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Denosumab-BBDZ is available as a single-dose prefilled syringe containing 60 mg in a 1 mL solution.

Denosumab-BBDZ is a RANK ligand (RANKL) used to: Treat postmenopausal women with osteoporosis at high risk for fracture. Increase bone mass in men with osteoporosis at high risk for fracture. Treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture. Increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. Increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Denosumab-BBDZ is a monoclonal antibody. It blocks a protein in your body that sends signals to break down your bones. This prevents bone loss and helps strengthen your bones.

Denosumab-BBDZ is given as 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. You should also take calcium 1000 mg daily and at least 400 IU vitamin D daily.

Denosumab-BBDZ is a safe and effective treatment when used for FDA approved indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not take Denosumab-BBDZ if you are allergic to denosumab products, are pregnant, or have low calcium levels.

Common side effects of Denosumab-BBDZ: Back pain Pain in your arms and legs Pain in your muscles, bones, joints, or nerves High cholesterol levels Pain or discomfort while urinating and other symptoms of a bladder infection Sensation that the room is spinning Swelling in the hands and feet Cough, sore throat, and other symptoms of an upper respiratory tract infection

Serious side effects are rare with Denosumab-BBDZ. Contact your healthcare provider immediately if you experience any of the following: Serious allergic reactions: dizziness, trouble, tightness in your throat, swelling in your face and throat, itchiness, rash

There are no drug interactions listed for Denosumab-BBDZ.

Various FDA-approved generic manufacturers

Denosumab-BBDZ may harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control (contraception) during treatment with Denosumab-BBDZ and for at least 5 months after your last dose of Denosumab-BBDZ. Tell your doctor right away if you become pregnant while taking Denosumab-BBDZ.

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