(alprostadil)
2 DOSAGE AND ADMINISTRATION
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Administration Instructions
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- Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient.
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- CAVERJECT is available in single-dose vials containing 20 mcg or 40 mcg of alprostadil. Make sure a new, correct strength vial of CAVERJECT is used for each patient dosage preparation.
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- Titrate the dose of CAVERJECT for each patient to the lowest effective dose.
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- CAVERJECT doses greater than 60 mcg are not recommended.
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- Administer the first injections of CAVERJECT in the health care provider’s office by medically trained personnel.
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- Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of home use. Refer to the Patient Information and Instructions for Use.
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- Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.
2.2 Recommended Dosage for Erectile Dysfunction
Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology
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- Initiate dosing with 2.5 mcg of CAVERJECT intracavernosally, as recommended [see Dosage and Administration (2.4)].
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- If there is a partial response at 2.5 mcg, administer another dose of 2.5 mcg within 1 hour. Use a new vial for each dose of CAVERJECT.
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- During titration, no more than 2 doses should be given within a 24-hour period.
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- If additional titration is required, administer doses in increments of 5 to 10 mcg at least 24 hours apart.
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- The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.
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- The patient must stay in the health care provider’s office until complete detumescence occurs.
Repeat the titration as necessary until the optimal dose is achieved. Doses greater than 60 mcg are not recommended.
Erectile Dysfunction of Pure Neurogenic Etiology (e.g., Spinal Cord Injury).
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- Initiate dosing with 1.25 mcg of CAVERJECT intracavernosally, as recommended [see Dosage and Administration (2.4)].
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- If there is a partial response at 1.25 mcg, administer another dose of 1.25 mcg within 1 hour. Use a new vial for each dose of CAVERJECT.
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- If additional titration is required, administer a dose of 5 mcg at least 24 hours later.
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- During titration, no more than 2 doses should be given within a 24-hour period.
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- The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.
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- The patient must stay in the health care provider’s office until complete detumescence occurs.
Repeat the titration as necessary until the optimal dose is achieved. Doses greater than 60 mcg are not recommended.
Maintenance Dosage for Patient Home Use
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- Once the dose of CAVERJECT has been determined in the health care provider’s office, additional dose adjustment may be required after consultation with the health care provider. Adjust the dose in accordance with the titration guidelines described above.
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- The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose.
Adjunct to the Diagnosis of Erectile Dysfunction
As an adjunct to the diagnosis of erectile dysfunction, inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection. Extensions of this testing are the use of CAVERJECT as an adjunct to laboratory investigations, such as duplex or Doppler ultrasound imaging. For any of these tests, use a single dose of CAVERJECT that induces a rigid erection. Use the dose regimen for ‘Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology’ above.
2.3 Preparation Instructions
Supplies Needed and Not Supplied With CAVERJECT
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- 1 mL of the diluent (bacteriostatic water for injection)
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- 1 mL to 3 mL syringe, dependent on the titrated dose
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- 21 to 27 gauge needle for reconstitution
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- 29 or 30 gauge one-half inch needle for injection
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- alcohol swabs
Reconstitution Instructions
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- CAVERJECT vial(s): Using the correct strength vial containing 20 mcg or 40 mcg of CAVERJECT, use a 1 mL to 3 mL syringe, a 21 to 27 gauge needle, and 1 mL of the diluent (bacteriostatic water for injection) for reconstitution. Reconstitution results in CAVERJECT 20 mcg/mL or 40 mcg/mL.
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- Visually inspect the solution in the vial for particulate matter and discoloration. Do not use the solution if it is cloudy, colored or contains particles.
| 20 mcg Vial | 40 mcg Vial | ||
|---|---|---|---|
| Dose | Volume to Inject | Dose | Volume to Inject |
1.25 mcg | 0.06 mL | 1.25 mcg | --- |
2.5 mcg | 0.125 mL | 2.5 mcg | --- |
5 mcg | 0.25 mL | 5 mcg | 0.125 mL |
10 mcg | 0.5 mL | 10 mcg | 0.25 mL |
15 mcg | 0.75 mL | 15 mcg | 0.375 mL |
20 mcg | 1 mL | 20 mcg | 0.5 mL |
25 mcg | --- | 25 mcg | 0.625 mL |
30 mcg | --- | 30 mcg | 0.75 mL |
40 mcg | --- | 40 mcg | 1 mL |
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- Draw the dose of CAVERJECT into the syringe.
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- Replace the needle used for reconstitution with a 29 or 30 gauge one-half inch needle prior to injection.
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- The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F).
Refer to the Patient Information and Instructions for Use in the FDA-approved patient labeling for the complete detailed instructions on reconstitution and needle preparation steps.
2.4 Administration Instructions
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- Use a 29 or 30 gauge one-half inch needle for injecting each dose.
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- The patient should be in a sitting or slightly reclined position when injecting a dose.
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- Retract the foreskin in uncircumcised patients.
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- Grasp the head of the penis with the thumb and forefinger and stretch it lengthwise along the thigh.
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- The site of injection is either the right or left lateral penis. See Figures A and B below.
Figure A | Figure B |
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- Wipe the intended injection site with an alcohol swab prior to injection.
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- Insert needle perpendicular to the long dorsolateral penile axis in the proximal third of penis. Avoid angulation of the syringe and do not bend the needle.
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- Avoid visible veins during injection.
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- With each use of CAVERJECT, alternate the side of the penis that is injected.
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- Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.
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- CAVERJECT is intended for single patient use only and should be discarded after use.
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
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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, 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
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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
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?
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- See the detailed Instructions for Use that comes with your CAVERJECT for information about how to prepare and inject CAVERJECT the right way.
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- 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.
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- 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.
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- 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:
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- 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.
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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 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. 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.
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- 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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