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Frequently asked questions

Get answers to frequently asked questions about CAMCEVI®.

CAMCEVI is a 6-month leuprolide formulation containing the salt “mesylate”. Other 6-month leuprolide formulations contain “acetate.” CAMCEVI is a pre-mixed product containing 42 mg of leuprolide mesylate, which is the equivalent of 45 mg of leuprolide acetate formulated in a solution of N-methyl-2-pyrrolidone (NMP) and poly (D,L-lactide) (PLA). The difference in salt weight has been accounted for so that the free base equivalent is the same between CAMCEVI and other 6-month leuprolide acetate products whose dose is 45 mg.1

The use of the mesylate salt enables the formulation to be stable when pre-filled into a single, ready-to-use syringe with a shelf life of 2 years when stored at 2 degrees C to 8 degrees C (36-46 degrees F).2,3

The only two excipients in CAMCEVI are N-methyl-2-pyrrolidone (NMP) and poly (D,L-lactide) (PLA). The combination of PLA and NMP provide the desired viscosity and physical characteristics to form a depot within the tissue, which releases leuprolide at a rate sufficient to sustain a 6-month delivery when stored at 2 degrees C to 8 degrees C (36-46 degrees F) prior to administration.2,3

The viscosity is approximately 50,000 CPS (centipoise), which is sufficient to form a depot within the tissue.2

The rubber used in the syringe tip cap and plunger is not made of natural rubber latex.2,3

Shelf life for CAMCEVI is 24 months when packaged and stored at 2 degrees C to 8 degrees C (36-46 degrees F).2,3

No clinically significant differences in the systemic exposure of leuprolide were observed based on age (51-88 years), race/ethnicity (White, Black, Asian), or body weight (54-134 kg/119-295 lbs).3

There were no differences in effectiveness based on age, race, or body weight noted in the clinical trial.4

Yes. In the phase 3, open-label trial of CAMCEVI 42 mg, the primary endpoint of maintaining serum testosterone levels ≤50 ng/dL from Week 4-48 was achieved by 97.0% of patients. The percentage of patients with testosterone suppression to ≤20 ng/dL was 69.3% on Day 28 and 95.9% at the end of the study.3,5

Yes. Following the initial injection of CAMCEVI, the mean serum testosterone concentration increased from a mean baseline value of 380 and 492 ng/dL to peaks of 562 and 739 ng/dL on Day 2 of study Part I and II, respectively. From the peak levels, serum testosterone concentration decreased rapidly after Day 7 to below 50 ng/dL (castrate level) by Week 4 (+/- 7 days) after the first dose of CAMCEVI: mean concentration on Day 21 was 43.5 ng/dL for study Part I and 38.2 ng/dL for study Part II. By Day 28, the mean testosterone concentrations dropped below or were equal to 50 ng/dL and continued to decrease. Following the second dose of CAMCEVI (Day 168), only a slight increase in serum testosterone concentrations was observed, and the levels were maintained below the castrate level through the end of the study in 97.0% of patients (Day 336).3,6

The CAMCEVI phase III clinical trial is publicly available at

https://link.springer.com/article/10.1007/s00345-019-02741-7.

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    IMPORTANT SAFETY INFORMATION

    Do not use CAMCEVI® in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI as anaphylactic reactions to these drugs have been reported in the medical literature.

    CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. As with other GnRH agonists, cases of ureteral obstruction and spinal cord compression, have been observed, which may contribute to paralysis with or without fatal complications.

    Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy.

    Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.

    Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer. Patients should be monitored for cardiovascular disease and be managed according to current clinical practice.

    Androgen deprivation therapy may prolong the QT/QTc interval. Consider periodic monitoring of electrocardiograms and electrolytes.

    Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Patients experiencing convulsions should be managed according to the current clinical practice.

    Monitor serum levels of testosterone following injection of CAMCEVI.

    Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women.

    The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

    INDICATION

    CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.

    Click here for full Prescribing Information.

    References:

    1. Leuprolide mesylate, New Drug Application #211488. 2.2 Introduction to Summary. Foresee Pharmaceuticals. 2. Leuprolide mesylate, New Drug Application #211488. 2.3 Quality Overall Summary – Product. Foresee Pharmaceuticals. 3. CAMCEVI. Prescribing information. Accord BioPharma; May 2021. 4. Leuprolide mesylate, New Drug Application #211488. 2.5 Clinical Overview. Foresee Pharmaceuticals. 5. Shore N, Mincik I, DeGuenther M, et al. A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients. World J Urol. 2020;38(1):111-119. 6. Leuprolide mesylate, New Drug Application #211488. 2.7.2 Summary of Clinical Pharmacology. Foresee Pharmaceuticals.