Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Caverject Impulse.

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 Impulse against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What Caverject Impulse is used for

Caverject Impulse may be prescribed by your doctor for the treatment of erectile dysfunction (inability to maintain an erection to have sexual intercourse).

Caverject Impulse may also be used to help in the diagnosis of erectile dysfunction.

Caverject Impulse contains alprostadil as the active ingredient. Alprostadil is also known as prostaglandin E1 (PGE1) and is found naturally in many parts of your body.

Caverject Impulse works by increasing the blood flow to your 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 Impulse is injected into the side of the penis and should produce an erection in 5 to 20 minutes. The erection should last for about 30 to 60 minutes.

Caverject Impulse is available only with a doctor's prescription.

Ask your doctor if you have any questions about why Caverject Impulse has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you use Caverject Impulse

When you must not use it

Do not use Caverject Impulse if you have an allergy to:

• any medicine containing alprostadil, the active ingredient in Caverject Impulse
• any of the ingredients listed at the end of this leaflet.
• have a penis which is scarred, not straight or if you experience painful erections (Peyronie's disease)
• have a penile implant
• have 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)
• have abnormal thickening of the tissues of your penis.

Caverject Impulse is not for use in women, children or newborns.

Caverject Impulse should not be used by men who have been advised not to have sex.

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 start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you are taking any medications used to stop blood clotting. For example, heparin or warfarin.

Tell your doctor or your partner's obstetrician if your partner intends to become pregnant.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Note: The use of Caverject Impulse 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 Impulse can cause a small amount of bleeding at the site of injection. If you have any diseases that can be passed by blood, e.g., hepatitis B, there could be a higher chance of passing them onto your partner.

How to use Caverject Impulse

Caverject Impulse is a single use device. The syringe device should only be used to administer one dose and then discarded.

How much to use

Your doctor will tell you how much Caverject Impulse to use. This depends on your condition and whether or not you are taking any other medicines.

You should use Caverject Impulse no more than once in a 24 hour period and not more than three times a week.

You should not change your dosage without first talking to your doctor.

How to prepare Caverject Impulse

You must be properly instructed and trained in the injection technique by your doctor before using Caverject Impulse.

Follow your doctor's instructions at all times.

If you are not certain about the way to prepare your Caverject Impulse injection, please contact your doctor. This leaflet is only intended to remind you about the instructions that your doctor has already given you.

Note: Follow these instructions carefully to prepare and inject a sterile dose of Caverject Impulse.

If the needle is bent at any time, do NOT use it for injecting Caverject Impulse. Do NOT attempt to straighten it prior to injecting Caverject Impulse.

A bent and straightened needle may be more likely to break. Needle breakage with a portion of the needle remaining in the penis has been reported and in some cases required hospitalisation and surgical removal.

If the needle is bent, remove it from the syringe, discard and attach a new, unused sterile needle to the syringe as described in point 4 below.

Before you start to prepare and inject Caverject Impulse, wash your hands thoroughly with soap and water

If your partner wishes to be included in preparing or giving the injection, they should also wash and dry their hands.

1. Connecting the needle to the device.

• Unpack 1 syringe, 1 needle and 2 alcohol swabs from your Caverject Impulse pack.
• Open one of the alcohol swab packets and use the swab to clean the rubber membrane at the tip of the syringe.
• Remove the needle from its sterile packaging.
• Hold the syringe with the needle-end pointing upwards.
• Attach the needle to the device by pressing the needle on to the tip of the device and turning clockwise until it is firmly in place.

2. Removing the outer needle cap

• Pull off the outer protective cap of the needle.
• Hold the device with the needle pointing upwards.
• The plunger rod is now in the extended position.

3. Mixing the powder and the liquid in the device

• Hold the device with the needle pointing upwards, gripping the blue chamber with one hand.
• Turn the plunger clockwise until it will not turn any further (fully wound). This automatically mixes the alprostadil powder with the diluent.
• The reconstituted solution will now appear in the clear chamber.
• The solution may be cloudy at first. Gently shake to make sure the solution is evenly mixed and the powder has dissolved. The solution should be clear. Do not use if it remains cloudy or contains particles.

