CAVERJECT POWDER FOR INJECTION 20 mcg/ml

INJECTION, POWDER, FOR SOLUTION

**4.2 Posology & Method of Administration** CAVERJECT® is administered by direct intracavernosal injection. A 1/2-inch, 27- to 30-gauge needle is generally recommended. The dose of CAVERJECT® should be individualized for each patient by careful titration under supervision by the physician. In clinical studies, patients were treated with CAVERJECT® in doses ranging from 0.2 to 140 mcg; however, since 99% of patients received doses of 60 mcg or less, doses of greater than 60 mcg are not recommended. In general, the lowest possible effective dose should always be employed. INITIAL TITRATION IN PHYSICIAN’S OFFICE The following titration schedule should be followed, depending on erectile response, until the dose that produces an erection suitable for intercourse and not exceeding a duration of 60 minutes is reached. If there is no response to the administered dose, then the next higher dose may be given within 1 hour. During titration no more than two doses should be given within a 24-hour period. If there is a response, then there should be at least a 1-day interval before the next dose is given. The patient must stay in the physician’s office until complete detumescence occurs.  MAINTENANCE THERAPY 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 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. Self-injection therapy for use at home should be initiated at the dose that was determined in the physician’s office. The dose that is selected for self-injection treatment should provide the patient with an erection that is satisfactory for sexual intercourse, and maintained for no longer than 60 minutes. If the duration of erection is longer than 60 minutes the dose should be reduced. 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 CAVERJECT® dose may be needed. Dose adjustment, if required, should be made only after consultation with the physician, and should be adjusted in accordance with the titration guidelines described above. (Up to 57% of patients in one clinical study required dose adjustment). While on self-injection treatment, it is recommended that the patient visits the prescribing physician’s office every 3 months. At that time, the efficacy and safety of the therapy should be assessed, and the dose of CAVERJECT® should be adjusted, if needed. The recommended frequency of injection is no more than once daily and no more than three times weekly. The reconstituted vial of CAVERJECT® is intended for single use only and should be discarded after use. The user should be instructed in the proper disposal of the syringe, needle, and vial. Once reconstituted, no additional materials should be injected into the vial. When stored in the original container, the reconstituted CAVERJECT® solution is physically, chemically, and microbiologically stable for a period of 24 hours at room temperature. The product should be inspected visually for particulate matter and discoloration prior to administration. Do not freeze reconstituted solutions. CAVERJECT® AS AN ADJUNCT TO THE DIAGNOSIS OF ERECTILE DYSFUNCTION In the simplest diagnostic test for erectile dysfunction (pharmacologic testing), patients are monitored for the occurrence of an erection after an intracavernosal injection of CAVERJECT®. Extensions of this testing are the use of CAVERJECT® as an adjunct to laboratory investigations, such as duplex or Doppler imaging, 133Xenon washout tests, radioisotope penogram, and penile arteriography, to allow visualization and assessment of penile vasculature. For any of these tests, a single dose of CAVERJECT® that induces an erection with firm rigidity should be used. DILUTION AND SELF-INJECTION PROCEDURE USING THE PRE-FILLED DILUENT SYRINGE WITH DETACHED NEEDLE This guide is not meant to substitute for the advice and counsel of your doctor. 1. **Check your pack** Make sure that the vial is the correct strength and the expiry date is still valid. The vial, syringe and needles all have protective covers. The flip-off cap on the vial can rotate; this is normal. Check that all the covers are on firmly and if they are not on properly, do not use them – take the whole pack back to your pharmacist. There are two needles in the pack: - The larger 22 gauge needle with the grey end is used to mix the solution and CAVERJECT® Powder. - The smaller and finer 30 gauge needle with the yellow end is used to inject the mixture into your penis. 2. **To prepare the vial** Flip the plastic cap off the vial. Wipe the rubbery top with one of the wet antiseptic pads.  3. **Fitting the needle to the syringe** Hold the syringe and twist the white tamper evident cap to break the seal. Take the foil off the larger needle, (22 gauge) with the grey end, keeping the cover on. Join the needle to the syringe by turning the needle clockwise tightly onto the syringe, then remove the needle cover by pushing it away from the syringe with your thumb and forefinger.  4. **Mixing the solution with the powder** Push the needle through the rubbery middle of the vial top. Press the plunger down firmly to squirt all the solution onto the powder. Gently swirl the vial until all the powder has dissolved. If the mixture is cloudy or does not dissolve completely, do not use it. Never use tap water or any liquid other than the one supplied in the syringe.  5. **Filling the syringe** With the needle still inserted, turn the vial upside down. The needle should support the vial unaided. Make sure the needle tip is underneath the level of the liquid. Gently pull the plunger to draw all the mixture into the syringe. Pull the needle out of the vial.  6. **Changing to the injecting needle** Gently twist the larger needle anticlockwise off the syringe. Remove the smaller injecting needle, (30 gauge) with the yellow end from its package, keeping the cover on. Twist the needle clockwise tightly onto the syringe, then remove the needle cover by pushing it away from the syringe with your thumb and forefinger.  7. **Setting the dose** Tap the syringe gently to send any air bubbles to the top, then push the plunger to squeeze the air bubbles out, ensuring that at least one drop of solution comes out of the needle. Continue pushing until the plunger is exactly at the right mark for your dose. Your doctor will have shown you where this is.   **How do you do the injection?** - Get undressed and make yourself comfortable. Take some time to relax yourself. If your prescriber has recommended use of the second antiseptic pad, open it now. - Make sure that the injection needle is **not** bent. If it is, **do not** use it and throw it away. **Do not** attempt to straighten it out. - Take hold of the penis from the front, with the first two fingers underneath close to the testicles and the thumb on top. 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. The injection will go into the part of the penis shown as the shaded area in diagram A.  - If recommended by your prescriber wipe the skin over this area with the second pad and let it dry. - 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 avoiding veins or other obvious blood vessels. The angle is shown in diagrams B and C. Push the plunger firmly and if the CAVERJECT® does not come out fairly easily, move the needle slightly and try again. **Do not** force the CAVERJECT® liquid from the syringe.   - Pull the needle out. On the needle mark, press gently with the pad or your thumb, as recommended by your prescriber. Massage the penis to help the CAVERJECT® spread through it. - Do not keep any mixture in the syringe to use for a second injection. After using the contents of this pack, dispose of all materials safely. Your pharmacist may be able to supply a disposal box especially for syringes.