5.1 Prolonged 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)].

5.2 Penile 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.

5.3 Hypotension

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.

5.4 Injection 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 Related to Underlying Medical Conditions

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including CAVERJECT, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

5.6 Risks of Use in Combination with Other Vasoactive Medications Injected Intracavernosally

The safety and efficacy of combinations of CAVERJECT and other vasoactive agents injected intracavernosally have not been established in clinical studies. The risks of prolonged erection, priapism, and hypotension may be increased.

5.7 Needle Breakage

Separate needles should be used for reconstitution and administration. A superfine needle is used for administration of CAVERJECT. As with all superfine needles, the possibility of needle breakage exists. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, has required hospitalization and surgical removal. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage [see Dosage and Administration (2.3) and Adverse Reactions (6.2)].

5.8 Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative

When reconstituted using the recommended diluent, the solution contains benzyl alcohol. Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. CAVERJECT is not indicated for use in pediatric patients.

5.9 Counsel Patients about Sexually Transmitted Diseases

The use of CAVERJECT offers no protection against sexually transmitted diseases. Counsel patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV).