Camcevi

Advanced prostate cancer (3-month and 6-month depot formulations).

42 mg SC injection every 6 months, or 3-month formulation per prescribing information.

Injectable emulsion: 42 mg prefilled syringe

None listed in the prescribing information.

• Tumor Flare: Initial rise in testosterone may worsen symptoms. Consider anti-androgen for initial weeks.
• QTc Prolongation: Monitor ECGs in patients at risk.
• Hyperglycemia/Diabetes: Monitor blood glucose.
• Cardiovascular Events: Increased risk reported with GnRH agonists.
• Embryo-Fetal Toxicity: Can cause fetal harm.

Hot Flush (48%), Injection Site Reactions (22%), Hypertension (18%), Fatigue (16%), Musculoskeletal Pain (14%), UTI (12%)

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

QTc Prolonging Drugs: Use caution.

Consult the full prescribing information for pregnancy-related considerations.

Refer to prescribing information for lactation guidance.

Pediatric safety and efficacy information is detailed in the full label.

Dose modifications for organ impairment are specified in the complete prescribing information.

Leuprolide is a GnRH agonist that initially stimulates then suppresses gonadotropin release, resulting in medical castration with serum testosterone suppression to castrate levels.

Sustained release over 3 or 6 months from SC depot. Testosterone suppression achieved by Day 28.

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

• FP-001 LMIS — Leuprolide mesylate 3-month in advanced prostate cancer. Phase III, n=144.
  🔬 NCT03261999 ↗

Camcevi has FDA-approved indications across the following cancer types covered on CancerDrugEvidence: