Drug Summary
What Is Osvyrti?
Osvyrti (denosumab-desu) is a RANK ligand (RANKL) inhibitor indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
Osvyrti is biosimilar to Prolia (denosumab).
What Are Side Effects of Osvyrti?
Side effects of Osvyrti include:
- back pain,
- pain in extremities,
- elevated cholesterol,
- musculoskeletal pain,
- cystitis,
- pancreatitis,
- joint pain,
- runny/stuffy nose,
- high blood pressure (hypertension),
- bronchitis, and
- headache.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision,tunnel vision,eye painor swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache,confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Osvyrti
The dose of Osvyrti is 60 mg administered every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen.
Osvyrti In Children
The safety and effectiveness of Osvyrti have not been established in pediatric patients.
What Drugs, Substances, or Supplements Interact with Osvyrti?
Osvyrti may interact with other medicines.
Tell your doctor all medications and supplements you use.
Osvyrti During Pregnancy and Breastfeeding
Osvyrti is contraindicated for use during pregnancy because it may harm a fetus. The pregnancy status of patients who can become pregnant should be verified prior to initiating Osvyrti treatment. Patients who can become pregnant are advised to use effective contraception during therapy, and for at least 5 months after the last dose of Osvyrti. It is unknown if Osvyrti passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Osvyrti (denosumab-desu) Injection, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.