Caverject
(Alprostadil)Caverject Prescribing Information
CAVERJECT is a prostaglandin E1 agonist indicated
• For the treatment of erectile dysfunction ().1.1 Erectile DysfunctionCAVERJECT is indicated for the treatment of erectile dysfunction.
• As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction ().1.2 Diagnostic TestCAVERJECT is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.
• Determine the most suitable dose and presentation of CAVERJECT to use. Use a new vial for each dose of CAVERJECT ().2.1 Important Dosage and Administration Instructions• Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient.• 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.• Titrate the dose of CAVERJECT for each patient to the lowest effective dose.• CAVERJECT doses greater than 60 mcg are not recommended.• Administer the first injections of CAVERJECT in the health care provider’s office by medically trained personnel.• 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.• Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.
• Administer first intracavernosal injections in the health care provider’s office and titrate the dose for each patient to the lowest effective dose ().2.1 Important Dosage and Administration Instructions• Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient.• 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.• Titrate the dose of CAVERJECT for each patient to the lowest effective dose.• CAVERJECT doses greater than 60 mcg are not recommended.• Administer the first injections of CAVERJECT in the health care provider’s office by medically trained personnel.• 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.• Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.
• 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 ().2.1 Important Dosage and Administration Instructions• Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient.• 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.• Titrate the dose of CAVERJECT for each patient to the lowest effective dose.• CAVERJECT doses greater than 60 mcg are not recommended.• Administer the first injections of CAVERJECT in the health care provider’s office by medically trained personnel.• 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.• Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.
• Recommended dosage for erectile dysfunction ():2.2 Recommended Dosage for Erectile DysfunctionErectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology• Initiate dosing with 2.5 mcg of CAVERJECT intracavernosally, as recommended[see Dosage and Administration (2.4)].• 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.• During titration, no more than 2 doses should be given within a 24-hour period.• If additional titration is required, administer doses in increments of 5 to 10 mcg at least 24 hours apart.• The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.• 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).• Initiate dosing with 1.25 mcg of CAVERJECT intracavernosally, as recommended[see Dosage and Administration (2.4)].• 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.• If additional titration is required, administer a dose of 5 mcg at least 24 hours later.• During titration, no more than 2 doses should be given within a 24-hour period.• The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.• 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• 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.• 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 DysfunctionAs 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.• 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 ().2.2 Recommended Dosage for Erectile DysfunctionErectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology• Initiate dosing with 2.5 mcg of CAVERJECT intracavernosally, as recommended[see Dosage and Administration (2.4)].• 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.• During titration, no more than 2 doses should be given within a 24-hour period.• If additional titration is required, administer doses in increments of 5 to 10 mcg at least 24 hours apart.• The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.• 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).• Initiate dosing with 1.25 mcg of CAVERJECT intracavernosally, as recommended[see Dosage and Administration (2.4)].• 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.• If additional titration is required, administer a dose of 5 mcg at least 24 hours later.• During titration, no more than 2 doses should be given within a 24-hour period.• The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.• 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• 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.• 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 DysfunctionAs 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.• The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose ().2.2 Recommended Dosage for Erectile DysfunctionErectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology• Initiate dosing with 2.5 mcg of CAVERJECT intracavernosally, as recommended[see Dosage and Administration (2.4)].• 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.• During titration, no more than 2 doses should be given within a 24-hour period.• If additional titration is required, administer doses in increments of 5 to 10 mcg at least 24 hours apart.• The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.• 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).• Initiate dosing with 1.25 mcg of CAVERJECT intracavernosally, as recommended[see Dosage and Administration (2.4)].• 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.• If additional titration is required, administer a dose of 5 mcg at least 24 hours later.• During titration, no more than 2 doses should be given within a 24-hour period.• The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.• 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• 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.• 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 DysfunctionAs 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.• While on self-injection treatment, the patient should visit the prescribing health care provider’s office every 3 months to assess the efficacy and safety of the therapy ().2.1 Important Dosage and Administration Instructions• Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient.• 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.• Titrate the dose of CAVERJECT for each patient to the lowest effective dose.• CAVERJECT doses greater than 60 mcg are not recommended.• Administer the first injections of CAVERJECT in the health care provider’s office by medically trained personnel.• 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.• Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.
• Follow the procedure for CAVERJECT syringe preparation ().2.3 Preparation InstructionsSupplies Needed and Not Supplied With CAVERJECT• 1 mL of the diluent (bacteriostatic water for injection)• 1 mL to 3 mL syringe, dependent on the titrated dose• 21 to 27 gauge needle for reconstitution• 29 or 30 gauge one-half inch needle for injection• alcohol swabs
Reconstitution Instructions• CAVERJECT vial(s): Using the correct strength vial containing 20 mcg or 40 mcg ofCAVERJECT, 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.• 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.
Table 1: Volume of CAVERJECT Solution to Inject using 1 mL syringe 20 mcg Vial40 mcg VialDoseVolume to InjectDoseVolume to Inject1.25 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
• Draw the dose of CAVERJECT into the syringe.• Replace the needle used for reconstitution with a 29 or 30 gauge one-half inch needle prior to injection.• The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F).
Refer to the
Patient InformationandInstructions for Usein the FDA-approved patient labeling for the complete detailed instructions on reconstitution and needle preparation steps.• Follow procedure for CAVERJECT intracavernosal injection administration ().2.4 Administration Instructions• Use a29 or 30 gauge one-half inch needlefor injecting each dose.• The patient should be in a sitting or slightly reclined position when injecting a dose.• Retract the foreskin in uncircumcised patients.• Grasp the head of the penis with the thumb and forefinger and stretch it lengthwise along the thigh.• The site of injection is either the right or left lateral penis. See Figures Aand Bbelow.
Figure A
Figure B
• Wipe the intended injection site with an alcohol swab prior to injection.• 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.• Avoid visible veins during injection.• With each use of CAVERJECT, alternate the side of the penis that is injected.• Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.• CAVERJECT is intended for single patient use only and should be discarded after use.
Figure A Figure B • To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection ().2.2 Recommended Dosage for Erectile DysfunctionErectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology• Initiate dosing with 2.5 mcg of CAVERJECT intracavernosally, as recommended[see Dosage and Administration (2.4)].• 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.• During titration, no more than 2 doses should be given within a 24-hour period.• If additional titration is required, administer doses in increments of 5 to 10 mcg at least 24 hours apart.• The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.• 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).• Initiate dosing with 1.25 mcg of CAVERJECT intracavernosally, as recommended[see Dosage and Administration (2.4)].• 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.• If additional titration is required, administer a dose of 5 mcg at least 24 hours later.• During titration, no more than 2 doses should be given within a 24-hour period.• The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.• 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• 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.• 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 DysfunctionAs 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.
For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution.
CAVERJECT is not indicated for use in females.
CAVERJECT is contraindicated:
• in men who have a known hypersensitivity to the drug[see]6.1 Clinical Trials ExperienceBecause 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.
Local Adverse Reactions:Local adverse reactions derived from 1861 patients in clinical studies of CAVERJECT, including an 18-month, open-label study, are shown in Table 2.Table 2. Local Adverse Reactions Reported by ≥ 1% of Patients Treated with CAVERJECT for up to 18 Months Penile pain
37%
Prolonged erection
4%
Penile fibrosis
3%
Injection site hematoma
3%
Penis disorderPenis disorder includes: numbness, irritation, sensitivity, pruritus, erythema, skin tear, discoloration, itching.
3%
Injection site ecchymosis
2%
Penile rash
1%
Penile edema
1%
The following local adverse reactions were reported in < 1% of patients: injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, irritation, sensitivity, pruritus, erythema, painful erection, and abnormal ejaculation.
In these studies, no local adverse reactions were reported in the 294 patients who received placebo, except for penile pain (2%).
Penile Pain:In the majority of the cases, penile pain was rated mild or moderate in intensity. Three percent of patients discontinued treatment because of penile painProlonged Erection/Priapism:Prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as an erection that lasted 6 hours or longer. In clinical studies the frequency of prolonged erection after CAVERJECT was 4%, while the frequency of priapism was 0.4%[seeWarnings and Precautions (5.1)].Penile Hematoma/Ecchymosis:In clinical studies, the frequency of penile hematoma and ecchymosis was 3% and 2%, respectively.Systemic Adverse Reactions:Systemic adverse reactions reported by ≥ 1% of subjects in clinical studies of CAVERJECT included: dizziness (1%).The following systemic adverse reactions were reported in < 1% of patients: testicular pain, scrotal edema, hematuria, pelvic pain, hypotension, vasodilation, vasovagal reaction, diaphoresis, rash, and non-application site pruritus. Three patients (0.2%) discontinued due to symptomatic hypotension.
No systemic adverse reactions were reported in the 294 patients who received placebo.
In addition to the adverse reactions observed for CAVERJECT, the following adverse reactions have been reported in clinical studies of CAVERJECT IMPULSE:
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 pruritis (1.6%).
• in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia[see]5.1 Prolonged Erection and PriapismProlonged erection, defined as erection lasting between 4 to 6 hours in duration, occurred in 4% of 1,861 patients treated up to 18 months in studies of CAVERJECT. The incidence of priapism (erections lasting more than 6 hours in duration) was 0.4%. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
To minimize the chances of prolonged erection or priapism, titrate CAVERJECT to the lowest effective dose
[see Dosage and Administration (2.1)].In addition, do not use CAVERJECT in patients who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia[see Contraindications (4)].• 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[see]5.2 Penile FibrosisThe overall incidence of penile fibrosis reported in clinical studies with CAVERJECT was 3%. In one self-injection clinical study where duration of use was up to 18 months, the incidence of penile fibrosis was 7.8%.
Physical examination of the penis should be performed periodically, to detect signs of penile fibrosis. Treatment with CAVERJECT should be discontinued in patients who develop penile angulation or cavernosal fibrosis.
• in men with penile implants.
• Prolonged erection and priapismhave occurred in patients receiving CAVERJECT. To minimize the chances of this occurring, titrate CAVERJECT slowly to the lowest effective dose (). Advise patients to seek immediate medical assistance for an erection that persists longer than 4 hours (2.1 Important Dosage and Administration Instructions• Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient.• 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.• Titrate the dose of CAVERJECT for each patient to the lowest effective dose.• CAVERJECT doses greater than 60 mcg are not recommended.• Administer the first injections of CAVERJECT in the health care provider’s office by medically trained personnel.• 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.• Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.
).5.1 Prolonged Erection and PriapismProlonged erection, defined as erection lasting between 4 to 6 hours in duration, occurred in 4% of 1,861 patients treated up to 18 months in studies of CAVERJECT. The incidence of priapism (erections lasting more than 6 hours in duration) was 0.4%. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
To minimize the chances of prolonged erection or priapism, titrate CAVERJECT to the lowest effective dose
[see Dosage and Administration (2.1)].In addition, do not use CAVERJECT in patients who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia[see Contraindications (4)].• Penile fibrosishas occurred in patients receiving CAVERJECT. Follow patients regularly to detect signs of penile fibrosis. Discontinue in patients who develop penile angulation or cavernosal fibrosis ().5.2 Penile FibrosisThe overall incidence of penile fibrosis reported in clinical studies with CAVERJECT was 3%. In one self-injection clinical study where duration of use was up to 18 months, the incidence of penile fibrosis was 7.8%.
Physical examination of the penis should be performed periodically, to detect signs of penile fibrosis. Treatment with CAVERJECT should be discontinued in patients who develop penile angulation or cavernosal fibrosis.
• Hypotension:Injections of CAVERJECT can lead to increased peripheral blood levels of alprostadil, especially in patients with significant corpora cavernosa venous leakage. Avoid use in patients with known cavernosal venous leakage ().5.3 HypotensionIntracavernous injections of CAVERJECT can increase peripheral blood levels of alprostadil which can result in hypotension. Avoid use of CAVERJECT in patients with known cavernosal venous leakage.
• Injection site bleedingmay occur in patients taking anticoagulants, such as warfarin or heparin. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes ().5.4 Injection Site Bleeding When Used with AnticoagulantsPatients on anticoagulants, such as warfarin or heparin, may have increased propensity for injection site bleeding after intracavernosal injection with CAVERJECT. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.
• Cardiovascular risk related to underlying medical conditions:Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy ().5.5 Cardiovascular Risk Related to Underlying Medical ConditionsThere is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including CAVERJECT, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.
• Risks of use in combination with other vasoactive medications injected intracavernosally:Safety and efficacy of combinations of CAVERJECT and other vasoactive agents have not been systematically studied. Use of such combinations is not recommended ().5.6 Risks of Use in Combination with Other Vasoactive Medications Injected IntracavernosallyThe safety and efficacy of combinations of CAVERJECT and other vasoactive agents injected intracavernosally have not been established in clinical studies. The risks of prolonged erection, priapism, and hypotension may be increased.
• Needle breakage:A superfine needle is used for administration of CAVERJECT and cases of needle breakage have been reported. Careful instruction in proper patient handling and injection techniques may minimize this risk ().5.7 Needle BreakageSeparate needles should be used for reconstitution and administration. A superfine needle is used for administration of CAVERJECT. 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, has required hospitalization and surgical removal. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage
[see Dosage and Administration (2.3)and Adverse Reactions (6.2)].• Benzyl alcohol:Serious and fatal adverse reactions can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT. CAVERJECT is not indicated in neonates and infants ().5.8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol PreservativeWhen 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 pediatric patients.
• Counsel patients about sexually transmitted diseases:Counsel patients about the protective measures necessary to guard against sexually transmitted disease including the Human Immunodeficiency Virus (HIV) ().5.9 Counsel Patients about Sexually Transmitted DiseasesThe use of CAVERJECT offers no protection against sexually transmitted diseases. Counsel patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV).