17 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 (6.1)].
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 (5.1)].
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 (5.2)].
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).