(alprostadil)
6 ADVERSE REACTIONS
6 ADVERSE REACTIONS
The following are discussed in more detail in other sections of the labeling:
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- Prolonged Erection and Priapism [see Warnings and Precautions (5.1)]
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- Penile Fibrosis [see Warnings and Precautions (5.2)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
CAVERJECT IMPULSE was evaluated in 87 patients in an open-label crossover study of 6 weeks treatment duration that compared the formulation of alprostadil for injection contained in CAVERJECT IMPULSE with the formulation contained in CAVERJECT. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penis disorder (4.6%), prolonged erection (1.1%), injection site erythema (1.1%), rash (1.1%), dizziness (1.1%), and hematospermia (1.1%). Penis disorder included penile pain, post-injection pain, and pain with erection.
CAVERJECT IMPULSE was also evaluated in 63 patients in a single-dose, double-blind, crossover study that compared CAVERJECT IMPULSE with CAVERJECT. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penile pain (1.6%) and pruritus (1.6%).
In addition to the adverse reactions observed for CAVERJECT IMPULSE in these two studies, the following adverse reactions have been reported in clinical studies of CAVERJECT:
Local Adverse Reactions: Local adverse reactions derived from 1861 patients in clinical studies of CAVERJECT, including an 18-month, open-label study, are shown in Table 1.
| |
Penile pain | 37% |
Prolonged erection | 4% |
Penile fibrosis | 3% |
Injection site hematoma | 3% |
Penis disorder* | 3% |
Injection site ecchymosis | 2% |
Penile rash | 1% |
Penile edema | 1% |
The following local adverse reactions were reported in < 1% of patients: injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, irritation, sensitivity, pruritus, erythema, painful erection, and abnormal ejaculation.
In these studies, no local adverse reactions were reported in the 294 patients who received placebo, except for penile pain (2%).
Penile Pain: In the majority of the cases, penile pain was rated mild or moderate in intensity. Three percent of patients discontinued treatment because of penile pain
Prolonged Erection/Priapism: Prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as an erection that lasted 6 hours or longer. In clinical studies, the frequency of prolonged erection after CAVERJECT was 4%, while the frequency of priapism was 0.4% [see Warnings and Precautions (5.1)].
Systemic Adverse Reactions: Systemic adverse reactions reported by ≥ 1% of subjects in clinical studies of CAVERJECT included: dizziness (1%).
The following systemic adverse reactions were reported in < 1% of patients: testicular pain, scrotal edema, hematuria, pelvic pain, hypotension, vasodilation, vasovagal reaction, diaphoresis, rash, and non-application site pruritus. Three patients (0.2%) discontinued due to symptomatic hypotension.
No systemic adverse reactions were reported in the 294 patients who received placebo.
6.2 Post-marketing Experience
The following additional adverse reactions have been reported during post approval use of CAVERJECT IMPULSE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Injury and procedural complication: device malfunction/failure, needle breakage, drug ineffective and drug effect decreased.
PATIENT INFORMATION
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
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