Ospomyv (Denosumab-dssb) for Osteoporosis

Ospomyv (denosumab-dssb) 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 approved to increase bone mass in men with osteoporosis who are at high risk for fracture.

How Ospomyv Works and How It’s Taken

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

Ospomyv 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 Ospomyv 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 has osteoporosis caused by glucocorticoid medicines, such as prednisone, is at high risk for fracture, and is expected to take these medicines for at least six months.

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

Typical Dosing for Osteoporosis

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

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

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

Ospomyv Side Effects

In clinical studies of denosumab, the active ingredient in Prolia, 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
Hypercholesterolemia (high cholesterol)
Cystitis (bladder infection)
Musculoskeletal pain (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 osteoporosis caused by glucocorticoid medicines, common side effects include:

Back pain
Hypertension (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
Musculoskeletal pain (muscle or bone pain)

Serious Side Effects and Warnings

Ospomyv has a boxed warning, the FDA’s strongest safety warning, for severe hypocalcemia in people with advanced chronic kidney disease. A boxed warning does not mean the drug is unsafe for everyone or that everyone faces the same level of risk.

Ospomyv 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, or numbness and tingling.
Serious allergic reactions — These include anaphylaxis, which can cause trouble breathing, hives, or swelling of the face, lips, or tongue.
Osteonecrosis of the jaw — This jawbone damage can cause jaw pain, infection, or slow healing, often after dental work.
Atypical femur fractures — These 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 can increase after stopping, skipping, or delaying doses.
Serious infections — These 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.

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

How To Save on Ospomyv

Cordavis, the manufacturer of Ospomyv, offers the Ospomyv Co-Pay Program. Eligible people may be able to reduce their out-of-pocket costs. The copay card does not expire, and enrollment renews automatically each year.

To learn more or ask about injection support, visit the Ospomyv website or call 833-267-3130.

What To Know Before Taking Ospomyv

Before you start Ospomyv:

Your doctor should make sure your blood calcium 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 may include tests for parathyroid hormone, calcium, and vitamin D.
If you can become pregnant, your healthcare provider should do a pregnancy test before you receive Ospomyv.

Before taking Ospomyv, tell your doctor if you:

Are allergic to denosumab products or any of the ingredients in Ospomyv

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 Ospomyv. Brush and floss regularly, and tell your dentist that you receive Ospomyv before having dental work.

Do not take Ospomyv if you:

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

Ospomyv 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 Ospomyv if you are pregnant because it may harm fetal health. 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 Ospomyv passes into breast milk. Do not breastfeed while receiving Ospomyv.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Ospomyv 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 placebo.
Fractures outside the spine occurred in 6.5 percent of women treated with denosumab, compared with 8.0 percent who received placebo.
At year 3, 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, which 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 by 2.0 percent at the total hip.
Bone mineral density increased by 2.2 percent at the femoral neck.

How long does Ospomyv take to work for osteoporosis?

Studies of denosumab showed that changes in bone breakdown began soon after treatment. One marker of bone breakdown, called serum type 1 C-telopeptide, decreased by about 85 percent within three days. The largest decreases were seen by one month.

In women with osteoporosis after menopause, denosumab significantly reduced new spine fractures at years 1, 2, and 3. It also significantly increased bone mineral density at measured bone sites after three years.

The study does not say exactly when a person will notice denosumab working.

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

Ospomyv 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 Ospomyv before treatment.

If you develop a serious infection while receiving Ospomyv, 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.