Frequently asked questions

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 at least 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).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.