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  • Generic Name: leuprolide mesylate injectable emulsion
  • Brand Name: Camcevi
  • Drug Class: How Do Antineoplastic GNRH Agonists Work?
Last updated on MDtodate: 10/04/2022


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




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