CAVERJECT- alprostadil injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALPROSTADIL (UNII: F5TD010360) (ALPROSTADIL - UNII:F5TD010360)

Available from:

Pharmacia & Upjohn Company LLC

INN (International Name):

ALPROSTADIL

Composition:

ALPROSTADIL 20.5 ug in 1 mL

Administration route:

INTRACAVERNOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CAVERJECT is indicated for the treatment of erectile dysfunction. CAVERJECT is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. CAVERJECT is contraindicated: CAVERJECT is not indicated for use in females. CAVERJECT is not indicated for use in females. Safety and effectiveness have not been established in pediatric patients [see Warnings and Precautions (5.8)] . A total of 341 subjects included in clinical studies were 65 and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients. CAVERJECT [KAV-er-jeckt]® (alprostadil) for injection, for intracavernosal use Your healthcare provider should show you how to prepare and inject CAVERJECT the right way before you inject it for the first time. Do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider. Information about how to safely inject CAVERJECT: Supplies you will need to give your CAVERJECT injection (Figure A) These items are needed for injection and are not supplied with CAVERJECT : Figure A: Supplies you will need for your Injection. Follow the instructions below to prepare and give your injection. Figure B explains the parts of the needle and syringe that are referred to in the instructions. Figure B: Parts of the needle and syringe CAVERJECT comes in 20 mcg or 40 mcg strengths. Make sure you have the right strength vial of CAVERJECT that your healthcare provider prescribed for you. Prepare the Syringe Step 1 . Wash your hands thoroughly and dry them with a clean towel. Step 2 . Assemble the needle and syringe as follows: Figure C: Remove the syringe Figure D: Open the needle wrapper Step 3 . Keeping hold of the needle assembly, remove the plastic syringe cap from the syringe tip (Figure E). Do not touch the syringe tip. Figure E: Remove the syringe cap Step 4 . Hold the needle assembly (still in the paper wrapper). Firmly attach the needle to the syringe tip. Turn it clockwise, like tightening a screw to lock it in place (Figure F). Figure F: Attach the needle to the syringe Mixing the powder and liquid to prepare the dose Step 5 . Remove the plastic cap from the vial of CAVERJECT and remove any cover from the diluent (Figure G). Figure G: Remove the vial cap Step 6 . Wipe the rubber stoppers on the vials of CAVERJECT and diluent with 1 alcohol swab. Throw away the alcohol swab. Step 7 . Carefully hold the syringe by the barrel and remove the needle cover (Figure H). Figure H: Remove the needle cover Step 8 . Hold the syringe with the needle attached and push the needle through the center of the diluent vial's rubber stopper (Figure I). Be careful not to bend the needle. Figure I: Push the needle into the diluent vial Figure J: Remove the liquid from the vial Step 9 . Push the syringe plunger to the 1mL mark on the syringe. This will remove air and extra liquid back into vial. Grasp the side of the syringe barrel (not the plunger) and pull the needle from the diluent vial in a straight line to avoid bending the needle (Figure K). Figure K: Adjust the amount of liquid in the syringe Step 10 . Holding the syringe with the needle attached in a straight line with the vial of CAVERJECT, push the needle through the center of the rubber stopper of the vial of CAVERJECT. Be careful not to bend the needle . Figure L: Push the needle into the CAVERJECT vial Step 11 . Without removing the needle or touching the needle or stopper, gently swirl (do not shake) the vial until all the powder is dissolved in the liquid. Then turn the vial and needle/syringe upside down and gently swirl the vial to dissolve any powder in the neck of the vial. Do not use the solution if it is cloudy, colored, or contains particles. Step 12 . Keeping the needle in the vial, firmly hold the vial and syringe upside down in one hand. Figure M: Remove the liquid from the vial Step 13 . If there are air bubbles, gently tap the syringe barrel until the bubbles float to the top of the liquid (see Error! Hyperlink reference not valid. ). Figure N: Tap the syringe barrel to remove air bubbles Step 14 . Carefully replace the needle used to mix the liquid with a new 29 to 30 gauge one half inch needle for your injection. Set the syringe down on a level surface. How to give the injection STEP 15 . The injection will go into the part of the penis shown as the shaded area in Figure O. Do not inject CAVERJECT into the white areas because there may be blood vessels in the white areas. (See Error! Hyperlink reference not valid. ). Figure O: Top view of the penis showing injection sites (shaded areas). Figure P: Cross-section of the penis Step 16 . Wipe the area for injection with an alcohol swab and let it dry. Step 17 . Do not throw away the swab; you will need to use it again after you give your injection. (See Error! Hyperlink reference not valid. ). Step 18 . If your penis is not circumcised, pull the foreskin back. Take hold of the tip of your penis with your thumb and forefinger; stretch it lengthwise along your thigh. Step 19 . Gently squeeze your penis between your thumb and finger so that the injection site bulges out. Step 20 . Remove the cover from the needle. Position your penis firmly against your thigh to keep it from moving during the injection. Step 21 . Keeping a firm grip on your penis, take the syringe in your other hand, and push the needle straight into the selected injection site (See Error! Hyperlink reference not valid. ). Figure Q: Insert the needle into the injection site Step 22 . Holding the syringe barrel between two fingers, move your thumb or finger to the top of the plunger and, with a steady motion, push down on the plunger so that the entire contents of the syringe is slowly injected (Figure R). Figure R: Inject the contents of the syringe. Step 23 . After completing the injection, carefully pull the needle out of your penis. Press gently on the injection site with the alcohol swab for about 5 minutes or until bleeding stops. After your injection: Dispose of your used CAVERJECT syringe and needles. How should I store CAVERJECT? CAVERJECT 20 mcg vial storage information CAVERJECT 40 mcg vial storage information Keep CAVERJECT 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-0009-8.0 Revised March 2023

