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Generic Name
Alprostadil
Brand Names
Caverject, Edex, Prostin
FDA approval date: October 16, 1981
Classification: Prostaglandin Analog
Form: Injection
What is Caverject (Alprostadil)?
CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated For the treatment of erectile dysfunction.
Approved To Treat
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Brand Information
Caverject Impulse (Alprostadil)
1DOSAGE FORMS AND STRENGTHS
Caverject Impulse (alprostadil) for injection contains sterile, freeze-dried alprostadil for reconstitution and sterile bacteriostatic water in a prefilled dual chamber glass cartridge. It is available in 10 mcg and 20 mcg strengths.
For injection: 10 mcg and 20 mcg of alprostadil freeze-dried powder for reconstitution in single-dose, pre‑filled, dual chambered glass cartridge syringe. The front chamber contains alprostadil and the rear chamber contains sterile bacteriostatic water. A 29 gauge needle system is also included.
The reconstituted solution is clear.
2CONTRAINDICATIONS
CAVERJECT IMPULSE is contraindicated:
- in men who have a known hypersensitivity to the drug
- in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia
- for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease
- in men with penile implants.
3ADVERSE REACTIONS
The following are discussed in more detail in other sections of the labeling:
- Prolonged Erection and Priapism
- Penile Fibrosis
3.1Clinical 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:
3.2Post-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.
4DRUG INTERACTIONS
The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied
5OVERDOSAGE
Overdosage was not observed in clinical trials with CAVERJECT IMPULSE. If intracavernous overdose of CAVERJECT IMPULSE occurs, the patient should be under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Treatment of any systemic symptoms (e.g., hypotension) would be appropriate.
6DESCRIPTION
CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E
Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water.
The structural formula of alprostadil is represented below:
CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration:
10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol.
20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol.
During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.
7CLINICAL STUDIES
The efficacy of CAVERJECT IMPULSE was based upon clinical studies of CAVERJECT.
The efficacy of CAVERJECT was investigated in men with a diagnosis of erectile dysfunction due to psychogenic, vasculogenic, neurogenic, and/or mixed etiology in two double-blind placebo-controlled studies (Study 1 and Study 2) and in one 6-month open-label study (Study 3). In clinical studies (Study 1 and Study 3), over 80% of patients experienced an erection sufficient for sexual intercourse after intracavernosal injection of CAVERJECT.
8HOW SUPPLIED/STORAGE AND HANDLING
CAVERJECT IMPULSE is supplied as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge, which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for reconstitution in the rear chamber. The syringes contain either 12.8 or 25.6 mcg of alprostadil to allow delivery of a maximum of 10 or 20 mcg/0.5mL. Store the unreconstituted product at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].
When reconstituted and used as directed, the deliverable amount for the 10 mcg strength is 10 mcg/0.5 mL or an increment of 10 mcg/0.5 mL: 2.5 mcg/0.125 mL, 5 mcg/0.25 mL, or 7.5 mcg/0.375 mL of alprostadil. The deliverable amount for the 20 microgram strength is 20 mcg/0.5 mL or an increment of 20 mcg/0.5 mL: 5 mcg/ 0.125 mL, 10 mcg/0.250 mL, or 15 mcg/0.375 mL of alprostadil. The reconstituted solution should be used within 24 hours when stored between 36–77°F (2°C to 25°C). Do not freeze.
CAVERJECT IMPULSE is supplied in a carton containing 2 blister trays. Each blister tray contains one dual chamber syringe system, one needle and 2 alcohol swabs. It is available in the following strengths:
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
10Patient Information
CAVERJECT IMPULSE
(alprostadil)
for injection, for intracavernosal use
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.
Do not use CAVERJECT IMPULSE if you:
- 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
- have 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.
How should I use CAVERJECT IMPULSE?
- See the detailed
- 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.
- 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.
What are the possible side effects of CAVERJECT IMPULSE?
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 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.
- 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
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
LAB-0641-8.0
Revised January 2023
11INSTRUCTIONS 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
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
- 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.
- 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
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)
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
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.
- A partial dose is 5 mcg, 10 mcg or 15 mcg for the BLUE plunger syringe.
- 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.
- 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:
- 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:
- 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
- Store
- 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
12PRINCIPAL DISPLAY PANEL - 10 microgram Syringe Label
Caverject Impulse
Dual Chamber System
10 micrograms
KEEP OUT OF REACH OF CHILDREN
PAA213741
LOT/EXP
13PRINCIPAL DISPLAY PANEL - 10 micrograms Syringe Carton
Pfizer
Caverject Impulse
(alprostadil) for injection
(alprostadil) for injection
10 micrograms
NDC 0009-5181-01
For intracavernosal use only
Rx only
14PRINCIPAL DISPLAY PANEL - 20 microgram Syringe Label
Caverject Impulse
Dual Chamber System
20 micrograms
KEEP OUT OF REACH OF CHILDREN
PAA213743
LOT/EXP
15PRINCIPAL DISPLAY PANEL - 20 micrograms Syringe Carton
Pfizer
Caverject Impulse
(alprostadil) for injection
(alprostadil) for injection
20 micrograms
NDC 0009-5182-01
For intracavernosal use only
Rx only
