(alprostadil)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CAVERJECT IMPULSE safely and effectively. See full prescribing information for CAVERJECT IMPULSE.
CAVERJECT IMPULSE® (alprostadil) for injection, for intracavernosal use
Initial U.S. Approval: 1981

INDICATIONS AND USAGE

CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated

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For the treatment of erectile dysfunction (1.1)
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As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).

DOSAGE AND ADMINISTRATION

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Determine the most suitable dose and presentation of CAVERJECT to use. Use a new syringe for each dose of CAVERJECT (2.1).
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Administer first intracavernosal injections in the health care provider’s office and titrate the dose for each patient to the lowest effective dose (2.1).
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Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of at-home use (2.1).
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Recommended dosage for erectile dysfunction (2.2):
o
Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology:
Initiate dosing with 2.5 mcg
o
Erectile dysfunction of pure neurogenic etiology (spinal cord injury):
Initiate dosing with 1.25 mcg
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Follow dose titration procedures for each type of erectile dysfunction and determine the maintenance dosage for patient home use in the health care provider’s office (2.2).
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The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose (2.2).
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While on self-injection treatment, the patient should visit the prescribing health care provider’s office every 3 months to assess the efficacy and safety of the therapy (2.1).
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Follow procedure for CAVERJECT IMPULSE syringe preparation (2.3).
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Follow the procedure for CAVERJECT IMPULSE administration (2.4).
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To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT IMPULSE intracavernosally and monitor patients for the occurrence of an erection (2.2).

DOSAGE FORMS AND STRENGTHS

For injection: 10 mcg or 20 mcg freeze-dried powder for reconstitution in a dual-chamber syringe (3).

CONTRAINDICATIONS

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Known hypersensitivity to the drug (4).
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Men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia (4).
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Treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease (4).
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Men with penile implants (4).

WARNINGS AND PRECAUTIONS

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Prolonged erection and priapism have occurred in patients receiving CAVERJECT. To minimize the chances of this occurring, titrate CAVERJECT IMPULSE slowly to the lowest effective dose (2.1). Advise patients to seek immediate medical assistance for an erection that persists longer than 4 hours (5.1).
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Penile fibrosis has occurred in patients receiving CAVERJECT. Follow patients regularly to detect signs of penile fibrosis. Discontinue in patients who develop penile angulation or cavernosal fibrosis (5.2).
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Hypotension - injections of CAVERJECT IMPULSE can lead to increased peripheral blood levels of alprostadil, especially in patients with significant corpora cavernosa venous leakage. Avoid use in patients with known cavernosal venous leakage (5.3).
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Injection site bleeding may occur in patients taking anticoagulants, such as warfarin or heparin. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes (5.4).
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Cardiovascular risk related to underlying medical conditions - Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy (5.5).
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Risks of use in combination with other vasoactive medications injected intracavernosally - Safety and efficacy of combinations of CAVERJECT and other vasoactive agents have not been systematically studied. Use of such combinations is not recommended (5.6).
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Risk of needle breakage – A superfine needle is used for CAVERJECT IMPULSE and cases of needle breakage have been reported. Careful instruction in proper patient handling and injection techniques may minimize this risk (5.7).
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Benzyl alcohol – Serious and fatal adverse reactions can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT IMPULSE. CAVERJECT IMPULSE is not indicated in neonates and infants (5.8).
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Counsel patients about sexually transmitted diseases. Counsel patients about the protective measures necessary to guard against sexually transmitted disease including the Human Immunodeficiency Virus (HIV) (5.9).

ADVERSE REACTIONS

Most common (≥10%) adverse reactions: penile pain (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (1-800-438-1985 and www.pfizer.com) or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2022

Medication Guide

PATIENT INFORMATION

Patient Information

CAVERJECT IMPULSE® [KAV-er-jeckt]

(alprostadil)
for injection, for intracavernosal use

Read this Patient Information before you start using CAVERJECT IMPULSE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is CAVERJECT IMPULSE?

CAVERJECT IMPULSE is a prescription medicine used:

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to treat erectile dysfunction (ED).
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with other medical tests to diagnose ED.

CAVERJECT IMPULSE is not meant for use in women or children under 18 years of age.

