Prolonged erection defined as erection lasting > 4 to ≤ 6 hours in duration occurred in 4% of 1861 patients treated up to 18 months in studies of CAVERJECT© Sterile Powder.
PRIAPISM is a much feared adverse effect of intra penile injection as it causes irreversible death of tissues of penis due to lack of fresh oxygen supply. Priapism is an emergency.
How to administer injections on penis has been covered in the previous chapter.
All other important side effects are given here.
Local Adverse Reactions:
The following local adverse reaction information was derived from controlled and uncontrolled studies, including an uncontrolled 18-month safety study.
TABLE 1 - Local Adverse Reactions Reported by ³ 1% of Patients Treated with Alprostadil for up to 18 Months*
Alprostadil
Event
N = 1861
Penile pain 37%
Prolonged erection 4%
Penile fibrosis** 3%
Injection site hematoma 3%
Penis disorder*** 3%
Injection site ecchymosis 2%
Penile rash 1%
Penile edema 1%
* Expected for penile pain (2%), no significant local adverse reactions were reported by 294 patients who received 1 to 3 injections of placebo.
** See PRECAUTIONS: General Precautions.
*** Included numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, penile skin tear, strange feeling of penis, discoloration of penile head, itch at tip of penis.
Penile Pain:
Penile pain after intracavernosal administration of Caverject was reported at least once by 37% of patients in clinical studies of up to 18 months in duration. 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. The frequency of penile pain was 2% in 294 patients who received 1 to 3 injections of placebo.
Prolonged Erection/Priapism:
In clinical trials, prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as erection that lasted 6 hours or longer. The frequency of prolonged erection after intracavernosal administration of Caverject was 4%, while the frequency of priapism was 0.4%. In the majority of cases, spontaneous detumescence occurred. To minimize the chances of prolonged erection or priapism. Caverject should be titrated slowly to the lowest effective dose (see DOSAGE AND ADMINISTRATION).
The patient must be instructed to immediately report to his physician or, if unavailable, to seek immediate medical assistance for any erection that persists for longer than 6 hours. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Hematoma/Ecchymosis: The frequency of hematoma and ecchymosis was 3% and 2%, respectively. In most cases, hematoma/ecchymosis was judged to be a complication of a faulty injection technique. Accordingly, proper instruction of the patient in self-injection is of importance to minimize the potential of hematoma/ecchymosis (see DOSAGE AND ADMINISTRATION).
The following local adverse reactions were reported by fewer than 1% of patients after injection of Caverject: balanitis, injection site hemorrhage, injection site-inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, yeast infection, irritation, sensitivity, phimosis, pruritus, erythema, venous leak, painful erection, and abnormal ejaculation.
Generalised
Systemic Adverse Events: The following systemic adverse event information was derived from controlled and uncontrolled studies, including an uncontrolled 18-month safety study.
STRICTLY NOT TO BE USED IN FOLLOWING CONDITIONS:
1] Hypersensitivity to the [PGE1] drug,
2] in patients who have 1. sickle cell anemia or trait, 2. multiple myeloma, or leukemia, or in patients with anatomical deformation of the penis, such as angulation, cavernosal fibrosis, or 3. Peyronie's disease as they are likely to have priapism.
3]Patients with penile implants should not be treated with Alprostadil.
4]Alprostadil should not be used in women or children and is not for use in newborns.
5]Alprostadil should not be used in men for whom sexual activity is inadvisable or contraindicated.
TABLE 2 -
Systemic Adverse Events Reported by ³ 1% of Patients Treated with Caverject© for up to 18 Months*
Body System/Reaction ALPROSTADIL N=1861
Cardiovascular System
Hypertension 2%
Central Nervous System
Headache 2%
Dizziness 1%
Musculoskeletal System
Back pain 1%
Respiratory System
Upper respiratory infection 4%
Flu syndrome 2%
Sinusitis 2%
Nasal congestion 1%
Cough 1%
Urogenital System
Prostatic Disorder** 2%
Miscellaneous
Localized pain*** 2%
Trauma**** 2%
* No significant adverse events were more reported 294 patients who received 1 to 3 injections of placebo.
** prostatitis, pain, hypertrophy, enlargement
*** pain in various anatomical structures other than injection site
**** injuries, fractures, abrasions, lacerations, dislocations
The following systemic events, which were reported for
| testicular pain, scrotal disorder, scrotal edema, hematuria, testicular disorder, impaired urination, urinary frequency, urinary urgency, pelvic pain, hypotension, vasodilation, peripheral vascular disorder, supraventricular extrasystoles, vasovagal reactions, hypesthesia, non-generalized weakness, diaphoresis, rash, non-application site pruritus, skin neoplasm, nausea, dry mouth, increased serum creatinine, leg cramps, and mydriasis. |
Hemodynamic changes, manifested as decreases in blood pressure and increases in pulse rate, were observed during clinical studies, principally at doses above 20 micrograms and above 30 micrograms of alprostadil, respectively, and appeared to be dose-dependent. However, these changes were usually clinically unimportant; only three patients discontinued the treatment because of symptomatic hypotension.
DOES INJECTION FOR PENILE ERECTION AFFECT FERTILITY?
Caverject had no clinically important effect on serum or urine laboratory tests.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: Long-term carcinogenicity studies have not been conducted. Rat reproductive studies indicate that alprostadil at doses of up to 0.2 milligram/kilogram/day does not adversely affect or alter rat spermatogenesis, providing a 200-fold margin of safety compared with the usual human doses.
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