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CAVERJECT- alprostadil injection, powder, lyophilized, for solution


  1. Patient Information
  2. Caverject Is A Prescription Medicine Used:
  3. Do Not Use Caverject If You:
  4. Caverject May Cause Serious Side Effects, Including:
  5. Active Ingredient:
  6. Inactive Ingredients:

Patient 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 intracavernosal treatment with CAVERJECT, at home. Inform the patient the initial dose administration and dose titration will take place in the physician's office[seeDosage and Administration (2.1)].

Once the home dose of CAVERJECT has been established instruct the patient not to change the dose without consulting their physician.

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[seeDosage and Administration (2.2)].

Inform the patient that they must visit the physician'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[seeDosage 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 access of the penis to avoid bending or breakage of the needle[seeDosage and Administration (2.4),Warnings and Precautions (5.7)andAdverse 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[seeAdverse Reactions (6.1)].

Priapism

A potentially serious adverse reaction with intracavernosal therapy of CAVERJECT is priapism. Instruct the patient to seek immediate medical assistance if an erection persists for longer than 4 hours[seeWarnings 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.[seeWarnings 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[seeWarnings and Precautions (5.4)].

Sexually Transmitted Disease

Use of intracavernosal 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)[seeWarnings and Precautions (5.9)].

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LAB-0764-3.0

Caverject Is A Prescription Medicine Used: 

  • to treat erectile dysfunction (ED).
  • with other medical tests to diagnose ED.

CAVERJECT is not meant for use in women or children.

Do Not Use Caverject If You: 

  • are allergic to alprostadil or any of the ingredients in CAVERJECT.

Caverject May Cause Serious Side Effects, Including: 

  • an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, this condition can permanently damage your penis.
  • deformed penis shape (penile fibrosis).Your healthcare provider should check your penis regularly for signs of penile fibrosis. You should not continue to use CAVERJECT if you get penile fibrosis.
  • low blood pressure (hypotension).
  • injection site bleeding.People who take certain medicines called anticoagulants (such as heparin or warfarin) may have a risk for increased bleeding at the injection site.
  • increased risk of heart problems.Sexual activity can put an extra strain on your heart, especially if your heart is weak from a heart attack or heart disease. Ask your healthcare provider if your heart is healthy enough to handle the extra strain of having sex. Stop sexual activity and get medical help right away if you get symptoms of a heart problem such as chest pain, dizziness or nausea.
  • needle breakage. There is a possibility of needle breakage with use of CAVERJECT. To best avoid breaking the needle, you should pay careful attention to your healthcare provider's instructions and try to handle the syringe and needle properly. If the needle breaks during injection and you are able to

Active Ingredient: 

alprostadil

Inactive Ingredients: 

alpha cyclodextrin, lactose, sodium citrate, benzyl alcohol (contained in the final solution) and hydrochloric acid and/or sodium hydroxide for pH adjustment.

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LAB-1045-1.0

Revised: December 2017



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