advised not to have sex.
Keep this leaflet. has been prescribed for you.
Your doctor may have prescribed Do not give this medicine to
You may need to read it again.
CAVERJECT for another reason. women.

This medicine is available only with Do not give CAVERJECT to


a doctor's prescription. children or newborns.
What CAVERJECT is CAVERJECT contains an
used for ingredient called benzyl alcohol
(see list of ingredients at the end of
What CAVERJECT does Before you are given this leaflet). Benzyl alcohol has

CAVERJECT may be prescribed by CAVERJECT been associated with serious side


effects which can be fatal in
your doctor for the treatment of children, especially premature and
erectile dysfunction (inability to low weight infants. Do not use this
When you must not use it
maintain an erection to have sexual medicine after the expiry date
intercourse). Do not use CAVERJECT if you printed on the pack or if the
have an allergy to: packaging is torn or shows signs of
CAVERJECT may also be used to tampering.
help in the diagnosis of erectile any medicine containing If it has expired or is damaged, return
dysfunction. alprostadil it to your pharmacist for disposal.
CAVERJECT contains alprostadil. any of the ingredients listed at the
end of this leaflet. If you are not sure whether you
Alprostadil is also known as should use this medicine, talk to
prostaglandin E1 (PGE1) and is Some of the symptoms of an allergic your doctor.
found naturally in many parts of your reaction may include:
body. shortness of breath Before you start to use it
wheezing or difficulty breathing
Tell your doctor if you have
swelling of the face, lips, tongue
allergies to any other medicines,
or other parts of the body
foods, preservatives or dyes.
rash, itching or hives on the skin.

CAVERJECT Published by MIMS/myDr April 2014 1


Tell your doctor or your partner's How to use Immediately telephone your
obstetrician if your partner intends
to become pregnant.
CAVERJECT doctor, or Poisons Information
Centre (telephone Australia 13 11
26 or New Zealand 0800 POISON
If you have not told your doctor CAVERJECT is a single use device.
or 0800 764 766) for advice, or go
about any of the above, tell The syringe device should only be to Accident and Emergency at the
him/her before you start taking used to administer one dose and then nearest hospital, if you think that
CAVERJECT. discarded. you or anyone else may have used
Follow all directions given to you too much CAVERJECT
Taking other medicines by your doctor or pharmacist Do this even if there are no signs of
carefully. discomfort or poisoning.
Tell your doctor or pharmacist if
you are taking any other They may differ from the You may need urgent medical
medicines, including: information contained in this leaflet. attention.
all prescription medicines If you do not understand the
all medicines, vitamins, herbal instructions provided at the end of
this leaflet, ask your doctor or
supplements or natural therapies
you buy without a prescription
pharmacist for help. While you are using
from a pharmacy, supermarket, CAVERJECT
naturopath or health food shop. How much to use
Some medicines may be affected by Your doctor will tell you how much Things you must do
CAVERJECT or may affect how CAVERJECT to use. This depends
well it works. You may need on your condition and whether or not Before you start on any new
different amounts of your medicines, you are taking any other medicines. medicine, tell your doctor,
or you may need to use different pharmacist and dentist that you
You should use CAVERJECT no are using CAVERJECT.
medicines. Your doctor will advise
more than once in a 24 hour period
you. If you are going to have surgery,
and not more than three times a
Tell your doctor or pharmacist if week. tell the surgeon or anaesthetist that
you are taking any of the you are taking this medicine.
You should not use more than 3 vials It may affect other medicines used
following:
for any one treatment. during surgery.
medicine used to prevent blood
clots, e.g., warfarin or heparin. You should not change your dosage If your partner becomes pregnant
without first talking to your doctor. while you are using CAVERJECT,
Your doctor and pharmacist have
tell your doctor or your partner's
more information on medicines to be
careful with or avoid while taking How long to use it obstetrician.
this medicine. Continue using your medicine for If you are about to have any blood
as long as your doctor tells you. tests, tell your doctor that you are
The use of CAVERJECT offers no
using this medicine.
protection from sexually transmitted This medicine helps to control your
diseases or those caused by the condition, but does not cure it. It may interfere with the results of
human immunodeficiency virus some tests.
(HIV) such as AIDS. Your doctor If you use too much If you are being treated with warfarin
can give you more information about (overdose) or heparin (medicines that are used to
the type of protection you should use stop your blood from clotting) you
against these diseases. Remember to only use the amount of need to be aware of an increased
CAVERJECT that your doctor told
You may also need to consider using chance of bleeding after injection.
you to use. If you use more
appropriate contraception. An injection with CAVERJECT
CAVERJECT than your doctor has
The injection of CAVERJECT can prescribed, your erection may last should produce an erection that lasts
cause a small amount of bleeding at longer than is medically safe and for 30 - 60 minutes and enables you
the site of injection. If you have any may require medical intervention. to have sex.
diseases that can be passed by blood, You should contact your doctor if Tell your doctor if your erection
e.g., hepatitis B, there could be a your erection lasts for more than four lasts for more than 60 minutes.
higher chance of passing them onto (4) hours. Your dose may need to be reduced.
your partner.

