Wyost (Subcutaneous)
This medication guide is specific to Xgeva and its Biosimilars.
Denosumab is used to prevent bone problems in people with multiple myeloma or tumors that have spread to the bone.
Denosumab is also used in adults and children at least 12 years and older with a fully matured bone structure to treat giant cell tumor of bone that cannot be removed with surgery.
Denosumab is also used to treat high calcium levels in the blood caused by cancer when a certain type of medicine used to lower blood calcium levels has not worked.
Denosumab may also be used for purposes not listed in this medication guide.
uses
What is Wyost (Subcutaneous) used for?
- Hypercalcemia of Malignancy
- Osteoporosis
- Osteolytic Bone Metastases of Solid Tumors
- Giant Cell Tumor of Bone
warnings
What is the most important information I should know about Wyost (Subcutaneous)?
You should not receive denosumab if you are allergic to it or if you have low levels of calcium in your blood (hypocalcemia). Your low blood calcium will need to be treated before you receive denosumab.
You should not use any other medicines that contain denosumab while you are receiving this medicine.
Tell your doctor if you have or have ever had:
- low levels of calcium in your blood (hypocalcemia);
- osteoporosis or broken bones;
- if you are scheduled for a dental procedure;
- if you cannot take daily calcium and vitamin D;
- if you are taking medicine that lowers your blood calcium levels; or
- kidney disease (or if you are on dialysis).
Denosumab may cause very low levels of calcium in your blood (hypocalcemia), which can lead to death. Talk with your doctor about this risk.
This medicine may cause jaw bone problems (osteonecrosis). The risk is highest in people with cancer, blood cell disorders, pre-existing dental problems, or people treated with steroids, chemotherapy, or radiation. Ask your doctor about your own risk.
May harm an unborn baby. Do not use if you are pregnant. You may need a pregnancy test before starting this treatment. Use effective birth control while receiving denosumab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Side Effects
What are the side effects of Wyost (Subcutaneous)?
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- new or unusual pain in your thigh, hip, or groin;
- jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work; or
- low blood calcium--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).
After you stop using denosumab, tell your doctor if you have symptoms of high calcium levels (hypercalcemia) such as confusion, tiredness, nausea, vomiting, loss of appetite, constipation, increased thirst or urination, weight loss.
Common side effects may include:
- tiredness, lack of energy;
- rash, shortness of breath;
- abnormal blood tests;
- nausea, vomiting, diarrhea, constipation, loss of appetite;
- headache, back or joint pain, pain or swelling in your arms or legs; or
- cold symptoms such as stuffy nose, sneezing, sore throat.
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.
Pregnancy & Breastfeeding
Can I take Wyost (Subcutaneous) if I’m pregnant or breastfeeding?
May harm an unborn baby. Do not use if you are pregnant. You may need a pregnancy test before starting this treatment. Use effective birth control while receiving denosumab and for at least 5 months after your last dose. Tell your doctor if you become pregnant.
Ask a doctor if it is safe to breastfeed while using this medicine.
Interactions
What drugs and food should I avoid while taking Wyost (Subcutaneous)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Wyost (Subcutaneous)?
Use Wyost (Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Denosumab is injected under the skin. A healthcare provider will give you this injection.
Denosumab is usually given once every 4 weeks. You may need to receive additional doses depending on the condition being treated. Follow your doctor's instructions.
Your blood will need to be tested often. Your doctor may have you take extra calcium and vitamin D while you are being treated with denosumab. Take only the amount of calcium and vitamin D that your doctor has prescribed.
If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are receiving denosumab.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medication. You may need to have an oral examination before you begin treatment with denosumab. Follow your doctor's instructions.
Your risk of bone fractures can increase when you stop using denosumab. Do not stop using this medicine without first talking to your doctor.
If you keep this medicine at home, store it in the original carton in a refrigerator. Protect from light and do not freeze. Do not shake the medicine.
After you have taken denosumab out of the refrigerator, you may keep it at room temperature for up to 14 to 30 days, depending on the brand form. Store in the original container away from heat and light.
Call your doctor for instructions if you miss an appointment for your denosumab injection.