Caverject Impulse Alprostadil 10 ug/.5mL Injection, Powder, Lyophilized, For Solution, 2 syringes — NDC 0009-5181-01 (Billing 00009-5181-01)

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 ).

1.1Erectile Dysfunction CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction.

1.2Diagnostic Test CAVERJECT IMPULSE is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

2 DOSAGE AND ADMINISTRATION • Determine the most suitable dose and presentation of CAVERJECT to use. Use a new syringe for each dose of CAVERJECT ( 2.1 ). • Administer first intracavernosal injections in the health care provider’s office and titrate the dose for each patient to the lowest effective dose ( 2.1 ). • 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 ( 2.1 ). • Recommended dosage for erectile dysfunction ( 2.2 ): o Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate dosing with 2.5 mcg o 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 patient home use in the health care provider’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 health care provider’s office every 3 months to assess the efficacy and safety of the therapy ( 2.1 ). • Follow procedure for CAVERJECT IMPULSE syringe preparation ( 2.3 ). • Follow the procedure for CAVERJECT IMPULSE administration ( 2.4 ). • To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT IMPULSE intracavernosally and monitor patients for the occurrence of an erection ( 2.2 ).

2.1Important 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.

2.2Recommended Dosage for Erectile Dysfunction Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology. • Initiate dosing with 2.5 mcg of CAVERJECT IMPULSE intracavernousally as recommended [see Dosage and Administration 2.4 ] . • If there is a partial response at 2.5 mcg, administer another dose of 2.5 mcg within 1 hour. • During titration, no more than 2 doses should be given within a 24-hour period. • If additional titration is required, administer doses in increments of 5 to 10 mcg at least 24 hours apart. • 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 health care provider’s office until complete detumescence occurs.

Repeat the titration as necessary until the optimal dose is achieved. Doses greater than 60 mcg are not recommended. Erectile Dysfunction of Pure Neurogenic Etiology (Spinal Cord Injury): • Initiate dosing with 1.25 mcg of alprostadil using CAVERJECT. • If there is a partial response, administer another dose of CAVERJECT of 1.25 mcg within 1 hour. • No more than 2 doses during initial titration should be given within a 24-hour period. • If additional titration is required, administer a dose of 5 mcg at least 24 hours later. • 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 health care provider’s office until complete detumescence occurs.

Repeat the titration as necessary until the optimal dose is achieved. Doses greater than 60 mcg are not recommended. Maintenance Dosage for Patient Home Use: • Once the dos… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS Caverject Impulse (alprostadil) for injection contains sterile, freeze-dried alprostadil for reconstitution and sterile bacteriostatic water in a prefilled dual chamber glass cartridge. It is available in 10 mcg and 20 mcg strengths. For injection: 10 mcg and 20 mcg of alprostadil freeze-dried powder for reconstitution in single-dose, pre‑filled, dual chambered glass cartridge syringe.

The front chamber contains alprostadil and the rear chamber contains sterile bacteriostatic water. A 29 gauge needle system is also included. The reconstituted solution is clear.

For injection: 10 mcg or 20 mcg freeze-dried powder for reconstitution in a dual-chamber syringe ( 3 ).

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 treatment with CAVERJECT IMPULSE, at home. Inform the patient the initial dose administration and dose titration will take place in the health care provider’s office [see Dosage and Administration (2.1) ] . Once the home dose of CAVERJECT IMPULSE has been established instruct the patient not to change the dose without consulting their health care provider.

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 health care provider’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 [see Dosage and Administration (2.3 , 2.4) ] : • 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 • Not use a bent needle.

Do not attempt to straighten a bent needle. 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. Needle Breakage Advise patients that needle breakage has occurred during self-injection of CAVERJECT.

Advise patients to insert the needle perpendicular to the long axis of the penis to avoid bending or breakage of the needle [see Warnings and Precautions (5.7) and Adverse Reactions (6.2) ] . Penile Pain 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) ] . Priapism A potentially serious adverse reaction with 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 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 [see Warnings and Precautions (5.4) ] . Sexually Transmitted Disease Use of 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) [see Warnings and Precautions (5.9) ] .

INSTRUCTIONS FOR USE CAVERJECT [KAV-er-jeckt]® (alprostadil) for injection, for intracavernosal use Before you use CAVERJECT, your doctor must train you in how to prepare and give the injection properly. Before using CAVERJECT, talk to your doctor about what to expect when using it, possible side effects, and what to do if side effects occur. Your dose has been selected for your individual needs.

Do not change your dose without consulting your doctor. If you are not sure of the volume or dose to be used, talk to your doctor or pharmacist. Follow these instructions exactly to properly prepare the syringe for use, and to correctly inject a sterile (germ-free) dose of CAVERJECT.

Supplies Needed The CAVERJECT IMPULSE carton contains two (2) sealed plastic trays, with one dose of Caverject in each tray. Each tray contains: (a) a syringe , (b) a separate needle assembly and (c) two alcohol swabs . The syringe and the needle assembly are shown in Figure A (below).

Please note that the needle assembly is packaged as a single piece and is sealed with a paper cover on the bottom. DO NOT try to assemble the syringe until you have read ALL of the instructions. First-read through ALL of the instructions (Step 1 through Step 12) before trying to assemble the syringe.

Then go back to Step 1 and begin to prepare the syringe for use. CAVERJECT IMPULSE is available in two versions: the 10 mcg strength (white plunger) and the 20 mcg strength (blue plunger). Each syringe is designed to be used only one time , but you can select the dose that will be delivered: • The 10 mcg strength syringe (white plunger) can deliver 10 mcg (the full dose), or one of three partial doses: 7.5 mcg, or 5 mcg, or 2.5 mcg. • The 20 mcg strength syringe (blue plunger) can deliver 20 mcg (the full dose), or one of three partial doses: 15 mcg, or 10 mcg, or 5 mcg.

If you deliver a partial dose there will be left-over solution in the syringe – this is normal. MAKE SURE YOU HAVE THE CORRECT STRENGTH OF CAVERJECT IMPULSE to deliver your assigned dose INSTRUCTIONS for PREPARING the SYRINGE (Step 1 through Step 12) Wash your hands thoroughly and dry them with a clean towel. STEP 1.

Open the sealed plastic tray. Remove the syringe, the needle assembly, and the alcohol swabs from the tray. All items should be present.

Look at the needle assembly . The needle assembly is a sealed unit that contains the outer protective cap, the inner protective cap, and the superfine needle, as shown in Figure A. It is sealed with a small round paper cover (not shown in Figure A).

Do not open the needle assembly at this point – leave it sealed inside the outer protective cap. Next, examine the syringe . Find the location of the dose window .

Right now you will not see anything in this window, but at a later Step, a number will appear in this window (the dose to be delivered). Finally, look at the Plunger, but do not move it at this time . During the assembly process, some Steps may ask you to ROTATE the plunger and other steps may ask you to PUSH the plunger.

It is important to only rotate the plunger – or only push – as directed in each Step, but DO NOT do both at the same time. Never PUSH on the plunger – even slightly – while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.

STEP 2. Open the packet containing the alcohol swab, and then pick up the syringe. Use the alcohol swab to wipe the rubber membrane at the tip of the syringe (Figure B).

Discard the alcohol swab. STEP 3. Pick up the Needle Assembly .

Grab the paper tab and peel off the paper cover (lid) from the bottom of the needle assembly (Figure C). STEP 4. Hold the needle assembly by the cap.

Pick up the syringe with your other hand. Press the needle assembly onto the tip of the syringe and turn it clockwise (like tightening a screw) until the needle assembly is firmly locked into place. Remove (twist off - clockwise) the outer protective cap from the needle (Figure D), but DO NOT REMOVE the inner p… [Excerpted — this section continues on DailyMed.]