Alprostadil

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 liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. CAVERJECT IMPULSE is not indicated for use in pediatric patients. 5.9 Counsel Patients About Sexually Transmitted Diseases The use of CAVERJECT IMPULSE offers no protection against sexually transmitted diseases.

Important Dosage and Administration Instructions

Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient. Use a new syringe for each dose of CAVERJECT.

Titrate the dose of CAVERJECT IMPULSE for each patient to the lowest effective dose.

CAVERJECT IMPULSE doses greater than 60 mcg are not recommended.

Administer the first doses of CAVERJECT IMPULSE in the health care provider’s office by medically trained personnel.

Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of home use. Refer to the Patient Information and Instructions for Use.

Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.

Syringe Preparation Instructions 1. Select the CAVERJECT IMPULSE syringe based upon dose to be administered. [See table below.] 20 mcg/0.5 mL 5 mcg 10 mcg 15 mcg 20 mcg 2. 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. 3. 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). 4. 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. 5. 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. 6. 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. 7. 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. 8. 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. 9.

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. 10.

After reconstitution, the syringe should be used within 24 hours when stored between 36 to 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.

Administration Instructions

Administer CAVERJECT IMPUSLE intracavernosally along the dorso-lateral aspect of the proximal third of the penis. See Figures A and B below. Figure A Figure B

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.

Each CAVERJECT IMPULSE syringe is intended for single use only (one dose only) and should be discarded after use. Injection site Top side