Consumer medicine information

Caverject Impulse

Alprostadil

BRAND INFORMATION

Brand name

Caverject Impulse

Active ingredient

Alprostadil

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Caverject Impulse.

SUMMARY CMI

CAVERJECT® IMPULSE

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CAVERJECT IMPULSE?

CAVERJECT IMPULSE contains the active ingredient alprostadil, also known as prostaglandin E1 (PGE1). CAVERJECT IMPULSE is used to treat erectile dysfunction. It may also be used to help in the diagnosis of erectile dysfunction.

For more information, see Section 1. Why am I using CAVERJECT IMPULSE? in the full CMI.

2. What should I know before I use CAVERJECT IMPULSE?

Do not use CAVERJECT IMPULSE if you have ever had an allergic reaction to alprostadil or any of the ingredients listed at the end of the CMI. Do not use CAVERJECT IMPULSE if you have a penis that is scarred or not straight, painful erections, a penile implant, certain illnesses, or abnormal thickening of the tissues of your penis.

Talk to your doctor if you have any other medical conditions, take any other medicines, or if your partner intends to become pregnant.

For more information, see Section 2. What should I know before I use CAVERJECT IMPULSE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CAVERJECT IMPULSE and affect how it works.

For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CAVERJECT IMPULSE?

  • Your doctor will tell you how much CAVERJECT IMPULSE to use.
  • You should use CAVERJECT IMPULSE no more than once in a 24-hour period and not more than 3 times a week.
  • You must be properly instructed and trained in the injection technique by your doctor before using CAVERJECT IMPULSE.

More instructions can be found in Section 4. How do I use CAVERJECT IMPULSE? in the full CMI.

5. What should I know while using CAVERJECT IMPULSE?

Things you should do
  • Tell any doctor or pharmacist you visit 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.
  • Tell your doctor if your erection lasts for more than one hour.
  • Visit your doctor regularly.
Things you should not do
  • Do not use CAVERJECT IMPULSE to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not change the dose without first checking with your doctor.
  • Do not use any mixture left in the syringe for a second injection.
  • Do not use the needle if it is bent.
Driving or using machines
  • Do not drive or use any machines or tools until you know how CAVERJECT IMPULSE affects you.
Looking after your medicine
  • Store CAVERJECT IMPULSE in a cool dry place below 25°C. Do not freeze or refrigerate.
  • Use the solution of CAVERJECT IMPULSE as soon as possible after dissolving the powder. If the solution is not used right away, store it in the refrigerator at 2°C to 8°C for not more than 24 hours.

For more information see Section 5. What should I know while using CAVERJECT IMPULSE? in the full CMI.

6. Are there any side effects?

Like many medicines CAVERJECT IMPULSE may have side effects. Any side effects are likely to be minor and temporary.

However, some may be serious and need medical attention. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

CAVERJECT® IMPULSE

Active ingredient(s): alprostadil


Consumer Medicine Information (CMI)

This leaflet provides important information about CAVERJECT IMPULSE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CAVERJECT IMPULSE.

Where to find information in this leaflet:

1. Why am I using CAVERJECT IMPULSE?
2. What should I know before I use CAVERJECT IMPULSE?
3. What if I am taking other medicines?
4. How do I use CAVERJECT IMPULSE?
5. What should I know while using CAVERJECT IMPULSE?
6. Are there any side effects?
7. Product details

1. Why am I using CAVERJECT IMPULSE?

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

CAVERJECT IMPULSE may be prescribed by your doctor to treat 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 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.

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.

2. What should I know before I use CAVERJECT IMPULSE?

Warnings

Do not use CAVERJECT IMPULSE if you:

  • are allergic to alprostadil, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
  • 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.

Check with your doctor if:

  • you have any other medical conditions
  • you take any medicines for any other conditions
  • your partner intends to become pregnant.

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.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor or your partner's obstetrician if your partner becomes pregnant while you are using CAVERJECT IMPULSE.

3. What if I am taking other medicines?

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

Tell your doctor if you are taking any medicines used to stop blood clotting (anticoagulants) such as heparin or warfarin.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CAVERJECT IMPULSE.

4. How do I use CAVERJECT IMPULSE?

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 the dose without first talking to your doctor.

How to prepare CAVERJECT IMPULSE

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

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.

Follow these instructions carefully to prepare and inject a 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.

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.
  1. 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.
  1. 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.
  1. 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.

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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)

If you think that you have used too much CAVERJECT IMPULSE you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Always take the outer carton of the medicine with you.

5. What should I know while using CAVERJECT IMPULSE?

Things you should do

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 straight away if your erection lasts for more than four (4) hours. This can be painful and may require medical treatment.

Remind any doctor, dentist or pharmacist you visit that you are using CAVERJECT IMPULSE.

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.

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

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 or stop your treatment with CAVERJECT IMPULSE.

Always discuss with your doctor any problems or difficulties during or after using CAVERJECT IMPULSE.

Things to be mindful of

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.

Things you should 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 the dose without first checking with your doctor.
  • 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")

Driving or using machines

Do not drive or use any machines or tools until you know how CAVERJECT IMPULSE affects you.

Looking after your medicine

Store your CAVERJECT IMPULSE in a cool dry place where the temperature stays below 25°C. Do not freeze or refrigerate; do not store it:

  • in the bathroom or near a sink, or
  • in the car or on windowsills.

Keep CAVERJECT IMPULSE where children cannot reach it.

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.

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 use this medicine after the expiry date or if the packaging is torn or shows signs of tampering.

When to discard your medicine

Do not keep unused solution of CAVERJECT IMPULSE.

After injecting CAVERJECT IMPULSE, immediately throw away the used medicine in a special 'sharps' container as instructed by your doctor, nurse or pharmacist.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date or damaged, take it to any pharmacy for safe 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.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary.
However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Side effects

Side effectsWhat to do
Eye disorders:
  • dilated pupils
Gastrointestinal disorders:
  • nausea
  • dry mouth
General disorders and administration site conditions:
  • bruising, redness, swelling, bleeding or itching at the site of injection
  • localized pain (buttocks, leg, genital, back or pelvis)
Infections:
  • yeast infection
Muscle or bone related issues:
  • leg cramps
Renal and urinary related issues:
  • 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).
Nervous system disorders:
  • numbness
  • dizziness
  • headache
  • fainting
  • increased sweating
Reproductive system related issues:
  • pain in the penis during erection
  • 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
  • abnormal ejaculation or painful erection
  • swelling, redness, pain of the scrotum
  • disorder of the testis (pain, warmth, swelling, thickening)
Skin related issues:
  • skin rash, redness, irritation, itchiness
  • increased feeling of pain or sensitivity
Speak to your doctor if you have any of these side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • changes in your heartbeat or palpitations
  • changes in blood pressure
  • prolonged erection (lasting 4 to 6 hours).
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is only available with a doctor's prescription.

What CAVERJECT IMPULSE contains

Active ingredient
(main ingredient)
alprostadil
Other ingredients
(inactive ingredients)
alfadex, lactose monohydrate, sodium citrate dihydrate, hydrochloric acid and sodium hydroxide.
The diluent contains water for injections and benzyl alcohol.

Do not use this medicine if you are allergic to any of these ingredients.

What CAVERJECT IMPULSE looks like

CAVERJECT IMPULSE is supplied in a disposable syringe device containing a dual chamber glass cartridge. 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 has a front sleeve and a finger grip/plunger assembly. It is designed to deliver a single dose only.

CAVERJECT IMPULSE 10 microgram - AUST R 90196

CAVERJECT IMPULSE 20 microgram - AUST R 90197

Who distributes CAVERJECT IMPULSE

CAVERJECT IMPULSE is supplied in Australia by:

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

CAVERJECT IMPULSE is supplied in New Zealand by:

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

This leaflet was prepared in October 2022.

® Registered Trademark

Published by MIMS November 2022

BRAND INFORMATION

Brand name

Caverject Impulse

Active ingredient

Alprostadil

Schedule

S4

 

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.

