DENOCLASTTM
Composition:
Solution for injection / 60 mg denosumab in 1 mL solution in a single use prefilled syringe
Description:
DENOCLAST (denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANK ligand (RANKL) that inhibits RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of RANKL-RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption.
Mechanism Of Action:
DENOCLAST is a RANK ligand (RANKL) inhibitor. RANK ligand is essential for the formation, function and survival of osteoclasts, the sole cell type responsible for bone resorption. Denosumab targets and binds with high affinity and specificity to RANKL, preventing RANKL from activating its only receptor, RANK, on the surface of osteoclasts. Prevention of RANKL-RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone throughout the skeleton.
Indications & Dosage:
Postmenopausal Osteoporosis DENOCLAST reduces the incidence of vertebral, non-vertebral and hip fractures. The recommended dose of denosumab is a single SC injection of 60 mg, once every 6 months.
Contraindications:
DENOCLAST is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, Hypocalcemia, Pregnant Women.
Special Warnings and Precautions:
Adequate intake of calcium and vitamin D is important in all patients. Hypocalcemia must be corrected by adequate intake of calcium and vitamin D.
Children:
DENOCLAST is not recommended for use in pediatric patients.
Elderly Patients (age ≥ 65):
No overall differences in safety or efficacy were observed between geriatric patients and younger patients.
Patients with renal impairment:
No dose adjustment is required in patients with renal impairment.
Patients with hepatic impairment:
No clinical studies were conducted in subjects with hepatic impairment.
Effects on ability to drive and use machines:
No studies on the effect on the ability to drive or use heavy machinery have been performed in patients receiving denosumab.
Osteonecrosis of Jaw:
A routine oral exam should be performed by the prescriber prior to initiation of DENOCLAST treatment.
Atypical femoral fractures:
During DENOCLAST treatment, patients should be advised to report new or unusual thigh, hip, or groin pain.
Use in Pregnancy and Lactation:
Pregnant Women:
There have been no studies of DENOCLAST in pregnant women. DENOCLAST is contraindicated in pregnant women and in women trying to conceive.
Lactation:
DENOCLAST is not recommended for use in nursing women. It is not known whether DENOCLAST is excreted into human milk.
Drug Interaction:
The pharmacokinetics and pharmacodynamics of DENOCLAST were similar in postmenopausal women with osteoporosis transitioning from alendronate therapy compared to those who had not received prior alendronate therapy. Interactions with other drugs have not been established.
Undesired Effects:
Back pain, Extremity pain. Musculoskeletal pain, Cystitis, Vertigo, Upper respiratory tract infection, Peripheral edema, Sciatica, Pneumonia, bone pain, Upper abdominal pain, Anemia, Insomnia, Myalgia, Angina pectoris, Rash. Drug-related hypersensitivity reactions: Anaphylaxis, rash, urticaria, facial swelling, and erythema, severe symptomatic hypocalcemia.
Storage Condition:
Store DENOCLAST in a refrigerator at 2oC to 8oC in the original carton. Do not freeze. If removed from the refrigerator, Protect DENOCLAST from light and do not expose to temperatures above 25oC.
Presentation:
DENOCLAST is supplied in a 60 mg/mL prefilled syringe (PFS) presentation with a 1.0 mL volume and intended for delivery by subcutaneous injection.
Please refer to the full Prescribing Information before starting DENOCLASTTM
