CAVERJECT® IMPULSE Full Patient Information

17 PATIENT COUNSELING INFORMATION

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

Patient Information

CAVERJECT IMPULSE [KAV-er-jeckt]

(alprostadil)
for injection, for intracavernosal use

Read this Patient Information before you start using CAVERJECT IMPULSE 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 IMPULSE?

CAVERJECT IMPULSE is a prescription medicine used:

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to treat erectile dysfunction (ED).

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with other medical tests to diagnose ED.

CAVERJECT IMPULSE is not meant for use in women or children under 18 years of age.

Do not use CAVERJECT IMPULSE if you:

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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.

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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.

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have a deformed penis shape

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have a penile implant

Before you use CAVERJECT IMPULSE, tell your healthcare provider if you:

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have had an erection that lasted more than 4 hours

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have sickle cell trait or sickle cell anemia

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

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have a deformed penis shape

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have a penile implant

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have low blood pressure (hypotension)

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have bleeding problems

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

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have any other medical conditions

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

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

Especially tell your healthcare provider if you take any other medicines that are 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 IMPULSE?

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

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Use CAVERJECT IMPULSE exactly as your healthcare provider tells you to.

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

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

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

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

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

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

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CAVERJECT IMPULSE is for one use only and should be thrown away properly after a single use.

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

What are the possible side effects of CAVERJECT IMPULSE?

CAVERJECT IMPULSE may cause serious side effects, including:

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an erection that will not go away. 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.

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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 IMPULSE if you get penile fibrosis.

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low blood pressure (hypotension)

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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.

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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.

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needle breakage. There is a possibility of needle breakage with use of CAVERJECT IMPULSE. 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. Remove the needle from the syringe, discard, and attach a new, unused sterile needle to the syringe. 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.

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benzyl alcohol toxicity. Benzyl alcohol is a preservative in CAVERJECT IMPULSE. 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 IMPULSE is not meant for use in children.

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

The most common side effects of CAVERJECT IMPULSE include:

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penile pain

These are not all the possible side effects of CAVERJECT IMPULSE.

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 IMPULSE

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use CAVERJECT IMPULSE for a condition for which it was not prescribed. Do not give CAVERJECT IMPULSE 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 IMPULSE that is written for health professionals.

What are the Ingredients in CAVERJECT IMPULSE?

Active ingredient: alprostadil

Inactive ingredients: alpha cyclodextrin, lactose, sodium citrate, benzyl alcohol and hydrochloric and/or sodium hydroxide for pH adjustment.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com

LAB-0641-8.0

Revised January 2023

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

Before you use CAVERJECT, your doctor must train you in how to prepare and give the injection properly.

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 properly prepare the syringe for use, and to correctly inject a sterile (germ-free) dose of CAVERJECT.

Supplies Needed

The CAVERJECT IMPULSE carton contains two (2) sealed plastic trays, with one dose of Caverject in each tray.

Each tray contains: (a) a syringe, (b) a separate needle assembly and (c) two alcohol swabs. The syringe and the needle assembly are shown in Figure A (below). Please note that the needle assembly is packaged as a single piece and is sealed with a paper cover on the bottom.

DO NOT try to assemble the syringe until you have read ALL of the instructions.

First-read through ALL of the instructions (Step 1 through Step 12) before trying to assemble the syringe. Then go back to Step 1 and begin to prepare the syringe for use.

CAVERJECT IMPULSE is available in two versions: the 10 mcg strength (white plunger) and the 20 mcg strength (blue plunger). Each syringe is designed to be used only one time, but you can select the dose that will be delivered:

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The 10 mcg strength syringe (white plunger) can deliver 10 mcg (the full dose), or one of three partial doses: 7.5 mcg, or 5 mcg, or 2.5 mcg.

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The 20 mcg strength syringe (blue plunger) can deliver 20 mcg (the full dose), or one of three partial doses: 15 mcg, or 10 mcg, or 5 mcg.

If you deliver a partial dose there will be left-over solution in the syringe – this is normal.

MAKE SURE YOU HAVE THE CORRECT STRENGTH OF CAVERJECT IMPULSE to deliver your assigned dose

INSTRUCTIONS for PREPARING the SYRINGE (Step 1 through Step 12)

