Evenity Injection

Description

brand Name : Evenity

Generic Name :Romosozumab Injection 

Pack : 2x105mg /1.17Ml singal -use 

manufacturer : Dr Reddye 

Use :INDICATIONS AND USAGE

1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture

EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for

fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who

have failed or are intolerant to other available osteoporosis therapy.

1.2 Limitations of Use

The anabolic effect of EVENITY wanes after 12 monthly doses of therapy. Therefore, the duration of

EVENITY use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted,

continued therapy with an anti-resorptive agent should be considered [see Dosage and Administration

(2.2) and Clinical Studies (14.1)].

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

 Two separate syringes (and two separate subcutaneous injections) are needed to administer the

total dose of 210 mg of EVENITY. Inject two 105 mg/1.17 mL prefilled syringes, one after the

other.

 EVENITY should be administered by a healthcare provider.

2.2 Recommended Dosage

 The recommended dose of EVENITY is 210 mg administered subcutaneously in the abdomen,

thigh or upper arm. Administer EVENITY once every month.

 The treatment duration for EVENITY is 12 monthly doses.

 Patients should be adequately supplemented with calcium and vitamin D during treatment with

EVENITY [see Warnings and Precautions (5.3) and Clinical Studies (14.1)].

 If the EVENITY dose is missed, administer as soon as it can be rescheduled. Thereafter,

EVENITY can be scheduled every month from the date of the last dose.