Get Email Alerts |
Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
CAVERJECT (NDA-020379)
(ALPROSTADIL)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
12/23/2022 (SUPPL-38)
6 Adverse Reactions
6.2 Postmarketing ExperienceAdditions and revisions underlined:
The following adverse reaction has been identified during post-approval use of CAVERJECT.
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 complications: Needle breakage during administration of CAVERJECT. In some instances, surgical removal of the needle was required.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient InformationAdditions and revisions underlined:
What are the possible side effects of CAVERJECT? CAVERJECT may cause serious side effects, including:
. . .
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.
12/06/2017 (SUPPL-31)
4 Contraindications
PLR conversion; please refer to label for complete information.
5 Warnings and Precautions
PLR conversion; this section now includes the following subsections (please refer to label for complete information):
5.1 Prolonged Erection and Priapism
5.2 Penile Fibrosis
5.3 Hypotension
5.4 Injection Site Bleeding When Used with Anticoagulants
5.5 Cardiovascular Risk Related to Underlying Medical Conditions
5.6 Risks of Use in Combination with Other Vasoactive Medications Injected Intracavernosally
5.7 Needle Breakage
5.8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative (Newly added information)
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 neonates or infants.
5.9 Counseling Patients against Sexually Transmitted Diseases
6 Adverse Reactions
PLR conversion; please refer to label for complete information.
8 Use in Specific Populations
PLR conversion
PLLR conversion; please refer to label, Sections 8.1 and 8.2 for complete information. Additions and/or revisions underlined:
8.4 Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
8.5 Geriatric Use
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.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONPLR conversion, as below:
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Dosing and Self-Administration ensure safe and effective use of CAVERJECT, instruct and train the patient in the self-injection technique before he begins intracavernosal treatment with CAVERJECT, at home. Inform the patient the initial dose administration and dose titration will take place in the physician’s office.
Once the home dose of CAVERJECT has been established instruct the patient not to change the dose without consulting their physician.
The patient may expect an erection to occur within 5 minutes to 20 minutes and it should last no longer than 1 hour. CAVERJECT should be used no more than 3 times per week, with at least 24 hours between each use.
Inform the patient that they must visit the physician’s office for regular check-ups for assessment of the therapeutic benefit and safety of treatment with CAVERJECT.
When self-administering the patient should be instructed to:
Discard any reconstituted solution with precipitates or discoloration
Administer the injection along the dorso-lateral aspect of the proximal third of the penis
Wipe the intended injection site with an alcohol swab prior to injection
Avoid visible veins during injection
Alternate the side of the penis that is injected and the site of injection
Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes
Use each CAVERJECT vial only once and discard after use. Use a new vial of CAVERJECT for each dose.
Not use a bent needle for reconstitution or injection. Do not attempt to straighten a bent needle.
Remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.
Not re-use or share needles and to properly discard after use
Needle Breakage
Advise patients that needle breakage has occurred during self-injection of CAVERJECT. Advise patients to insert the needle perpendicular to the long access of the penis to avoid bending or breakage of the needle.
Penile Pain
Advise patients that the most frequently occurring side-effect is penile pain after injection, and is usually mild to moderate in severity.
Priapism
A potentially serious adverse reaction with intracavernosal therapy of CAVERJECT is priapism. Instruct the patient to seek immediate medical assistance if an erection persists for longer than 4 hours.
Penile Fibrosis
Penile fibrosis has been reported in clinical studies with CAVERJECT. Advise the patient to report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis or curvature of the erect penis to his physician as soon as possible.
Injection Site Reactions
Inform the patient that injection of CAVERJECT can induce a small amount of bleeding at the site of injection and that hematoma and ecchymosis may occur. Advise the patient to report any persistent redness, tenderness or swelling.
Sexually Transmitted Disease
Use of intracavernosal CAVERJECT offers no protection from the transmission of sexually transmitted diseases. Advise the patient about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV).
PLR conversion; newly added section; please refer to label for complete information.
Other
PLR Conversion
12/06/2017 (SUPPL-32)
4 Contraindications
PLR conversion; please refer to label for complete information.
5 Warnings and Precautions
PLR conversion; this section now includes the following subsections (please refer to label for complete information):
5.1 Prolonged Erection and Priapism
5.2 Penile Fibrosis
5.3 Hypotension
5.4 Injection Site Bleeding When Used with Anticoagulants
5.5 Cardiovascular Risk Related to Underlying Medical Conditions
5.6 Risks of Use in Combination with Other Vasoactive Medications Injected Intracavernosally
5.7 Needle Breakage
5.8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative (Newly added information)
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 neonates or infants.
5.9 Counseling Patients against Sexually Transmitted Diseases
6 Adverse Reactions
PLR conversion; please refer to label for complete information.
8 Use in Specific Populations
PLR conversion
PLLR conversion; please refer to label, Sections 8.1 and 8.2 for complete information. Additions and/or revisions underlined:
8.4 Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
8.5 Geriatric Use
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.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONPLR conversion, as below:
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Dosing and Self-Administration ensure safe and effective use of CAVERJECT, instruct and train the patient in the self-injection technique before he begins intracavernosal treatment with CAVERJECT, at home. Inform the patient the initial dose administration and dose titration will take place in the physician’s office.
Once the home dose of CAVERJECT has been established instruct the patient not to change the dose without consulting their physician.
The patient may expect an erection to occur within 5 minutes to 20 minutes and it should last no longer than 1 hour. CAVERJECT should be used no more than 3 times per week, with at least 24 hours between each use.
Inform the patient that they must visit the physician’s office for regular check-ups for assessment of the therapeutic benefit and safety of treatment with CAVERJECT.
When self-administering the patient should be instructed to:
Discard any reconstituted solution with precipitates or discoloration
Administer the injection along the dorso-lateral aspect of the proximal third of the penis
Wipe the intended injection site with an alcohol swab prior to injection
Avoid visible veins during injection
Alternate the side of the penis that is injected and the site of injection
Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes
Use each CAVERJECT vial only once and discard after use. Use a new vial of CAVERJECT for each dose.
Not use a bent needle for reconstitution or injection. Do not attempt to straighten a bent needle.
Remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.
Not re-use or share needles and to properly discard after use
Needle Breakage
Advise patients that needle breakage has occurred during self-injection of CAVERJECT. Advise patients to insert the needle perpendicular to the long access of the penis to avoid bending or breakage of the needle.
Penile Pain
Advise patients that the most frequently occurring side-effect is penile pain after injection, and is usually mild to moderate in severity.
Priapism
A potentially serious adverse reaction with intracavernosal therapy of CAVERJECT is priapism. Instruct the patient to seek immediate medical assistance if an erection persists for longer than 4 hours.
Penile Fibrosis
Penile fibrosis has been reported in clinical studies with CAVERJECT. Advise the patient to report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis or curvature of the erect penis to his physician as soon as possible.
Injection Site Reactions
Inform the patient that injection of CAVERJECT can induce a small amount of bleeding at the site of injection and that hematoma and ecchymosis may occur. Advise the patient to report any persistent redness, tenderness or swelling.
Sexually Transmitted Disease
Use of intracavernosal CAVERJECT offers no protection from the transmission of sexually transmitted diseases. Advise the patient about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV).
PLR conversion; newly added section; please refer to label for complete information.
Other
PLR Conversion
12/06/2017 (SUPPL-34)
4 Contraindications
5 Warnings and Precautions
PLR conversion; this section now includes the following subsections (please refer to label for complete information):
5.1 Prolonged Erection and Priapism
5.2 Penile Fibrosis
5.3 Hypotension
5.4 Injection Site Bleeding When Used with Anticoagulants
5.5 Cardiovascular Risk Related to Underlying Medical Conditions
5.6 Risks of Use in Combination with Other Vasoactive Medications Injected Intracavernosally
5.7 Needle Breakage
5.8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative (Newly added information)
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 neonates or infants.
5.9 Counseling Patients against Sexually Transmitted Diseases
6 Adverse Reactions
PLR conversion; please refer to label for complete information.
8 Use in Specific Populations
PLR conversion
PLLR conversion; please refer to label, Sections 8.1 and 8.2 for complete information. Additions and/or revisions underlined:
8.4 Pediatric Use
Safety and effectiveness have not been established in pediatric patients.
8.5 Geriatric Use
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.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATIONPLR conversion, as below:
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Dosing and Self-Administration ensure safe and effective use of CAVERJECT, instruct and train the patient in the self-injection technique before he begins intracavernosal treatment with CAVERJECT, at home. Inform the patient the initial dose administration and dose titration will take place in the physician’s office.
Once the home dose of CAVERJECT has been established instruct the patient not to change the dose without consulting their physician.
The patient may expect an erection to occur within 5 minutes to 20 minutes and it should last no longer than 1 hour. CAVERJECT should be used no more than 3 times per week, with at least 24 hours between each use.
Inform the patient that they must visit the physician’s office for regular check-ups for assessment of the therapeutic benefit and safety of treatment with CAVERJECT.
When self-administering the patient should be instructed to:
Discard any reconstituted solution with precipitates or discoloration
Administer the injection along the dorso-lateral aspect of the proximal third of the penis
Wipe the intended injection site with an alcohol swab prior to injection
Avoid visible veins during injection
Alternate the side of the penis that is injected and the site of injection
Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes
Use each CAVERJECT vial only once and discard after use. Use a new vial of CAVERJECT for each dose.
Not use a bent needle for reconstitution or injection. Do not attempt to straighten a bent needle.
Remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe.
Not re-use or share needles and to properly discard after use
Needle Breakage
Advise patients that needle breakage has occurred during self-injection of CAVERJECT. Advise patients to insert the needle perpendicular to the long access of the penis to avoid bending or breakage of the needle.
Penile Pain
Advise patients that the most frequently occurring side-effect is penile pain after injection, and is usually mild to moderate in severity.
Priapism
A potentially serious adverse reaction with intracavernosal therapy of CAVERJECT is priapism. Instruct the patient to seek immediate medical assistance if an erection persists for longer than 4 hours.
Penile Fibrosis
Penile fibrosis has been reported in clinical studies with CAVERJECT. Advise the patient to report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis or curvature of the erect penis to his physician as soon as possible.
Injection Site Reactions
Inform the patient that injection of CAVERJECT can induce a small amount of bleeding at the site of injection and that hematoma and ecchymosis may occur. Advise the patient to report any persistent redness, tenderness or swelling.
Sexually Transmitted Disease
Use of intracavernosal CAVERJECT offers no protection from the transmission of sexually transmitted diseases. Advise the patient about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV).
PLR conversion; newly added section; please refer to label for complete information.
Other
PLR Conversion
05/05/2016 (SUPPL-30)
5 Warnings and Precautions
General Precautions:- CAVERJECT uses a superfine needle for administration. 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, required hospitalization and surgical removal. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage.
- The patient should be instructed that, if the needle is bent, it must not be used; they should also not attempt to straighten a bent needle. They should remove the needle from the syringe, discard it, and attach a new, unused sterile needle to the syringe. The needle must be properly discarded after use; it must not be re-used or shared with other persons. Patient instructions for administration are included in each package of CAVERJECT.