Caverject Alprostadil 41.1 ug/mL Injection, Powder, Lyophilized, For Solution, 6 vials
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Prostaglandin Analog class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Alprostadil injection and suppositories are used to treat certain types of erectile dysfunction (impotence; inability to get or keep an erection) in men. Alprostadil injection is also sometimes used in combination with other tests to diagnose erectile dysfunction. Alprostadil is in a class of medications called vasodilators. It works by relaxing the muscles and blood vessels in the penis to keep enough blood in the penis so that an erection can occur. Alprostadil does not cure erectile dysfunction or increase sexual desire. Alprostadil does not prevent pregnancy or the spread of sexually trans...
Read the full MedlinePlus article ↗Patient education
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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8.4 mg / 1 mL
UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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172 mg / 1 mL
UNII J2B2A4N98G
Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
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47 ug / 1 mL
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J0270 | No ASP payment limit on file for J0270 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Caverject 41.1 ug/mLthis 00009-7686-04 | Pharmacia | 6 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00009-7686-04 You're viewing this | 6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-7686-04) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-7686-01) | 1995-07-06 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE CAVERJECT is a prostaglandin E1 agonist indicated • For the treatment of erectile dysfunction ( 1.1 ). • As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction ( 1.2 ).
1.1Erectile Dysfunction CAVERJECT is indicated for the treatment of erectile dysfunction.
1.2Diagnostic Test CAVERJECT is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Determine the most suitable dose and presentation of CAVERJECT to use. Use a new vial for each dose of CAVERJECT ( 2.1 ). • 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 ). • 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 ). • Recommended dosage for erectile dysfunction ( 2.2 ): • 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 ). • The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose ( 2.2 ). • 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 ). • Follow the procedure for CAVERJECT syringe preparation ( 2.3 ). • Follow procedure for CAVERJECT intracavernosal injection administration ( 2.4 ). • To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection ( 2.2 ).
2.1Important 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.
2.2Recommended Dosage for Erectile Dysfunction Erectile 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 m…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution. For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS CAVERJECT is contraindicated: • in men who have a known hypersensitivity to the drug [see Adverse Reactions (6.1) ] • in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see Warnings and Precautions (5.1) ] • 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 Warnings and Precautions (5.2) ] • in men with penile implants. • Men who have known hypersensitivity to the drug ( 4 ). • Men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia ( 4 ). • Treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease ( 4 ). • Men with penile implants ( 4 ).
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Prolonged erection and priapism have occurred in patients receiving CAVERJECT. To minimize the chances of this occurring, titrate CAVERJECT slowly to the lowest effective dose ( 2.1 ). Advise patients to seek immediate medical assistance for an erection that persists longer than 4 hours ( 5.1 ). • Penile fibrosis has 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 ). • 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 ). • Injection site bleeding may 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 ). • 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 ). • 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 ). • 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 ). • 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 ). • 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 ).
5.1Prolonged Erection and Priapism Prolonged 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) ] .
5.2Penile Fibrosis The 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.
5.3Hypotension Intracavernous 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.
5.4Injection Site Bleeding When Used with Anticoagulants Patients 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.
5.5 Cardiovascular Risk Relat…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following are described elsewhere in the labeling: • Prolonged Erection and Priapism [see Warnings and Precautions (5.1) ] • Penile Fibrosis [see Warnings and Precautions (5.2) ] The most common (≥10%) adverse reaction is penile pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (1-800-438-1985 and www.pfizer.com ) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because 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 disorder Penis 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 pain Prolonged 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% [ see Warnings 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%).
6.2 Postmarketing Experience The follo…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied [see Warnings and Precautions (5.6) ] .
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy CAVERJECT is not indicated for use in females.
8.2Lactation CAVERJECT is not indicated for use in females.
8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients [see Warnings and Precautions (5.8) ] .
8.5Geriatric 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.
🤰 Pregnancy ▾
8.1Pregnancy CAVERJECT is not indicated for use in females.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness have not been established in pediatric patients [see Warnings and Precautions (5.8) ] .
🧓 Geriatric Use ▾
8.5Geriatric 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.
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage was not observed in clinical trials with CAVERJECT. If intracavernous overdose of CAVERJECT occurs, the patient should be under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Treatment of any systemic symptoms (e.g., hypotension) would be appropriate.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Alprostadil (PGE1) is a prostaglandin with a wide variety of pharmacological actions including vasodilation and inhibition of platelet aggregation. Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries by binding to its receptors and increasing intracellular cyclic adenosine monophosphate (cAMP) levels via modulation of adenylate cyclase. This leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism.
Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum. Studies in vitro have shown that alprostadil relaxed isolated preparations of human corpus cavernosum and spongiosum, as well as cavernous arterial segments contracted by either noradrenaline or PGF2α. In pigtail monkeys ( Macaca nemestrina ), alprostadil increased cavernous arterial blood flow in a dose-dependent manner in vivo .
12.3Pharmacokinetics Absorption: For the treatment of erectile dysfunction, alprostadil is administered by injection into the corpora cavernosa. The absolute bioavailability of alprostadil has not been determined. Distribution: Following intracavernosal injection of 20 mcg alprostadil, mean peripheral plasma concentrations of alprostadil at 30 and 60 minutes after injection (89 picograms/mL and 102 picograms/mL, respectively) were not significantly greater than baseline levels of endogenous alprostadil (96 picograms/mL).
Plasma levels of alprostadil were measured using a radioimmunoassay method. Alprostadil is bound in plasma primarily to albumin (81% bound) and to a lesser extent α-globulin IV-4 fraction (55% bound). No significant binding to erythrocytes or white blood cells was observed.
Metabolism: Alprostadil is converted to compounds which are further metabolized prior to excretion. Following intravenous administration, approximately 80% of circulating alprostadil is metabolized in one pass through the lungs, primarily by beta- and omega-oxidation. Following intracavernosal injection of 20 mcg alprostadil, peripheral levels of the major circulating metabolite, 13, 14-dihydro-15-oxo-PGE 1 , increased to reach a peak 30 minutes after injection and returned to pre-dose levels by 60 minutes after injection.
Excretion: The metabolites of alprostadil are excreted primarily by the kidney, with almost 90% of an administered intravenous dose excreted in urine within 24 hours post-dose. The remainder of the dose is excreted in the feces. There is no evidence of tissue retention of alprostadil or its metabolites following intravenous administration.
Pharmacokinetics in Specific Populations Geriatric: The potential effect of age on the pharmacokinetics of alprostadil has not been formally evaluated. Race: The potential effect of race on the pharmacokinetics of alprostadil has not been formally evaluated. Renal and Hepatic Insufficiency: The pharmacokinetics of alprostadil have not been formally studied in patients with renal or hepatic insufficiency.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Alprostadil (PGE1) is a prostaglandin with a wide variety of pharmacological actions including vasodilation and inhibition of platelet aggregation. Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries by binding to its receptors and increasing intracellular cyclic adenosine monophosphate (cAMP) levels via modulation of adenylate cyclase. This leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism.
Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum. Studies in vitro have shown that alprostadil relaxed isolated preparations of human corpus cavernosum and spongiosum, as well as cavernous arterial segments contracted by either noradrenaline or PGF2α. In pigtail monkeys ( Macaca nemestrina ), alprostadil increased cavernous arterial blood flow in a dose-dependent manner in vivo .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING 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: • 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
📦 Storage and Handling ▾
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: • 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
📋 Description ▾
11 DESCRIPTION CAVERJECT contains alprostadil, a synthetic form of prostaglandin E 1 (PGE 1 ), and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 115°C and 116° C.
CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in sizes: 20 mcg and 40 mcg per vial. When reconstituted as directed with 1 mL of bacteriostatic water for injection, the volume of the reconstituted solution is 1.13 mL. Each mL of CAVERJECT contains 20.5 mcg or 41.1 mcg of alprostadil depending on vial strength, 172 mg of lactose, 47 mcg of sodium citrate and 8.4 mg of benzyl alcohol.
The deliverable amount of alprostadil is 20 mcg or 40 mcg per mL because approximately 0.5 mcg for the 20 mcg strength and 1.1 mcg for the 40 mcg strength is lost due to adsorption to the vial and syringe. During manufacture, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization. The structural formula of alprostadil is represented below: Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Dosing and Self-Administration To ensure safe and effective use of CAVERJECT, instruct and train the patient in the self-injection technique before he begins treatment with CAVERJECT, at home. Inform the patient the initial dose administration and dose titration will take place in the health care provider’s office [see Dosage and Administration (2.1) ] .
Once the home dose of CAVERJECT has been established, instruct the patient not to change the dose without consulting their health care provider. 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 [see Dosage and Administration (2.2) ] .
Inform the patient that they must visit the health care provider’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 [see Dosage and Administration (2.2 , 2.3) ] : • 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 axis of the penis to avoid bending or breakage of the needle [see Dosage and Administration (2.4) , Warnings and Precautions (5.7) and Adverse Reactions (6.2) ] . Penile Pain Advise patients that the most frequently occurring side-effect is penile pain after injection and is usually mild to moderate in severity [see Adverse Reactions (6.1) ] .
Priapism A potentially serious adverse reaction with CAVERJECT is priapism. Instruct the patient to seek immediate medical assistance if an erection persists for longer than 4 hours [see Warnings and Precautions (5.1) ] . 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. [see Warnings and Precautions (5.2) ] . 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 [see Warnings and Precautions (5.4) ] .
Sexually Transmitted Disease Use of 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) [see Warnings and Precautions (5.9) ] .