Each mL of reconstituted solution contains 8.9 mg/mL of benzyl alcohol.
For the full list of excipients, see Section 6.1 List of Excipients.

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.

Before initiation of treatment with Caverject Impulse, patients should be carefully assessed by a specialist practitioner in erectile dysfunction with appropriate training in the use of this drug. The dose should be titrated carefully according to individual need.

Erectile dysfunction of neurogenic or psychogenic etiology.

If the erectile dysfunction is known to be of neurogenic or psychogenic aetiology, the generally recommended initial dose of Caverject Impulse is 2.5 microgram with subsequent upward titration of the dose in increments of 2.5 microgram.

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

If the erectile dysfunction is known to be of arteriogenic origin or due to other organic causes, the generally recommended initial dose of Caverject Impulse is 5 microgram with subsequent upward titration of the dose in increments of 5 microgram.

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

If the aetiology of the erectile dysfunction is unknown, or the Caverject Impulse is being used as an adjunct in the diagnosis of impotence, the generally recommended initial dose of Caverject Impulse is 2.5 microgram, with subsequent upward titration of the dose in increments of 2.5 microgram.
The dose that is selected for self injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse. It is recommended that the dose administered produce an erection not exceeding one hour duration.
The majority of patients obtain a satisfactory response with doses in the range of 10-20 microgram. The maximum recommended frequency of injection is no more than once in a 24 hour period and no more than three times weekly.

Method of administration.

Caverject Impulse is administered by direct intracavernosal injection.
The first injection of Caverject Impulse must be given by medically trained personnel. If self administration is planned, the specialist should make an assessment of the patient's (or, as appropriate, the partner's) skill and competence with the procedure. After proper training and instruction, Caverject Impulse may be injected at home. While on self injection treatment, it is recommended that the patient visit the specialist at periodic intervals. At that time, the efficacy and safety of the therapy should be assessed and the dose of Caverject Impulse should be adjusted if needed.

Note.

(a) Caverject Impulse uses a superfine needle for administration. As with all superfine needles, the possibility of needle breakage exists. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalisation and surgical removal. Careful patient instruction in proper handling and injection techniques may minimise the potential for needle breakage. The patient should be instructed that, if the needle is bent, it must not be used; and no attempt should be made to straighten a bent needle. A bent needle should be removed from the syringe and discarded; and a new, unused, sterile needle attached to the syringe.
(b) Instructions for the patient on how to use Caverject Impulse are provided in each pack and are also provided below. The instructions are a summary of the procedure for self injection with Caverject Impulse and are intended only to support the instruction provided by medically qualified personnel after a patient has been assessed as competent to manage the procedure.
(c) The Caverject Impulse device is designed for single use in one patient only and should be discarded after use regardless of the dose given and any solution that may be left in the cartridge. The patient should be instructed regarding appropriate injection technique and disposal of the syringe and needle after each injection.
Caverject Impulse should be used as follows.

1. Connect the needle to the device.

Remove all pieces from the package.
Clean the rubber membrane at the tip of the syringe using one of the alcohol swabs provided.
Peel the foil from the needle cap.
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. Remove the outer protective cap.

Hold the device with the needle pointing upwards.
The plunger rod is now in the extended position.

3. Reconstituting the powder and liquid.

Turn the plunger rod until it stops. This automatically mixes the alprostadil powder and the diluent.
Invert the device twice in order to make sure that the solution becomes evenly mixed. The solution should be clear.
Do not use if it is cloudy or contains particles.

4. Remove the inner protective cap.

Hold the device with the needle pointing upwards.
Carefully remove the inner protective cap from the needle.
Do not use if the needle is bent.

5. Remove air from the device.

Keeping the device upright, press 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.

6. Dialling the right dose.

Turn the end of the plunger rod slowly to choose the right dose.
The number appearing in the window indicates the dose of the injection.
If you make a mistake, continue to turn the plunger rod until you reach the correct dose.

7. Before inserting the needle.

Stretch the penis straight out with the foreskin retracted in uncircumcised men.
Clean the site with an alcohol swab.

