Alprostadil Injection

Caverject®
(alprostadil) for Injection

IMPOTENCE: CAUSES AND TREATMENTS

There are several causes of impotence, a condition known medically as erectile dysfunction. These include: medications that you may be taking for other conditions, impaired blood circulation in the penis, nerve damage, emotional problems, excessive smoking or alcohol use, use of street drugs, and hormonal imbalances. Often, impotence is due to more than one cause.

Treatments for impotence include: switching medications (if you are taking a medication that causes impotence), administration of hormones, penile injections, use of medical devices that produce an erection, surgical procedures to correct blood flow in the penis, penile implants, and psychological counseling. Your doctor has selected CAVERJECT for injection to treat your impotence. Your doctor can also discuss other available treatments. You should not stop taking any prescription medications, unless told to do so by your doctor.

USE OF CAVERJECT

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 about 1 hour. Generally, you should not use CAVERJECT more than 3 times a week, with at least 24 hours between uses.

Who Should Not Use CAVERJECT?

Men who have conditions that might result in long-lasting erections should not use CAVERJECT. Some of these conditions include: sickle cell anemia or trait, leukemia, and tumor of the bone marrow (multiple myeloma). Men with penile implants, or an abnormally formed penis, or who have been advised not to engage in sexual activity should not use CAVERJECT. CAVERJECT should not be used by women or children.

What Are The Risks Of Using CAVERJECT?

Erections that last more than 4 hours 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.

Call your doctor if you notice any redness, lumps, swelling, tenderness, or curving of the erect penis.

A small amount of bleeding at the injection site may occur. Tell your doctor if you have a condition or are taking a medicine that interferes with blood clotting.

NOTE: CAVERJECT offers no protection from the transmission of sexually transmitted diseases such as HIV (the virus that causes AIDS). Small amounts of bleeding at the injection site can increase the risk of transmission of blood-borne diseases between partners.

There is no approved injectable treatment using multiple drug components or “cocktails” for erectile dysfunction. Moreover, there are no data on the efficacy and safety of these combinations.

Storage

1. Unused packs of 5, 10 and 20 microgram vials of CAVERJECT may be stored at or below 25°C (77°F). Unused packs of the 40 microgram vial may be stored at or below 25°C (77°F) for 3 months or until expiration date, whichever occurs first. Do not freeze.
2. After reconstitution, the solution of CAVERJECT should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.
3. During travel, care should be taken to avoid allowing the product to freeze or be stored at temperatures above 25°C (77°F). Therefore, do not store in checked luggage during air travel or leave in a closed automobile.

Additional Information

There is a technical leaflet discussion of CAVERJECT written for health-care professionals that your pharmacist can let you read.

More information about erectile dysfunction and its treatment is available from the National Institutes of Health (Washington, DC), the American Foundation for Urological Diseases (Baltimore, MD), or the Impotence Institute of America (Washington, DC).

Preparing And Injecting Caverject

You must be properly instructed and trained in the injection technique by your doctor before using CAVERJECT.

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 prepare and inject a sterile dose of CAVERJECT.

If the needle is severely bent at any time, do not use it for injecting CAVERJECT and do not attempt to straighten it prior to injecting CAVERJECT. A severely bent and restraightened needle may be is predisposed to breakage. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, required hospitalization and surgical removal. If the needle is severely bent while preparing the injection, remove it from the syringe, discard, and attach a new, unused sterile needle to the syringe as described under “Prepare the Dose” below.

Use the needle, syringe, alcohol swabs, and vials only once then safely discard the supplies and any unused solution. Discard your needle/syringe, and alcohol swabs in a special container for disposal of sharp medical supplies. Ask your doctor or pharmacist where you can get these special containers.

Supplies Needed

To prepare and inject CAVERJECT you will need a vial of CAVERJECT Sterile Powder, a vial of diluent (bacteriostatic water for injection or sterile water, both preserved with benzyl alcohol 0.945% w/v), a disposable sterile 3-milliliter (3-cc) syringe, a ½-inch 27gauge sterile needle, and two alcohol swabs (Figure A).

Figure A

CAVERJECT comes in 5, 10, 20 or 40 microgram strengths. MAKE SURE YOU HAVE THE RIGHT STRENGTH VIAL OF CAVERJECT.

Prepare the Dose

1. Wash your hands thoroughly, and dry them with a clean towel.

2. Assemble the needle and syringe as follows:

a. Remove the syringe from its sterile wrapping.

b. To remove the sterile needle from its wrapping, carefully pull the wrapper tabs back enough to expose the sterile open end of the needle assembly. Do not touch  to open end of the needle (Figure B)

Figure B

c. While holding the sterile needle assembly between thumb and forefinger, pick up syringe with other hand. With same two fingers, remove the plastic syringe cap (Figure C). Do not touch the syringe tip.

Figure C

d. Without removing the plastic needle cover, firmly attach the needle to the syringe tip (twist to tighten) (Figure D)

Figure D

e. With the needle cover in place, set the syringe and needle down on a clean, level surface.

3. Remove the plastic caps from the vials of CAVERJECT and diluent.

4. Wipe the rubber stoppers on the vials of CAVERJECT and diluent with one alcohol swab. Discard this alcohol swab.

5. Grasp the syringe barrel (not the plunger) and remove the needle cover. Do not discard the needle cover, you will need to use it again (see step 16). Do not touch the exposed needle. Holding the syringe/needle in a straight line with the diluent vial to avoid bending the needle, push the needle through the center of the diluent vial's rubber stopper.

6. Keeping the needle in the vial, firmly hold the vial and syringe upside down in one hand (see Figure E)

Figure E

7. Keeping the needle tip below the level of fluid, pull back on the syringe plunger until all the diluent is removed from vial.

8. Push the syringe plunger to the 1-cc (mL) mark on the syringe. This will expel air and excess diluent back into vial.

9. Grasp the side of syringe barrel (not the plunger) and pull the needle/syringe from the diluent vial in a straight line to avoid bending the needle.

10. Holding the syringe/needle in a straight line with the vial of CAVERJECT to avoid bending the needle, push the needle through the center of the rubber stopper of the vial of CAVERJECT and push the syringe plunger all the way down to expel all the diluent into the vial. Proceed immediately to step 11.

11. Without removing the needle or touching the needle or stopper, gently swirl (do not shake) the vial until all the powder is dissolved in the diluent. Then turn the vial and needle/syringe upside down and gently swirl the vial to dissolve any powder in the neck of the vial. DO NOT USE THE SOLUTION IF IT IS CLOUDY, COLORED OR CONTAINS PARTICLES.

12. Keeping the needle in the vial, firmly hold the vial and syringe upside down in one hand (see Figure E).

13. Keeping the needle tip below the level of fluid, slowly pull back on the syringe plunger until all the fluid is removed from the vial.

14. If there are air bubbles, gently tap the syringe barrel until they float to the top of the solution (see Figure F). Holding the syringe upright, push the syringe plunger to the correct volume mark for the dose prescribed by your doctor. This will expel any air and excess solution into the vial.

Figure F

15. Grasp the syringe barrel (not the plunger) and pull the needle/syringe from the vial of CAVERJECT in a straight line to avoid bending the needle.

16. Place the needle cover over the needle and set the syringe down on a level surface.

Select Injection Site

1. CAVERJECT will be injected into a corpus cavernosum (spongy tissue) of the penis. One corpus cavernosum runs the length of the right side of the penis. Another corpus cavernosum runs the length of the left side of the penis (see Figures G and H).

Figures G and H

2. Choose an injection site on one side of the shaft of the penis as shown in Figure G. AVOID VISIBLE BLOOD VESSELS.

3. WITH EACH USE OF CAVERJECT, ALTERNATE THE SIDE OF THE PENIS AND VARY THE SITE OF THE INJECTION.

Inject Your Dose of CAVERJECT

1. You should be sitting upright or slightly reclined when injecting CAVERJECT.

2. If your penis is not circumcised, pull the foreskin back. Holding the head of your penis with your thumb and forefinger, stretch it lengthwise along your thigh so that you can clearly see the selected injection site.

3. Clean the injection site with a new alcohol swab. Do not discard this swab, you will need to use it again (see step 7).

4. Remove the cover from the needle. Reposition the penis firmly against your thigh as in step 2 to keep it from moving during the injection.

5. Hold the syringe between your thumb and index finger (Figure I). Using a steady motion, push the needle straight into the selected site until the metal part of the needle is almost entirely in the penis.

Figure I

6. Holding the syringe barrel between two fingers, move your thumb or finger to the top of the plunger and, with a steady motion, push down on the plunger so that the entire volume of CAVERJECT is slowly injected (Figure J).

Figure J

7. Grasp the syringe barrel and pull the needle out of your penis. APPLY PRESSURE TO THE INJECTION SITE WITH THE ALCOHOL SWAB FOR ABOUT 5 MINUTES OR UNTIL BLEEDING STOPS.

Disposal of Injection Materials

1. Discard your needle, syringe, and alcohol swabs in a special container for disposal of sharp medical supplies. Ask your doctor or pharmacist where you can obtain these special containers. Follow the directions on your disposal container for proper disposal procedures.

2. Do not re-use or share needles or syringes. As with all prescription medicines, do not allow anyone else to use your medicine.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Penile pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consult your pharmacist.

How to use Alprostadil Vial

Consult your pharmacist.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Since alprostadil is used as needed, you will not be on a dosing schedule.