CAVERJECT Published by MIMS/myDr April 2014 2


Keep all of your doctor's pain in the penis during erection Your doctor will check regularly that
appointments so that your progress bruising at the site of injection. CAVERJECT is not causing
can be checked. abnormal thickening of the tissues of
From time to time your doctor will Tell your doctor if you experience
the penis. If this happens, your
the following uncommon or rare
need to examine the injection site to treatment with CAVERJECT will be
side effects:
detect any abnormal thickening of stopped.
the tissues of the penis. If this redness, swelling, bleeding and
happens, your treatment with itching at the site of injection If your erection lasts for more than
localised pain (buttocks, leg, 1 hour, you should tell your doctor
CAVERJECT will be stopped.
as your dose may need to be
genital, back or pelvis)
Always discuss with your doctor any reduced.
problems or difficulties during or leg cramps
numbness If your erection lasts for more than
after using CAVERJECT.
2 hours, try walking around,
increased sweating especially up and down stairs,
Things you must not do increased feeling of pain or emptying your bladder, or taking a
sensitivity, especially in the skin hot or cold shower. You should
Do not use CAVERJECT to treat
yeast infection avoid any further sexual activity.
any other complaints unless your
doctor tells you to. inflammation of the head of the Contact your doctor immediately if
penis your erection lasts for 4 hours or
Do not give your medicine to
tight foreskin more. This can be painful and may
anyone else, even if they have the require medical treatment.
same condition as you. hardened areas developing at the
Other side effects not listed above
site of injection. This can result in
Do not stop using your medicine or may occur in some patients.
curvature of the penis
lower the dosage without checking
prolonged erection (lasting 4 to 6 Tell your doctor or pharmacist if
with your doctor. you notice anything that is making
hours). Additional instructions of
Do not use any mixture left in the what you can do if this happens you feel unwell.
syringe or vial for a second are provided below. Do not be alarmed by this list of
injection.
abnormal ejaculation or painful possible side effects.
Do not use the needle to inject if it erection You may not experience any of them.
is bent (refer to notes at the end of swelling, redness, pain of the Ask your doctor or pharmacist to
this leaflet under the subheading scrotum answer any questions you may
"Injecting the Caverject
disorder of the testis (pain, have.
solution").
warmth, swelling, thickening)
changes in your heartbeat or
palpitations
Side effects changes in blood pressure After using
dizziness and headache CAVERJECT
Check with your doctor as soon as fainting
possible if you have any problems nausea, dry mouth Storage
while using CAVERJECT, even if the desire to pass urine more
you do not think the problems are frequently than normal or Keep your unused packs of
connected with the medicine or are difficulty in urinating. If CAVERJECT vials in a cool dry
not listed in this leaflet. CAVERJECT is injected by place where the temperature stays
Like many medicines, CAVERJECT mistake into the tube which below 25C. Do not freeze. After
may cause side effects. If they occur, carries urine out through the penis dissolving the CAVERJECT powder,
they are likely to be minor and (urethra), some blood may appear the solution of CAVERJECT should
temporary. However, some may be in the urine or at the end of the be used as soon as possible. If
serious and need medical attention. penis storage is necessary, store at 2C -
8C (Refrigerate. Do not freeze.) for
Ask your doctor or pharmacist to skin rash, redness, sensitivity,
not more than 24 hours after
answer any questions you may irritation, itchiness
dissolving.
have. dilated pupil.
Care should be taken to avoid storing
These are common side effects of the product at temperatures above
CAVERJECT. Mostly these are mild
25C even when you travel.
and short lived:

CAVERJECT Published by MIMS/myDr April 2014 3


Do not store CAVERJECT in The diluent in CAVERJECT contains The remaining solution in the
checked luggage during air travel. Water for Injections and benzyl Caverject vial should be
Do not store CAVERJECT or any alcohol. discarded after the dose is
other medicine in the bathroom or withdrawn.
This medicine does not contain
near a sink. Do not leave it on a sucrose, gluten, tartrazine or any It is important that you follow the
window sill or in the car. other azo dyes. instructions carefully to prepare
Heat and dampness can destroy some and inject Caverject.
medicines.
Supplier It is important that you also read
Keep it where children cannot the Consumer Medicine
reach it. CAVERJECT is supplied in Information leaflet available from
A locked cupboard at least one-and- Australia by: your pharmacist or at
a-half metres above the ground is a Pfizer Australia Pty Ltd www.pfizer.com.au and follow
good place to store medicines. ABN 50 008 422 348 your doctor's advice.
38-42 Wharf Road
Disposal
West Ryde NSW 2114 PART I Preparing the syringe
Australia
After using CAVERJECT, put all Toll Free number: 1800 675 229. Prepare your syringe just before use.
the injection material back into its If storage is necessary, store at 2C -
It is supplied in New Zealand by: 8C (Refrigerate. Do not freeze.) for
original box and ask your Pfizer New Zealand Ltd
pharmacist to dispose them safely. not more than 24 hours after
PO Box 3998
If your doctor tells you to stop dissolving.
using this medicine or the expiry Auckland, New Zealand
Toll Free number: 0800 736 363. There are two needles in the pack
date has passed, ask your
pharmacist what to do with any The larger 22 gauge needle is
medicine that is left over. Australian registration used for adding diluent to
numbers dissolve the Caverject powder.
The smaller and finer 27 or 30
CAVERJECT 10 micrograms,
gauge needle is used to inject the
AUST R 202518.
Product description dissolved solution into your
CAVERJECT 20 micrograms, penis.
AUST R 202519.
1. Prepare the vial
What it looks like Flip the plastic cap off the vial.
Date of preparation
CAVERJECT 10 microgram or Wipe the rubber top with one of
CAVERJECT 20 microgram is This leaflet was prepared in January the alcohol swabs. Discard this
available as a sterile freeze-dried 2014. alcohol swab.
powder. It is supplied in a clear glass Registered trademark of Pfizer Inc. 2. Fitting the needle
vial. CAVERJECT is available in Pfizer Australia Pty Ltd 2014. Hold the syringe, break the seal
packs containing 1, 5 or 10. and remove by rocking the cap up
*Not all pack sizes are available. and down and pulling.
Twist the base of the cover on the
Ingredients INSTRUCTIONS ON larger needle (22 gauge) and
HOW TO USE remove.
CAVERJECT powder for injection
CAVERJECT Keep the cover on the needle.
contains either 10 micrograms or 20
Join the needle to the syringe by
micrograms of the active ingredient,
My prescribed dose is turning the needle clockwise
alprostadil (prostaglandin E1; PGE1).
tightly onto the syringe.
______microgram =_______ mL.
The other ingredients are DO NOT TWIST TOO
lactose, TIGHTLY.
Before you use Caverject
alfadex, Remove the needle cover by
sodium citrate, Wash and dry your hands before pushing it away from the syringe
using Caverject. If your partner with your thumb and forefinger.
hydrochloric acid,
wishes to be involved in Do not touch the exposed needle.
sodium hydroxide. preparing or giving the injection, 3. Dissolving the powder with the
they should also wash and dry supplied diluent
their hands.

CAVERJECT Published by MIMS/myDr April 2014 4


Push the needle through the Push the plunger to squeeze the Withdraw the needle from your
rubber middle of the vial top. air bubbles out, ensuring that a penis. Apply pressure to the
Press the plunger down firmly to drop of solution comes out of the injection site for at least 5
squirt all the solution onto the needle. minutes with the alcohol swab or
powder. 7. Check your dose until the bleeding stops.
The reconstituted solution may Continue pushing until the Safely dispose of the used
appear cloudy at first. plunger is exactly at the right syringe, vial and needles as
Without removing the syringe mark for your dose. Your doctor instructed by your doctor or
from the vial, gently shake the will have shown you where this pharmacist.
vial until all the powder has is.
dissolved.
If the solution is cloudy or does PART II Injecting the Caverject
not dissolve completely, do not solution
use it.
The prepared Caverject solution is
Never use tap water or any injected into either side of the penis
liquid other than the one shaded below (corpora cavernosa).
supplied in the syringe.
Alternate the injection site each time
4. Filling the syringe
you use Caverject; choose one side of
With the needle still inserted, turn
your penis for this injection, use the
the vial upside down. Make sure
other side next time and so on.
the needle tip is underneath the
Within each area, the actual point of
level of the liquid. If the plunger
injection should also be changed
has moved whilst turning the vial
each time.
upside down, push back into its
original position. 8. Injecting the Caverject solution
DO NOT USE THE NEEDLE
Gently pull the plunger to draw
IF IT IS BENT.
all the mixture into the syringe.
Make sure the gap in the rubber Perform the self-injection
stopper in the vial is facing you procedure whilst sitting in an
so you can check the position of upright, slightly reclining or
the needle tip so that all liquid standing position.
can be withdrawn from the vial. Hold the head of your penis with
5. Changing the 22 gauge needle your thumb and forefinger and
to the 27 or 30 gauge needle squeeze gently. The injection site
will then bulge out.
Hold the sides of the syringe (not
the plunger or the white cap) and Stretch your penis tightly against
remove the needle from the your thigh so that it does not slip
syringe by twisting it in an during the procedure. If you are
anticlockwise direction. The uncircumcised the foreskin must
needle stays in the vial. be pulled back before you inject
the solution.
DO NOT pull the needle out of
the vial. Clean the injection area with an
alcohol swab. Put swab on one
Remove the smaller injecting
side.
needle (27 or 30 gauge) from its
package, keeping the cover on. Hold the syringe between your
thumb and index finger. Do not
Twist the needle clockwise
press on the plunger. Gently rest
tightly onto the syringe, then
the needle on the penis.
remove the needle cover by
pushing it away from the syringe With a steady, continuous
with your thumb and forefinger. motion, insert the entire length of
the needle at a 90 degree angle
6. Setting the dose
into the injection site.
Tap the syringe gently to send
any air bubbles to the top.

CAVERJECT Published by MIMS/myDr April 2014 5