(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. Use a new syringe for each dose of CAVERJECT.
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- Titrate the dose of CAVERJECT IMPULSE for each patient to the lowest effective dose.
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- CAVERJECT IMPULSE doses greater than 60 mcg are not recommended.
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- Administer the first doses of CAVERJECT IMPULSE 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 IMPULSE intracavernousally 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.
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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 (Spinal Cord Injury):
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- Initiate dosing with 1.25 mcg of alprostadil using CAVERJECT.
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- If there is a partial response, administer another dose of CAVERJECT of 1.25 mcg within 1 hour.
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- No more than 2 doses during initial titration should be given within a 24-hour period.
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- If additional titration is required, administer a dose of 5 mcg at least 24 hours later.
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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 IMPULSE 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
To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT IMPULSE 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 imaging. For any of these tests, use a single dose of CAVERJECT IMPULSE that induces a rigid erection. Use the dose regimen for ‘Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology’ above.
2.3 Syringe Preparation Instructions
- 1.
- Select the CAVERJECT IMPULSE syringe based upon dose to be administered.
| Syringe Strength | Reconstituted Concentration | Dosages Available for Delivery after Reconstitution | |||
|---|---|---|---|---|---|
10 mcg | 10 mcg/0.5 mL | 2.5 mcg | 5 mcg | 7.5 mcg | 10 mcg |
20 mcg | 20 mcg/0.5 mL | 5 mcg | 10 mcg | 15 mcg | 20 mcg |
- 2.
- Open the sealed plastic tray. Remove the syringe, the needle assembly, and the alcohol swabs from the tray. The syringe has a dose window and a plunger. The needle assembly is a sealed unit that contains the outer protective cap, the inner protective cap, and the superfine needle.
- 3.
- Use the alcohol swab to wipe the rubber membrane at the tip of the syringe. Pick up the needle assembly, grasp the paper tab, and peel off the paper cover (the lid).
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- Hold the needle assembly by the cap and press the needle assembly onto the tip of the syringe. Turn it clockwise until the needle assembly is firmly locked into place.
- 5.
- Remove the outer protective cap from the needle by twisting it clockwise. Do not yet remove the inner protective cap, the thin plastic tube that directly covers the needle.
- 6.
- Hold the syringe system with the needle pointing upward. The plunger rod should still be in the fully extended position, with all of the threads visible. Slowly rotate the plunger rod clockwise until it goes all the way in and stops. Do not push on the plunger while trying to rotate it.
- 7.
- Turn the syringe upside down several times to make sure the solution is evenly mixed. The solution should be clear. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The product should not be used if particulate matter or discoloration are present.
- 8.
- Hold the syringe with the needle upward and carefully remove the inner protective cap from the needle. Lightly tap the glass cartridge a few times with your finger until any large bubbles disappear up into the tip. With the syringe pointed upward, push in the plunger rod until it stops to push any air out.
- 9.
- To set the dose: locate the dose window on the syringe and then slowly turn the plunger rod clockwise until the correct dose number appears in the center of the window. The syringe is now ready for use. If you pass the correct number, keep turning the plunger in the same direction until the correct number comes around again – do not try to turn it backward.
- 10.
- After reconstitution, the syringe should be used within 24 hours when stored between 36 to 77°F (2°C to 25°C). Do not freeze. CAVERJECT IMPULSE is for single use only. Discard the injection delivery system and any remaining solution after use.
2.4 Administration Instructions
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- Administer CAVERJECT IMPUSLE intracavernosally along the dorso-lateral aspect of the proximal third of the 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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- Avoid visible veins during injection.
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- Alternate the side of the penis that is injected and the site of injection.
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- Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.
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- Each CAVERJECT IMPULSE syringe is intended for single use only (one dose only) and should be discarded after use.
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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