	STEP 2.	Open the packet containing the alcohol swab, and then pick up the syringe. Use the alcohol swab to wipe the rubber membrane at the tip of the syringe (Figure B). Discard the alcohol swab.
	STEP 3.	Pick up the Needle Assembly. Grab the paper tab and peel off the paper cover (lid) from the bottom of the needle assembly (Figure C).
	STEP 4.	Hold the needle assembly by the cap. Pick up the syringe with your other hand. Press the needle assembly onto the tip of the syringe and turn it clockwise (like tightening a screw) until the needle assembly is firmly locked into place. Remove (twist off - clockwise) the outer protective cap from the needle (Figure D), but DO NOT REMOVE the inner protective cap at this time. The inner protective cap is the thin plastic tube that directly covers the needle. It will be removed later. If you are not sure which piece is the inner protective cap, see Figure A (Step 1) to identify the inner protective cap.
	STEP 5.	The next few steps will mix the powder and the fluid to make the Caverject Impulse solution. Hold the syringe system with the needle pointing upward. The plunger rod should still be in the fully extended position, with all of the threads visible, as shown in Figure E.
	STEP 6.	Slowly ROTATE the plunger rod clockwise (like tightening a screw,) until it goes all the way in and stops (Figure F). This automatically combines the drug powder and the fluid.
			DO NOT turn the plunger rod counter-clockwise (do not try to "unscrew" the plunger rod).
			DO NOT PUSH on the plunger while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.
	STEP 7.	Turn the syringe upside down several times to make sure the solution is evenly mixed. The solution should be clear. Do not use it if it is cloudy or contains particles.
	STEP 8. STEP 9.	Hold the syringe with the needle upward and carefully remove the inner protective cap from the needle (Figure G). Do not touch the exposed needle because it is sterile. Next, you need to remove any large bubbles from the solution. Lightly tap the glass cartridge a few times with your finger until any large bubbles disappear up into the tip. Very small bubbles may remain.
	STEP 10.	With the syringe pointed upward (Figure H), use your thumb to push in the plunger rod until it stops. This will push the air out. Some liquid will appear at the needle point. After pressing the plunger you may still see some small bubbles on the wall of the glass cartridge. This is normal.
			If you can't press the plunger rod in, check that the plunger rod is rotated all the way: turn it clockwise until it stops, and then repeat Step 10.
			After the plunger is pushed in – Do Not rotate the plunger. That will be done in the next step.
	STEP 11.	PLEASE READ the following before going on. In Step 11, you will need to set the dose by ROTATING the plunger until the correct dose appears in the small oval Dose Window on the syringe. The plunger must be rotated "clock-wise" – like tightening a screw.
			DO NOT PUSH on the plunger while trying to rotate it. This can cause the plastic threads on the plunger rod to stick. If the plunger does stick, you can try to free it by gently turning it backward ("unscrewing it") and trying again.
		TO SET THE DOSE: Locate the Dose Window on the syringe. This small oval window (above the left thumb in Figure I) is where the dose number will appear when the plunger is rotated. Then – holding the syringe as shown in Figure I, slowly turn the plunger rod clockwise (like tightening a screw – see arrow in Figure I) until the correct dose number appears in the center of the window (Figure J). If you pass the correct number, keep turning the plunger in the same direction until the correct number comes around again – do not try to turn it backward

How to give the injection

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Make yourself comfortable. Take some time to relax yourself and your partner. If your doctor has recommended you use an alcohol cleansing swab, open one now.

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Make sure that the needle is not bent. If it is, do not use it. Do not attempt to straighten the needle out. Properly discard it.

	1. The injection will go into the part of the penis shown as the shaded area in Figure K. Do not inject into the white areas because there may be blood vessels in the white areas. Also see Figure L.
	2. The correct injection angle is shown in Figure L. 3. If your doctor has recommended that you use an alcohol swab, wipe over the area for injection and let it dry. Reconfirm that the correct dose is visible in the dose window. If the correct dose is not in the dose window, repeat Step 11.
	4. Take hold of the penis from the front, with the first two fingers underneath close to the testicles and the thumb on top (Figure M). 5. 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. 6. 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 (corpora cavernosa). Avoid veins or other obvious blood vessels (Figures K and L). 7. Push the plunger firmly and steadily until it no longer moves. Plunger movement may be very small or undetectable if administering a partial dose. 8. If the plunger does not move easily adjust the needle depth slightly and try again. Do not force the solution from the syringe. 9. After completing the injection, carefully pull the needle out. A drop of liquid may remain on the tip of the needle. Press gently on the injection site with the alcohol swab. Massage the penis to help the Caverject Impulse solution spread through it.

Some liquid will remain in the syringe if you delivered a PARTIAL dose. This is expected. Do not try to inject left-over liquid from a partial dose. Syringes used to inject a partial dose must be discarded since each syringe can only be used one time. Discard syringes with left-over liquid.

 

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A partial dose is 5 mcg, 10 mcg or 15 mcg for the BLUE plunger syringe.

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A partial dose is 2.5 mcg, 5 mcg, or 7.5 mcg for the WHITE plunger syringe.

Do not keep any solution in the cartridge to use for a second injection. When you have finished with the syringe, discard it carefully as recommended by your doctor, so no one will use it or stick themselves with it.

After your injection:

Dispose of your used CAVERJECT IMPULSE syringes and needle.

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Put your used CAVERJECT IMPULSE syringe and needle in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.

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If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

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made of a heavy-duty plastic

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can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out

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upright and stable during use

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leak-resistant

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properly labeled to warn of hazardous waste inside the container

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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.

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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 IMPULSE?

1.

Store unmixed CAVERJECT IMPULSE at room temperature between 68°F to 77°F (20°C to 25°C).

2.

Store mixed CAVERJECT IMPULSE between 36°F to 77°F (2°C to 25°C). Do not freeze.

3.

CAVERJECT IMPULSE should be used within 24 hours after it is mixed.

Keep CAVERJECT IMPULSE 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-1504-2.0

Revised January 2023