2 DOSAGE AND ADMINISTRATION
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.