Leuprolide
Generic Name: leuprolide
Brand Names:
Camcevi
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
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.
Dosage
2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for instructions on the preparation and administration of the injectable emulsion in a pre-filled syringe. ( 2 ) Recommended Dosage: 42 mg subcutaneously every 6 months. ( 2 ) 2.1 Recommended Dosage The recommended dose of CAMCEVI is 42 mg administered subcutaneously once every 6 months. 2.2 Preparation and Administration CAMCEVI must be administered by a healthcare provider. Important: Read the instructions completely before you administer Camcevi for the first time. Do NOT substitute any of the components from the kit for administration. CAMCEVI is packaged in a blister in the kit.
Side Effects
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.
Warnings
5 WARNINGS AND PRECAUTIONS Tumor Flare: Transient worsening of bone pain, uretral obstruction, spinal cord compression, or the occurrence of additional signs and symptoms of prostate cancer may develop during the first few weeks of treatment. Monitor patients closely and manage symptoms. ( 5.1 ) Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose levels and manage according to current clinical practice. ( 5.2 ) Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in men receiving GnRH agonists. Monitor for cardiovascular disease and manage according to current clinical practice. 4 CONTRAINDICATIONS 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. Hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on findings in animal studies and mechanism of action, CAMCEVI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. There are no available data in pregnant women to inform the drug-associated risk.
Storage
16 HOW 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.
Frequently Asked Questions
What is Leuprolide used for?▼
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.
What are the side effects of Leuprolide?▼
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.
Can I take Leuprolide during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings in animal studies and mechanism of action, CAMCEVI can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. There are no available data in pregnant women to inform the drug-associated risk.
What are the important warnings for Leuprolide?▼
5 WARNINGS AND PRECAUTIONS Tumor Flare: Transient worsening of bone pain, uretral obstruction, spinal cord compression, or the occurrence of additional signs and symptoms of prostate cancer may develop during the first few weeks of treatment. Monitor patients closely and manage symptoms. ( 5.1 ) Hyperglycemia and Diabetes: Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Monitor blood glucose levels and manage according to current clinical practice. ( 5.2 ) Cardiovascular Diseases: Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in men receiving GnRH agonists. Monitor for cardiovascular disease and manage according to current clinical practice. 4 CONTRAINDICATIONS 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. Hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of CAMCEVI. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.