Brand Name
Camcevi
Generic Name
Leuprolide
View Brand Information FDA approval date: April 05, 2022
Classification: Gonadotropin Releasing Hormone Receptor Agonist
Form: Injection
What is Camcevi (Leuprolide)?
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone agonist indicated for the treatment of adult patients with advanced prostate cancer.
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Brand Information
CAMCEVI (LEUPROLIDE)
1INDICATIONS AND USAGE
CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
2DOSAGE FORMS AND STRENGTHS
Injectable emulsion: 42 mg leuprolide (equivalent to approximately 48 mg leuprolide mesylate) as a sterile, off-white to pale yellow, viscous, and opalescent emulsion in a single-dose, pre-filled syringe for subcutaneous injection.
3CONTRAINDICATIONS
CAMCEVI is contraindicated in patients known to be hypersensitive to GnRH, GnRH agonist analogs, or any of the excipients in CAMCEVI. Anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature.
4ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Tumor Flare
- Hyperglycemia and Diabetes
- Cardiovascular Diseases
- QT/QTc Prolongation
- Convulsions
4.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
FP01C-13-001
The safety of CAMCEVI was evaluated in an open-label, single-arm, international clinical trial (FP01C-13-001) in patients with advanced prostate cancer. Patients received CAMCEVI administered subcutaneously at a dose of 42 mg on Day 0 and Day 168. Of 137 patients enrolled, 93% received both doses of CAMCEVI.
Serious adverse reactions occurred in 15% of patients who received CAMCEVI, including 1% of patients who experienced subdural hematoma. Fatal adverse reactions occurred in 2% of patients, including cerebrovascular accident (0.7%) and pulmonary embolism (0.7%).
The most common adverse reactions (≥10%) occurring during a median follow-up duration of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.
Table 1 summarizes the adverse reactions in FP01C-13-001.
Table 1. Adverse Reactions Occurring in ≥5% of CAMCEVI in Advanced Prostate Cancer Patients - FP01C-13-001
aincludes hot flush and flushing
bincludes hypertension, essential hypertension, and blood pressure increased
cincludes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth
dincludes fatigue and asthenia
eincludes upper respiratory tract infection, sinusitis, and nasopharyngitis
fincludes musculoskeletal pain, back pain, and bone pain
gincludes micturition urgency and dysuria
hincludes dizziness, dizziness postural, vertigo, and vertigo positional.
bincludes hypertension, essential hypertension, and blood pressure increased
cincludes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth
dincludes fatigue and asthenia
eincludes upper respiratory tract infection, sinusitis, and nasopharyngitis
fincludes musculoskeletal pain, back pain, and bone pain
gincludes micturition urgency and dysuria
hincludes dizziness, dizziness postural, vertigo, and vertigo positional.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of CAMCEVI or leuprolide. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
During postmarketing surveillance, which includes other dosage forms and other patient populations, the following adverse reactions were reported.
Allergic Conditions: hypersensitivity reactions including anaphylaxis, rash, urticaria, and photosensitivity reactions
Cardiovascular System:hypotension, myocardial infarction, pulmonary embolism
Central/Peripheral Nervous System:convulsion, peripheral neuropathy, spinal fracture/paralysis
Endocrine System:pituitary apoplexy, diabetes
Hepato-biliary disorder:drug-induced liver injury
Hematologic:leukopenia
Psychiatric:mood swings, including depression, suicidal ideation and attempt
Respiratory, thoracic and mediastinal disorder:interstitial lung disease
Musculoskeletal System:decreased bone density, tenosynovitis-like symptoms, fibromyalgia
Skin and Subcutaneous:injection site induration or swelling, SJS/TEN, DRESS, AGEP, dermatitis exfoliative, bullous dermatitis, and erythema multiforme
Urogenital System:prostate pain
5DESCRIPTION
CAMCEVI is a sterile formulation of leuprolide mesylate for subcutaneous injection. CAMCEVI is designed to deliver approximately 42 mg of leuprolide over 6 months.
Leuprolide mesylate is a synthetic nonapeptide analog of naturally occurring GnRH and is a GnRH agonist. The analog possesses greater potency than the natural hormone. The chemical name is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide mesylate (salt) with the following structural formula. The pH of 50 mg/mL solution of leuprolide mesylate in water is approximately 5.7.
CAMCEVI is supplied as a kit with a pre-filled, single-dose, sterile syringe for subcutaneous injection. Each pre-filled syringe delivers 42 mg leuprolide (equivalent to approximately 48 mg leuprolide mesylate), poly(D, L-lactide) (184 mg) polymer and
6CLINICAL STUDIES
The efficacy of CAMCEVI was evaluated in an open label, single arm, multinational study FP01C-13-001 (
The population (n = 137) had a median age of 71 years (range 51 to 88) and was 90% White, 6% Black, and 4% Asian. Disease stage was distributed as follows: 23% metastatic (M1), 27% locally advanced (T3/4 NX M0 or any T N1 M0), 26% localized (T1 or T2 N0 M0), and 24% not classifiable. The median testosterone concentration at baseline was 440 ng/dL.
The major efficacy outcome measure was medical castration rate, defined as achieving and maintaining serum testosterone suppression to ≤ 50 ng/dL by Week 4 through Week 48 of treatment. Following the first injection of CAMCEVI, serum testosterone levels were suppressed to ≤ 50 ng/dL by Week 4 (+/-7 days) in 98.5% of the patients; and from Week 4 through Week 48 in 97.0% of patients (95% CI: 92.2-98.9) estimated using the Kaplan-Meier method. The time course of percent change from baseline in testosterone suppression are shown in Figure 1. The percentage of patients with testosterone suppression to ≤ 20 ng/dL was 69.3% on Day 28.
Figure 1 CAMCEVI Mean (95% CI) Percentage Change from Baseline in Serum Testosterone Concentration Over Time (N =137)
In the clinical trial, PSA levels were monitored and were lowered on average by 51% after 4 weeks after administration of CAMCEVI, 83% after 3 months and remained suppressed throughout the 48 weeks of treatment. These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline correlates with clinical benefit.
7HOW SUPPLIED/STORAGE AND HANDLING
CAMCEVI is a sterile, off-white to pale yellow, viscous and opalescent injectable emulsion supplied in a kit as a single-dose, pre-filled syringe. CAMCEVI is available as follows:
Store CAMCEVI at 2°C–8°C (36°F–46°F). Protect CAMCEVI from light by storing in the original package until time of use. Do not freeze or shake.
Excursions permitted to room temperature 25°C (77°F) for up to 6 days.
The rubber used in syringe tip cap and plunger stopper is not made of natural rubber latex.
8PATIENT COUNSELING INFORMATION
Hypersensitivity
- Inform patients that if they have experienced hypersensitivity with other GnRH agonist drugs like CAMCEVI, CAMCEVI is contraindicated
Tumor Flare
- Inform patients that CAMCEVI can cause tumor flare during the first weeks of treatment. Inform patients that the increase in testosterone can cause an increase in urinary symptoms or pain. Advise patients to contact their healthcare provider if uretral obstruction, spinal cord compression, paralysis, or new or worsened symptoms occur after beginning CAMCEVI treatment
Hyperglycemia and Diabetes
- Advise patients that there is an increased risk of hyperglycemia and diabetes with CAMCEVI therapy. Inform patients that periodic monitoring for hyperglycemia and diabetes is required when being treated with CAMCEVI
Cardiovascular Diseases
- Inform patients that there is an increased risk of myocardial infarction, sudden cardiac death, and stroke with CAMCEVI treatment. Advise patients to immediately report signs and symptoms associated with these events to their healthcare provider for evaluation
QT/QTc Prolongation
- Inform patients that CAMCEVI can cause QT/QTc prolongation. Advise patients to immediately contact their healthcare provider in the event of syncope, presyncopal symptoms, or cardiac palpitations
Convulsions
- Inform patients that there is an increased risk of convulsions with CAMCEVI treatment. Advise patients to immediately contact their healthcare provider if they experience convulsions
Severe Cutaneous Adverse Reactions
- Inform patients that severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), which may be life threatening or fatal, may occur during treatment with CAMCEVI. Advise patients to contact their healthcare provider or seek medical attention right away if they experience signs or symptoms of SCARs, e.g., a prodrome of fever, flu-like symptoms, mucosal lesions, progressive skin rash, or lymphadenopathy
Injection Site Reactions
- Inform patients that injection site related adverse reactions may occur such as transient burning/stinging, pain, bruising, and redness. Advise patients to contact their healthcare provider if they experience rash or severe injection site reactions
Urogenital Disorders
- Advise patients that CAMCEVI may cause impotence.
Infertility
- Inform patients that CAMCEVI may cause infertility
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10PRINCIPAL DISPLAY PANEL -Carton Label (front)
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12PRINCIPAL DISPLAY PANEL -Syringe Label