4. Removing the inner needle cap

• Hold the device with the needle pointing upwards.
• Carefully remove the inner protective cap from the needle.

Do not touch the exposed needle.
The needle is very fine. Take care not to bump it.
Do NOT use if the needle is bent.

5. Removing air from the device

• Remove any large bubbles by gently tapping the clear chamber with your finger.
• Ensure the plunger rod is fully wound.
• Hold the device in one hand with the needle pointing upwards.
• Remove air from the clear chamber by pressing the plunger rod as far as it will go. A few drops will appear at the needle point and the solution will be free from bubbles. There may be small microbubbles at the side of the glass cartridge.

6. Dialling your dose

• Hold the device in one hand.
• Grip the blue chamber with the dose window facing you (needle tip to the left).
• Turn the plunger rod slowly clockwise to choose the right dose. Your doctor will tell you what this should be. The number appearing in the window indicates the dose of the injection.
• If you make a mistake, continue to turn the plunger rod clockwise until you reach the correct dose.
• If you do not wish to use Caverject Impulse immediately, you can keep the reconstituted solution for up to 24 hours if refrigerated.

7. How to inject

Caverject Impulse injection is injected into either of two sections of the penis called the corpora cavernosa. Your doctor will show you these areas on the sides of your penis.
Follow these instructions carefully before proceeding with your Caverject Impulse injection.
DO NOT USE THE NEEDLE IF IT IS BENT.

• Perform the self-injection procedure whilst sitting in an upright, slightly reclining or standing position.
• Inject only in the side of the penis (corpus cavernosum) as shown by your doctor.
  Do not inject into any visible veins, the top or the underside of the penis.
• Alternate the injection site each time you use Caverject Impulse; 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. Preparing the injection site

• Open the second alcohol swab packet.
• Hold the head of your penis with your thumb and forefinger.
• Fully stretch your penis away from your body, straight ahead. If you are uncircumcised, the foreskin must be pulled back before you inject the solution.
• Clean the injection area with the second alcohol swab and let it dry.

9. Inserting the needle

• Keeping a firm grip on your penis, take the syringe in your free hand. The needle should be inserted at a 90 degree angle. With a steady, continuous motion, insert the entire length of the needle straight into the injection site.
• Push the plunger firmly with your thumb. This may require some pressure.
• Withdraw the needle from your penis. Apply pressure to the injection site for at least five minutes with the alcohol swab. If bleeding occurs, maintain this pressure on the injection site until the bleeding stops.
• Massage the penis to help the Caverject Impulse spread through it.
• If there is any solution left in the syringe DO NOT keep it to use for a second injection.
• The syringe device is designed for single use only.
• After using the contents of this pack, dispose of all materials safely. Do not reuse or share needles or syringes.

If you use too much (overdose)

Remember to use only the amount of Caverject Impulse that your doctor told you to use. If you use more Caverject Impulse than your doctor has prescribed, your erection may last longer than is medically safe and may require medical intervention.

Contact your doctor if your erection lasts for more than four (4) hours.

Immediately telephone your doctor or the Poison Information Centre (Australia: 13 11 26; NZ: 0800 POISON or 0800 764 766) for advice or go to the Accident and Emergency (Casualty) Department at your nearest hospital if you think you or anyone else may have used too much Caverject Impulse.

While you are using Caverject Impulse

Things you must do

If you are about to be started on any new medicine, tell your doctor or pharmacist that you are using Caverject Impulse.

Tell your doctor and pharmacist who are treating you that you are using Caverject Impulse.

If your partner becomes pregnant while you are using Caverject Impulse, tell your doctor or your partner's obstetrician.

If you are being treated with warfarin or heparin (medicines that are used to stop your blood from clotting) there is an increased chance of bleeding after injection.

An injection with Caverject Impulse should produce an erection that lasts for 30 minutes to 1 hour and enables you to have sex.

