CAMCEVI SIDE EFFECTS
- Generic Name: leuprolide mesylate injectable emulsion
- Brand Name: Camcevi
- Drug Class: How Do Antineoplastic GNRH Agonists Work?
SIDE EFFECTS
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
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. In an open-label, non-comparative clinical trial (FP01C13-001), patients with advanced prostate cancer 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 Patients -FP01C-13-001
| Adverse Reaction | N = 137 | |
| All Grades (%) |
Grade 3-4 (%) |
|
| Vascular disorders | ||
| Hot flusha | 50 | 0 |
| Hypertensionb | 15 | 0 |
| General disorders and administration site conditions | ||
| Injection site reactionsc | 11 | 0 |
| Fatigued | 10 | 0 |
| Infections and infestations | ||
| Upper respiratory tract infectione | 11 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal painf | 11 | 0 |
| Pain in extremity | 10 | 0 |
| Arthralgia | 7 | 0 |
| Renal and urinary disorders | ||
| Micturition urgencyg | 6 | 0 |
| Nocturia | 6 | 0 |
| Nervous system disorders | ||
| Dizzinessh | 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 warmthd 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. |
||
Postmarketing Experience
The following adverse reactions have been identified during post approval use of 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: anaphylactoid or asthmatic process, 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: white blood cells
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 reactions
Urogenital System: prostate pain
SRC: NLM .