HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use CAVERJECT safely and effectively. See full prescribing information for CAVERJECT.
CAVERJECT ® (alprostadil) for injection, for intracavernosal use
Initial U.S. Approval: 1981 INDICATIONS AND USAGECAVERJECT is a prostaglandin E1 agonist indicated - •
- 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- •
- Determine the most suitable dose and presentation of CAVERJECT to use. Use a new vial 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 the procedure for CAVERJECT syringe preparation (2.3).
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- Follow procedure for CAVERJECT intracavernosal injection administration (2.4).
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- To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection (2.2).
DOSAGE FORMS AND STRENGTHSFor injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution (3). CONTRAINDICATIONS- •
- Men who have 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- •
- Prolonged erection and priapism have occurred in patients receiving CAVERJECT. To minimize the chances of this occurring, titrate CAVERJECT 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 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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- Needle breakage: A superfine needle is used for administration of CAVERJECT 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. CAVERJECT 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 REACTIONSThe most common (≥10%) adverse reaction is 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 www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 3/2023 |