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 hormonalimbalances. Often, impotence is due to more than one cause. Treatments for impotence include: switching medications (if you are taking a medication thatcauses 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 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. CAVERJECT Injection is distributed and stored in the pharmacy as a frozen pack, which you should place in your freezer or refrigerator as soon as possible. Brief (2 hours or less) exposure to conditions as warm as 25°C (77°F) will not harm your medicine. If placed in your refrigerator, it must be used within 7 days (see #2 below).
2. Store unused packs of CAVERJECT Injection in the unopened foil wrapping in your freezer at -20° to -10°C (-4° to 14°F) for no longer than 3 months. During this 3-month period, CAVERJECT Injection may be moved to and kept in a refrigerator at 2° to 8°C (36° to 46°F) for up to 7 days. Once refrigerated, it must beused within 7 days or discarded; do not refreeze the ampoule.
3. Once removed from the foil wrapping, use the solution in the ampoule immediately after allowing it to warm to room temperature or discard it.
4. After opening the ampoule, CAVERJECT Injection should be used immediately.
5. During travel, care should be taken to avoid allowing the medicine to be stored at temperatures above 8°C (46°F). Therefore, do not store in checked luggage during air travel or leave in a closed automobile. Transporting your medicine in a cooler with wet ice is recommended. Brief (2 hours or less) exposure to conditions as warm as 25°C (77°F) will not harm your medicine. However, it should be replaced in the refrigerator or freezer as soonas practical.
ADDITIONAL INFORMATION
There is a technical leaflet discussion of CAVERJECT written for health-care professionals that your pharmacist can let you read. More 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. Use the needle, syringe and ampoule only once, then safely discard the supplies and any unused solution (see the "Disposal of Injection Materials" section of these instructions).
Supplies Needed
Along with an ampoule of CAVERJECT Injection, you will need a needle, a syringe, and an alcohol swab. A complete set of these items is available from your doctor or pharmacist, or is supplied in the CAVERJECT Companion Pack. Two needles of different size are provided in the Companion Pack; a 1/2", 27 gauge needle and a thinner 1/2", 30 gauge needle. Your doctor should advise you on the appropriate needle to use foryour injection. CAVERJECT comes in ampoules containing 10, 20 and 40 micrograms. MAKE SURE YOU HAVE THE RIGHT STRENGTH AMPOULE OF CAVERJECT.
Prepare the Dose
1. Remove an ampoule of CAVERJECT Injection from the foil wrapping. Allow the ampoule contents to warm to room temperature. The ampoule should not be cool to the touch. Do not immerse in water. Do not microwave. Once removed from the foil wrapping, use the solution in the ampoule immediately after allowing it to warm to room temperature or discard it.
2. Wash your hands thoroughly, and dry them with a clean towel.
3. Remove the syringe from its packaging by handling the syringe barrel only. Remove the syringe tip cover, pull the plunger back about half way, and set the syringe aside on a clean surface. Do not touch the tip of the syringe.
4. Shake the ampoule vigorously for at least 30 seconds. Next, hold the shorter tab closest to the neck of the ampoule and shake it downward with a quick snap to clear any solution from the neck.
Shaking fluid from the neck of the ampoule
5. Holding the ampoule by the side edges, twist the top of the ampoule and lift upward to remove. Make sure the open ampoule does not touch your hands or any other surface
C. Removing the top of the ampoule
6. While continuing to hold the ampoule upright, securely attach to the tip of the syringe, push and twist in a clockwise fashion to assure as nug fit.
7. With the ampoule snugly attached, point the syringe upward, push the plunger to expel air in the syringe, and slowly pull back the syringe plunger until liquid appears at the tip of the needle. If the syringe plunger is still below the correct volume mark for the dose prescribed by your doctor, any excess solution may be expelled into the open ampoule.
8. If there are air bubbles, gently tap the syringe barrel until they float to the top of the solution. Holding the syringe upright, push the syringe plunger until it is slightly below the correct volume mark for the dose prescribed by your doctor. This will expel any air and most of the excess solution back into the ampoule.
9. Remove the ampoule from the syringe, place the syringe tip cover on the syringe and set the syringe on a clean surface.
