17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Patient Information

CAVERJECT [KAV-er-jeckt]®
(alprostadil)
for injection, for intracavernosal use

Read this Patient Information before you start using CAVERJECT and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is CAVERJECT?

CAVERJECT is a prescription medicine used:

•

to treat erectile dysfunction (ED).

•

with other medical tests to diagnose ED.

CAVERJECT is not meant for use in women or children.

Do not use CAVERJECT if you:

•

are allergic to alprostadil or any of the ingredients in CAVERJECT. See the end of this leaflet for a complete list of ingredients in CAVERJECT

•

have certain medical problems that might cause you to have an erection that lasts for more than 4 hours, such as sickle cell anemia, sickle cell trait, multiple myeloma, leukemia

•

have a deformed penis shape

•

have a penile implant

Before you use CAVERJECT, tell your healthcare provider about all your other medical conditions, especially if you:

•

have had an erection that lasted more than 4 hours

•

have sickle cell trait or sickle cell anemia

•

have or have had a blood cell cancer called multiple myeloma or leukemia

•

have a deformed penis shape

•

have a penile implant

•

have low blood pressure (hypotension)

•

have bleeding problems

•

have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

CAVERJECT may affect the way other medicines work, and other medicines may affect the way CAVERJECT works causing side effects.

Especially tell your healthcare provider if you take any other medicines that are treatments for ED, other medicines injected into your penis (intracavernosally), or certain medicines called anticoagulant medicines (such as heparin or warfarin).

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I use CAVERJECT?

•

See the detailed Instructions for Use that comes with your CAVERJECT for information about how to prepare and inject CAVERJECT the right way.

•

You should receive your first dose of CAVERJECT in your healthcare provider's office.

•

Use CAVERJECT exactly as your healthcare provider tells you to.

•

Your healthcare provider will tell you how much CAVERJECT to use and when to use it.

•

Your healthcare provider may change your dose if needed. Do not change your dose of CAVERJECT without first talking to your healthcare provider.

•

Your healthcare provider should show you how to prepare and inject CAVERJECT the right way before you inject it for the first time.

•

CAVERJECT should not be used more than 3 times per week.

•

CAVERJECT should not be used more than 1 time every 24 hours.

•

Change the exact place and side of the penis that you inject CAVERJECT each time you use it.

•

CAVERJECT is for 1 time use only and should be thrown away properly after each use.

You should see your healthcare provider every 3 months for check-ups to be sure that CAVERJECT is working the right way and to change your CAVERJECT dose if needed.

What are the possible side effects of CAVERJECT?

CAVERJECT may cause serious side effects, including:

•

an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, this condition can permanently damage your penis.

•

deformed penis shape (penile fibrosis). Your healthcare provider should check your penis regularly for signs of penile fibrosis. You should not continue to use CAVERJECT if you get penile fibrosis.

•

low blood pressure (hypotension).

•

injection site bleeding. People who take certain medicines called anticoagulants (such as heparin or warfarin) may have a risk for increased bleeding at the injection site.

•

increased risk of heart problems. Sexual activity can put an extra strain on your heart, especially if your heart is weak from a heart attack or heart disease. Ask your healthcare provider if your heart is healthy enough to handle the extra strain of having sex. Stop sexual activity and get medical help right away if you get symptoms of a heart problem such as chest pain, dizziness or nausea.

•

needle breakage. There is a possibility of needle breakage with use of CAVERJECT. To best avoid breaking the needle, you should pay careful attention to your healthcare provider's instructions and handle the syringe and needle properly. If the needle is bent at any time, do not attempt to straighten it and do not use it. A bent and re-straightened needle is more likely to break. If the needle breaks during injection and you are able to see and grasp the broken end, you should remove it and contact your healthcare provider. If you cannot see or cannot grasp the broken end, you should promptly contact your healthcare provider.

•

benzyl alcohol toxicity. Benzyl alcohol is a preservative that is present in CAVERJECT when it is mixed. Benzyl alcohol has caused serious side effects, including death, in children, especially premature and low-birth weight infants, who have received the preservative benzyl alcohol. CAVERJECT is not meant for use in children.

CAVERJECT does not protect you or your partner from getting sexually transmitted infections, including HIV-the virus that causes AIDS.

