Alprostadil

Caverject

Goedgekeurde toepassingen

• As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. Erectile Dysfunction CAVERJECT is indicated for the treatment of erectile dysfunction. Diagnostic Test CAVERJECT is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

Vormen en sterktes

• For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution.

Hoe het wordt ingenomen

• Determine the most suitable dose and presentation of CAVERJECT to use. Use a new vial for each dose of CAVERJECT.
• Administer first intracavernosal injections in the health care provider's office and titrate the dose for each patient to the lowest effective dose.
• Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of at-home use.
• Recommended dosage for erectile dysfunction:
• Follow dose titration procedures for each type of erectile dysfunction and determine the maintenance dosage for patient home use in the health care provider's office.
• The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose.

Mag niet worden gebruikt bij

• Men who have known hypersensitivity to the drug.
• Men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia.
• Treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease.
• Men with penile implants.

Interacties

• The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied.

Waarschuwingen en voorzorgen

• Prolonged erection and priapism have occurred in patients receiving CAVERJECT. To minimize the chances of this occurring, titrate CAVERJECT slowly to the lowest effective dose. Advise patients to seek immediate medical assistance for an erection that persists longer than 4 hours.
• Penile fibrosis has occurred in patients receiving CAVERJECT. Follow patients regularly to detect signs of penile fibrosis. Discontinue in patients who develop penile angulation or cavernosal fibrosis.
• Hypotension: Injections of CAVERJECT can lead to increased peripheral blood levels of alprostadil, especially in patients with significant corpora cavernosa venous leakage. Avoid use in patients with known cavernosal venous leakage.
• Injection site bleeding may occur in patients taking anticoagulants, such as warfarin or heparin. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.
• Cardiovascular risk related to underlying medical conditions: Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy.
• Risks of use in combination with other vasoactive medications injected intracavernosally: Safety and efficacy of combinations of CAVERJECT and other vasoactive agents have not been systematically studied. Use of such combinations is not recommended.
• Needle breakage: A superfine needle is used for administration of CAVERJECT and cases of needle breakage have been reported. Careful instruction in proper patient handling and injection techniques may minimize this risk.
• Benzyl alcohol: Serious and fatal adverse reactions can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT. CAVERJECT is not indicated in neonates and infants.

Vaak voorkomende bijwerkingen

• The following are described elsewhere in the labeling: • Prolonged Erection and Priapism • Penile Fibrosis The most common (≥10%) adverse reaction is penile pain. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (1-800-438-1985 and www.pfizer.com) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Zwangerschap

CAVERJECT is not indicated for use in females.

Werkingsmechanisme

Alprostadil (PGE1) is a prostaglandin with a wide variety of pharmacological actions including vasodilation and inhibition of platelet aggregation. Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries by binding to its receptors and increasing intracellular cyclic adenosine monophosphate (cAMP) levels via modulation of adenylate cyclase. This leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism.

Handelsvergunninghouder:

Pharmacia & Upjohn Company LLC

Versie van de productinformatie:

13 mei 2024

De secties hierboven zijn geciteerd uit de Engelstalige productinformatie, want dat is het document dat de goedkeuring draagt. Waar een Europese instantie dezelfde informatie in het Nederlands publiceert, staat de link bij de bronnen. Wij vertalen regelgevende teksten niet zelf: een vertaalfout in een contra-indicatie is gevaarlijker dan een regel in een vreemde taal.

Deze sectie geeft de goedgekeurde productinformatie weer. De formulering is ingedikt uit de samenvatting van de toezichthouder zelf, en het volledige document staat bij de bronnen.