10. Two needles of different size are provided in the Companion Pack; a 1/2", 27 gauge needle and a thinner 1/2", 30 gauge needle. Your doctor should advise you on the appropriate needle to use for your injection.
11. Remove the selected needle from its package by handling the needle cover only and set on a clean surface.
12. Remove the tip from the syringe and attach the needle to the syringe with a twisting movement in a clockwise fashion to assure a tight fit
13. Grasp the syringe barrel (not the plunger) and carefully remove the needle cover. Do not touch the exposed needle with your hands or any surface.
14. Holding the syringe upright, apply extremely gentle upward pressure on the syringe plunger until liquid appears at the tip of the needle. If the syringe plunger is still below the correct volume mark for the dose prescribed by your doctor, any excess solution may be expelled into the open ampoule.
15. 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.
G. Top view of penis
H. Cross-section of penis
2. Choose an injection site on one side of the shaft of the penis.
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. 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.
I. Inserting the needle into the injection site
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.
J. Inserting the contents of the syringe
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 ANY BLEEDING STOPS.
Disposal of Injection Materials
After use, dispose of all injection materials safely. Your pharmacist may be able to supply a disposal box especially for syringes and needles. Do not re-use or share needles or syringes. As with all prescription medicines, do not allow anyone else to use your medicine.
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CAVERJECT Injection contains alprostadil as the naturally occurring form of prostaglandin E1 (PGE1).
Alprostadil has a wide variety of pharmacological actions; vasodilation and inhibition of platelet aggregation are among the most notable of these effects.
Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries.
CAVERJECT Injection is indicated for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology.
Intracavernosal CAVERJECT is also indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.
CAVERJECT Injection should not be used in patients who have a known hypersensitivity to the drug, in patients who have conditions that might predispose them to priapism, such as sickle cell anemia or trait, multiple myeloma, or leukemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronie's disease. Patients with penile implants should not be treated with CAVERJECT. CAVERJECT is intended for use in adult men only. CAVERJECT is not indicated for use in children or newborns. CAVERJECT should not be used in men for whom sexual activity is inadvisable or contraindicated.
Patients should be aware of possible side effects of therapy with CAVERJECT; the most frequently occurring is penile pain after injection, usually mild to moderate in severity. A potentially serious adverse reaction with intracavernosal therapy is priapism. Accordingly, the patient should be instructed to contact the physician's office immediately or, if unavailable, to seek immediate medical assistance if an erection persists for longer than 4 hours.
The patient should 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 to his physician as soon as possible. As with any injection, an infection is a possibility. Patients should be instructed to report to the physician any penile redness, swelling, tenderness or curvature of the erect penis. The patient must visit the physician's office for regular checkups for assessment of the therapeutic benefit and safety of treatment with CAVERJECT. Note: Use of intracavernosal CAVERJECT offers no protection from the transmission of sexually transmitted diseases. Individuals who use CAVERJECT should be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV). The injection of CAVERJECT can induce a small amount of bleeding at the site of injection . In patients infected with blood-borne diseases, this could increase the risk of transmission of blood-borne diseases between partners. In clinical trials, concomitant use of agents such as antihypertensive drugs, diuretics, antidiabetic agents (including insulin), or non-steroidal anti-inflammatory drugs had no effect on the efficacy or safety of CAVERJECT.
Pregnancy, Nursing Mothers, and Pediatric Use: CAVERJECT is not indicated for use in pediatric patients or women.
ADVERSE REACTIONS
Local Adverse Reactions: The following local adverse reaction information was derived from controlled and uncontrolled studies of CAVERJECT Sterile Powder, including an uncontrolled 18-month safety study. Local Adverse Reactions Reported by ³ 1% of Patients Treated with CAVERJECT Sterile Powder for up to 18 Months*
Event N = 1861
Penile pain 37%
Prolonged erection 4%
Penile fibrosis** 3%
Injection site hematoma 3%
Penis disorder*** 3%
Injection site ecchymosis 2%
Penile rash 1%
Penile edema 1%
* Except for penile pain (2%), no significant local adverse reactions were reported by 294 patients who received 1 to 3 injections of placebo.
** See General Precautions.
*** Includes numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, penile skin tear, strange feeling of penis, discoloration of penile head, itch at tip of penis.
Systemic Adverse Events Reported by ³ 1% of Patients Treated with CAVERJECT Sterile Powder
for up to 18 Months*
Body System/Reaction N = 1861
Cardiovascular System
Hypertension 2%
Central Nervous System
Headache 2%
Dizziness 1%
Musculoskeletal System
Back pain 1%
Respiratory System
Upper respiratory infection 4%
Flu syndrome 2%
Sinusitis 2%
Nasal congestion 1%
Cough 1%
Urogenital System
Prostatic Disorder** 2%
Miscellaneous
Localized pain*** 2%
Trauma**** 2%
* No significant adverse events were reported by 294 patients who received 1 to 3 injections of placebo.
** prostatitis, pain, hypertrophy, enlargement
*** pain in various anatomical structures other than
injection site
**** injuries, fractures, abrasions, lacerations
The first injections of CAVERJECT must be done at the physician's office by medically trained personnel. Self-injection therapy by the patient can be started only after the patient is properly instructed and well trained in the self-injection technique. The physician should determine the most suitable size needle for the patient and instruct the patient on the appropriate size to use for self-injection. Two needles are provided in the Companion Pack; a 1/2-inch, 27 gauge needle and a 1/2-inch, 30 gauge needle. The physician should make a careful assessment of the patient's skills and competence with this procedure. The intracavernosal injection must be done under sterile conditions. The site of injection is usually along the dorso-lateral aspect of the proximal third of the penis.
Visible veins should be avoided. The side of the penis that is injected and the site of injection must be alternated; the injection site must be cleansed with an alcohol swab.
The dose of CAVERJECT that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse and that is maintained for no longer than 1 hour. If the duration of erection is longer than 1 hour, the dose of CAVERJECT should be reduced. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician's office; however, dose adjustment, if required (up to 57% of patients in one clinical study), should be made only after consultation with the physician. The dose should be adjusted in accordance with the titration guidelines described above. The effectiveness of CAVERJECT for long-term use of up to 6 months has been documented in an uncontrolled, self-injection study. The mean dose of CAVERJECT Sterile Powder at the end of 6 months was 20.7 mcg in this study.
Careful and continuous follow-up of the patient while in the self-injection program must be exercised. This is especially true for the initial self-injections, since adjustments in the dose of CAVERJECT may be needed.
General Procedure for Dose Preparation: CAVERJECT Injection is packaged in a one milliliter polyethylene ampoule containing 10.2 or 20.2 mcg per mL of alprostadil, depending on ampoule strength. The deliverable amount of alprostadil is 10 or 20 mcg/mL because approximately 0.2 mcg is lost due to adsorption to the syringe during administration. CAVERJECT Injection is also available in two milliliter ampoules containing 40.4 mcg/2 mL (20.2 mcg/mL) of alprostadil. The deliverable amount of alprostadil is 40 mcg/2 mL (20 mcg/mL) because approximately 0.4 mcg is lost due to adsorption to the syringe during administration.
To prepare a dose for administration, remove the ampoule from the foil wrapping. Allow the ampoule contents to warm to room temperature. The ampoule should not be cool to the touch. Do not immerse in water. Do not microwave. Shake the ampoule vigorously for at least 30 seconds. Next, hold the shorter tab closest to the neck of the ampoule and shake it downward with a quick snap to clear any solution from the neck. Holding the ampoule by the edges, twist the top of the ampoule and lift upward to remove it. Make sure the open end of the ampoule does not touch your hands or any other surface.
After opening the ampoule, the solution should be immediately transferred to a syringe and used promptly.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Caution: Do not re-use any remaining CAVERJECT solution due to the possibility of bacterial contamination.
Store CAVERJECT Injection frozen at -20° to -10°C (-4° to 14°F) until dispensed. After dispensing, store in a freezer at -20° to -10°C (-4° to 14°F) for up to 3 months. During this 3-month period, CAVERJECT Injection may be moved to and kept in a refrigerator at 2° to 8°C (36° to 46 F) up to 7 days. Once refrigerated, it must be used within 7 days or discarded; it should not be refrozen. Once removed from the foil wrapping, the solution in the ampoule should be used immediately after allowing it to warm to room temperature or it should be discarded. Open ampoules of CAVERJECT Injection should be used immediately and not stored.
For every other information you have to ask your physician.
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