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Caverject Impulse

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Caverject Impulse

PATIENT INFORMATION

CaverJect Impulse®
Dual Chamber System
(alprostadil) for Injection

Read this information carefully before using CAVERJECT [KAV-er-jeckt]. Read the information you get each time you renew your prescription, in case anything has changed. This is a summary and does not replace talking with your doctor when you start this medication and at check-ups. If you have any questions or concerns, talk to your doctor about them.

What is CAVERJECT?

CAVERJECT is a medicine to treat male impotence (erectile dysfunction). CAVERJECT is injected into a specific area of the penis and should produce an erection in 5 to 20 minutes. The erection should last for no longer than 1 hour.

CAVERJECT IMPULSE is for one use only and should be thrown away properly after a single use.

CAVERJECT does not protect you from sexually transmitted diseases (STDs), such as HIV (the virus that causes AIDS). In addition, small amounts of bleeding at the injection site can increase the risk of passing diseases carried by the blood, such as HIV.

What are the causes of and treatments for impotence?

There are several causes of impotence. 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, impotence is due to more than one cause.

Treatments for impotence include switching medications if you are taking a medication that causes impotence, 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 impotence in combination with CAVERJECT is not recommended. Discuss any concerns you may have about combination treatment with your doctor.

Who should not use CAVERJECT?

Do not use CAVERJECT if you have certain conditions that might cause long-lasting erections (lasting more than 4 hours). Long-lasting erections may cause penis damage. These conditions include:

Do not use CAVERJECT if you

  • have a penile implant
  • have an abnormally formed penis
  • have other penis problems
  • were told by your doctor not to have sex

Women and children should not use CAVERJECT.

How should I use CAVERJECT?

You will be treated with CAVERJECT in your doctor's office to find out what dose is best for you. After that, you can inject it yourself at home. Do not use it more than 3 times a week. There should be at least 24 hours between doses. See your doctor for regular check-ups to be sure CAVERJECT is not causing damage and that it is working as well as possible.

See the section “Instructions for Use” at the end of this leaflet for details about how to use CAVERJECT.

What are the possible side effects of CAVERJECT?

About 4 in 100 men who use CAVERJECT may get erections that last more than 4 hours. These can cause serious and permanent damage. Call your doctor or seek professional help immediately if you still have an erection 4 hours after injection.

The most common side effect of CAVERJECT is mild to moderate pain after injection. About one-third of patients report this effect.

You may get a small amount of bleeding at the injection site. This is more likely if you have a medical condition or are taking a medicine that interferes with blood clotting.

Call your doctor if you notice any redness, lumps, swelling, tenderness, or curving of the erect penis. Also, tell your doctor about any penis pain you did not have before or other penis problems you have.

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 doctor's instructions and try to handle the syringe and needle properly. If the needle breaks during injection and you are able to see and grasp the broken end, you should remove it and contact your doctor. If you cannot see or cannot grasp the broken end, you should promptly contact your doctor.

How should I store CAVERJECT IMPULSE?

  1. Unmixed packages of CAVERJECT IMPULSE should be stored at room temperature. Temperatures between 59° to 86°F (15° to 30°C) are allowed. Avoid storing CAVERJECT IMPULSE at very high and very low temperatures.
  2. During travel, do not let the medicine freeze or be stored at a temperature above 77°F (25°C). For example, do not store it in checked luggage during air travel or leave it in a closed automobile.
  3. After mixing, CAVERJECT IMPULSE should be used within 24 hours. It should be kept at a temperature of 77°F or below during this storage time.

General advice about prescription medicines

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. If you have any concerns about CAVERJECT, ask your doctor. Your doctor or pharmacist can give you information about CAVERJECT that was written for health care professionals. Do not use CAVERJECT for a condition for which it was not prescribed. Do not share CAVERJECT with other people.

You can get more information about impotence (erectile dysfunction) and its treatment from the National Institutes of Health (Washington, DC), the American Foundation for Urological Diseases (Baltimore, MD), or the Impotence Institute of America (Washington, DC).

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) 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.

Figure A

CAVERJECT IMPULSE syringe and needle assembly - Illustration

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.

Figure B

Wipe the rubber membrane - Illustration

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).

Figure C

Peel off the paper cover - Illustration

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 protective cap at this time. The inner protective cap is the thin plastic tube that directly covers the needle. It will be removed later. If you are not sure which piece is the inner protective cap, see Figure A (Step 1) to identify the inner protective cap. The next few steps will mix the powder and the fluid to make the Caverject Impulse solution.

Figure D

Remove the outer protective cap - Illustration

STEP 5. Hold the syringe system with the needle pointing upward. The plunger rod should still be in the fully extended position, with all of the threads visible, as shown in Figure E.

Figure E

Hold the syringe system upright - Illustration

STEP 6. Slowly ROTATE the plunger rod clockwise (like tightening a screw,) until it goes all the way in and stops (Figure F).

This automatically combines the drug powder and the fluid.

Figure F

Slowly ROTATE the plunger rod - Illustration

DO NOT turn the plunger rod counter-clockwise (do not try to “unscrew” the plunger rod).

DO NOT PUSH on the plunger while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.

STEP 7. Turn the syringe upside down several times to make sure the solution is evenly mixed. The solution should be clear. Do not use it if it is cloudy or contains particles.