Product summary:

CAVERJECT is a lyophilized powder supplied in vials containing 23.2 or 46.4 mcg of alprostadil for intracavernosal administration. When reconstituted as directed with 1 milliliter of bacteriostatic water for injection, the delivered amount of alprostadil is 20 mcg or 40 mcg. Store CAVERJECT 20 mcg vials between 20°C to 25°C (68°F to 77°F). The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen. Store CAVERJECT 40 mcg vials between 2°C to 8°C (36° to 46°F) until dispensed. Once dispensed, vials should be stored at or below 25°C (77°F) for up to 3 months or until the expiration date, whichever occurs first. The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen. When reconstituted and used as directed, the deliverable amount of alprostadil is 20 micrograms or 40 micrograms, respectively. Only bacteriostatic water for injection, should be used when reconstituting CAVERJECT. CAVERJECT is available in the following packages: Package of six 20 mcg vials NDC 0009-3701-05 Package of six 40 mcg vials NDC 0009-7686-04 The following supplies are needed for injection and are not supplied with CAVERJECT:

Authorization status:

New Drug Application

Summary of Product characteristics

CAVERJECT- ALPROSTADIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
PHARMACIA & UPJOHN COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CAVERJECT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CAVERJECT.
CAVERJECT (ALPROSTADIL) FOR INJECTION, FOR INTRACAVERNOSAL USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
CAVERJECT is a prostaglandin E1 agonist indicated
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in
single-dose vials for reconstitution (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
For the treatment of erectile dysfunction (1.1).
As an adjunct to other diagnostic tests in the diagnosis of erectile
dysfunction (1.2).
Determine the most suitable dose and presentation of CAVERJECT to use.
Use a new vial for each
dose of CAVERJECT (ERROR! HYPERLINK REFERENCE NOT VALID.).
Administer first intracavernosal injections in the health care
provider’s office and titrate the dose for
each patient to the lowest effective dose (ERROR! HYPERLINK REFERENCE
NOT VALID.).
Instruct the patient on proper use and assess that they are well
trained in the self-injection technique
prior to initiation of at-home use (ERROR! HYPERLINK REFERENCE NOT
VALID.).
Recommended dosage for erectile dysfunction (ERROR! HYPERLINK
REFERENCE NOT VALID.):
o
o
Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology:
Initiate dosing with 2.5 mcg
Erectile dysfunction of pure neurogenic etiology (spinal cord injury):
Initiate dosing with 1.25 mcg
Follow dose titration procedures for each type of erectile dysfunction
and determine the maintenance
dosage for patient home use in the health care provider’s office
(ERROR! HYPERLINK REFERENCE NOT
VALID.).
The recommended frequency of injection is no more than 3 times weekly,
with at least 24 hours
between each dose (ERROR! HYPERLINK REFERENCE NOT VALID.