Tell your doctor as soon as possible if your erection lasts for more than 1 hour. Your dose may need to be reduced.

Visit your doctor regularly. From time to time your doctor will need to examine the injection site to detect any abnormal thickening of the tissues of your penis and may need to change your dose of Caverject Impulse.

Always discuss with your doctor any problems or difficulties during or after using Caverject Impulse.

Things you must not do

Do not give Caverject Impulse to anyone else, even if they have the same condition as you.

Do not use Caverject Impulse to treat any other complaints unless your doctor or pharmacist tells you to.

Do not change your dose yourself without first asking your doctor for advice.

Do not use any mixture left in the syringe for a second injection.

Do not use the needle to inject if it is bent (refer to notes under the subheading "How to prepare Caverject Impulse").

Side effects

Check with your doctor as soon as possible if you have any problems while using Caverject Impulse, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like many medicines, Caverject Impulse 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 Impulse. Mostly these are mild and short lived:

• pain in the penis during erection.
• bruising at the site of injection.

Tell your doctor if you experience the following uncommon or rare side effects:

• redness, swelling, bleeding and itching at the site of injection.
• localised pain (buttocks, leg, genital, back or pelvis).
• leg cramps.
• numbness.
• increased sweating.
• increased feeling of pain or sensitivity, especially in the skin.
• yeast infection.
• inflammation of the head of the penis.
• tight foreskin.
• hardened areas developing at the site of injection. This can result in curvature of the penis
• prolonged erection (lasting 4 to 6 hours).
• 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 Impulse 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 pupils.

Your doctor will check regularly that Caverject Impulse is not causing abnormal thickening of the tissues of the penis. If this happens, your treatment with Caverject Impulse will be stopped.

Contact your doctor immediately or go to hospital 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.

After using Caverject Impulse

Storage

Store your Caverject Impulse in a cool dry place where the temperature stays below 25°C. Do not freeze or refrigerate.

After dissolving the Caverject Impulse powder, use the solution of Caverject Impulse as soon as possible. If storage is necessary, then store in the refrigerator at 2-8°C for not more than 24 hours. Do not freeze the dissolved solution.

Do NOT keep unused solution of Caverject Impulse. Be sure that any discarded solution is out of reach of children.

During travel, care should be taken to avoid allowing the product to be stored at temperatures above 25°C or below 2-8°C.

Do not store Caverject Impulse in checked luggage during air travel.

Do not leave Caverject Impulse in the car on hot days or on window sills. Do not store Caverject Impulse in the bathroom or near a sink. Heat and dampness can destroy some medicines.

Keep Caverject Impulse 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 Impulse, dispose of all injection material safely. Your doctor or pharmacist will advise you on how to dispose of the used syringes and needles.

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 Impulse contains a dual chamber glass cartridge in a disposable syringe device. The front chamber of the glass cartridge contains a white to off-white powder and the rear chamber contains a clear liquid.

The disposable syringe device consists of a front sleeve and a finger grip/plunger assembly. The syringe device is designed to deliver a single dose only.

Ingredients

Caverject Impulse powder contains either 10 or 20 micrograms of the active ingredient, alprostadil.

The other ingredients are alfadex, lactose monohydrate, sodium citrate dihydrate, hydrochloric acid and sodium hydroxide.

The diluent in Caverject Impulse contains Water for Injections and benzyl alcohol.

Supplier

Caverject Impulse is supplied in: Australia by:

Pfizer Australia Pty Ltd
SYDNEY NSW.
Toll Free Number: 1800 675 229.
www.pfizer.com.au

It is supplied in New Zealand by:

Pfizer New Zealand Limited
PO Box 3998
Auckland
New Zealand.
Toll Free Number: 0800 736 363.

Australian Registration Numbers

10 microgram - AUST R 90196.

20 microgram - AUST R 90197.

This leaflet was prepared in May 2019.

® Registered trademark.

© Pfizer Australia Pty Ltd 2019.

Published by MIMS July 2019

1 Name of Medicine

Alprostadil.

2 Qualitative and Quantitative Composition

Caverject Impulse dual chamber syringe is available in two strengths, 10 and 20 micrograms. Each 0.5 mL cartridge delivers a maximum dose of 10 micrograms or 20 micrograms of alprostadil.

Excipient(s) with known effect.

3 Pharmaceutical Form

Powder for intracavernosal injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Intracavernosal alprostadil (PGE₁) is indicated for the treatment of erectile dysfunction in adult males. Intracavernosal alprostadil may be a useful adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

4.2 Dose and Method of Administration

Dosage.

Erectile dysfunction of neurogenic or psychogenic etiology.

Erectile dysfunction of arteriogenic origin or due to other organic causes.

Caverject Impulse as an adjunct to the diagnosis of erectile dysfunction.

Method of administration.

Note.

1. Connect the needle to the device.

2. Remove the outer protective cap.

3. Reconstituting the powder and liquid.

4. Remove the inner protective cap.

5. Remove air from the device.

6. Dialling the right dose.

7. Before inserting the needle.

8. Inserting the needle.

4.3 Contraindications

Intracavernosal alprostadil should not be used in patients who have a known hypersensitivity to alprostadil, the active ingredient in Caverject Impulse, or any of the excipients, or in patients who have conditions that might predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Patients with pre-existing penile fibrosis should not be accepted into intracavernosal self injection therapy. Caverject Impulse should not be used in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis or Peyronie's disease.
Caverject Impulse should not be used in men for whom sexual activity is inadvisable or contraindicated. Caverject Impulse should not be used in women. It should not be used in children and is not for use in newborns (see Section 4.4 Special Warnings and Precautions for Use).
Caverject Impulse should not be used in patients with penile implants.

4.4 Special Warnings and Precautions for Use

Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy with Caverject Impulse.
Prolonged erection and/or priapism are known to occur following intracavernosal administration of vasoactive substances, including alprostadil. The treatment of priapism may include different approaches such as aspiration, intracavernosal injection of sympathomimetic amines or surgery. In evaluating a patient for alprostadil therapy, the physician should determine which of these interventions would be appropriate for the individual patient. Patients should be instructed to report to a physician any erection lasting for an overly prolonged time period, such as 4 hours or longer.
Painful erection is more likely to occur in patients with anatomical deformations of the penis. Penile fibrosis, such as angulation, phimosis, cavernosal fibrosis, fibrotic nodules and Peyronie's disease or plaques, may occur following the intracavernosal administration of Caverject Impulse. The occurrence of fibrosis may increase with increased duration of use of Caverject Impulse.
Patients should be carefully assessed for pre-existing penile fibrosis before initiation of treatment with intracavernosal Caverject Impulse. If pre-existing penile fibrosis is found, the patient should not be accepted into intracavernosal self injection therapy. This assessment should be made during pharmacologically induced erection. At regular visits the physician must examine the penis carefully, preferably in the erect state, for potential development of fibrotic changes. If there are signs of fibrotic complications, treatment with Caverject Impulse must be stopped immediately. During self injection therapy, the patient must be instructed to report to the physician any unusual new adverse effects such as increased or new penile pain, penile bending, and/or nodule formation in the penile shaft.
Patients on anticoagulants such as warfarin or heparin may have an increased propensity for bleeding after the intracavernosal injection.
Caverject Impulse can induce a small amount of bleeding at the site of injection (see Section 4.8 Adverse Effects (Undesirable Effects)). In patients infected with blood borne diseases, this could increase the transmission of such diseases to the partner.

Note.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No known interactions. Caverject Impulse is not intended for coadministration with any other agent for the treatment of erectile dysfunction.
In clinical trials, concomitant use of agents such as antihypertensive drugs, diuretics, antidiabetic agents (including insulin), or nonsteroidal anti-inflammatory drugs had no effect on the safety or efficacy of Caverject Impulse. The safety and efficacy of combinations of Caverject Impulse and other vasoactive agents have not been systematically studied.
Patients on anticoagulants such as warfarin or heparin may have an increased propensity for bleeding after the intracavernosal injection.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No data available.

