Caverject 40mcg Inj Vial
Overview
What is this medicine?
How to Use This Medicine
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.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Do not shake the vial or prefilled syringe.
3. Attach a new needle before each dose, and do not use a bent or damaged needle. If a needle becomes bent, do not attempt to straighten it, as this may cause it to break.
4. After administering the dose, apply light pressure to the injection site for 5 minutes to prevent bruising and until any bleeding stops.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles.
Do not use the medication if the solution has changed color.
Each prefilled syringe or vial is for single use only; discard any remaining medication after administration.
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the box when it is full. If you have questions, consult your doctor or pharmacist.
Administration Technique
Alternate the side of the penis and injection site with each dose to minimize the risk of complications.
Storage and Disposal
The storage requirements for this medication vary by 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, so you do not need to follow a regular dosing schedule. However, do not use the medication more frequently than directed by your doctor.
Lifestyle & Tips
- Always use a new, sterile needle and syringe for each injection.
- Rotate injection sites on the penis (alternate sides and locations) to prevent scarring and fibrosis.
- Do not inject into the same spot twice in a row.
- Do not use more than one injection in a 24-hour period and no more than three injections per week.
- Avoid using alcohol or other recreational drugs, as they can impair erectile function and potentially interact with the medication.
- Do not use alprostadil with other erectile dysfunction medications (e.g., Viagra, Cialis) due to the risk of dangerously prolonged erections (priapism) and low blood pressure.
- Properly dispose of used needles and syringes in a sharps container.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
While rare, some people may experience severe and potentially life-threatening side effects when 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
Erectile Dysfunction Warning
If you experience a painful erection or an erection that lasts longer than 4 hours, seek medical attention immediately. This can occur even when you are not engaging in sexual activity. If left untreated, it may lead to permanent sexual dysfunction and impotence.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Penile pain
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, 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 1 hour: Contact your doctor immediately.
- Erection lasting longer than 4 hours (priapism): Seek immediate emergency medical attention. This is a medical emergency that can cause permanent damage to the penis.
- Severe penile pain, swelling, or bruising that does not resolve.
- Development of lumps, bumps, or curvature in the penis (signs of penile fibrosis or Peyronie's disease).
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. 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.
If you have been diagnosed with polycythemia or thrombocythemia.
If you have any of the following health conditions: 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.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor.
Precautions & Cautions
When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position. Be cautious when climbing stairs.
Before consuming alcohol, discuss the potential risks with your doctor. It is crucial to remember that this medication does not protect against the transmission of diseases like HIV or hepatitis through sexual contact. 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. In some cases, the broken needle may remain in the penis. If the needle breaks and you can grasp the broken end, carefully remove it and contact your doctor immediately. If you are unable to retrieve the broken end, seek medical attention right away.
This medication contains benzyl alcohol, which can cause severe side effects in newborns and infants, particularly when combined with other medications containing benzyl alcohol. This medication is not approved for use in children. It is essential to discuss the potential risks with your doctor.
Overdose Information
Overdose Symptoms:
- Priapism (erection lasting >4 hours)
- Severe penile pain
- Hypotension (low blood pressure), dizziness, lightheadedness
What to Do:
For priapism, seek immediate emergency medical attention. Management may involve aspiration of blood from the corpus cavernosum and/or intracavernosal injection of alpha-adrenergic agonists (e.g., phenylephrine). For hypotension, supportive care.
Drug Interactions
Contraindicated Interactions
- Other treatments for erectile dysfunction (e.g., oral PDE5 inhibitors like sildenafil, tadalafil, vardenafil, avanafil) due to increased risk of priapism and/or hypotension.
Moderate Interactions
- Anticoagulants (e.g., warfarin, heparin, direct oral anticoagulants): Increased risk of injection site hematoma or bleeding.
- Antihypertensives: Although systemic absorption is minimal, theoretical risk of additive hypotensive effects, especially in patients prone to orthostatic hypotension.
Confidence Interactions
Monitoring
Baseline Monitoring
Rationale: To identify underlying causes of ED, contraindications, and assess cardiovascular status.
Timing: Prior to initiation of therapy
Rationale: To ensure safe and effective self-administration and minimize adverse effects.
Timing: Prior to first self-injection
Routine Monitoring
Frequency: With each dose
Target: Erection sufficient for intercourse, not exceeding 1 hour.
Action Threshold: If erection lasts >1 hour, patient should seek medical attention. If >4 hours, seek immediate medical attention for priapism.
Frequency: With each dose and during follow-up visits
Target: Minimal to no bruising/pain
Action Threshold: Significant or persistent pain, large hematoma, or signs of infection require medical evaluation.
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Absence of palpable nodules, plaques, or significant curvature.
Action Threshold: Development of penile fibrosis, nodules, or angulation may necessitate discontinuation of therapy.
Frequency: Periodically, especially during dose titration
Target: Within normal limits for the patient
Action Threshold: Significant hypotension or orthostatic changes may require dose adjustment or discontinuation.
Symptom Monitoring
- Penile pain (during or after injection)
- Prolonged erection (priapism, erection lasting >4 hours)
- Penile fibrosis, nodules, or curvature
- Injection site bruising, swelling, or hematoma
- Dizziness or lightheadedness (rare, due to systemic hypotension)
Special Patient Groups
Pregnancy
Not applicable. Caverject is indicated for use in adult males.
Trimester-Specific Risks:
Lactation
Not applicable. Caverject is indicated for use in adult males.
Pediatric Use
Caverject is not indicated for use in pediatric patients for erectile dysfunction. Safety and efficacy have not been established in this population.
Geriatric Use
No specific dose adjustment is required based on age alone. However, older patients may have underlying cardiovascular conditions or be on multiple medications, which should be considered. Caution should be exercised in patients with pre-existing cardiovascular disease.
Clinical Information
Clinical Pearls
- Proper patient selection and education on injection technique are crucial for successful and safe use.
- Patients should be instructed on how to manage a prolonged erection (e.g., applying ice packs, seeking medical attention for erections >1 hour, and immediate emergency care for priapism >4 hours).
- Rotation of injection sites is essential to minimize the risk of penile fibrosis, which can lead to permanent penile deformity.
- The lowest effective dose should be used to achieve an erection sufficient for intercourse, not exceeding 1 hour.
- Alprostadil is often considered for patients who do not respond to or have contraindications to oral PDE5 inhibitors.
- Patients should be advised to avoid sharing needles or vials.
Alternative Therapies
- Oral Phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil, tadalafil, vardenafil, avanafil)
- Vacuum erection devices (VEDs)
- Penile implants (prostheses)
- Urethral suppositories (e.g., MUSE - Medicated Urethral System for Erection, which also contains alprostadil)
- Lifestyle modifications (e.g., diet, exercise, smoking cessation, alcohol reduction)
- Psychological counseling