(alprostadil)
5 WARNINGS AND PRECAUTIONS
5 WARNINGS AND PRECAUTIONS
5.1 Prolonged Erection and Priapism
Prolonged erection, defined as erection lasting between 4 to 6 hours in duration, occurred in 4% of 1,861 patients treated up to 18 months in studies of CAVERJECT. The incidence of priapism (erections lasting more than 6 hours in duration) was 0.4%. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
To minimize the chances of prolonged erection or priapism, titrate CAVERJECT to the lowest effective dose [see Dosage and Administration (2.1)]. In addition, do not use CAVERJECT in patients who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see Contraindications (4)].
5.2 Penile Fibrosis
The overall incidence of penile fibrosis reported in clinical studies with CAVERJECT was 3%. In one self-injection clinical study where duration of use was up to 18 months, the incidence of penile fibrosis was 7.8%.
Physical examination of the penis should be performed periodically, to detect signs of penile fibrosis. Treatment with CAVERJECT should be discontinued in patients who develop penile angulation or cavernosal fibrosis.
5.3 Hypotension
Intracavernous injections of CAVERJECT can increase peripheral blood levels of alprostadil which can result in hypotension. Avoid use of CAVERJECT in patients with known cavernosal venous leakage.
5.4 Injection Site Bleeding When Used with Anticoagulants
Patients on anticoagulants, such as warfarin or heparin, may have increased propensity for injection site bleeding after intracavernosal injection with CAVERJECT. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.
5.5 Cardiovascular Risk Related to Underlying Medical Conditions
There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including CAVERJECT, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
5.6 Risks of Use in Combination with Other Vasoactive Medications Injected Intracavernosally
The safety and efficacy of combinations of CAVERJECT and other vasoactive agents injected intracavernosally have not been established in clinical studies. The risks of prolonged erection, priapism, and hypotension may be increased.
5.7 Needle Breakage
Separate needles should be used for reconstitution and administration. A superfine needle is used for administration of CAVERJECT. As with all superfine needles, the possibility of needle breakage exists. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, has required hospitalization and surgical removal. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage [see Dosage and Administration (2.3) and Adverse Reactions (6.2)].
5.8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative
When reconstituted using the recommended diluent, the solution contains benzyl alcohol. Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. CAVERJECT is not indicated for use in pediatric patients.
PATIENT INFORMATION
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:
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- to treat erectile dysfunction (ED).
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- with other medical tests to diagnose ED.
CAVERJECT is not meant for use in women or children.
Do not use CAVERJECT 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
- •
- 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
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- have a penile implant
Before you use CAVERJECT, tell your healthcare provider about all your other medical conditions, especially if you:
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- 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
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- have a penile implant
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- have low blood pressure (hypotension)
- •
- 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
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.
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- Use CAVERJECT exactly as your healthcare provider tells you to.
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- Your healthcare provider will tell you how much CAVERJECT 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 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.
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- CAVERJECT should not be used more than 3 times per week.
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- 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.
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- 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.
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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.
- •
- 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
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