(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:
- to treat erectile dysfunction (ED).
- with other medical tests to diagnose ED. CAVERJECT
IMPULSE is not meant for use in women or children under 18 years of age.
Who should not use CAVERJECT IMPULSE?
Do not use CAVERJECT IMPULSE if you 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.
- a deformed penis shape
- a penile implant
What should I tell my healthcare provider before using
Before you use CAVERJECT IMPULSE, tell your healthcare
provider 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
- 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
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?
- 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.
- Use CAVERJECT IMPULSE exactly as your healthcare provider
tells you to.
- Your healthcare provider will tell you how much CAVERJECT
IMPULSE to use and when to use it.
- Your healthcare provider may change your dose if needed. Do
not change your dose of CAVERJECT IMPULSE without first talking to your
- Your healthcare provider should show you how to
prepare and inject CAVERJECT IMPULSE the right way before you inject it for the
- CAVERJECT IMPULSE should not be used more than 3 times
- CAVERJECT IMPULSE should not be used more than 1 time every
- Change the exact place and side of the penis that you
inject Caverject Impulse each time you use it.
- 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
CAVERJECT IMPULSE may cause serious side effects,
- 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.
- 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
- 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 IMPULSE. To best avoid breaking the needle, you
should pay careful attention to your healthcare provider's instructions and try
to 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 predisposed to breakage. 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
- 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
The most common side effects of CAVERJECT IMPULSE
- penile pain
- erection lasting 4 to 6 hours (prolonged erection)
- penile fibrosis (deformed penis shape)
- bruising at the injection site
- penile numbness, irritation, sensitivity, itching,
swelling and discoloration
- skin tears of the penis
- penile rash
Tell your healthcare provider if you have any side effect
that bothers you or that does not go away.
These are not all the possible side effects of CAVERJECT
IMPULSE. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1800-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.
This Patient Information summarizes the most important
information about CAVERJECT IMPULSE. If you would like more information, talk
with your healthcare provider. You can ask your pharmacist or healthcare
provider for information about CAVERJECT IMPULSE that is written for health
For more information, go to www.pfizer.com or call 1-800-438-1985.
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
What are the causes of and treatments for ED?
There are several causes of ED. These include medications
that you may be taking for other conditions, poor blood circulation in the
penis, nerve damage, emotional problems, too much smoking or alcohol use, use
of street drugs, and hormonal problems. Often, ED is due to more than one
Treatments for ED include switching medications if you
are taking a medication that causes erectile dysfunction, prescription
medications, medical devices that produce an erection, surgical procedures to
correct blood flow in the penis, penile implants, and psychological counseling.
You should not stop taking any prescription medications,
unless told to do so by your doctor.
The use of other medical treatments for ED in combination
with CAVERJECT is not recommended. Discuss any concerns you may have about combination
treatment with your doctor.
INSTRUCTIONS FOR 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
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:
- 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
- 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
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
Wash your hands thoroughly and dry them with a clean
STEP 1. Open the sealed plastic tray. Remove the
syringe, the needle assembly, and the alcohol swabs from the tray. All items
should be present.
Look at the needle assembly. The needle assembly is a
sealed unit that contains the outer protective cap, the inner protective cap,
and the superfine needle, as shown in Figure A. It is sealed with a small round
paper cover (not shown in Figure A).
Do not open the needle assembly at this point – leave it
sealed inside the outer protective cap.
Next, examine the syringe. Find the location of the dose
window. Right now you will not see anything in this window, but at a later Step,
a number will appear in this window (the dose to be delivered).
Finally, look at the Plunger, but do not move it at this
time. During the assembly process, some Steps may ask you to ROTATE the plunger
and other steps may ask you to PUSH the plunger.
It is important to only rotate the plunger – or only push
– as directed in each Step, but DO NOT do both at the same time.
Never PUSH on the plunger – even slightly – while
trying to rotate it. This can cause the plastic threads on the plunger rod to
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.
The next few steps will mix the powder and the fluid to
make the Caverject Impulse solution.
STEP 5. Hold the syringe system with the needle
pointing upward. Â
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
This automatically combines the drug powder and the
DO NOT turn the plunger rod counterclockwise (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. 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.
STEP 9. 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
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 Â that
the plunger rod is rotated all the way: turn Â it clockwise until it stops, and
then repeat Step 10.
After the plunger is pushed in – Do Not Â rotate the
plunger. That will be done in the Â 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
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
STEP 12. The syringe is now ready for use.
Set the syringe down on a flat level surface.
The needle is sterile .Make sure the needle does not
touch the surface or anything else.
How to give the injection
- 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.
- Make sure that the needle is not bent. If it is, do
not use it. Do not attempt to straighten the needle out. Properly
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.
Figure K and 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
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
- A partial dose is 5 mcg, 10 mcg or 15 mcg for the BLUE
- 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
- 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.
- If you do not have a FDA-cleared sharps disposal
container, you may use a household container that is:
- made of a heavy-duty plastic
- can be closed with a tight-fitting, puncture-resistant
lid, without sharps being able to come out
- upright and stable during use
- properly labeled to warn of hazardous waste inside the
- 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 IMPULSE?
- Store unmixed CAVERJECT IMPULSE at room
temperature between 68°F to 77°F (20°C to 25°C).
- Store mixed CAVERJECT IMPULSE between 36-77°F
(2°C to 25°C). Do not freeze.
- 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.