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).

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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):

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Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology:
Initiate dosing with 2.5 mcg

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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).

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

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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).

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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).

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.