Do not use CAVERJECT IMPULSE if you:

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are allergic to alprostadil or any of the ingredients in CAVERJECT. See the end of this leaflet for a complete list of ingredients in CAVERJECT.
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have certain medical problems that might cause you to have an erection that lasts for more than 4 hours, such as sickle cell anemia, sickle cell trait, multiple myeloma, leukemia.
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have a deformed penis shape
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have a penile implant

Before you use CAVERJECT IMPULSE, tell your healthcare provider if you:

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have had an erection that lasted more than 4 hours
•
have sickle cell trait or sickle cell anemia
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have or have had a blood cell cancer called multiple myeloma or leukemia
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have a deformed penis shape
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have a penile implant
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have low blood pressure (hypotension)
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have bleeding problems
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have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure
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have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CAVERJECT IMPULSE may affect the way other medicines work, and other medicines may affect the way CAVERJECT IMPULSE works causing side effects.

Especially tell your healthcare provider if you take any other medicines that are injected into your penis (intracavernosally) or certain medicines called anticoagulant medicines (such as heparin or warfarin).

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I use CAVERJECT IMPULSE?

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See the detailed Instructions for Use that comes with your CAVERJECT IMPULSE for information about how to prepare and inject CAVERJECT IMPULSE the right way.
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Use CAVERJECT IMPULSE exactly as your healthcare provider tells you to.
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Your healthcare provider will tell you how much CAVERJECT IMPULSE to use and when to use it.
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Your healthcare provider may change your dose if needed. Do not change your dose of CAVERJECT IMPULSE without first talking to your healthcare provider.
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Your healthcare provider should show you how to prepare and inject CAVERJECT IMPULSE the right way before you inject it for the first time.
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CAVERJECT IMPULSE should not be used more than 3 times per week.
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CAVERJECT IMPULSE should not be used more than 1 time every 24 hours.
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Change the exact place and side of the penis that you inject Caverject Impulse each time you use it.
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CAVERJECT IMPULSE is for one use only and should be thrown away properly after a single use.

You should see your healthcare provider every 3 months for check-ups to be sure that CAVERJECT IMPULSE is working the right way and to change your CAVERJECT IMPULSE dose if needed.

What are the possible side effects of CAVERJECT IMPULSE?

CAVERJECT IMPULSE may cause serious side effects, including:

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an erection that will not go away. If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, this condition can permanently damage your penis.
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deformed penis shape (penile fibrosis). Your healthcare provider should check your penis regularly for signs of penile fibrosis. You should not continue to use CAVERJECT IMPULSE if you get penile fibrosis.
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low blood pressure (hypotension)
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injection site bleeding. People who take certain medicines called anticoagulants (such as heparin or warfarin) may have a risk for increased bleeding at the injection site.
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increased risk of heart problems. Sexual activity can put an extra strain on your heart, especially if your heart is weak from a heart attack or heart disease. Ask your healthcare provider if your heart is healthy enough to handle the extra strain of having sex. Stop sexual activity and get medical help right away if you get symptoms of a heart problem such as chest pain, dizziness or nausea.
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needle breakage. There is a possibility of needle breakage with use of CAVERJECT IMPULSE. To best avoid breaking the needle, you should pay careful attention to your healthcare provider's instructions and handle the syringe and needle properly. If the needle is bent at any time, do not attempt to straighten it and do not use it. A bent and re-straightened needle is more likely to break. Remove the needle from the syringe, discard, and attach a new, unused sterile needle to the syringe. If the needle breaks during injection and you are able to see and grasp the broken end, you should remove it and contact your healthcare provider. If you cannot see or cannot grasp the broken end, you should promptly contact your healthcare provider.
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benzyl alcohol toxicity. Benzyl alcohol is a preservative in CAVERJECT IMPULSE. Benzyl alcohol has caused serious side effects, including death, in children, especially premature and low-birth weight infants, who have received the preservative benzyl alcohol. CAVERJECT IMPULSE is not meant for use in children.

CAVERJECT IMPULSE does not protect you or your partner from getting sexually transmitted infections, including HIV-the virus that causes AIDS.

The most common side effects of CAVERJECT IMPULSE include:

•
penile pain

These are not all the possible side effects of CAVERJECT IMPULSE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of CAVERJECT IMPULSE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use CAVERJECT IMPULSE for a condition for which it was not prescribed. Do not give CAVERJECT IMPULSE to other people even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about CAVERJECT IMPULSE that is written for health professionals.

What are the Ingredients in CAVERJECT IMPULSE?

Active ingredient: alprostadil

Inactive ingredients: alpha cyclodextrin, lactose, sodium citrate, benzyl alcohol and hydrochloric and/or sodium hydroxide for pH adjustment.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com

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LAB-0641-8.0

Revised January 2023

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