What is Wyost®
Wyost® (denosumab-bbdz) is an FDA-approved biosimilar to denosumab, used for treating bone-related conditions such as preventing bone complications in patients with multiple myeloma, treating adults and adolescents with giant cell tumor of bone, and treating hypercalcemia of malignancy that does not respond to standard therapies.
Wyost FDA Approval
Manufacturer: Sandoz Inc.
On March 5, 2024, Sandoz announced the FDA’s approval of Wyost®, a groundbreaking biosimilar to denosumab, known as denosumab-bbdz. This approval marks Wyost® as the first of its kind for treating specific bone-related conditions. It’s designed to:
- Help prevent serious bone complications in people with multiple myeloma and those with bone metastases from solid tumors.
- Treat adults and young people with a certain type of bone tumor that can’t be removed surgically or would cause significant harm if removed.
- Address severe cases of hypercalcemia (high calcium levels in the blood) in cancer patients that don’t respond to standard treatments.
This approval is a significant step forward, offering new treatment options for patients facing these challenging conditions.
Wyost Side Effects
Wyost has similar side effects to Xgeva, which include:
- feeling tired
- diarrhea
- nausea
- and issues with blood components like low phosphate, red blood cells, and calcium levels
It can also cause:
- back pain
- swelling in the legs or hands
- infections in the upper respiratory tract
- rash
- headaches
More serious risks involve
- infections
- skin issues
- bone death in the jaw
- allergic reactions, and
- very low calcium levels
How Wyost Works
Wyost works by targeting a protein involved in cancer-related bone destruction called RANKL. It binds to this protein, preventing it from activating osteoclasts, which are cells that break down bone tissue. By inhibiting these cells, Wyost helps to prevent bone complications like fractures in patients with bone metastases from tumors. This mechanism is crucial for patients with cancer that has spread to the bones, offering a therapeutic approach to manage and reduce skeletal-related events.
Wyost Indications & Usages
Wyost is used for preventing bone problems in people with multiple myeloma or cancer that has spread to the bones. It also treats a type of bone tumor in adults and young people when surgery isn’t an option or is too risky, and it’s used for treating high calcium levels in cancer patients when other medications don’t work.
Wyost Dosage & Strength
Wyost is supplied as an Injectable drug:- Strength: 120 mg/1.7 mL (70 mg/mL) solution in a single-dose vial.
- Wyost (denosumab-bbdz) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution.
Wyost Dosage & Administration
Wyost is intended only for subcutaneous route (SQ) and should not be
administered intravenously (I.V.), intramuscularly (I.M.), or intradermally.
- For Multiple Myeloma and Bone Metastasis from Solid Tumors: Administer
120 mg every 4 weeks S.Q. in the upper arm,
upper thigh, or abdomen. - For Giant Cell Tumor of Bone: Administer 120 mg every 4 weeks with
additional 120 mg doses S.Q. on Days 8 and 15 of the first month of therapy.
Administer subcutaneously in the upper arm, upper thigh, or abdomen.
Continue calcium and vitamin D treatment as necessary to treat or prevent
hypocalcemia.
- For Hypercalcemia of Malignancy: Administer 120 mg every 4 weeks with
additional 120 mg doses on Days 8 and 15 of the first month of therapy.
Administer subcutaneously in the upper arm, upper thigh, or abdomen.
Wyost Contraindications
Wyost should not be used if you have low calcium levels in your blood or if you’ve had serious allergic reactions to denosumab products in the past. These conditions make it unsafe to receive this treatment.
Wyost Warnings & Precautions
Patients should not receive other denosumab products simultaneously with Wyost.
Hypersensitivity Reactions: Anaphylaxis and other hypersensitivity reactions may occur. Discontinue permanently if a clinically significant reaction happens.
Hypocalcemia: Severe symptomatic hypocalcemia can occur. Fatal cases have been reported. Correct hypocalcemia before starting Wyost. Monitor calcium levels, especially during initial therapy, and ensure adequate calcium and vitamin D supplementation for all patients.
Osteonecrosis of the Jaw (ONJ): Reported in patients on denosumab products. Perform oral examinations before initiating Wyost. Monitor for ONJ symptoms and avoid invasive dental procedures during treatment.
Atypical Femoral Fracture: Evaluate patients experiencing thigh or groin pain to rule out femoral fracture.
Hypercalcemia Following Treatment Discontinuation: Monitor patients for signs of hypercalcemia after stopping treatment, particularly in patients with Giant Cell Tumor of Bone and in those with growing skeletons.
Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation: Assess the individual patient’s risk for vertebral fractures when discontinuing Wyost treatment.
Embryo-Fetal Toxicity: Wyost can cause fetal harm. Advise females of reproductive potential about the potential risk to the fetus and recommend effective contraception.
Wyost & Pregnancy
Based on animal studies and the mechanism of action, Wyost (denosumab) products have the potential to cause fetal harm when administered to pregnant women. However, there is insufficient data available regarding the use of denosumab products in pregnant women to determine the associated risks for adverse developmental outcomes.
In studies involving cynomolgus monkeys, exposure to denosumab during pregnancy resulted in increased fetal loss, stillbirths, postnatal mortality, as well as abnormalities such as absent lymph nodes, abnormal bone growth, and decreased neonatal growth. Pregnant women should be informed about the potential risk to the fetus if exposed to denosumab products. The background rate of major birth defects and miscarriage in the population for which the drug is indicated is unknown. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Wyost & Lactation
Based on the available information, there is no data on the presence of denosumab products in human milk or their effects on breastfed infants or milk production. Studies conducted on cynomolgus monkeys showed that denosumab was detected in maternal milk up to a month after the last dose, with minimal transfer (≤ 0.5% milk:serum ratio) and normal mammary gland development, suggesting no impaired lactation. However, in pregnant RANKL knockout mice, altered maturation of the maternal mammary gland led to impaired lactation.
Given these findings, healthcare providers should consider the developmental and health benefits of breastfeeding in conjunction with the mother’s clinical need for Wyost treatment and any potential adverse effects on the breastfed child from both Wyost and the underlying maternal condition. Further research and monitoring may be necessary to fully understand the implications of denosumab use during lactation.
Wyost & Pediatric Patients
The safety and effectiveness of Wyost have not been established in pediatric patients, except in skeletally mature adolescents aged 12–16 years with giant cell tumor of bone. It is specifically recommended for the treatment of skeletally mature adolescents in this age group with giant cell tumor of bone. However, clinically significant hypercalcemia following treatment discontinuation has been reported in pediatric patients with growing skeletons who received denosumab products for giant cell tumor of bone or for unapproved indications. Healthcare providers should consider these factors when prescribing Wyost to pediatric patients and carefully monitor for adverse effects, particularly hypercalcemia, during and after treatment.
Wyost Storage
Keep Wyost stored in a refrigerator at temperatures between 2°C to 8°C (36°F to 46°F), ensuring it remains in its original packaging. Avoid freezing. After taking it out of the refrigerator, it is crucial that Wyost is not subjected to temperatures over 25°C/77°F or direct sunlight, and it should be used within 30 days.
If not utilized within this timeframe, Wyost should be disposed of. Additionally, refrain from using Wyost past its expiration date as indicated on the label.