CAMCEVI
Generic: LEUPROLIDE
Basic Information
Manufacturer
Accord BioPharma, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
d7a8761a-d953-413a-e053-2a95a90a60ee
Indications & Usage
1 INDICATIONS AND USAGE CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer.
CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Tumor Flare [see Warnings and Precautions (5.1) ] Hyperglycemia and Diabetes [see Warnings and Precautions (5.2) ] Cardiovascular Diseases [see Warnings and Precautions (5.3) ] QT/QTc Prolongation [see Warnings and Precautions (5.4) ] Convulsions [see Warnings and Precautions (5.5) ] The most common (≥5%) adverse reactions were hot flushes, hypertension, injection site reactions, fatigue, upper respiratory tract infections, musculoskeletal pain, pain in extremity, arthralgia, micturition urgency, nocturia, and dizziness.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc.
at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical 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 Adverse Reaction CAMCEVI N = 137 All Grades (%) Grade 3-4 (%) Vascular disorders Hot flushes a 50 0 Hypertension b 15 0 General disorders and administration site conditions Injection site reactions c 11 0 Fatigue d 10 0 Infections and infestations Upper respiratory tract infection e 11 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain f 11 0 Pain in extremity 10 0 Arthralgia 7 0 Renal and urinary disorders Micturition urgency g 6 0 Nocturia 6 0 Nervous system disorders Dizziness h 5 0.7 a includes hot flush and flushing b includes hypertension, essential hypertension, and blood pressure increased c includes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth d includes fatigue and asthenia e includes upper respiratory tract infection, sinusitis, and nasopharyngitis f includes musculoskeletal pain, back pain, and bone pain g includes micturition urgency and dysuria h includes dizziness, dizziness postural, vertigo, and vertigo positional.
6.2 Postmarketing 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
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc.
at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical 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 Adverse Reaction CAMCEVI N = 137 All Grades (%) Grade 3-4 (%) Vascular disorders Hot flushes a 50 0 Hypertension b 15 0 General disorders and administration site conditions Injection site reactions c 11 0 Fatigue d 10 0 Infections and infestations Upper respiratory tract infection e 11 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain f 11 0 Pain in extremity 10 0 Arthralgia 7 0 Renal and urinary disorders Micturition urgency g 6 0 Nocturia 6 0 Nervous system disorders Dizziness h 5 0.7 a includes hot flush and flushing b includes hypertension, essential hypertension, and blood pressure increased c includes injection site pain, injection site erythema, injection site hemorrhage, injection site nodule, injection site paraesthesia, injection site pruritus, and injection site warmth d includes fatigue and asthenia e includes upper respiratory tract infection, sinusitis, and nasopharyngitis f includes musculoskeletal pain, back pain, and bone pain g includes micturition urgency and dysuria h includes dizziness, dizziness postural, vertigo, and vertigo positional.
6.2 Postmarketing 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