Data from FDA - Curated by EPG Health - Last updated 23 March 2017

Indication(s)

1 INDICATIONS AND USAGE CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated For the treatment of erectile dysfunction (1.1) As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2). 1.1 Erectile Dysfunction CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction. 1.2 Diagnostic Test CAVERJECT IMPULSE is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

+ 3 more

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Anticoagulation Therapy for Stroke Prevention

Anticoagulation Therapy for Stroke Prevention

Anticoagulation therapy for Stroke Prevention Learning Zone offers a deep-dive into atrial fibrillation causes, consequences, diagnosis and management to help you deliver optimal care and prevent strokes in patients living with this common arrhythmia.

Load more

Related Content

Advisory information

contraindications
4 CONTRAINDICATIONS CAVERJECT IMPULSE should not be used: in men who have a known hypersensitivity to the drug [see Adverse Reactions (6.1)] in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see Warnings and Precautions (5.1)] for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease [see Warnings and Precautions (5.2)] in men with penile implants. Known hypersensitivity to the drug (4) Men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia (4) Treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease (4) Men with penile implants (4)
Adverse reactions
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Prolonged Erection and Priapism [see Warnings and Precautions (5.1)] Penile Fibrosis [see Warnings and Precautions (5.2)] 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 www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. CAVERJECT IMPULSE was evaluated in 87 patients in an open-label crossover study of 6 weeks treatment duration that compared the formulation of alprostadil for injection contained in CAVERJECT IMPULSE with the formulation contained in CAVERJECT Sterile Powder. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penis disorder (4.6%), prolonged erection (1.1%), injection site erythema (1.1%), rash (1.1%), dizziness (1.1%), and hematospermia (1.1%). Penis disorder included penile pain, post-injection pain, and pain with erection. CAVERJECT IMPULSE was also evaluated in 63 patients in a single-dose, double-blind, crossover study that compared CAVERJECT IMPULSE with CAVERJECT Sterile Powder. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penile pain (1.6%) and pruritus (1.6%). In addition to the adverse reactions observed for CAVERJECT IMPULSE in these two studies, the following adverse reactions have been reported in clinical studies of CAVERJECT Sterile Powder: Local Adverse Reactions: Local adverse reactions derived from 1861 patients in clinical studies of CAVERJECT Sterile Powder, including an 18-month, open-label study, are shown in Table 1. Table 1. Local Adverse Reactions Reported by ≥ 1% of Patients Treated with CAVERJECT Sterile Powder for up to 18 Months Penile pain 37% Prolonged erection 4% Penile fibrosis 3% Injection site hematoma 3% Penis disorderPenis disorder includes: numbness, irritation, sensitivity, pruritus, erythema, skin tear, discoloration, itching. 3% Injection site ecchymosis 2% Penile rash 1% Penile edema 1% The following local adverse reactions were reported in < 1% of patients: injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, irritation, sensitivity, pruritus, erythema, painful erection, and abnormal ejaculation. In these studies, no local adverse reactions were reported in the 294 patients who received placebo, except for penile pain (2%). Penile Pain: In the majority of the cases, penile pain was rated mild or moderate in intensity. Three percent of patients discontinued treatment because of penile pain Prolonged Erection/Priapism: Prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as an erection that lasted 6 hours or longer. In clinical studies, the frequency of prolonged erection after intracavernosal administration of CAVERJECT Sterile Powder was 4%, while the frequency of priapism was 0.4% [see Warnings and Precautions (5.1)]. Penile Hematoma/Ecchymosis: In clinical studies the frequency of penile hematoma and ecchymosis was 3% and 2%, respectively. Systemic Adverse Reactions : Systemic adverse reactions reported by ≥ 1% of subjects in clinical studies of CAVERJECT Sterile Powder included: dizziness (1%). The following systemic adverse reactions, were reported in < 1% of patients: testicular pain, scrotal edema, hematuria, pelvic pain, hypotension, vasodilation, vasovagal reaction, diaphoresis, rash, and non-application site pruritus. Three patients (0.2%) discontinued due to symptomatic hypotension. No systemic adverse reactions were reported in the 294 patients who received placebo. 6.2 Post-marketing Experience The following additional adverse reactions have been reported: device malfunction/failure, drug ineffective and drug effect decreased.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION Determine the most suitable dose and formulation of CAVERJECT to use (2.1) Administer first intracavernosal injections in the physician's office and titrate the dose for each patient to the lowest effective dose (2.1) Dosage for erectile dysfunction (2.2): Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate dosing with 2.5 mcg Erectile dysfunction of pure neurogenic etiology (spinal cord injury): Initiate dosing with 1.25 mcg Follow dose titration procedures for each type of erectile dysfunction and determine the maintenance dosage for erectile dysfunction for patient home use in the physician's office (2.2) The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose (2.2) While on self-injection treatment, the patient should visit the prescribing physician's office every 3 months to assess the efficacy and safety of the therapy (2.2) 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 (2.3) To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT IMPULSE intracavernosally and monitor patients for the occurrence of an erection (2.4) Follow procedure for CAVERJECT IMPULSE syringe preparation (2.5) 2.1 Dosage and Administration Information Overview Determine the most suitable dose and formulation of CAVERJECT (CAVERJECT IMPULSE or CAVERJECT Sterile Powder) for each patient. Administration of the first injections of CAVERJECT IMPULSE should be done in the physician's office by medically trained personnel. Carefully titrate the dose of CAVERJECT IMPULSE for each patient to the lowest effective dose. The site of injection is usually along the dorso-lateral aspect of the proximal third of the penis. Wipe the intended injection site with an alcohol swab prior to injection. Avoid visible veins during injection. Alternate the side of the penis that is injected and the site of injection. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes. CAVERJECT IMPULSE is intended for single use only and should be discarded after use. Safety and efficacy of CAVERJECT doses greater than 60 mcg have not been established. 2.2 Dosage for Erectile Dysfunction Starting Dosage for Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology. Initiate dosing with 2.5 mcg of alprostadil. If there is a partial response at 2.5 mcg, the dose may be increased to 5 mcg within 1 hour. During titration, no more than 2 doses should be given within a 24-hour period. The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour. The patient must stay in the physician's office until complete detumescence occurs. If additional titration is required, doses in increments of 5 to 10 mcg may be given at least 24 hours apart. Repeat the titration as necessary until the optimal dose is achieved. Starting Dosage for Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury): Initiate dosing with 1.25 mcg of alprostadil using CAVERJECT Sterile Powder. If there is a partial response, the dose may be increased to 2.5 mcg within 1 hour. No more than 2 doses during initial titration should be given within a 24-hour period. The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour. The patient must stay in the physician's office until complete detumescence occurs. If additional titration is required, a dose of 5 mcg may be given during the next 24 hours. Thereafter, doses in increments of 5 mcg may be given at least 24 hours apart until the optimal dose is reached. Maintenance Dosage for Erectile Dysfunction for Patient Home Use: Once the dose of CAVERJECT IMPULSE has been determined in the physician's office, additional dose adjustment may be required after consultation with the physician. Adjust the dose in accordance with the titration guidelines described above. The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose. While on self-injection treatment, it is recommended that the patient visit the prescribing physician's office every 3 months to assess the efficacy and safety of the therapy and to adjust the dose of CAVERJECT IMPULSE, if needed. 2.3 Patient Instruction for Self-Injection Technique for Treatment of Erectile Dysfunction 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. Advise the patient to read the Patient Information and Instructions for Use for detailed instructions on use of the product (see FDA-approved patient labeling [Patient Information and Instructions for Use]). 2.4 Adjunct to the Diagnosis of Erectile Dysfunction To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT IMPULSE intracavernosally and monitor patients for the occurrence of an erection. Extensions of this testing are the use of CAVERJECT as an adjunct to laboratory investigations, such as duplex or Doppler imaging. For any of these tests, use a single dose of CAVERJECT IMPULSE that induces a rigid erection. 2.5 CAVERJECT IMPULSE Syringe Preparation Select the CAVERJECT IMPULSE syringe based upon dose to be administered. Syringe Strength Reconstituted Concentration Dosages Available for Delivery after Reconstitution 10 mcg 10 mcg/0.5 mL 2.5 mcg 5 mcg 7.5 mcg 10 mcg 20 mcg 20 mcg/0.5 mL 5 mcg 10 mcg 15 mcg 20 mcg Open the sealed plastic tray. Remove the syringe, the needle assembly, and the alcohol swabs from the tray. The syringe has a dose window and a plunger. The needle assembly is a sealed unit that contains the outer protective cap, the inner protective cap, and the superfine needle. Use the alcohol swab to wipe the rubber membrane at the tip of the syringe. Pick up the needle assembly, grasp the paper tab, and peel off the paper cover (the lid). Hold the needle assembly by the cap and press the needle assembly onto the tip of the syringe. Turn it clockwise until the needle assembly is firmly locked into place. Remove the outer protective cap from the needle by twisting it clockwise. Do not yet remove the inner protective cap, the thin plastic tube that directly covers the needle. Hold the syringe system with the needle pointing upward. The plunger rod should still be in the fully extended position, with all of the threads visible. Slowly rotate the plunger rod clockwise until it goes all the way in and stops. Do not push on the plunger while trying to rotate it. Turn the syringe upside down several times to make sure the solution is evenly mixed. The solution should be clear. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The product should not be used if particulate matter or discoloration are present. Hold the syringe with the needle upward and carefully remove the inner protective cap from the needle. Lightly tap the glass cartridge a few times with your finger until any large bubbles disappear up into the tip. With the syringe pointed upward, push in the plunger rod until it stops to push any air out. To set the dose: locate the dose window on the syringe and then slowly turn the plunger rod clockwise until the correct dose number appears in the center of the window. The syringe is now ready for use. If you pass the correct number, keep turning the plunger in the same direction until the correct number comes around again – do not try to turn it backward. After reconstitution, the syringe should be used within 24 hours when stored between 36–77°F (2°C to 25°C). Do not freeze. CAVERJECT IMPULSE is for single use only. Discard the injection delivery system and any remaining solution after use.
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy CAVERJECT IMPULSE is not indicated for use in females. 8.2 Lactation CAVERJECT IMPULSE is not indicated for use in females. 8.4 Pediatric Use CAVERJECT IMPULSE is not indicated for use in pediatric patients [see Warnings and Precautions (5.8)]. 8.5 Geriatric Use A total of 341 subjects included in clinical studies were 65 and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients.

Interactions

7 DRUG INTERACTIONS The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied [see Warnings and Precautions (5.6)].

More information

Category Value
Authorisation number NDA021212
Agency product number F5TD010360
Orphan designation No
Product NDC 0009-5181,0009-5182
Date Last Revised 24-02-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 763474
Marketing authorisation holder Pharmacia and Upjohn Company LLC