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Get to know BOMYNTRA® (denosumab-bnht)
BOMYNTRA® (denosumab-bnht) is an FDA-approved biosimilar to Xgeva® (denosumab) used for:
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Prevention of fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors
Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity
Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy
Within healthy bones, old tissue is frequently broken down and replaced with new bone through osteoclasts and osteoblasts, respectively. The bone remodeling process allows bones to maintain their strength. However, for some, an imbalance of osteoclasts weakens their bones, leading to pain, fractures, and limited mobility.
BOMYNTRA blocks RANKL, a protein that tells bone cells to break down bone. By stopping RANKL, BOMYNTRA helps keep bones from breaking down too quickly, which protects them and makes them stronger with more mass.
Your healthcare provider will give you 120 mg of medicine as a single injection under your skin in the upper arm, the upper thigh, or the abdomen. You will get the injection in your healthcare provider’s office or at an infusion center.
Your BOMYNTRA treatment plan is shown in the chart below:
Helpful Reminders:
Take Calcium and Vitamin D Every Day
You may need to take calcium and vitamin D supplements (as needed) to help prevent or treat low blood calcium levels and keep your bones strong.
Don't Wait If You Miss an Injection
If you miss an injection, go to your healthcare provider’s office as soon as possible to receive it.
Mark Your Calendar
To stay on track and avoid missing your next dose, mark your calendar for the next scheduled injection date.
If you miss an injection, contact your healthcare provider's office as soon as possible to reschedule and receive the missed dose.
Talk to your healthcare provider if you or your caregiver have any questions about BOMYNTRA.
A biosimilar is a medicine that is highly similar to the original product (also called "reference product") with no clinically meaningful differences in safety, purity, or effectiveness.
BOMYNTRA® (denosumab-bnht) and Xgeva® (denosumab) are similar in the following ways:
- Both made from living cells
- Work in the body in the same way
- Equally safe and effective
Why are biosimilars important?
- Help reduce costs for patients and healthcare systems
- Increase availability to more patients in need
- Encourage innovation in health care
"FDA requires biosimilar and interchangeable biological products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference [original] product."
—US Food and Drug Administration
- Filename
- KabiCare-Biosimilars-Patient-Brochure-3285.pdf
- Size
- 1 MB
- Format
Resources for BOMYNTRA
Download BOMYNTRA resource materials
- Filename
- KabiCare-Biosimilars-Patient-Brochure-3285.pdf
- Size
- 1 MB
- Format
Important Safety Information
Do not take Bomyntra (denosumab-bnht) if you have low blood calcium (hypocalcemia). Your low blood calcium must be treated before you receive Bomyntra. Denosumab can significantly lower the calcium levels in your blood and some deaths have been reported. Take calcium and vitamin D as your doctor tells you to. Tell your doctor right away if you experience spasms, twitches, cramps, or stiffness in your muscles or numbness or tingling in your fingers, toes, or around your mouth.
Do not take Bomyntra if you are allergic to denosumab or any of the ingredients of Bomyntra. Serious allergic reactions have happened in people who take denosumab. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of the face, lips, or tongue, rash; itching; or hives.
What is the most important information you should know about Bomyntra?
Do not take Bomyntra if you take other denosumab products. Patients receiving Bomyntra should not receive other denosumab products at the same time.
Severe jaw bone problems (osteonecrosis)
Severe jaw bone problems may happen when you take Bomyntra. Your doctor should examine your mouth before you start, and while you are taking Bomyntra. Tell your dentist that you are taking Bomyntra. It is important for you to practice good mouth care during treatment with Bomyntra. In studies of patients with bone involvement, the rate of severe jaw problems was higher the longer they were being treated with denosumab.
Unusual thigh bone fracture
Unusual thigh bone fracture has been reported in patients receiving denosumab. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
Risk of high calcium levels in patients with Giant Cell Tumor of Bone and in patients who are still growing
Patients with a type of cancer called Giant Cell Tumor of Bone and patients with bones that are not fully matured are at a greater risk to develop high blood calcium levels after they stop taking Bomyntra, that can be serious.
Increased risk of broken bones in the spine after discontinuing Bomyntra
After your treatment with Bomyntra is stopped, your risk for breaking bones in your spine can increase, especially if you have a history of risk factors such as osteoporosis or prior fractures.
Possible harm to your unborn baby
You should not become pregnant while taking Bomyntra. Tell your doctor right away if you are pregnant, plan to become pregnant, or suspect you are pregnant. Bomyntra can harm your unborn baby.
Tell your doctor if you:
- Are taking other denosumab products.
- Have symptoms of low blood calcium such as muscle stiffness or cramps
- Have symptoms of severe jaw bone problems such as pain or numbness
- Have ongoing pain or slow healing after dental surgery
- Have symptoms of high blood calcium such as nausea, vomiting, headache, and decreased alertness
- Are pregnant, plan to become pregnant, suspect you are pregnant, or breastfeeding
While taking Bomyntra, you should:
- Tell your doctor about all medications you are taking. Your doctor needs to know if you are taking other medications that also lower blood calcium levels
- Take good care of your teeth and gums and visit a dentist as recommended
- Tell your dentist that you are taking Bomyntra
- Tell your doctor if you plan to have dental surgery or teeth removed
- Talk to your doctor before you stop taking Bomyntra about your risk for broken bones in your spine
- Women of child bearing age should use highly effective contraception while taking Bomyntra and for at least 5 months after the last dose of Bomyntra
What are the possible side effects of Bomyntra?
In patients with bone metastases from solid tumors receiving denosumab, the most common side effects were tiredness/weakness, low phosphate levels in your blood, and nausea. The most common serious side effect of denosumab was shortness of breath.
In patients with multiple myeloma receiving denosumab, the most common side effects were diarrhea, nausea, low red blood cells, low blood platelets and calcium levels, back pain, swelling of the lower legs or hands, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction was pneumonia.
The most common adverse reactions in patients with giant cell tumor of bone were joint pain, back pain, pain in arms and legs, musculoskeletal pain, tiredness, headache, nausea, common cold (runny nose or sore throat), toothache, vomiting, low phosphate levels in your blood, constipation, diarrhea, and cough. The most common serious adverse reactions were severe jaw bone problems (osteonecrosis), bone giant cell tumor, low red blood cells, pneumonia, and back pain.
The most common adverse reactions in patients with hypercalcemia of malignancy were nausea, shortness of breath, decreased appetite, headache, swelling of the lower legs or hands, vomiting, low red blood cells, constipation, and diarrhea. The most common serious adverse reactions of denosumab were fatigue and infection.
These are not all the possible side effects of Bomyntra. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Indications
Bomyntra is a prescription medicine used for:
- Prevention fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors.
- Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
- Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Please see Bomyntra Full Prescribing Information.
Indications
Bomyntra is a prescription medicine used for:
- Prevention fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma and in patients with bone metastases from solid tumors.
- Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
- Treatment of hypercalcemia of malignanancy refractory to bisphosphonate therapy.