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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Bildyos
Generic Name
Denosumab
Active Ingredient
DenosumabCategory
RANK Ligand Inhibitor [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 60 mg/mL | INJECTION, SOLUTION | SUBCUTANEOUS | 78206-193 |
Detailed information about Bildyos
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Bildyos, you must consult a qualified healthcare professional.
Denosumab is a human monoclonal antibody and RANK ligand inhibitor used to treat osteoporosis, bone metastases, and giant cell tumor of bone by reducing bone resorption and increasing bone mineral density.
The dosage of denosumab is strictly dependent on the indication being treated. It is vital that patients do not confuse the two brands, as the dosing intervals differ significantly.
Denosumab is generally not approved for use in pediatric patients (children and adolescents). The safety and effectiveness have not been established in children because RANKL inhibition can significantly interfere with bone growth and the development of teeth (specifically the eruption of secondary teeth).
An exception exists for Giant Cell Tumor of Bone, where denosumab (Xgeva) may be used in skeletally mature adolescents (those whose growth plates have closed) who weigh at least 45 kg. Clinical monitoring of bone growth is required in these cases.
No dosage adjustment is necessary for patients with renal (kidney) impairment. However, patients with severe renal impairment (Creatinine Clearance < 30 mL/min) or those on dialysis are at a much higher risk of developing severe hypocalcemia. Frequent monitoring of calcium levels is mandatory in this population.
The safety and efficacy of denosumab have not been studied in patients with hepatic (liver) impairment. Since denosumab is not metabolized by liver enzymes, it is generally expected that no dose adjustment is required, but clinical caution is advised.
No overall differences in safety or efficacy have been observed between patients over age 65 and younger patients. No dosage adjustment is required for geriatric populations.
Denosumab must be administered by a healthcare professional. It is given as a subcutaneous injection into the upper arm, the upper thigh, or the abdomen.
If a dose of Prolia is missed, the injection should be administered as soon as possible. Thereafter, injections should be scheduled every 6 months from the date of the last injection. If a dose of Xgeva is missed, it should be administered as soon as possible, and the regular monthly schedule should be resumed based on that new date.
There is no specific experience with denosumab overdose in clinical trials. In theory, an overdose could lead to excessively suppressed bone turnover or severe changes in calcium levels. If an overdose is suspected, contact a poison control center or seek emergency medical care immediately. Symptoms may not be immediately apparent due to the long half-life of the drug.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose or skip appointments without medical guidance. Discontinuing denosumab can lead to a rapid loss of bone mineral density.
Common side effects associated with denosumab vary depending on whether it is used for osteoporosis (Prolia) or oncology (Xgeva).
> Warning: Stop taking Denosumab and call your doctor immediately if you experience any of these.
In early 2024, the FDA added a Black Box Warning to the Prolia label. Patients with advanced chronic kidney disease (CKD), especially those on dialysis, are at a significantly increased risk for severe, life-threatening hypocalcemia. This can lead to hospitalization, cardiac events, and death. Healthcare providers must screen for CKD and ensure calcium and vitamin D levels are optimized before and during treatment.
Report any unusual symptoms to your healthcare provider immediately. Early intervention is key to managing the serious side effects of denosumab.
Denosumab is a potent biological medication that requires careful medical supervision. Before starting treatment, patients must be screened for pre-existing conditions that could increase the risk of complications. The most critical safety point is the maintenance of calcium homeostasis (balance). Denosumab can rapidly lower blood calcium levels; therefore, any existing low calcium must be corrected before the first dose is administered.
The FDA has issued its highest level of warning regarding the use of Prolia in patients with advanced renal impairment. Clinical data indicates that patients with Stage 4 or 5 Chronic Kidney Disease (CKD) or those undergoing dialysis have a much higher incidence of severe hypocalcemia. In some cases, calcium levels dropped so low they caused life-threatening heart rhythm disturbances or seizures. If you have kidney disease, your doctor must perform frequent blood tests to monitor your mineral levels.
Your healthcare provider will require regular blood tests to ensure the medication is safe for you. These typically include:
Denosumab has no known effect on the ability to drive or operate heavy machinery. However, if you experience side effects like dizziness or fatigue, you should wait until these symptoms resolve before performing tasks that require alertness.
