Bildyos (Denosumab-Nxxp) for Osteoporosis

Bildyos (denosumab-nxxp) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat osteoporosis in women after menopause who are at high risk for fracture. It is also used to increase bone mass in men with osteoporosis who are at high risk for fracture.

How Bildyos Works and How It’s Taken

Bildyos is a type of osteoporosis treatment called a RANK ligand (RANKL) inhibitor. It blocks a protein called RANKL that helps control cells that break down bone. By blocking this protein, Bildyos slows bone breakdown and helps increase bone mass and strength.

Bildyos is a biosimilar of Prolia. This means it is made from living cells and is designed to work like the original medicine. The FDA requires biosimilars to have no meaningful differences in safety or how well they work.

Doctors prescribe Bildyos when:

A woman after menopause has osteoporosis and is at high risk for fracture. This includes women who have had an osteoporosis-related fracture, have several fracture risk factors, or cannot use or did not respond to other available osteoporosis treatments.
A man has osteoporosis and is at high risk for fracture.
A man or woman is at high risk for fracture from osteoporosis caused by glucocorticoid medicines, such as prednisone, and is expected to take these medicines for at least six months.

Bildyos is given as an injection under the skin by a healthcare provider.

Typical Dosing for Osteoporosis

The recommended dose of Bildyos is 60 milligrams given as an injection under the skin once every six months.

People receiving Bildyos should also receive 1,000 milligrams of calcium each day and at least 400 international units of vitamin D each day.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Bildyos Side Effects

In clinical studies of denosumab, the active ingredient in Prolia, the reference product for Bildyos, the most common side effects differed depending on why people were taking it.

In women with osteoporosis after menopause, common side effects include:

Back pain
Pain in the arms or legs
High cholesterol
Cystitis (bladder infection)
Muscle or bone pain

In men with osteoporosis, common side effects include:

Back pain
Nasopharyngitis (coldlike symptoms, such as a runny nose or sore throat)
Joint pain

In people with glucocorticoid-induced osteoporosis, common side effects include:

Back pain
High blood pressure
Bronchitis
Headache

In people with bone loss related to certain prostate or breast cancer treatments, side effects include:

Joint pain
Back pain
Pain in the arms or legs
Muscle or bone pain

Serious Side Effects and Warnings

Bildyos can cause serious side effects that may require immediate medical attention. These include:

Severe hypocalcemia (dangerously low calcium levels in the blood) — This can cause muscle cramps or spasms, numbness, or tingling.
Serious allergic reactions — Anaphylaxis can cause trouble breathing, hives, or swelling of the face, lips, or tongue.
Osteonecrosis of the jaw — Jawbone damage can cause jaw pain, infection, or slow healing, often after dental work.
Atypical femur fractures — Unusual thigh bone fractures can cause new or unusual hip, groin, or thigh pain.
Multiple vertebral fractures after stopping treatment — The risk of spine fractures may increase after stopping, skipping, or delaying doses.
Serious infections — These can include skin infections such as cellulitis and infections of the abdomen, bladder, or ear.
Severe bone, joint, or muscle pain — The pain can be severe or disabling.
Skin reactions — Dermatitis, eczema, or rash may be severe.
Pancreatitis — Inflammation of the pancreas can cause severe stomach pain, nausea, or vomiting.
Suppression of bone turnover — Low bone remodeling may raise the risk of certain bone problems over time.

Get medical help right away if you think you are having a serious reaction.

How To Save on Bildyos

Organon offers The Organon Co-Pay Assistance Program for eligible people with private insurance who need help with out-of-pocket costs. Eligible people may pay as little as $0.

The Organon Access Program also offers support with understanding insurance coverage, estimating out-of-pocket costs, and navigating prior authorization or other coverage requirements. A separate patient assistance program may be available to some people without prescription drug coverage.

To learn more, visit the Bildyos affordability and support page, call 855-459-9922, or visit Organon Helps.

What To Know Before Taking Bildyos

Before you start Bildyos:

Your doctor should make sure your blood calcium level is not too low.
If you have advanced chronic kidney disease, your doctor should also check for a bone and mineral problem linked to kidney disease. This includes tests for parathyroid hormone, calcium, and vitamin D.
If you can become pregnant, your healthcare provider should do a pregnancy test before you receive Bildyos.

Tell your doctor if you have any allergies to denosumab-nxxp or any ingredients in Bildyos.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Also tell your doctor if you:

Are taking another medicine that contains denosumab
Have low blood calcium
Cannot take calcium and vitamin D every day
Have had thyroid or parathyroid surgery
Have trouble absorbing minerals from your stomach or intestines
Have kidney problems or are on dialysis
Take medicines that can lower your blood calcium
Plan to have dental surgery or a tooth removed

Take good care of your teeth and gums while receiving Bildyos. Brush and floss regularly, and tell your dentist that you receive Bildyos before having dental work.

Do not take Bildyos if you:

Have low blood calcium
Are pregnant
Have had a serious allergic reaction to a denosumab product or any of the ingredients in Bildyos

Bildyos is also FDA-approved to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for prostate cancer that has not spread to other parts of the body. It is also approved to increase bone mass in women at high risk for fracture who are receiving adjuvant aromatase inhibitor therapy as part of breast cancer care.

If you miss a dose, get the injection as soon as possible. After that, your next dose should be scheduled six months from the date of your last injection.

Do not take Bildyos if you are pregnant because it may cause fetal harm. If you can become pregnant, use effective birth control during treatment and for at least five months after your last dose. Tell your doctor right away if you become pregnant during treatment.

If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if Bildyos passes into breast milk. Do not breastfeed while receiving Bildyos.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Bildyos for osteoporosis?

In a three-year study of women with osteoporosis after menopause:

New spine fractures occurred in 2.3 percent of women treated with denosumab, compared with 7.2 percent who received a placebo (an inactive treatment).
Hip fractures occurred in 0.7 percent of women treated with denosumab, compared with 1.2 percent who received a placebo.
Nonvertebral fractures occurred in 6.5 percent of women treated with denosumab, compared with 8.0 percent who received a placebo.
After three years, bone mineral density increased compared with placebo by 8.8 percent at the lower spine, 6.4 percent at the total hip, and 5.2 percent at the femoral neck. The femoral neck is the upper part of the thigh bone near the hip.

In a separate one-year study of men with osteoporosis:

Bone mineral density increased compared with placebo by 4.8 percent at the lower spine.
Bone mineral density increased compared with placebo by 2.0 percent at the total hip.
Bone mineral density increased compared with placebo by 2.2 percent at the femoral neck.

How long does Bildyos take to work for osteoporosis?

Clinical studies of denosumab found that its effects on bone breakdown began soon after treatment. A marker of bone breakdown called serum type 1 C-telopeptide decreased by about 85 percent within three days, with the largest decreases seen by month 1.

At years 1, 2, and 3, denosumab significantly reduced new spine fractures in women with osteoporosis after menopause. It also increased bone mineral density at the bone sites measured after three years. The studies do not say exactly when a person will notice Bildyos working.

Should I take Bildyos for osteoporosis if I have an infection?

Bildyos may increase the risk of serious infections. These can include infections of the skin, abdomen, urinary tract, or ear.

People who take medicines that weaken the immune system, or who already have a weakened immune system, may have a higher risk of serious infections. Your doctor should consider the benefits and risks of Bildyos before treatment.

If you develop a serious infection while receiving Bildyos, your doctor should decide whether you should continue treatment. Get medical care promptly if you develop signs or symptoms of a serious infection, including cellulitis, which is a serious skin infection.