Caverject Alprostadil 20.5 ug/mL Injection, Powder, Lyophilized, For Solution, 6 vials — NDC 0009-3701-05 (Billing 00009-3701-05)

1 INDICATIONS AND USAGE CAVERJECT 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 is indicated for the treatment of erectile dysfunction.

1.2Diagnostic Test CAVERJECT 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 vial 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 ): • Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate dosing with 2.5 mcg • 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 the procedure for CAVERJECT syringe preparation ( 2.3 ). • Follow procedure for CAVERJECT intracavernosal injection administration ( 2.4 ). • To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT 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. • CAVERJECT is available in single-dose vials containing 20 mcg or 40 mcg of alprostadil. Make sure a new, correct strength vial of CAVERJECT is used for each patient dosage preparation. • Titrate the dose of CAVERJECT for each patient to the lowest effective dose. • CAVERJECT doses greater than 60 mcg are not recommended. • Administer the first injections of CAVERJECT 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 intracavernosally, 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. Use a new vial for each dose of CAVERJECT. • 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 (e.g., Spinal Cord Injury). • Initiate dosing with 1.25 mcg of CAVERJECT intracavernosally, as recommended [see Dosage and Administration (2.4 )] . • If there is a partial response at 1.25 mcg, administer another dose of 1.25 mcg within 1 hour.

Use a new vial for each dose of CAVERJECT. • If additional titration is required, administer a dose of 5 mcg at least 24 hours later. • 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 m… [Excerpted — this section continues on DailyMed.]

3 DOSAGE FORMS AND STRENGTHS For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution. For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution ( 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, instruct and train the patient in the self-injection technique before he begins treatment with CAVERJECT, 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 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 minutes to 20 minutes and it should last no longer than 1 hour. CAVERJECT should be used no more than 3 times per week, with at least 24 hours between each use [see Dosage and Administration (2.2) ] .

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. When self-administering the patient should be instructed to [see Dosage and Administration (2.2 , 2.3) ] : • 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 vial only once and discard after use.

Use a new vial of CAVERJECT for each dose. • Not use a bent needle for reconstitution or injection. 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 Dosage and Administration (2.4) , 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 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 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 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 Your healthcare provider should show you how to prepare and inject CAVERJECT the right way before you inject it for the first time. Do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider. Information about how to safely inject CAVERJECT: • Read and follow these instructions so that you inject CAVERJECT the right way.

Call your healthcare provider if you have any questions about the right way to inject CAVERJECT. • Separate needles should be used for reconstitution and administration. Do not use damaged or bent needles to inject CAVERJECT. • If you accidentally bend a needle, do not attempt to straighten it. • Using bent or re-straightened needles may cause part of the needle to break off and remain in the penis. Some people have reported needle breakage in their penis during the injection and, in some cases, had to go to hospital for surgery to remove the needle. • If you accidentally bend the needle while preparing your CAVERJECT injection, remove it from the syringe, throw it away, and attach a new, needle to the syringe as described under "Prepare the Dose" below.

( See "Dispose of your used CAVERJECT syringe and needle" at the end of these Instructions). • Do not share your needles or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. • Use the needles, syringe, alcohol swabs, and vials only 1 time then safely throw away the supplies and any unused solution in a puncture resistant container (See "Dispose of your used CAVERJECT syringe and needle" at the end of these instructions).

Ask your healthcare provider or pharmacist where you can get a puncture resistant or sharps container. Supplies you will need to give your CAVERJECT injection (Figure A) • 1 CAVERJECT sterile powder vial These items are needed for injection and are not supplied with CAVERJECT : • 1 - diluent vial (bacteriostatic water for injection) • 1 - sterile 1 milliliter (mL) to 3 mL syringe • 1 - 21 to 27 gauge sterile needle to mix the medicine • 1 - 29 or 30 gauge one-half inch needle for injection • 2 - alcohol swabs • 1 - puncture-resistant or sharps container (not shown) for throwing away the used CAVERJECT syringe and needle.

See "Dispose of your used CAVERJECT syringe and needle" at the end of these instructions. Figure A: Supplies you will need for your Injection. Follow the instructions below to prepare and give your injection.

Figure B explains the parts of the needle and syringe that are referred to in the instructions. Figure B: Parts of the needle and syringe CAVERJECT comes in 20 mcg or 40 mcg strengths. Make sure you have the right strength vial of CAVERJECT that your healthcare provider prescribed for you.

Prepare the Syringe Step 1 . Wash your hands thoroughly and dry them with a clean towel. Step 2 .

Assemble the needle and syringe as follows: • Remove the syringe from its sterile wrapping. (Figure C) Figure C: Remove the syringe • Use a 21 to 27 gauge needle. Carefully pull the wrapper tabs back enough to expose the sterile open end of the needle assembly.

Do not completely remove the wrapper. • Do not touch the open end of the needle (Figure D). Figure D: Open the needle wrapper Step 3 . Keeping hold of the needle assembly, remove the plastic syringe cap from the syringe tip (Figure E).

Do not touch the syringe tip. Figure E: Remove the syringe cap Step 4 . Hold the needle assembly (still in the paper wrapper).

Firmly attach the needle to the syringe tip. Turn it clockwise, like tightening a screw to lock it in place (Figure F). • With the needle cover in place, set the syringe and needle down on a clean, level surface, like a table. Figure F: Attach the needle to the syringe Mixing the powder and liquid to prepare the dose Step 5 .

Remove the plastic cap from the vial of CAVER… [Excerpted — this section continues on DailyMed.]