There are no direct chemical interactions between denosumab and alcohol. However, excessive alcohol consumption is a known risk factor for osteoporosis and can increase the risk of falls and fractures. It is generally advised to limit alcohol intake to support overall bone health.
Discontinuing denosumab is a high-risk period. Unlike bisphosphonates (like Fosamax), which stay in the bone for years, the effects of denosumab wear off quickly (within 6 months of a missed dose). If treatment is stopped, your doctor will likely prescribe an oral or intravenous bisphosphonate to 'lock in' the bone density gains and prevent rebound fractures.
> Important: Discuss all your medical conditions with your healthcare provider before starting Denosumab. Be sure to mention if you have kidney problems, a history of low calcium, or upcoming dental surgery.
There are no absolute drug-drug contraindications where the chemical interaction is fatal; however, the following should be strictly avoided due to overlapping mechanisms:
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. Keep a list of all your medicines to show your healthcare provider and pharmacist.
Conditions where Denosumab must NEVER be used include:
Conditions requiring a careful risk-benefit analysis by a specialist:
There are no other RANKL inhibitors currently on the market, so cross-sensitivity within the class is not a primary concern. However, patients who have had reactions to other fully human monoclonal antibodies (such as certain treatments for rheumatoid arthritis or psoriasis) should be monitored closely, although the risk of cross-reaction is low because the protein sequences are different.
> Important: Your healthcare provider will evaluate your complete medical history, including your kidney function and dental health, before prescribing Denosumab.
Denosumab is not recommended for use in pregnant women. In animal studies, denosumab was shown to cross the placental barrier and cause increased fetal loss, stillbirths, and postnatal mortality. It also caused abnormal bone development and the absence of lymph nodes in the offspring.
It is unknown whether denosumab is excreted in human milk. Because many drugs and maternal IgG (antibodies) are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants (specifically regarding bone and immune development), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Denosumab is generally not approved for use in children. In animals, denosumab has been shown to inhibit the growth of the 'growth plates' (epiphyseal plates) and can result in abnormal tooth eruption.
Clinical trials included thousands of patients aged 65 and older. No overall differences in safety or effectiveness were observed between these patients and younger patients. However, elderly patients are more likely to have decreased kidney function and may be taking other medications that affect calcium levels, requiring more diligent monitoring.
No clinical studies have been conducted in patients with hepatic impairment. Because denosumab is a protein cleared by the immune system and not the liver's CYP450 system, hepatic impairment is not expected to affect the drug's levels in the body.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are planning to become pregnant or have underlying kidney disease.
Denosumab is a fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL).
By binding to RANKL, denosumab prevents the RANKL/RANK interaction from occurring. In a healthy body, RANKL is produced by osteoblasts and binds to RANK receptors on the surface of osteoclast precursors. This binding is the 'on switch' for bone destruction. By blocking this switch, denosumab inhibits the formation, function, and survival of osteoclasts. This leads to a rapid and profound reduction in bone resorption markers (such as serum CTx) within hours of the first injection.
| Parameter | Value |
|---|---|
| Bioavailability | 62% |
| Protein Binding | Not applicable (Monoclonal Antibody) |
| Half-life | 25 - 28 days |
| Tmax | 10 days (Range: 3-21 days) |
| Metabolism | Non-specific proteolysis (Reticuloendothelial system) |
| Excretion | Not renally excreted as intact drug |
Denosumab is the first-in-class RANK Ligand Inhibitor. While it is used for osteoporosis similarly to bisphosphonates (like Zoledronic acid), its biological mechanism is entirely different. It is categorized as a bone-modifying agent and an antiresorptive therapy.
Common questions about Bildyos
Denosumab is primarily used to treat conditions characterized by excessive bone loss or destruction. Under the brand name Prolia, it is used to treat osteoporosis in postmenopausal women and men at high risk for fractures, as well as bone loss caused by certain cancer treatments or long-term steroid use. Under the brand name Xgeva, it is used to prevent bone complications (like fractures) in patients whose cancer has spread to the bones. It is also used to treat giant cell tumor of bone and dangerously high calcium levels caused by cancer. Your doctor will determine which brand and dosage are appropriate based on your specific medical diagnosis.
