Stoboclo (Denosumab-Bmwo) for Osteoporosis

Stoboclo (denosumab-bmwo) 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 Stoboclo Works and How It’s Taken

Stoboclo 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, Stoboclo slows bone breakdown and helps increase bone mass and strength.

Stoboclo 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 Stoboclo when one of the following applies:

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.
A man is at high risk for fracture and is receiving androgen deprivation therapy for prostate cancer that has not spread to other parts of the body.
A woman is at high risk for broken bones and is receiving adjuvant aromatase inhibitor therapy as part of breast cancer care.

Stoboclo is given as an injection under the skin by a healthcare provider once every six months.

Typical Dosing for Osteoporosis

The recommended dose of Stoboclo 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 Stoboclo.

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

Stoboclo Side Effects

In clinical studies of denosumab, the active ingredient in Prolia, the reference medicine for Stoboclo, 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 osteoporosis caused by corticosteroid medicines, 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

Stoboclo 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.

Stoboclo 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 can include anaphylaxis, which can cause trouble breathing, hives, or swelling of the face, lips, or tongue.
Osteonecrosis of the jaw (jawbone damage) — This can cause jaw pain, infection, or slow healing, often after dental work.
Atypical femur fractures (unusual thigh bone fractures) — These 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 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 — These can include dermatitis, eczema, or rash and may be severe.

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

How To Save on Stoboclo

Celltrion USA, the manufacturer of Stoboclo, offers the Celltrion CARES Co-Pay Assistance Program. Eligible people with commercial insurance may pay as little as $0.

Eligibility screening is also available through the Celltrion CONNECT Patient Support Program.

To learn more, visit the Stoboclo support page or call 877-812-6662.

What To Know Before Taking Stoboclo

Before you start Stoboclo:

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 Stoboclo.

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

Before taking Stoboclo, 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
Are allergic to denosumab products or any of the ingredients in Stoboclo

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

Do not take Stoboclo if you:

Have low blood calcium
Are pregnant
Are allergic to denosumab products or any of the ingredients in Stoboclo

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 Stoboclo if you are pregnant because it may harm a fetus. 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 Stoboclo passes into breast milk. Do not breastfeed while receiving Stoboclo.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Stoboclo 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 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, 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 Stoboclo 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 after one, two, and three years. 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 Stoboclo working.

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

Stoboclo 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 Stoboclo before treatment.

If you develop a serious infection while receiving Stoboclo, 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.