17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
Dosing and Self-Administration
To ensure safe and effective use of CAVERJECT IMPULSE, instruct and train the patient in the self-injection technique before he begins intracavernosal treatment with CAVERJECT IMPULSE, at home. Inform the patient the initial dose administration and dose titration will take place in the physician's office.
Once the home dose of CAVERJECT IMPULSE has been established instruct the patient not to change the dose without consulting their physician.
The patient may expect an erection to occur within 5 to 20 minutes and it should last no longer than 1 hour. CAVERJECT IMPULSE should be used no more than 3 times per week, with at least 24 hours between each use.
Inform the patient that they must visit the physician's office for regular check-ups for assessment of the therapeutic benefit and safety of treatment with CAVERJECT IMPULSE.
When self-administering the patient should be instructed to:
- Discard any reconstituted solution with precipitates or discoloration
- Administer the injection along the dorso-lateral aspect of the proximal third of the penis
- Wipe the intended injection site with an alcohol swab prior to injection
- Avoid visible veins during injection
- Alternate the side of the penis that is injected and the site of injection
- Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes
- Use each CAVERJECT IMPULSE system only once and discard after use
- Do not use a bent needle. If the needle is bent, it must not be used; they should also not attempt to straighten a bent needle. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.
- Not re-use or share needles and to properly discard after use
Advise patients that the most frequently occurring side-effect is penile pain after injection, and is usually mild to moderate in severity [see Adverse Reactions (6.1)].
A potentially serious adverse reaction with intracavernosal therapy of CAVERJECT IMPULSE is priapism. Instruct the patient to seek immediate medical assistance if an erection persists for longer than 4 hours [see Warnings and Precautions (5.1)].
Penile fibrosis has been reported in clinical studies with CAVERJECT. Advise the patient to report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis or curvature of the erect penis to his physician as soon as possible. [see Warnings and Precautions (5.2)].
Injection Site Reactions
Inform the patient that injection of CAVERJECT IMPULSE can induce a small amount of bleeding at the site of injection and that hematoma and ecchymosis may occur. Advise the patient to report any persistent redness, tenderness or swelling.
Sexually Transmitted Disease
Use of intracavernosal CAVERJECT IMPULSE offers no protection from the transmission of sexually transmitted diseases. Advise the patient about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV).
CAVERJECT IMPULSE® [KAV-er-jeckt]
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.
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.
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
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 failure
- 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.
- 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 healthcare provider.
- Your healthcare provider should show you how to prepare and inject CAVERJECT IMPULSE the right way before you inject it for the first time.
- CAVERJECT IMPULSE should not be used more than 3 times per week.
- CAVERJECT IMPULSE should not be used more than 1 time every 24 hours.
- 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.
CAVERJECT IMPULSE may cause serious side effects, including:
- 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 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 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 causes AIDS.
The most common side effects of CAVERJECT IMPULSE include:
- 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 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.
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 professionals.
For more information, go to www.pfizer.com or call 1-800-438-1985.
Active ingredient: alprostadil
Inactive ingredients: alpha cyclodextrin, lactose, sodium citrate, benzyl alcohol and hydrochloric and/or sodium hydroxide for pH adjustment.
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 cause.
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.