NEW
Evenity

Evenity

romosozumab

Manufacturer:

Patheon Italia

Distributor:

Zuellig
Concise Prescribing Info
Contents
Romosozumab
Indications/Uses
Osteoporosis in postmenopausal women at high risk of fracture.
Dosage/Direction for Use
SC 210 mg administered as 2 SC inj (105 mg each) once every mth for 12 doses.
Contraindications
Hypersensitivity to romosozumab or CHO-derived proteins. Uncorrected hypocalcaemia.
Special Precautions
Discontinue use & initiate appropriate therapy if an anaphylactic or other clinically significant allergic reactions occur. Not to be initiated in patients who had MI or stroke w/in the preceding yr. Discontinue use if patient experiences MI or stroke during therapy. Correct hypocalcaemia prior to initiating therapy. Monitor patients for signs & symptoms of hypocalcemia. Patients should be adequately supplemented w/ Ca & vit D. Risk of osteonecrosis of the jaw generally associated w/ tooth extraction &/or local infection w/ delayed healing; atypical low-energy or trauma fracture of femoral shaft. Greater risk of developing hypocalcemia in patients w/ severe renal impairment (eGFR 15-29 mL/min/1.73 m2) or those receiving dialysis. Pregnancy & lactation. Not to be used in paed patients.
Adverse Reactions
Viral URTI; arthralgia. Hypersensitivity, rash, dermatitis urticaria, angioedema, erythema multiforme; headache; cough; neck pain, muscle spasms; peripheral oedema, inj site reactions.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BX06 - romosozumab ; Belongs to the class of other drugs affecting bone structure and mineralization. Used in the treatment of bone diseases.
Presentation/Packing
Form
Evenity soln for inj 105 mg/1.17 mL
Packing/Price
2 × 1's
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