4.8 Adverse Effects (Undesirable Effects)

Based on a review of studies using alprostadil in the treatment of erectile dysfunction, the most frequently reported adverse reaction after intracavernosal injection of alprostadil was penile pain during erection, which was also described as a burning sensation or a tension in the penis. However, the occurrence of pain rarely interfered with sexual intercourse. Haematoma and ecchymosis at the site of injection, which was related to the injection technique rather than to the effects of alprostadil, occurred less frequently. In four clinical studies, the frequency of penile fibrosis (including Peyronie's disease, angulation, and fibrotic nodules) was 4.8%. Complete resolution of the fibrotic pathology was observed in 28% of the patients. Prolonged erection (defined as an erection that lasts for 4 to 6 hours) after intracavernosal administration of Caverject Impulse was reported in 4% of patients. The frequency of priapism (defined as an erection that lasts 6 hours or longer) was 0.4%. In the majority of cases, spontaneous detumescence occurred.
Adverse reactions reported by less than 1% of patients in clinical studies are listed in Table 1.
In some patients, these adverse events may be related to the injection procedure rather than to the pharmacological effects of alprostadil.

Reporting suspected adverse effects.

4.9 Overdose

Overdose data is limited. The pharmacologic signs of alprostadil are similar in all animal species and include depression, soft stool or diarrhoea and rapid breathing.
In man, prolonged erection and/or priapism are known to occur following intracavernosal administration of vasoactive substances, including alprostadil. Patients should be instructed to report to a physician any erection lasting for a prolonged time period, such as 4 hours or longer. Prolonged erection or priapism (lasting more than 6 hours) should be treated to prevent tissue hypoxia and possible necrosis.
The treatment of priapism may include different approaches such as aspiration, intracavernosal injection of sympathomimetic amines or surgery.
There is no antidote for alprostadil overdose. Treatment is symptomatic and supportive. Support respiratory and cardiac function. Monitor pulmonary function, vital signs, ECG, pulse oximetry, and fluid and electrolyte status in patients with significant diarrhoea.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The pharmacokinetics of intravenously administered alprostadil has been extensively studied. When administered intravenously to man, alprostadil is rapidly transformed to relatively inactive metabolites. In healthy men, 70% to 90% of alprostadil is extensively extracted and metabolised in a single pass through the lungs, resulting in a metabolic half-life of less than one minute. 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.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

The front compartment contains: lactose monohydrate, alfadex, sodium citrate dihydrate, hydrochloric acid solution and/or sodium hydroxide solution (used for pH adjustment).
The rear compartment contains: bacteriostatic water for injections, benzyl alcohol.

6.2 Incompatibilities

This product is not intended to be administered with other intracavernosal medications.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Unreconstituted product.

Reconstituted solution.

6.5 Nature and Contents of Container

The Caverject Impulse dual chamber type 1 glass cartridge is assembled as a single unit in a disposable syringe device consisting of a front sleeve and finger-grip/plunger assembly. The syringe device is designed to deliver a single dose only.
Caverject Impulse dual chamber syringe is available in two strengths, 10 and 20 micrograms. In order to increase dosage flexibility, each syringe is capable of delivering 25% dosage increments:
Caverject Impulse 10 micrograms: 2.5, 5.0, 7.5, 10 micrograms;
Caverject Impulse 20 micrograms: 5.0, 10, 15, 20 micrograms.
Caverject Impulse is supplied in packs of 2. Each pack contains 2 x 29 G needles and four alcohol swabs.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The non-proprietary name is alprostadil, Prostaglandin E₁, (PGE₁) and the chemical name is (11α, 13E, 15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.
Alprostadil is the naturally occurring form of PGE₁.
Alprostadil is a white to off-white crystalline powder with a melting point between 115°C - 116°C and has a molecular weight of 354.49. Alprostadil is practically insoluble in water with a solubility of 8,000 micrograms in 100 mL double distilled water at 35°C.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes