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Prolonged Erection And Priapism
Prolonged erection defined as erection lasting between 4 to 6 hours in duration occurred in 4% of 1,861 patients treated up to 18 months in studies of CAVERJECT Sterile Powder. The incidence of priapism (erections lasting more than 6 hours in duration) was 0.4%. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
To minimize the chances of prolonged erection or priapism, CAVERJECT IMPULSE should be titrated slowly to the lowest effective dose [see DOSAGE AND ADMINISTRATION]. In addition, do not use CAVERJECT IMPULSE in patients who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see CONTRAINDICATIONS].
The overall incidence of penile fibrosis, reported in clinical studies with CAVERJECT Sterile Powder was 3%. In one self-injection clinical study where duration of use was up to 18 months, the incidence of penile fibrosis was 7.8%.
Physical examination of the penis, should be performed periodically to detect signs of penile fibrosis. Treatment with CAVERJECT IMPULSE should be discontinued in patients who develop penile angulation or cavernosal fibrosis.
Intracavernous injections of CAVERJECT IMPULSE can increase peripheral blood levels of alprostadil which can result in hypotension. Avoid use of CAVERJECT IMPULSE in patients with known cavernosal venous leakage.
Injection Site Bleeding When Used With Anticoagulants
Patients on anticoagulants, such as warfarin or heparin, may have increased propensity for injection site bleeding after intracavernosal injection with CAVERJECT IMPULSE. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.
Cardiovascular Risk Related To Underlying Medical Conditions
There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including CAVERJECT IMPULSE, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
Risks Of Use In Combination With Other Vasoactive Medications Injected Intracavernosally
The safety and efficacy of combinations of CAVERJECT IMPULSE and other vasoactive agents injected intracavernosally have not been established in clinical studies. The risks of prolonged erection, priapism, and hypotension may be increased.
CAVERJECT IMPULSE uses a superfine (29 gauge) needle for administration. As with all superfine needles, the possibility of needle breakage exists and cases of needle breakage have been reported. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalization and surgical removal. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage.
The preservative benzyl alcohol contained in CAVERJECT IMPULSE has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. The minimum amount of benzyl alcohol at which toxicity may occur is not known. The risk of benzyl alcohol toxicity depends on the quantity administered and the hepatic capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. CAVERJECT IMPULSE is not indicated for pediatric patients.
Counseling Patients About Sexually Transmitted Diseases
The use of CAVERJECT IMPULSE offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV) is advised.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
Dosing And Self-Administration
To ensure safe and effective use of CAVERJECT IMPULSE, instruct and train the patient in the self-injection technique before he begins intracavernosal treatment with CAVERJECT IMPULSE, at home. Inform the patient the initial dose administration and dose titration will take place in the physician's office.
Once the home dose of CAVERJECT IMPULSE has been established instruct the patient not to change the dose without consulting their physician.
The patient may expect an erection to occur within 5 to 20 minutes and it should last no longer than 1 hour. CAVERJECT IMPULSE should be used no more than 3 times per week, with at least 24 hours between each use.
Inform the patient that they must visit the physician's office for regular check-ups for assessment of the therapeutic benefit and safety of treatment with CAVERJECT IMPULSE.
When self-administering the patient should be instructed to:
- Discard any reconstituted solution with precipitates or discoloration
- Administer the injection 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
- Use each CAVERJECT IMPULSE system only once and discard after use
- Do not use a bent needle. If the needle is bent, it must not be used; they should also not attempt to straighten a bent needle. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.
- Not re-use or share needles and to properly discard after use
Advise patients that the most frequently occurring side-effect is penile pain after injection, and is usually mild to moderate in severity [see ADVERSE REACTIONS].
A potentially serious adverse reaction with intracavernosal therapy of CAVERJECT IMPULSE is priapism. Instruct the patient to seek immediate medical assistance if an erection persists for longer than 4 hours [see WARNINGS AND PRECAUTIONS].
Penile fibrosis has been reported in clinical studies with CAVERJECT. Advise the patient to report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis or curvature of the erect penis to his physician as soon as possible. [see WARNINGS AND PRECAUTIONS].
Injection Site Reactions
Inform the patient that injection of CAVERJECT IMPULSE can induce a small amount of bleeding at the site of injection and that hematoma and ecchymosis may occur. Advise the patient to report any persistent redness, tenderness or swelling.
Sexually Transmitted Disease
Use of intracavernosal CAVERJECT IMPULSE offers no protection from the transmission of sexually transmitted diseases. Advise the patient about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV).
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long-term carcinogenicity studies have not been conducted. The following battery of mutagenicity assays revealed no potential for mutagenesis: bacterial mutation (Ames), alkaline elution, rat micronucleus, sister chromatid exchange, CHO/HGPRT mammalian cell forward gene mutation, and unscheduled DNA synthesis (UDS). Rat reproductive studies indicate that alprostadil at doses of up to 0.2 mg/kg/day does not adversely affect or alter rat spermatogenesis, providing a 200-fold margin of safety compared with the usual human doses.
Use In Specific Populations
CAVERJECT IMPULSE is not indicated for use in women.
CAVERJECT IMPULSE is not indicated for use in pediatric patients [see WARNINGS AND PRECAUTIONS].
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.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/28/2016
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