8. Inserting the needle.

Inject into either of the two corpora cavernosa, avoiding any visible veins.
Inject at 90 degrees to the skin; push the plunger firmly.
Do not force the Caverject Impulse liquid from the syringe.
After injecting, remove the needle and apply pressure to the injection site with the alcohol swab for about 5 minutes or until any bleeding stops.
The penis should be massaged to help the alprostadil spread through it.
Subsequent injections should be alternated between the two cavernosa. The injection site should be varied from the base of the penis to just proximal to the glans avoiding the midline and any veins.
Injections should not be made into the underside of the penis. See Figure 1.
This procedure should result in an erection that is adequate for intercourse for approximately 30-60 minutes. If the erection is sustained beyond 60 minutes the dose of Caverject Impulse should be halved for the next injection.

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 of intracavernosal alprostadil offers no protection from the transmission of sexually transmitted diseases. Patients prescribed alprostadil should be counselled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV) and blood borne diseases.
The bacteriostatic water for injections provided with Caverject Impulse contains benzyl alcohol, which is associated with severe adverse effects, including fatal 'gasping syndrome' in paediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is unknown. The risk of benzyl alcohol toxicity depends on the quantity administered and the capacity of the liver and kidneys to detoxify the chemical. Premature and low birth weight infants may be more likely to develop toxicity.
The possibility of needle breakage exists with Caverject Impulse, and careful patient instruction in proper handling and injection techniques is required (see Section 4.2 Dose and Method of Administration).

Use in the elderly.

No data available.

Paediatric use.

Caverject Impulse should not be used in paediatric patients (see Section 4.3 Contraindications).

Effects on laboratory tests.

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

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.

Subcutaneous doses of PGE1 of up to 0.2 mg/kg/day, does not adversely affect or alter rat spermatogenesis.
Caverject Impulse should not be used in women (see Section 4.3 Contraindications). Alprostadil is an abortifacient and stimulates uterine smooth muscle. Since PGE1 occurs naturally in seminal fluid at doses greater than would be achieved if the Caverject Impulse were inadvertently injected into the urethra the injected alprostadil would not significantly increase the activity of the endogenous PGE1. However, patients should be advised that pregnant partners should discuss the use of Caverject Impulse with their obstetrician.
Caverject Impulse should not be used in women (see Section 4.3 Contraindications).

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.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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.

Alprostadil (PGE1) is one of a family of naturally occurring acidic lipids. Vasodilation and inhibition of platelet aggregation are among the most notable pharmacological effects. In regard to the penile structures, in most animal species tested, alprostadil had relaxant actions on retractor penis and corpus cavernosum urethrae in vitro. Alprostadil also relaxed isolated preparations of human corpus cavernosum and spongiosum as well as cavernous arterial segments contracted by either noradrenaline or PGE2a. In pigtail monkeys (Macaca nemestrina), alprostadil increased cavernous arterial blood flow in vivo. The degree and duration of cavernous smooth muscle relaxation in this animal model was dose dependent.
Alprostadil, when given by intracavernosal injection, induces erection in men with erectile dysfunction. The erection usually starts within 5-20 minutes after injection and the duration of erection is dose dependent. Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries. This leads to expansion of lacunar spaces and entrapment of blood by compressing venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism.

Clinical trials.

No data available.

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.

No potential for mutagenic activity or genetic toxicity was revealed in assays of gene mutation in bacterial and mammalian cells, or in DNA damage assays with alprostadil. Limited data are available to assess the mutagenic potential of this formulation.

Carcinogenicity.

Long-term carcinogenicity studies have not been performed with this formulation.

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.

Store below 25°C. Protect from moisture.

Reconstituted solution.

To reduce microbiological hazard use as soon as possible. If storage is necessary, hold at 2-8°C (refrigerate, do not freeze) for not more than 24 hours.
Only the accompanying diluent (bacteriostatic water for injections preserved with benzyl alcohol) should be used for reconstituting Caverject Impulse.

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.

The structural formula is as follows:

CAS number.

745-65-3.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes