Caverject, 10 mcg lyophilizate 1 pc+(1 ml in syringe)

Caverject is prescribed for erectile dysfunction.

In intracavernosal administration (in the penis), alprostadil inhibits alpha1-adrenoreceptors of penile tissue, relaxes the muscles of the cavernous bodies, increases blood flow and improves microcirculation, causes an erection by relaxation of the trabecular smooth muscles of cavernous bodies and dilation of the cavernous arteries.

Indications

Erectile dysfunction of neurogenic, vascular, psychogenic or mixed etiology, diagnosis of erectile dysfunction in addition to other diagnostic tests.

Active ingredient

Composition

The composition of the drug:

the active ingredient

alprostadil 10 mcg,

auxiliary substances:

Lactose,

Sodium citrate.

Solvent composition:

benzyl alcohol 9 mg, water for injection q.s. 1 ml, dosage form: lyophilisate for preparation of solution for intracavernous injection.

How to take, the dosage

Direct intracavernosal injection.

The use of a 27-30 G needle, 13 mm long, is recommended.

The insertion site is the dorso-lateral part of the proximal third of the penis.

Interaction

It is not intended for mixing or concomitant administration with other drugs, or for co-administration with other drugs for the treatment of erectile dysfunction.

The possibility of pharmacokinetic interactions with other drugs has not been studied.

The co-administration with hypotensive drugs, diuretics, antidiabetic drugs (including insulin), or nonsteroidal anti-inflammatory drugs has no effect on the safety or effectiveness of the drug.

Special Instructions

The patient on self-treatment should be monitored at all times, especially during the initial period when dosage changes may be necessary. Every 3 months, it is recommended that the patient see the attending physician to assess the efficacy and safety of the treatment and to adjust the dose (if necessary).

The bottle with the diluted drug is for single use and should be discarded after use. The patient should be instructed on how to dispose of the needle, syringe and vial.

It is known that priapism (an erection lasting more than 6 hours) may occur after intracavernosal administration of vasoactive drugs, including CAVERJECT. To reduce the risk of priapism, the lowest effective dose should be administered. The patient should immediately inform the physician about all cases of erections lasting more than 4 hours. The treatment of priapism is carried out in accordance with established medical practice.

Before therapy with CAVERJECT is initiated, a diagnosis of treatable causes of erectile dysfunction must be made.

The first injections of the drug must be given in a physician’s office by trained medical personnel. Self-injections can be started only after the patient has been given a detailed briefing and has mastered the self-injection technique. The physician should carefully assess the patient’s skills and ability to perform the procedure. Intracavernous injection should be performed in compliance with aseptic rules.

After intracavernosal injection, penile fibrosis, including penile angulation, fibrotic nodule formation, and Peyronie’s disease may develop. The incidence of fibrosis may increase with increasing duration of use. To detect signs of penile fibrosis or Peyronie’s disease, regular examination of patients with close inspection of the penis is highly recommended. In patients who develop penile angulation, cavernous fibrosis or Peyronie’s disease, treatment with the drug should be discontinued.

Because minor bleeding is possible with intracavernous injection, patients using CAVERJECT should be aware of precautions against sexually transmitted and blood-borne infections, including human immunodeficiency virus (HIV). Patients treated with anticoagulants such as warfarin or heparin have an increased tendency to bleed after intracavernous injection.

Particular monitoring is necessary in patients receiving MAO inhibitors and in the case of prolonged erections in those treated with α-adrenomimetics (hypertensive crisis may develop); and in patients with CHD, chronic heart failure or lung disease (sexual stimulation and intercourse may exacerbate the disease).

The dosage form of alprostadil used should be closely matched to the specific indication for its use.

Contraindications

An established hypersensitivity to the components of the drug, diseases that may predispose to the occurrence of priapism, such as sickle cell anemia, myeloma disease, leukemia, anatomical deformities of the penis (angulation of the penis, cavernous fibrosis, Peyronie’s disease), presence of a penile implant, men who are contraindicated or not recommended for sexual activity.

Side effects

Local (less than 1%): priapism (duration of erection more than 6 hours), balanitis, hemorrhages at the injection site, inflammation, itching and swelling at the injection site, bleeding from the urethra, feeling of warmth in the penis, numbness, fungal infection, irritation, increased skin sensitivity (hyperesthesia), phimosis, itching, erythema, “venous discharge” from cavernous bodies, painful erection, ejaculation disorders.

Local (most often): pain and burning in the penis, prolonged erection (duration 4-6 hours), penile fibrosis, hematoma and ecchymosis at the injection site. Penile fibrosis, including penile angulation, formation of fibrous nodules, and Peyronie’s disease have been reported in 3-8% of patients. Hematoma at the injection site (3% of patients) and ecchymosis at the injection site (2% of patients) are related to the injection technique rather than the action of alprostadil. The frequency of prolonged erections (4-6 hours) was 4%.

Systemic effects (most common): increased BP, dizziness, headache, back pain, upper respiratory tract infections, flu-like syndrome, sinusitis, nasal congestion, cough, prostatitis, pain not at the injection site.

Systemic effects (less than 1%): Testicular pain, testicular edema, testicular warmth sensation, testicular thickening, scrotal redness, scrotal pain, spermatoceles, scrotal edema, hematuria, urinary disorders, frequent urination, urgent urge to urinate, pelvic pain, lower BP, tachycardia, vasodilation, Peripheral vascular disorders, supraventricular extrasystole, vasovagal reactions, hypoesthesia, muscle weakness, hyperhidrosis, rash, itching not at the injection site, nausea, dry mouth, increased serum creatinine levels, cramping of the calf muscles, dilated pupils.

Overdose

Symptoms: pain in the penis, prolonged erection and/or priapism, irreversible deterioration of erectile function.

Treatment: if an erection lasts less than 6 h, medical supervision is necessary, because spontaneous detumescence (cessation of erection, reduction of genital size due to blood outflow) often occurs; if more than 6 h, intracavernous injection of α-adrenomimetics (e.g., ephedrine, epinephrine, phenylephrine, ethylephrine) or blood aspiration from the cavernous bodies should be performed or surgical treatment should be performed.

The patient should be under medical observation until the systemic phenomena disappear and/or until the onset of complete penile detumescence.