The most common side effect of CAVERJECT is penile pain

These are not all the possible side effects of CAVERJECT.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of CAVERJECT

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use CAVERJECT for a condition for which it was not prescribed. Do not give CAVERJECT to other people even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about CAVERJECT that is written for health professionals.

What are the Ingredients in CAVERJECT?

Active ingredient: alprostadil

Inactive ingredients: lactose, sodium citrate, benzyl alcohol (contained in the final solution) and hydrochloric acid and/or sodium hydroxide for pH adjustment.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com

LAB-1045-3.0

Revised: March 2023

INSTRUCTIONS FOR USE

CAVERJECT [KAV-er-jeckt]®
(alprostadil)
for injection, for intracavernosal use

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.

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

Step 1.
Wash your hands thoroughly and dry them with a clean towel.
Step 2.
Assemble the needle and syringe as follows: • Remove the syringe from its sterile wrapping. (Figure C)	Figure C: Remove the syringe
• Use a 21 to 27 gauge needle. Carefully pull the wrapper tabs back enough to expose the sterile open end of the needle assembly. Do not completely remove the wrapper. • Do not touch the open end of the needle (Figure D).	Figure D: Open the needle wrapper
Step 3.
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
Step 4.
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). • With the needle cover in place, set the syringe and needle down on a clean, level surface, like a table.	Figure F: Attach the needle to the syringe
Mixing the powder and liquid to prepare the dose
Step 5.
Remove the plastic cap from the vial of CAVERJECT and remove any cover from the diluent (Figure G).	Figure G: Remove the vial cap
Step 6.
Wipe the rubber stoppers on the vials of CAVERJECT and diluent with 1 alcohol swab. Throw away the alcohol swab.
Step 7.
Carefully hold the syringe by the barrel and remove the needle cover (Figure H). • Do not discard the needle cover, you will need to use it again (see step 13). • Do not touch the needle.	Figure H: Remove the needle cover
Step 8.
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
• Keeping the needle in the vial, firmly hold the vial and syringe upside down in one hand (see Figure J). • Keep the needle tip below the level of the liquid and pull back on the syringe plunger until all the diluent is removed from vial.	Figure J: Remove the liquid from the vial
Step 9.
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
Step 10.
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. • Push the syringe plunger all the way down to move all the liquid into the vial. Go immediately to step 11.	Figure L: Push the needle into the CAVERJECT vial
Step 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 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.
Step 12.
Keeping the needle in the vial, firmly hold the vial and syringe upside down in one hand. • Keeping the needle tip below the level of the liquid, slowly pull back on the syringe plunger until all the liquid is removed from the vial (see Figure M).	Figure M: Remove the liquid from the vial
Step 13.
If there are air bubbles, gently tap the syringe barrel until the bubbles float to the top of the liquid (see Figure N). • Holding the syringe upright, push the syringe plunger to the correct volume mark for the dose prescribed by your healthcare provider. This will remove any air and extra liquid into the vial. • Grasp the syringe barrel (not the plunger) and pull the needle/syringe straight out of the vial of CAVERJECT in a straight line to avoid and be sure not to bend the needle. • Carefully replace the needle cover over the needle that you used to mix the liquid.	Figure N: Tap the syringe barrel to remove air bubbles
Step 14.
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 • Make yourself comfortable. You should be sitting upright or slightly reclined when injecting CAVERJECT. • Make sure that the needle is not bent. If it is, do not use it. Do not attempt to straighten the needle out. Properly throw away any bent needles.
STEP 15.
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). • The correct injection angle and depth of injection is shown in Figure P. • With each injection of CAVERJECT change the side of the shaft of the penis, and choose a different location for each injection, as shown in the shaded area in Figure O.	Figure O: Top view of the penis showing injection sites (shaded areas). Figure P: Cross-section of the penis
Step 16.
Wipe the area for injection with an alcohol swab and let it dry.
Step 17.
Do not throw away the swab; you will need to use it again after you give your injection. (See Step 23).
Step 18.
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.
Step 19.
Gently squeeze your penis between your thumb and finger so that the injection site bulges out.
Step 20.
Remove the cover from the needle. Position your penis firmly against your thigh to keep it from moving during the injection.
Step 21.
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). • Refer to Figure P for the correct angle and depth of injection. • Do not inject CAVERJECT into veins or other blood vessels (the white areas in Figure O).	Figure Q: Insert the needle into the injection site
Step 22.
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.
Step 23.
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.

LAB-0009-8.0

Revised March 2023