Your healthcare provider should show you how to prepare and inject CAVERJECT the right way before you inject it for the first time. Do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider.
Information about how to safely inject CAVERJECT:
• Read and follow these instructions so that you inject CAVERJECT the right way. Call your healthcare provider if you have any questions about the right way to inject CAVERJECT. • Separate needles should be used for reconstitution and administration. Do not use damaged or bent needles to inject CAVERJECT. • If you accidentally bend a needle, do not attempt to straighten it. • Using bent or re-straightened needles may cause part of the needle to break off and remain in the penis. Some people have reported needle breakage in their penis during the injection and, in some cases, had to go to hospital for surgery to remove the needle. • If you accidentally bend the needle while preparing your CAVERJECT injection, remove it from the syringe, throw it away, and attach a new, needle to the syringe as described under "Prepare the Dose" below. ( See "Dispose of your used CAVERJECT syringe and needle" at the end of these Instructions). • Do not share your needles or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. • Use the needles, syringe, alcohol swabs, and vials only 1 time then safely throw away the supplies and any unused solution in a puncture resistant container (See "Dispose of your used CAVERJECT syringe and needle" at the end of these instructions). Ask your healthcare provider or pharmacist where you can get a puncture resistant or sharps container.
Supplies you will need to give your CAVERJECT injection (Figure A)
• 1 CAVERJECT sterile powder vial
These items are needed for injection and are not supplied with CAVERJECT :
Figure A: Supplies you will need for your Injection.
Follow the instructions below to prepare and give your injection. Figure B explains the parts of the needle and syringe that are referred to in the instructions.
Figure B: Parts of the needle and syringe
CAVERJECT comes in 20 mcg or 40 mcg strengths. Make sure you have the right strength vial of CAVERJECT that your healthcare provider prescribed for you.
Prepare the Syringe
Wash your hands thoroughly and dry them with a clean towel.
Assemble the needle and syringe as follows:
Figure C: Remove the syringe
Figure D: Open the needle wrapper
Keeping hold of the needle assembly, remove the plastic syringe cap from the syringe tip (Figure E). Do not touch the syringe tip.
Figure E: Remove the syringe cap
Hold the needle assembly (still in the paper wrapper). Firmly attach the needle to the syringe tip. Turn it clockwise, like tightening a screw to lock it in place (Figure F).
Figure F: Attach the needle to the syringe
Mixing the powder and liquid to prepare the dose
Remove the plastic cap from the vial of CAVERJECT and remove any cover from the diluent (Figure G).
Figure G: Remove the vial cap
Wipe the rubber stoppers on the vials of CAVERJECT and diluent with 1 alcohol swab. Throw away the alcohol swab.
Carefully hold the syringe by the barrel and remove the needle cover (Figure H).
Figure H: Remove the needle cover
Hold the syringe with the needle attached and push the needle through the center of the diluent vial's rubber stopper (Figure I). Be careful not to bend the needle.
Figure I: Push the needle into the diluent vial
Figure J: Remove the liquid from the vial
Push the syringe plunger to the 1mL mark on the syringe. This will remove air and extra liquid back into vial.
Grasp the side of the syringe barrel (not the plunger) and pull the needle from the diluent vial in a straight line to avoid bending the needle (Figure K).
Figure K: Adjust the amount of liquid in the syringe
Holding the syringe with the needle attached in a straight line with the vial of CAVERJECT, push the needle through the center of the rubber stopper of the vial of CAVERJECT. Be careful not to bend the needle .
Figure L: Push the needle into the CAVERJECT vial
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 liquid. 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.
Keeping the needle in the vial, firmly hold the vial and syringe upside down in one hand.
Figure M: Remove the liquid from the vial
If there are air bubbles, gently tap the syringe barrel until the bubbles float to the top of the liquid (see Figure N).
Figure N: Tap the syringe barrel to remove air bubbles
Carefully replace the needle used to mix the liquid with a new 29 to 30 gauge one half inch needle for your injection.
• Remove the old needle from the syringe and immediately throw it away in an FDA-cleared sharps disposal container. • Unwrap the new needle as in step 2. • Attach the new needle as in step 3.
Set the syringe down on a level surface.
How to give the injection
The injection will go into the part of the penis shown as the shaded area in Figure O. Do not inject CAVERJECT into the white areas because there may be blood vessels in the white areas. (See Figure P).
Figure O: Top view of the penis showing injection sites (shaded areas).
Figure P: Cross-section of the penis
Wipe the area for injection with an alcohol swab and let it dry.
Do not throw away the swab; you will need to use it again after you give your injection. (See Step 23).
If your penis is not circumcised, pull the foreskin back. Take hold of the tip of your penis with your thumb and forefinger; stretch it lengthwise along your thigh.
Gently squeeze your penis between your thumb and finger so that the injection site bulges out.
Remove the cover from the needle. Position your penis firmly against your thigh to keep it from moving during the injection.
Keeping a firm grip on your penis, take the syringe in your other hand, and push the needle straight into the selected injection site (See Figure Q).
Figure Q: Insert the needle into the injection site
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 contents of the syringe is slowly injected (Figure R).
Figure R: Inject the contents of the syringe.
After completing the injection, carefully pull the needle out of your penis. Press gently on the injection site with the alcohol swab for about 5 minutes or until bleeding stops.
After your injection:
Dispose of your used CAVERJECT syringe and needles.
• Put your used CAVERJECT syringe and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away loose needles and syringes in your household trash. • If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: o made of a heavy-duty plastic o can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out o upright and stable during use o leak-resistant o properly labeled to warn of hazardous waste inside the container • When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share your needles or syringes with other people. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. • Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
How should I store CAVERJECT?
CAVERJECT 20 mcg vial storage information
1. Store CAVERJECT 20 mcg vials between 20°C to 25°C (68°F to 77°F). 2. The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.
CAVERJECT 40 mcg vial storage information
1. Store CAVERJECT 40 mcg vials between 2°C to 8°C (36°F to 46°F) until dispensed. Once dispensed, vials should be stored at or below 25°C (77°F) for up to 3 months or until the expiration date, whichever occurs first. 2. The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.
Keep CAVERJECT 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.