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CAVERJECT IMPULSE- alprostadil injection, powder, lyophilized, for solution


  1. Patient Information
  2. When Self-administering The Patient Should Be Instructed To:
  3. Caverject Impulse Is A Prescription Medicine Used:
  4. Do Not Use Caverject Impulse If You Have:
  5. Before You Use Caverject Impulse, Tell Your Healthcare Provider If You:
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Caverject Impulse May Cause Serious Side Effects, Including:
  9. What Are The Causes Of And Treatments For Ed?
  10. Manufactured By:

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 IMPULSE, instruct and train the patient in the self-injection technique before he begins intracavernosal treatment with CAVERJECT IMPULSE, at home. Inform the patient the initial dose administration and dose titration will take place in the physician's office.

Once the home dose of CAVERJECT IMPULSE 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 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 physician'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: 

  • 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
  • Do not use a bent needle. If the needle is bent, it must not be used; they should also not attempt to straighten a bent needle. They should 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

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 IMPULSE 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 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.

Sexually Transmitted Disease

Use of intracavernosal 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).

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com

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LAB-0007-9.0

Caverject Impulse Is A Prescription Medicine Used: 

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

CAVERJECT IMPULSE is not meant for use in women or children under 18 years of age.

Do Not Use Caverject Impulse If You Have: 

  • certain medical problems that might cause you to have an erection that lasts for more than 4 hours, such as sickle cell anemia, sickle cell trait, multiple myeloma, leukemia.
  • a deformed penis shape
  • a penile implant

Before You Use Caverject Impulse, Tell Your Healthcare Provider If You: 

  • have had an erection that lasted more than 4 hours
  • have sickle cell trait or sickle cell anemia
  • have or have had a blood cell cancer called multiple myeloma or leukemia
  • have a deformed penis shape
  • have a penile implant
  • have low blood pressure (hypotension)
  • have bleeding problems
  • have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure
  • have any other medical conditions

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CAVERJECT IMPULSE may affect the way other medicines work, and other medicines may affect the way CAVERJECT IMPULSE works causing side effects.

Especially tell your healthcare provider if you takeany other medicines that are injected into your penis (intracavernosally) or certain medicines called anticoagulant medicines (such as heparin or warfarin).

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Active Ingredient: 

alprostadil

Inactive Ingredients: 

alpha cyclodextrin, lactose, sodium citrate, benzyl alcohol and hydrochloric and/or sodium hydroxide for pH adjustment.

Caverject Impulse May Cause Serious Side Effects, Including: 

  • an erection that will not go away .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 IMPULSE 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 IMPULSE. 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 is bent at any time, do not attempt to straighten it and do not use it. A bent and re-straightened needle is predisposed to breakage. Remove the needle from the syringe, discard, and attach a new, unused sterile needle to the syringe. If the needle breaks during injection and you are able to

What Are The Causes Of And Treatments For Ed? 

There are several causes of ED. These include medications that you may be taking for other conditions, poor blood circulation in the penis, nerve damage, emotional problems, too much smoking or alcohol use, use of street drugs, and hormonal problems. Often, ED is due to more than one cause.

Treatments for ED include switching medications if you are taking a medication that causes erectile dysfunction, prescription medications, medical devices that produce an erection, surgical procedures to correct blood flow in the penis, penile implants, and psychological counseling.

You should not stop taking any prescription medications, unless told to do so by your doctor.

The use of other medical treatments for ED in combination with CAVERJECT is not recommended. Discuss any concerns you may have about combination treatment with your doctor.

INSTRUCTIONS FOR 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) asyringe, (b) a separateneedle assemblyand (c) twoalcohol swabs. The syringe and the needle assembly are shown in Figure A (below). Please note that theneedle assemblyis 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.

Figure A

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 usedonly 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 dosethere will be left-over solution in the syringethis 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 theneedle 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 assemblyat this point leave it sealed inside the outer protective cap.



Next, examine thesyringe. Find the location of thedose window. Right now you will not

1.
StoreunmixedCAVERJECT IMPULSE at room temperature between 68 F to 77 F (20 C to 25 C).
2.
StoremixedCAVERJECT IMPULSE between 36 77 F (2 C to 25 C). Do not freeze.
3.
CAVERJECT IMPULSE should be used within 24 hours after it is mixed.

Keep CAVERJECT IMPULSE and all medicines out of the reach of children.

This Patient Information and Instructions for Use has been approved by the U.S Food and Drug Administration.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Rx only

Manufactured By: 

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LAB-0641-6.0
October 2016



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