STEP 8. Hold the syringe with the needle upward and carefully remove the inner protective cap from the needle (Figure G). Do not touch the exposed needle because it is sterile.

Figure G

Remove the inner protective cap - Illustration

STEP 9. Next, you need to remove any large bubbles from the solution. Lightly tap the glass cartridge a few times with your finger until any large bubbles disappear up into the tip. Very small bubbles may remain.

STEP 10. With the syringe pointed upward (Figure H), use your thumb to push in the plunger rod until it stops.

Figure H

push in the plunger rod - Illustration

This will push the air out. Some liquid will appear at the needle point.

After pressing the plunger you may still see some small bubbles on the wall of the glass cartridge. This is normal.

If you can't press the plunger rod in, check that the plunger rod is rotated all the way: turn it clockwise until it stops, and then repeat Step 10.

After the plunger is pushed in – Do Not rotate the plunger. That will be done in the next step.

STEP 11. PLEASE READ the following before going on.

In Step 11, you will need to set the dose by ROTATING the plunger until the correct dose appears in the small oval Dose Window on the syringe. The plunger must be rotated “clock-wise” – like tightening a screw.

Figure I

Set the dose - Illustration

DO NOT PUSH on the plunger while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.

If the plunger does stick, you can try to free it by gently turning it backward (“unscrewing it”) and trying again.

TO SET THE DOSE:

Locate the Dose Window on the syringe. This small oval window (above the left thumb in Figure I) is where the dose number will appear when the plunger is rotated.

Then – holding the syringe as shown in Figure I, slowly turn the plunger rod clockwise (like tightening a screw – see arrow in Figure I) until the correct dose number appears in the center of the window (Figure J).

Figure J

Dose window - Illustration

If you pass the correct number, keep turning the plunger in the same direction until the correct number comes around again – do not try to turn it backward

STEP 12. The syringe is now ready for use.

Set the syringe down on a flat level surface.

The needle is sterile .Make sure the needle does not touch the surface or anything else.

How to give the injection

  • Make yourself comfortable. Take some time to relax yourself and your partner. If your doctor has recommended you use an alcohol cleansing swab, open one now.
  • Make sure that the needle is not bent. If it is, do not use it. Do not attempt to straighten the needle out. Properly discard it.

1. The injection will go into the part of the penis shown as the shaded area in Figure K. Do not inject into the white areas because there may be blood vessels in the white areas. Also see Figure L.

2. The correct injection angle is shown in Figure L.

Figure K AND L

Injection site - Illustration

3. If your doctor has recommended that you use an alcohol swab, wipe over the area for injection and let it dry. Reconfirm that the correct dose is visible in the dose window. If the correct dose is not in the dose window, repeat Step 11.

4. Take hold of the penis from the front, with the first two fingers underneath close to the testicles and the thumb on top (Figure M).

Figure M

Injecting the dose - Illustration

5. Gently squeeze the penis between your thumb and finger so that the injection site bulges out. If there is a foreskin on the penis, make sure it is stretched.

6. Keeping a firm grip on the penis and taking the syringe in your free hand, push the needle straight through the skin all the way into the bulgy part (corpora cavernosa). Avoid veins or other obvious blood vessels (Figures K and L).

7. Push the plunger firmly and steadily until it no longer moves. Plunger movement may be very small or undetectable if administering a partial dose.

8. If the plunger does not move easily adjust the needle depth slightly and try again. Do not force the solution from the syringe.

9. After completing the injection, carefully pull the needle out. A drop of liquid may remain on the tip of the needle. Press gently on the injection site with the alcohol swab. Massage the penis to help the Caverject Impulse solution spread through it.

Some liquid will remain in the syringe if you delivered a PARTIAL dose. This is expected. Do not try to inject left-over liquid from a partial dose. Syringes used to inject a partial dose must be discarded since each syringe can only be used one time. Discard syringes with left-over liquid.

  • A partial dose is 5 mcg, 10 mcg or 15 mcg for the BLUE plunger syringe.
  • A partial dose is 2.5 mcg, 5 mcg, or 7.5 mcg for the WHITE plunger syringe.

Do not keep any solution in the cartridge to use for a second injection. When you have finished with the syringe, discard it carefully as recommended by your doctor, so no one will use it or stick themselves with it.

How often can you use Caverject Impulse?

Do not use Caverject Impulse more than once in 24 hours or more than three times in a week. Change the exact place and side of the penis that you inject Caverject Impulse each time you use it.

Your erection after injecting Caverject Impulse

It will take a little while for your erection to occur after the injection. With the correct dose of Caverject Impulse your erection should be sufficiently firm enough for you and your partner to engage in sexual intercourse. Usually, your erection should not last longer than an hour. If you would like it to last longer, talk to your doctor. If your erection lasts longer than four hours, you should seek medical assistance immediately (see section on side effects below).

If you use too much Caverject Impulse

Tell your doctor immediately as you may need treatment; particularly if you experience an erection that lasts for longer than four hours. If you have any further questions on how to use this product, ask your doctor.

Disposal of Injection Materials

After use, dispose of all injection materials safely. Your pharmacist may be able to supply a disposal box especially for disposable injection delivery systems. As with all prescription medicines, do not allow anyone else to use your medicine.

Last reviewed on RxList: 3/3/2014
This monograph has been modified to include the generic and brand name in many instances.

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Caverject Impulse - User Reviews

Caverject Impulse User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.



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