Prolia

Prolia

denosumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Denosumab
Indications/Uses
Increase bone mineral density & reduce incidence of hip, vertebral & non-vertebral fractures in postmenopausal women w/ osteoporosis at increased risk of fracture. Bone loss in patients undergoing hormone ablation for prostate or aromatase inhibitor treatment for breast cancer. Reduce incidence of vertebral fractures in patients w/ prostate cancer. Increase bone mass in men w/ osteoporosis at increased risk of fracture. Glucocorticoid-induced osteoporosis in men & women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in daily dosage equiv to prednisone ≥7.5 mg & expected to remain on glucocorticoid for at least 6 mth.
Dosage/Direction for Use
60 mg single SC inj once every 6 mth.
Contraindications
Special Precautions
Hypersensitivity to latex. Osteonecrosis of the jaw (ONJ) & external auditory canal. Skin infections (predominantly cellulitis) leading to hospitalization. Atypical femoral fractures. Multiple vertebral fractures following discontinuation of treatment. Ensure adequate intake of Ca & vit D to correct hypocalcaemia prior to therapy. Perform dental exam w/ preventive dentistry prior to treatment. Avoid invasive dental procedures & maintain good oral hygiene during treatment. Concomitant use w/ other denosumab- or sorbitol-containing medicinal products & dietary intake of sorbitol. Severe renal impairment (CrCl <30 mL/min) or patients receiving dialysis. Hepatic impairment. Women of childbearing potential should use effective contraception. Not recommended during pregnancy. Lactation. Not recommended in childn w/ open growth plates.
Adverse Reactions
Pain in extremity, musculoskeletal pain. UTI, upper resp tract infection; sciatica; constipation, abdominal discomfort; rash, eczema, alopecia.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BX04 - denosumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Presentation/Packing
Form
Prolia soln for inj (pre-filled syringe) 60 mg/mL
Packing/Price
1 mL x 1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in