Caverject 20mcg Vial Inj
It is used to treat erectile dysfunction (ED).Some products may be used to help test for ED.
Drug Class
Erectile Dysfunction Agent
Pharmacologic Class
Prostaglandin E1 analog; Vasodilator
Pregnancy Category
Not applicable for indicated use (male ED)
FDA Approved
Sep 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Caverject is a medicine injected directly into the side of the penis to help men get and keep an erection. It works by relaxing the blood vessels in the penis, allowing more blood to flow in, which causes an erection. It is used for erectile dysfunction (ED).
How to Use This Medicine
Proper Administration of This Medication
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. Administer the injection into the side of the penis as directed by your doctor or as described in the package insert. Before and after use, wash your hands thoroughly.
Preparation and Injection Technique
Do not shake the medication. Attach a new needle before each dose, and never use a bent needle. If a needle becomes bent, do not attempt to straighten it, as this may cause it to break. After administering the dose, apply light pressure to the injection site for 5 minutes to prevent bruising and continue until any bleeding stops.
Inspecting the Medication
Before use, check the solution for cloudiness, leakage, or particles. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
Single-Use Only and Disposal
Each prefilled syringe or vial is intended for a single use only. Discard any remaining medication after administering the dose. Dispose of needles in a designated needle/sharp disposal box. Never reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Alternating Injection Sites
To minimize the risk of bruising or other complications, alternate the side of the penis and the injection site with each dose of this medication.
Storage and Disposal
The storage requirements for this medication may vary depending on the brand. Some brands require refrigeration, while others should be stored at room temperature. If you are unsure about the storage instructions, consult your pharmacist.
Missed Dose
This medication is used as needed. Do not use it more frequently than prescribed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all provided information carefully. Administer the injection into the side of the penis as directed by your doctor or as described in the package insert. Before and after use, wash your hands thoroughly.
Preparation and Injection Technique
Do not shake the medication. Attach a new needle before each dose, and never use a bent needle. If a needle becomes bent, do not attempt to straighten it, as this may cause it to break. After administering the dose, apply light pressure to the injection site for 5 minutes to prevent bruising and continue until any bleeding stops.
Inspecting the Medication
Before use, check the solution for cloudiness, leakage, or particles. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
Single-Use Only and Disposal
Each prefilled syringe or vial is intended for a single use only. Discard any remaining medication after administering the dose. Dispose of needles in a designated needle/sharp disposal box. Never reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Alternating Injection Sites
To minimize the risk of bruising or other complications, alternate the side of the penis and the injection site with each dose of this medication.
Storage and Disposal
The storage requirements for this medication may vary depending on the brand. Some brands require refrigeration, while others should be stored at room temperature. If you are unsure about the storage instructions, consult your pharmacist.
Missed Dose
This medication is used as needed. Do not use it more frequently than prescribed by your doctor.
Lifestyle & Tips
- Follow your doctor's instructions carefully regarding injection technique and dose.
- Do not inject more than once in 24 hours and no more than three times per week.
- Rotate injection sites on the penis to avoid scarring or damage.
- Store the medication as directed (refrigerated or at room temperature depending on formulation, protect from light).
- Do not share needles or medication.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose 2.5 mcg, titrated to achieve an erection suitable for intercourse lasting no longer than 1 hour. Maintenance dose typically 5-20 mcg. Max 60 mcg per injection. Max 3 injections per week, with at least 24 hours between doses.
Dose Range:
2.5 - 60 mg
Condition-Specific Dosing:
erectile_dysfunction:
Initial dose 2.5 mcg. If partial response, increase to 5 mcg. If no response, increase to 7.5 mcg, then 10 mcg, 20 mcg, 30 mcg, and 40 mcg until optimal response. If initial response is full, decrease to 1.25 mcg. Doses should be titrated in a physician's office.
Pediatric Dosing
Neonatal:
Not established (indicated for PDA in neonates, but not for ED)
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended
Dialysis:
No specific dose adjustment recommended; use with caution
Hepatic Impairment:
Mild:
No specific dose adjustment recommended
Moderate:
No specific dose adjustment recommended
Severe:
No specific dose adjustment recommended
Pharmacology
Mechanism of Action
Alprostadil is a synthetic prostaglandin E1 (PGE1) analog. It acts by binding to specific PGE1 receptors on the smooth muscle cells of the corpus cavernosum. This binding activates adenylate cyclase, leading to an increase in intracellular cyclic adenosine monophosphate (cAMP) levels. Elevated cAMP causes relaxation of the trabecular smooth muscle and dilation of the cavernosal arteries, resulting in increased arterial inflow into the lacunar spaces of the penis. This increased blood flow, coupled with compression of the venules against the tunica albuginea (veno-occlusive mechanism), leads to penile erection.
Pharmacokinetics
Absorption:
Bioavailability:
Rapidly absorbed from the corpus cavernosum after intracavernosal injection.
Tmax:
Not precisely quantifiable for local effect, but onset of erection is typically within 5-20 minutes.
FoodEffect:
Not applicable (intracavernosal administration)
Distribution:
Vd:
Not precisely determined for intracavernosal administration due to local action.
ProteinBinding:
Approximately 81% (to albumin and alpha-globulin) in systemic circulation.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 0.5-10 minutes (for alprostadil in cavernosal tissue); metabolites have longer half-lives (e.g., 13,14-dihydro-15-keto-PGE1 has a half-life of about 30 minutes).
Clearance:
Rapid local and systemic clearance.
ExcretionRoute:
Metabolites are primarily excreted via the urine (approximately 90% within 24 hours) and feces (approximately 10%).
Unchanged:
Less than 2% of the injected dose reaches the systemic circulation as unchanged alprostadil.
Pharmacodynamics
OnsetOfAction:
5-20 minutes
PeakEffect:
Variable, typically within 30 minutes
DurationOfAction:
Dependent on dose, typically 30-60 minutes (should not exceed 1 hour for an erection suitable for intercourse)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Redness, lumps, swelling, tenderness, or curving of the erection (hard penis)
Irritation at the injection site
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Severe headache
Shortness of breath
Unexplained bruising or bleeding
Swelling of the leg veins
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which can occur even when not having sex. If left untreated, this may lead to long-term sexual dysfunction and impotence.
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
* Penile pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Redness, lumps, swelling, tenderness, or curving of the erection (hard penis)
Irritation at the injection site
Chest pain or pressure, or a rapid heartbeat
Dizziness or fainting
Severe headache
Shortness of breath
Unexplained bruising or bleeding
Swelling of the leg veins
A painful erection (hard penis) or an erection that lasts longer than 4 hours, which can occur even when not having sex. If left untreated, this may lead to long-term sexual dysfunction and impotence.
Other Possible Side Effects
As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
* Penile pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Erection lasting longer than 4 hours (priapism): This is a medical emergency. Seek immediate medical attention (e.g., go to an emergency room).
- Severe penile pain or discomfort that does not go away.
- New lumps, bumps, or bends in the penis (signs of fibrosis or Peyronie's disease).
- Signs of infection at the injection site (redness, swelling, warmth, pus, fever).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have been advised against engaging in sexual activity due to health concerns.
If you have a deformed penis, penile implant, or other penile problems.
Certain health conditions, such as polycythemia or thrombocythemia.
Leukemia, multiple myeloma, sickle cell anemia, or other conditions that may increase the risk of painful erections (priapism) or prolonged erections lasting more than 4 hours. If you are unsure about your condition, consult your doctor.
If you are female, as this medication is not approved for use in women.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help identify potential interactions and ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have been advised against engaging in sexual activity due to health concerns.
If you have a deformed penis, penile implant, or other penile problems.
Certain health conditions, such as polycythemia or thrombocythemia.
Leukemia, multiple myeloma, sickle cell anemia, or other conditions that may increase the risk of painful erections (priapism) or prolonged erections lasting more than 4 hours. If you are unsure about your condition, consult your doctor.
If you are female, as this medication is not approved for use in women.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help identify potential interactions and ensure safe treatment. Do not start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
When starting this medication, be cautious when driving or performing tasks that require alertness, as its effects on you are unknown. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise care when navigating stairs.
Before consuming alcohol, consult with your doctor to discuss potential interactions.
It is crucial to understand that this medication does not prevent the transmission of sexually transmitted diseases like HIV or hepatitis. To protect yourself and your partner, always use a latex or polyurethane condom during sexual activity. If you have questions or concerns, consult your doctor.
When using the injection form of this medication, there is a risk of the needle breaking, which can result in part of the needle remaining in the penis. If the needle breaks and you can grasp the broken end, carefully remove it and contact your doctor. However, if you are unable to retrieve the broken end, seek medical attention immediately.
This medication contains benzyl alcohol, which can cause severe side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. As this medication is not approved for use in children, it is essential to discuss any concerns with your doctor.
When starting this medication, be cautious when driving or performing tasks that require alertness, as its effects on you are unknown. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise care when navigating stairs.
Before consuming alcohol, consult with your doctor to discuss potential interactions.
It is crucial to understand that this medication does not prevent the transmission of sexually transmitted diseases like HIV or hepatitis. To protect yourself and your partner, always use a latex or polyurethane condom during sexual activity. If you have questions or concerns, consult your doctor.
When using the injection form of this medication, there is a risk of the needle breaking, which can result in part of the needle remaining in the penis. If the needle breaks and you can grasp the broken end, carefully remove it and contact your doctor. However, if you are unable to retrieve the broken end, seek medical attention immediately.
This medication contains benzyl alcohol, which can cause severe side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. As this medication is not approved for use in children, it is essential to discuss any concerns with your doctor.
Overdose Information
Overdose Symptoms:
- Prolonged erection (priapism)
- Severe penile pain
- Hypotension (low blood pressure)
- Dizziness or fainting
What to Do:
For priapism, seek immediate medical attention. Management may involve aspiration of blood from the corpus cavernosum and/or intracavernosal injection of an alpha-adrenergic agonist (e.g., phenylephrine). For systemic symptoms like hypotension, supportive care. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Moderate Interactions
- Anticoagulants (e.g., warfarin, heparin): Increased risk of bleeding or hematoma at the injection site.
- Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding or hematoma at the injection site.
- Antihypertensives (e.g., alpha-blockers, nitrates): Potential for additive hypotensive effects, though systemic absorption is minimal.
Monitoring
Baseline Monitoring
Patient education on proper injection technique
Rationale: To ensure safe and effective self-administration and minimize adverse events.
Timing: Before first self-injection, during initial physician-supervised titration.
Assessment of cardiovascular status
Rationale: To identify patients for whom sexual activity is inadvisable due to underlying cardiovascular risk.
Timing: Prior to initiation of therapy.
Routine Monitoring
Duration of erection
Frequency: With each injection
Target: Erection suitable for intercourse, lasting no longer than 1 hour.
Action Threshold: If erection lasts >4 hours (priapism), seek immediate medical attention. If erection lasts >1 hour but <4 hours, consider dose reduction.
Injection site reactions (pain, bruising, hematoma)
Frequency: With each injection and follow-up visits
Target: Minimal to no reaction
Action Threshold: Persistent or severe pain, significant bruising/hematoma, or signs of infection warrant evaluation and potential dose/technique adjustment or discontinuation.
Penile fibrosis or curvature
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Absence of significant fibrosis or curvature
Action Threshold: Development of new penile angulation, fibrotic nodules, or Peyronie's disease warrants discontinuation of therapy.
Symptom Monitoring
- Erection lasting longer than 4 hours (priapism)
- Severe penile pain
- Penile bruising or hematoma
- Penile swelling or tenderness
- Development of penile nodules or curvature
- Signs of infection at injection site (redness, warmth, pus)
Special Patient Groups
Pregnancy
Not applicable for indicated use (male erectile dysfunction). Caverject is not indicated for use in women.
Trimester-Specific Risks:
First Trimester:
Not applicable
Second Trimester:
Not applicable
Third Trimester:
Not applicable
Lactation
Not applicable for indicated use (male erectile dysfunction). Caverject is not indicated for use in women.
Infant Risk:
Not applicable
Pediatric Use
Not indicated for erectile dysfunction in pediatric patients. Alprostadil is used in neonates for maintaining patency of the ductus arteriosus, but this is a different formulation and indication.
Geriatric Use
No specific dose adjustment is required based on age alone. However, geriatric patients may have a higher incidence of underlying cardiovascular disease or other comorbidities that could make sexual activity inadvisable or increase the risk of adverse effects. Caution is advised.
Clinical Information
Clinical Pearls
- Proper injection technique is crucial to minimize adverse effects like pain, bruising, and fibrosis. Patients must be thoroughly trained.
- Patients should be advised to rotate injection sites (e.g., left side, right side) to prevent localized tissue damage and fibrosis.
- The most serious adverse effect is priapism (erection lasting >4 hours), which requires immediate medical attention to prevent permanent penile damage.
- Alprostadil is a second-line therapy for ED, often used when oral PDE5 inhibitors are contraindicated, ineffective, or not tolerated.
- Patients should be screened for conditions that predispose to priapism (e.g., sickle cell anemia, multiple myeloma, leukemia) before starting therapy.
Alternative Therapies
- Oral phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
- Vacuum erection devices (VEDs)
- Penile implants (prostheses)
- Urethral suppositories (MUSE - Medicated Urethral System for Erection, also alprostadil)
- Penile revascularization surgery (rarely indicated)
- Psychosexual counseling
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 2-dose kit (20mcg)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand), may require prior authorization
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.