Frequently asked questions
Get answers to frequently asked questions about CAMCEVI®.
Why are the doses of other 6-month leuprolide products 45 mg and CAMCEVI is 42 mg?
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
Why does CAMCEVI not need to be reconstituted at the time of administration like the other leuprolide products?
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
What are the excipients in CAMCEVI and why are they used?
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
What is the viscosity of CAMCEVI?
The viscosity is approximately 50,000 CPS (centipoise), which is sufficient to form a depot within the tissue.2
Is the CAMCEVI syringe latex-free?
The rubber used in the syringe tip cap and plunger is not made of natural rubber latex.2,3
What is the shelf life of CAMCEVI?
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
Do age, race, or body weight have an impact on CAMCEVI pharmacokinetics?
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
Do age, race, or body weight have any impact on CAMCEVI efficacy?
There were no differences in effectiveness based on age, race, or body weight noted in the clinical trial.4
Do you have data on castration levels <20 ng/dL?
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
Do you have more data describing the testosterone flare following the initial dose of CAMCEVI?
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
Can you share the phase III clinical trial?
The Camcevi phase III clinical trial is publicly available at
https://link.springer.com/article/10.1007/s00345-019-02741-7.
If you still have questions regarding CAMCEVI, please submit an inquiry to Medical Affairs.