The most common side effects depend on the dose and the condition being treated. For patients taking Prolia for osteoporosis, the most frequent reports include back pain, pain in the arms and legs, high cholesterol, and muscle aches. Patients taking Xgeva for cancer-related bone issues often experience fatigue, nausea, and low phosphate levels. Both groups may experience skin reactions like rashes or eczema. Because it affects the immune system, minor infections like colds or urinary tract infections are also common. Always report new or worsening symptoms to your healthcare provider.
There is no known direct chemical interaction between alcohol and denosumab injections. However, clinical guidelines suggest that excessive alcohol consumption (more than 2-3 drinks per day) can weaken bones and increase your risk of falling, which counteracts the benefits of the medication. Alcohol can also interfere with your body's ability to maintain healthy calcium and vitamin D levels. It is best to discuss your alcohol intake with your doctor to ensure it does not interfere with your overall bone health strategy. Moderation is generally recommended for patients with osteoporosis.
No, denosumab is generally not considered safe during pregnancy. Clinical data and animal studies indicate that the drug can cross the placenta and interfere with the developing fetus's bone and immune system growth. It may lead to fetal harm, including skeletal abnormalities and the absence of lymph nodes. Women who could become pregnant should use effective birth control during treatment and for at least five months after their last dose. If you become pregnant while taking denosumab, you must notify your healthcare provider immediately to discuss the potential risks.
Denosumab begins working at the molecular level very quickly, with bone resorption markers dropping significantly within just three days of the first injection. However, the visible benefits, such as increased bone mineral density (BMD), take much longer to measure. Most doctors will wait 12 to 24 months before performing a follow-up DXA scan to see how much your bone density has improved. For patients taking it for bone pain related to cancer, some relief may be felt within the first few weeks or months of regular dosing. Consistency in the 6-month or 4-week dosing schedule is essential for the drug to be effective.
You should never stop taking denosumab without a detailed plan from your healthcare provider. Unlike some other bone medications that stay in your system for a long time, the effects of denosumab disappear rapidly after six months. When the drug wears off, there is a 'rebound' effect where bone breakdown increases quickly, leading to a rapid loss of the bone density you gained. This significantly increases the risk of multiple fractures in the spine (vertebral fractures). If you must stop denosumab, your doctor will usually transition you to another medication, like a bisphosphonate, to protect your bones.
If you miss an appointment for your denosumab injection, you should contact your healthcare provider as soon as possible to reschedule. For Prolia (the 6-month injection), it is important to receive the missed dose quickly to prevent the 'rebound' bone loss that occurs when the drug levels drop. Once you receive the missed dose, your next injection will typically be scheduled six months from that new date. For Xgeva (the monthly injection), you should also get the missed dose as soon as possible and then work with your doctor to get back on a regular 4-week schedule. Timely dosing is the key to preventing fractures.
Weight gain is not listed as a common or direct side effect of denosumab in clinical trials. Most patients do not experience significant changes in body weight solely due to the medication. However, some patients may experience peripheral edema (swelling in the arms or legs), which can feel like weight gain or make clothes feel tighter. If you notice rapid weight gain or significant swelling, you should contact your doctor, as this could be a sign of a different underlying issue. Maintaining a healthy lifestyle with weight-bearing exercise is encouraged while on this medication.
Denosumab can be taken with many common medications, but certain combinations require caution. It is often taken alongside calcium and vitamin D supplements, which are necessary for it to work safely. However, you should be careful if you are taking other drugs that suppress the immune system (like chemotherapy or biologics) or drugs that also lower calcium levels. You should never take Prolia and Xgeva at the same time, as they contain the same active ingredient. Always provide your doctor with a full list of your current medications, including over-the-counter supplements, to avoid potential interactions.
As of early 2024, the FDA has approved the first biosimilars for denosumab (such as Wyost and Jubbonti), which are highly similar to Xgeva and Prolia, respectively. A biosimilar is the 'generic' equivalent for biological drugs. These biosimilars are expected to become more widely available as patent protections for the original brands expire and legal settlements are reached. Biosimilars undergo rigorous testing to ensure they have the same safety and effectiveness as the original brand-name drug. Ask your doctor or pharmacist if a lower-cost biosimilar version is available and appropriate for your treatment.
Other drugs with the same active ingredient (Denosumab)