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)]:

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Discard any reconstituted solution with precipitates or discoloration

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Administer the injection along the dorso-lateral aspect of the proximal third of the penis

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Wipe the intended injection site with an alcohol swab prior to injection

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Avoid visible veins during injection

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Alternate the side of the penis that is injected and the site of injection

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Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes

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Use each CAVERJECT vial only once and discard after use. Use a new vial of CAVERJECT for each dose.

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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

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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)].