Active Ingredients
- Single-use prefilled syringe containing Denosumab 60 mg in 1 mL solution
Indication
- Postmenopausal Osteoporosis at high risk of fracture; To increase bone mass in men with osteoporosis
Dosage & Administration
- Denosumab 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen
Contraindications
- Hypocalcemia, Pregnancy, Known hypersensitivity to Denosumab
Warnings & Precautions
- Hypersensitivity including anaphylactic reactions may occur
- Discontinue permanently if a clinically significant reaction occurs
- Hypocalcemia: Must be corrected before initiating Denosumab. May worsen, especially in patients with renal impairment. Adequately supplement patients with calcium and vitamin D
- Osteonecrosis of the jaw: Has been reported with Denosumab. Monitor for symptoms
- Atypical femoral fractures: Have been reported. Evaluate patients with thigh or groin pain to rule out a femoral fracture
- Serious infections including skin infections: May occur, including those leading to hospitalization
- Advice patients to seek prompt medical attention if they develop signs or symptoms of infection, including cellulitis; Dermatologic reactions: Dermatitis, rashes, and eczema have been reported
- Consider discontinuing Denosumab if severe symptoms develop; Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop
- Suppression of bone turnover: Significant suppression has been demonstrated. Monitor for consequences of bone oversuppression
- Pregnancy & Lactation
- Pregnancy Category X. It is contraindicated in women who are or may become pregnant
- Nursing mothers: Discontinue drug or nursing taking into consideration importance of drug to mother
- Paediatric patients: Safety and efficacy not established
- Adverse reactions: Back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, cystitis, arthralgia, and nasopharyngitis
