Wyost

Pronunciation: Why-ost
Generic name: denosumab-bbdz
Dosage form: subcutaneous injection
Drug class: Miscellaneous bone resorption inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on May 29, 2024.

What is Wyost?

Wyost (denosumab-bbdz) is an injection that is administered subcutaneously (under the skin) by a healthcare provider for the:

• Prevention of skeletal-related events (for example, fractures, vertebral compression) in patients with multiple myeloma and in patients with cancer that has spread to the bone (bone metastases) from solid tumors
• Treatment of giant cell tumor of the bone that cannot be removed by surgery or when surgery is too risky in adults and adolescents who have fully grown
• Treatment of high calcium levels associated with cancer (hypercalcemia of malignancy) that has not responded to bisphosphonates.

Wyost works by binding to RANKL, a protein on the membrane of osteoclasts essential for their formation, function, and survival. This inhibits osteoclast formation, decreasing bone resorption and increasing bone mass and strength in both cortical (hard bone) and trabecular (spongy bone). Wyost is a monoclonal antibody that targets and inhibits RANK ligand (RANKL) and belongs to the class of medicines known as RANK ligand (RANKL) inhibitors.

Wyost is an interchangeable biosimilar to Xgeva (denosumab) that was FDA-approved on 5 March 2024. An interchangeable biosimilar is a biological product that can be substituted in the pharmacy for the reference biologic because there are no clinically meaningful differences in safety, purity, and potency.

Warnings

If you receive Wyost, you should not receive Xgeva or Prolia. Wyost contains the same medicine (denosumab).

Serious and life-threatening hypersensitivity reactions, including anaphylaxis, have occurred with Wyost and other products that contain denosumab. Seek emergency help or tell your doctor immediately if you experience shortness of breath, throat tightness, swelling of the airways and throat, itching, low blood pressure, or hives.

Life-threatening severe hypocalcemia (very low calcium levels) has occurred with products containing denosumab; the risk is higher in patients with poor renal function (ClCR less than 30 mL/min or receiving dialysis, or in those with preexisting hypocalcemia. Pre-existing low calcium levels should be corrected before starting treatment, and your healthcare provider will monitor your levels throughout treatment, especially in the first few weeks, and for certain conditions prescribe calcium and vitamin D supplements if necessary.

Osteonecrosis of the jaw has been reported in patients receiving denosumab products. A routine oral exam should be performed before Wyost treatment and preventive dentistry undertaken if necessary, especially for those with risk factors such as prior tooth extraction, dental implants, oral surgery, cancer, or poor oral hygiene. Good oral hygiene practices should be maintained during treatment with Wyost and invasive dental procedures should be avoided.

Atypical low energy or low trauma femoral fractures have been reported with denosumab products. Contact your doctor immediately if you develop thigh or groin pain. Multiple vertebral fractures have been reported following discontinuation of denosumab. Your healthcare provider should consider transitioning you to another antiresorptive agent.

High calcium levels (hypercalcemia) following treatment discontinuation have been reported in patients with giant cell tumor of the bone and those with growing skeletons. Your healthcare provider will monitor your calcium levels once you stop treatment with Wyost and treat appropriately.

Can cause harm to an unborn baby. Females who can become pregnant should have a negative pregnancy test before starting treatment and use adequate contraception throughout treatment.

Do not administer intravenously, intramuscularly, or intradermally.

Not recommended for children. Recommended only for the treatment of skeletally mature adolescents with giant cell tumor of the bone.

Before taking

Tell your doctor about all of your medical conditions, including if you:

• are allergic to denosumab
• are taking a medicine called Xgeva (denosumab) or Prolia (denosumab). Wyost contains the same medicine
• have low blood calcium
• cannot take daily calcium and vitamin D
• had parathyroid or thyroid surgery (glands located in your neck) or intestinal surgery
• have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
• have kidney problems or are on kidney dialysis
• have a weak immune system
• are taking medicine that can lower your blood calcium levels
• plan to have dental surgery or teeth removed
• are pregnant or plan to become pregnant. Wyost may harm your unborn baby
• are breastfeeding or plan to breastfeed.

Discuss all aspects of Wyost treatment with your doctor before starting. After your treatment with Wyost is stopped, or if you skip or delay taking a dose, your risk of breaking bones, including bones in your spine, is increased. Your risk of having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip, or delay taking Wyost without first talking with your doctor. If your Wyost treatment is stopped, talk to your doctor about other medicines that you can take.

Pregnancy

For females who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with Wyost. You should use an effective method of birth control (contraception) during treatment with Wyost and for at least 5 months after your last dose. Tell your doctor right away if you inadvertently become pregnant.

Breastfeeding

It is not known if Wyost passes into your breast milk. You and your doctor should decide if you will take Wyost or breastfeed. You should not do both.

How is Wyost administered?

Wyost is an injection that will be given to you by a healthcare professional. Wyost is injected under your skin (subcutaneously).

• How often you receive Wyost depends on the condition being treated, but it is usually administered once every 4 weeks. For some conditions, additional doses are needed in the first month of treatment.
• Wyost is administered subcutaneously into the upper arm, upper thigh, or abdomen.
• Take good care of your teeth and gums while you receive Wyost. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using Wyost. You may need to stop using the medicine for a short time.

Dosage

Multiple myeloma and bone metastasis from solid tumors: 120 mg given as a subcutaneous injection every 4 weeks.

• Supplements of calcium and vitamin D should be administered as necessary to treat or prevent hypocalcemia.

Giant cell tumor of the bone: 120 mg administered every 4 weeks with additional 120 mg doses on days 8 and 15 of the first month of therapy.

• Supplements of calcium and vitamin D should be administered as necessary to treat or prevent hypocalcemia.

Hypercalcemia of malignancy: 120 mg administered every 4 weeks with additional 120 mg doses on days 8 and 15 of the first month of therapy.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose or miss an appointment for your Wyost injection. You should receive your missed injection as soon as possible.

What are the side effects of Wyost?

Serious allergic reactions have happened in people who take denosumab products including Wyost. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction such as low blood pressure (hypotension), trouble breathing, throat tightness, swelling of your face, lips, or tongue, rash, itching, or hives.

Wyost can cause serious side effects including:

• Increased risk of severe low calcium levels in your blood (hypocalcemia). Wyost may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Wyost, it may get worse during treatment. Your low blood calcium must be treated before you start treatment and your doctor may prescribe calcium and vitamin D supplements to help prevent low calcium levels while taking it. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as spasms, twitches, or cramps in your muscles, or numbness or tingling in your fingers, toes, or around your mouth
• Severe jaw bone problems (osteonecrosis). Your doctor should examine your mouth before you start Wyost and may tell you to see your dentist. You need to practice good mouth care during treatment
• Unusual thigh bone fractures. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh
• Increased risk of broken bones, including broken bones in the spine, after stopping, skipping, or delaying Wyost
• High calcium levels (hypercalcemia) following treatment discontinuation have been reported in patients with Giant cell tumor of the bone and those with growing skeletons.

Common Wyost side effects depend on the condition being treated.

For bone metastasis from solid tumors, the most common side effects affecting 25% or more patients were:

• Fatigue/weakness
• Low phosphate levels
• Nausea.

For multiple myeloma, the most common side effects affecting 10% or more patients were:

• Diarrhea
• Nausea
• Low blood counts (low red cells and platelets)
• Back pain,
• Swelling in the hands and feet
• Low calcium levels
• Upper respiratory tract infection
• Rash
• Headache.

For giant cell tumor of the bone, the most common side effects affecting 10% or more patients were:

• Joint and back pain
• Headache
• Nausea
• Fatigue
• Pain in the extremities.

For hypercalcemia of malignancy, the most common side effects affecting more than 20% of patients were:

• Nausea
• Shortness of breath
• Decreased appetite
• Headache
• Swelling in the hands and feet
• Vomiting
• Anemia
• Constipation
• Diarrhea.

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 the FDA at 1-800-FDA-1088.

Related/similar drugs

What should I avoid while receiving Wyost?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Avoid invasive dental procedures during treatment and practice good oral hygiene.

What other drugs will affect Wyost?

Other drugs may interact with denosumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

No formal drug interaction studies have been conducted but interactions with other denosumab products include avoiding:

• calcimimetic drugs, such as cinacalcet, which may worsen hypocalcemia risk
• the use of other drugs associated with ONJ, such as bisphosphonates, which may increase the risk of developing ONJ.

See the prescribing information for a full list of interactions.

Storage

Keep Wyost in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton. Do not freeze.

• Before administration, take Wyost out of the refrigerator and bring it up to room temperature over 15 to 30 minutes. Do not warm in any other way.
• Wyost may be kept out of the refrigerator for up to 30 days at room temperature [up to 77°F (25°C)] in the original carton to protect from light. Do not keep at temperatures above 77°F (25°C). Warm temperatures will affect how it works.

Do not vigorously shake.

Keep out of the reach of children.

Ingredients

Active ingredients: denosumab-bbdz 120 mg/1.7 mL (70 mg/mL).

Inactive ingredients: glacial acetic acid, polysorbate 20, sodium hydroxide, sorbitol, and water for
injection (USP). Hydrochloric acid and sodium hydroxide may be added to adjust the pH.

Manufacturer

Sandoz Inc.

Wyost Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Wyost.

Prolia, Xgeva interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Popular FAQ

More FAQ

• What biosimilars have been approved in the United States?
• How many years should you take Prolia?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer