Caverject Information for the Patient: The patient should be instructed to transfer the solution from the pharmacy to his home freezer or refrigerator as soon as possible. Brief (2 hours or less) exposure to conditions as warm as 25°C (77°F) will not harm the product.
To ensure safe and effective use of CAVERJECT, the patient should be thoroughly instructed and trained in the self-injection technique before he begins intracavernosal treatment with CAVERJECT at home. The desirable dose should be established in the physicians office.
Any ampoule containing sterile solution with precipitates or discoloration should be discarded. The ampoule is designed for one use only and should be discarded after withdrawal of proper volume of the solution. Needles must be properly discarded after use; they must not be re-used or shared with other persons. Patient instructions for administration are included in each package of CAVERJECT.
The dose of CAVERJECT that is established in the physicians office should not be changed by the patient without consulting the physician. The patient may expect an erection to occur within 5 to 20 minutes. A standard treatment goal is to produce an erection lasting no longer than 1 hour. Generally, CAVERJECT should be used no more than 3 times per week, with at least 24 hours between each use.
Patients should be aware of possible side effects of therapy with CAVERJECT; the most frequently occurring is penile pain after injection, usually mild to moderate in severity. A potentially serious adverse reaction with intracavernosal therapy is priapism. Accordingly, the patient should be instructed to contact the physicians office immediately or, if unavailable, to seek immediate medical assistance if an erection persists for longer than 4 hours.
The patient should 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 to his physician as soon as possible. As with any injection, an infection is a possibility. Patients should be instructed to report to the physician any penile redness, swelling, tenderness or curvature of the erect penis. The patient must visit the physicians office for regular checkups for assessment of the therapeutic benefit and safety of treatment with CAVERJECT.
Note: Use of intracavernosal CAVERJECT offers no protection from the transmission of sexually transmitted diseases. Individuals who use CAVERJECT should be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV).
The injection of CAVERJECT can induce a small amount of bleeding at the site of injection. In patients infected with blood-borne diseases, this could increase the risk of transmission of blood-borne diseases between partners.
In clinical trials, concomitant use of agents such as antihypertensive drugs, diuretics, antidiabetic agents (including insulin), or non-steroidal anti-inflammatory drugs had no effect on the efficacy or safety of CAVERJECT.
Patient instructions for Caverject
IMPOTENCE: CAUSES AND TREATMENTS
There are several causes of impotence, a condition known medically as erectile dysfunction. These include: medications that you may be taking for other conditions, impaired blood circulation in the penis, nerve damage, emotional problems, excessive smoking or alcohol use, use of street drugs, and hormonal imbalances. Often, impotence is due to more than one cause.
Treatments for impotence include: switching medications (if you are taking a medication that causes impotence), administration of hormones, penile injections, use of medical devices that produce an erection, surgical procedures to correct blood flow in the penis, penile implants, and psychological counseling. Your doctor has selected CAVERJECT to treat your impotence. Your doctor can also discuss other available treatments. You should not stop taking any prescription medications, unless told to do so by your doctor
USE OF CAVERJECT
CAVERJECT is injected into a specific area of the penis and should produce an erection in 5 to 20 minutes. The erection should last for about 1 hour. Generally, you should not use CAVERJECT more than 3 times a week, with at least 24 hours between uses.
Who Should Not Use CAVERJECT?
Men who have conditions that might result in long-lasting erections should not use CAVERJECT. Some of these conditions include: sickle cell anemia or trait, leukemia, and tumor of the bone marrow (multiple myeloma). Men with penile implants, or an abnormally formed penis, or who have been advised not to engage in sexual activity should not use CAVERJECT. CAVERJECT should not be used by women or children.
What are the Risks of Using CAVERJECT?
Erections that last more than 4 hours can cause serious and permanent damage. Call your doctor or seek professional help immediately if you still have an erection 4 hours after injection.
The most common side effect of CAVERJECT is mild to moderate pain after injection. About onethird of patients report this effect.
Call your doctor if you notice any redness, lumps, swelling, tenderness, or curving of the erect penis.
A small amount of bleeding at the injection site may occur. Tell your doctor if you have a condition or are taking a medicine that interferes with blood clotting.
NOTE: CAVERJECT offers no protection from the transmission of sexually transmitted diseases such as HIV (the virus that causes AIDS). Small amounts of bleeding at the injection site can increase the risk of transmission of blood-borne diseases between partners.
There is no approved injectable treatment using multiple drug components or "cocktails" for erectile dysfunction. Moreover, there are no data on the efficacy and safety of these combinations.
There is a technical leaflet discussion of CAVERJECT written for health-care professionals that your pharmacist can let you read.
More information about erectile dysfunction and its treatment is available from the National Institutes of Health (Washington, DC), the American Foundation for Urological Diseases (Baltimore, MD), or the Impotence Institute of America (Washington, DC).
PREPARING AND INJECTING CAVERJECT
You must be properly instructed and trained in the injection technique by your doctor before using CAVERJECT.
Before using CAVERJECT, talk to your doctor about what to expect when using it, possible side effects, and what to do if side effects occur. Your dose has been selected for your individual needs. Do not change your dose without consulting your doctor. If you are not sure of the volume or dose to be used, talk to your doctor or pharmacist.
Follow these instructions exactly to prepare and inject a sterile dose of CAVERJECT. Use the needle, syringe and ampoule only once, then safely discard the supplies and any unused solution (see the "Disposal of Injection Materials" section of these instructions).
Along with an ampoule of CAVERJECT Injection, you will need a needle, a syringe, and an alcohol swab. A complete set of these items is available from your doctor or pharmacist, or is supplied in the CAVERJECT Companion Pack.
Two needles of different size are provided in the Companion Pack; a 1/2", 27 gauge needle and a thinner 1/2", 30 gauge needle. Your doctor should advise you on the appropriate needle to use for your injection.
CAVERJECT comes in ampoules containing 10, 20 and 40 micrograms. MAKE SURE YOU HAVE THE RIGHT STRENGTH AMPOULE OF CAVERJECT.
A. Caverject Injection and injection supplies
Prepare the Dose
Select Injection Site
Inject Your Dose of CAVERJECT
Disposal of Injection Materials
After use, dispose of all injection materials safely. Your pharmacist may be able to supply a disposal box especially for syringes and needles. Do not reuse or share needles or syringes. As with all prescription medicines, do not allow anyone else to use your medicine.
Prostin VR Pediatric Sterile Solution
No drug interactions have been reported between Prostin VR Pediatric and the therapy standard in neonates with restricted pulmonary or systemic blood flow. Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide.
The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents has not been formally studied.
Alprostadil should not be used in patients who have a known hypersensitivity to the drug, in patients who have conditions that might predispose them to priapism, such as sickle cell anemia or trait, multiple myeloma, or leukemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or Peyronies disease. Patients with penile implants should not be treated with Alprostadil.
Alprostadil should not be used in women or children and is not for use in newborns.
Alprostadil should not be used in men for whom sexual activity is inadvisable or contraindicated.