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Biosimilar icon

STOBOCLO works the same way as Prolia® (denosumab)

STOBOCLO is a prescription biosimilar of Prolia.

Biosimilar means that:

  • A biologic product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product
  • There are no clinically meaningful differences in how it works or in how safe it is compared to the reference product

A biosimilar is typically more affordable than the reference product.

Since STOBOCLO is a biosimilar of Prolia, it can be used instead of Prolia.

FDA, Food and Drug Administration.

Similar to Prolia, STOBOCLO works to strengthen bones and reduce the risk of fractures

Osteoporosis is a condition where bones become weaker and less dense, which can lead to an increased risk of fractures. Certain cancers can affect the way your bones break down and can increase your risk of serious bone problems.

STOBOCLO works by blocking a natural protein in your body called RANKL. This protein signals cells that break down bones. By blocking RANKL, STOBOCLO helps slow bone breakdown, keeping your bones stronger for longer.

STOBOCLO is not a cancer treatment.

STOBOCLO can be used to strengthen and protect bones at high risk for fracture in:

Men and postmenopausal women with

Osteoporosis

Patients with

Osteoporosis

from long-term steroid treatment

Men with

Bone Loss

from prostate cancer treatment

Women with

Bone Loss

from breast cancer treatment

Syringe icon

Approved for multiple conditions

STOBOCLO is approved to treat other diseases it has not been directly tested on in studies. The FDA looks at a wide variety of tests and data to determine that a drug is biosimilar to a reference product, including clinical trials, blood and immune system evaluations, and chemical analyses. STOBOCLO has passed these tests and is officially approved by FDA as a biosimilar to Prolia.

FDA, Food and Drug Administration.

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STOBOCLO was shown to be as effective and as safe as Prolia

In a clinical study of 479 postmenopausal women with osteoporosis, both STOBOCLO and Prolia similarly strengthened bones—increasing bone mineral density by about 5%.

Percentage of patients without fractures

Patients with no

Spine/Neck Fractures

Stoboclo graph

Patients with no

Hip Fractures

Stoboclo graph

Patients with no

Other Fractures

Stoboclo graph

Individual results may vary.

STOBOCLO and Prolia delivered similar results—over 98% of STOBOCLO and Prolia patients did not experience spine/neck, hip, or other fractures.

As the trial continued, these results generally stayed the same.

Of patients who continued STOBOCLO:

  • 99% had no spine/neck fractures
  • 100% had no hip fractures
  • 99% had no other fractures

Of patients who switched to STOBOCLO:

  • 100% had no spine/neck fractures
  • 100% had no hip fractures
  • 99% had no other fractures

In the same clinical trial of postmenopausal women with osteoporosis, the STOBOCLO safety profile was similar to that of Prolia and was generally well tolerated.

Side effects of STOBOCLO

Common side effects of STOBOCLO may include:

In postmenopausal women with osteoporosis:

  • Back pain
  • Pain in the arms and legs
  • High cholesterol levels
  • Muscle pain
  • Bladder infection

In men with osteoporosis:

  • Back pain
  • Joint pain
  • Common cold (runny nose or sore throat) 

In patients with steroid-induced osteoporosis:

  • Back pain
  • High blood pressure
  • Lung infection (bronchitis)
  • Headache

In patients receiving certain treatments for prostate or breast cancer:

  • Joint pain
  • Back pain
  • Pain in the arms and legs
  • Muscle pain

Patients with advanced chronic kidney disease, including dialysis-dependent patients, are at risk of severe hypocalcemia (low calcium levels in your blood) following STOBOCLO administration.

Most people with low blood calcium levels do not have symptoms, but some people may have symptoms that include:

  • Spasms, twitches, or cramps in your muscles
  • Numbness or tingling in your fingers, toes, or around your mouth

Call your doctor right away if you think you may be having any of these symptoms.

These are not all of the possible side effects of STOBOCLO. Before starting STOBOCLO, you should also review “What is the most important information I should know about STOBOCLO?” in the Medication Guide.

In patients receiving certain treatments for prostate or breast cancer:

  • Joint pain
  • Back pain
  • Pain in the arms and legs
  • Muscle pain

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. You may also report side effects to Celltrion USA, Inc. at 1‑800‑560‑9414.

FDA, Food and Drug Administration.

IMPORTANT SAFETY INFORMATION

If you receive STOBOCLO, you should not receive other denosumab products at the same time.

STOBOCLO can cause serious side effects including:

Increased risk of severe low calcium levels in your blood (hypocalcemia). STOBOCLO may lower the calcium levels in your blood. Your doctor should treat any low calcium levels before starting STOBOCLO and may prescribe calcium and vitamin D supplements—take these exactly as instructed. If you have advanced chronic kidney disease (with or without dialysis) or chronic kidney disease-mineral bone disorder (CKD-MBD), your risk of severe hypocalcemia increases, potentially leading to hospitalization, life-threatening events, or death. Your doctor may monitor your blood levels before and during treatment. Low blood calcium often has no symptoms, but call your doctor immediately if you notice muscle spasms, twitches, cramps, or numbness and tingling in your fingers, toes, or around your mouth.

Serious allergic reactions. Serious allergic reactions have occurred with denosumab products. Call your doctor or seek emergency care immediately if you experience symptoms such as low blood pressure (hypotension), rash, difficulty breathing, itching, throat tightness, hives, or swelling of your face, lips, or tongue.

Severe jawbone problems (osteonecrosis). Severe jaw bone problems may happen when you take STOBOCLO. Your doctor should examine your mouth before starting treatment and may advise seeing a dentist. Practice good oral care and consult your doctor or dentist if needed.

Unusual thigh bone fractures. Symptoms include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying STOBOCLO. Talk with your doctor before starting STOBOCLO treatment. Stopping, skipping, or delaying doses can increase your risk of bone fractures, especially in your spine. This risk is higher if you’ve already had a spine fracture. Do not change your dosing without consulting your doctor, who may recommend other treatments if STOBOCLO is stopped.

Serious infections. STOBOCLO may increase your risk of serious infections in your skin, abdomen, bladder, ear, or heart (endocarditis). Your risk is higher if you have a weakened immune system or take medicines that affect immunity. You may need hospital treatment if an infection develops. Call your doctor immediately if you experience fever or chills; red, swollen, hot, or tender skin; persistent cough or shortness of breath; severe abdominal pain; or frequent, urgent, or painful urination.

Skin problems. STOBOCLO may cause skin problems like dermatitis, rash, or eczema. Call your doctor if symptoms such as persistent redness, dry or leathery skin, itching, blisters that ooze or crust, small bumps or rash patches, or skin peeling worsen or do not resolve.

Severe bone, joint, or muscle pain. Some people who take denosumab products develop severe bone, joint, or muscle pain.

Do not take STOBOCLO if you have low blood calcium, are pregnant or planning pregnancy, or if you’re allergic to denosumab or any ingredients in STOBOCLO.

Before taking STOBOCLO, tell your doctor if you:

  • take other denosumab products
  • have low blood calcium
  • cannot take daily calcium and vitamin D supplements
  • have had parathyroid or thyroid surgery
  • have malabsorption syndrome (trouble absorbing minerals)
  • have kidney problems or receive dialysis
  • take medicines that can lower blood calcium
  • plan dental surgery or tooth removal
  • are pregnant, planning pregnancy, or breastfeeding. STOBOCLO may harm an unborn baby; a pregnancy test is required before treatment; use effective birth control during treatment and for 5 months after your last dose; inform your doctor immediately if pregnancy occurs. It is unknown if STOBOCLO passes into breast milk; do not breastfeed during treatment.

Tell your doctor of all medicines, vitamins, and herbal supplements you take. Keep an updated list to share with healthcare providers.

The most common side effects of STOBOCLO are:

For women with osteoporosis after menopause: back pain, muscle pain, pain in arms and legs, bladder infection, high cholesterol.

For men with osteoporosis: back pain, common cold (runny nose or sore throat), joint pain.

For patients with glucocorticoid-induced osteoporosis: back pain, lung infection (bronchitis), high blood pressure, headache.

For patients treated for prostate or breast cancer: joint pain, pain in arms and legs, back pain, muscle pain.

Tell your doctor if side effects are bothersome or persistent. These are not all possible side effects. Call your doctor for advice on side effects or report them to the FDA at 1‑800‑FDA‑1088.

Please see the Medication Guide and talk with your healthcare provider.

INDICATIONS

STOBOCLO (denosumab-bmwo) is a prescription medicine used to:

  • Treat osteoporosis in women after menopause who are at high risk for fracture or who cannot use or haven’t responded well to other osteoporosis medicines.
  • Increase bone mass in men with osteoporosis who are at high risk for fracture.
  • Treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least 6 months and are at high risk for fracture.
  • Treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
  • Treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

It is not known if STOBOCLO is safe and effective in children. STOBOCLO is not approved for use in children.

INDICATIONS

STOBOCLO (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment:

  • of postmenopausal women with osteoporosis at high risk for fracture
  • to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
  • of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
  • to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer;

IMPORTANT SAFETY INFORMATION

If you receive STOBOCLO, you should not receive other denosumab products at the same time.

STOBOCLO can cause serious side effects including:

Increased risk of severe low calcium levels in your blood (hypocalcemia). STOBOCLO may lower the calcium levels in your blood. Your doctor should treat any low calcium levels before starting STOBOCLO and may prescribe calcium and vitamin D supplements—take these exactly as instructed. If you have advanced chronic kidney disease (with or without dialysis) or chronic kidney disease-mineral bone disorder (CKD-MBD), your risk of severe hypocalcemia increases, potentially leading to hospitalization, life-threatening events, or death. Your doctor may monitor your blood levels before and during treatment. Low blood calcium often has no symptoms, but call your doctor immediately if you notice muscle spasms, twitches, cramps, or numbness and tingling in your fingers, toes, or around your mouth.

Serious allergic reactions. Serious allergic reactions have occurred with denosumab products. Call your doctor or seek emergency care immediately if you experience symptoms such as low blood pressure (hypotension), rash, difficulty breathing, itching, throat tightness, hives, or swelling of your face, lips, or tongue.

Severe jawbone problems (osteonecrosis). Severe jaw bone problems may happen when you take STOBOCLO. Your doctor should examine your mouth before starting treatment and may advise seeing a dentist. Practice good oral care and consult your doctor or dentist if needed.

Unusual thigh bone fractures. Symptoms include new or unusual pain in your hip, groin, or thigh.

Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying STOBOCLO. Talk with your doctor before starting STOBOCLO treatment. Stopping, skipping, or delaying doses can increase your risk of bone fractures, especially in your spine. This risk is higher if you’ve already had a spine fracture. Do not change your dosing without consulting your doctor, who may recommend other treatments if STOBOCLO is stopped.

Serious infections. STOBOCLO may increase your risk of serious infections in your skin, abdomen, bladder, ear, or heart (endocarditis). Your risk is higher if you have a weakened immune system or take medicines that affect immunity. You may need hospital treatment if an infection develops. Call your doctor immediately if you experience fever or chills; red, swollen, hot, or tender skin; persistent cough or shortness of breath; severe abdominal pain; or frequent, urgent, or painful urination.

Skin problems. STOBOCLO may cause skin problems like dermatitis, rash, or eczema. Call your doctor if symptoms such as persistent redness, dry or leathery skin, itching, blisters that ooze or crust, small bumps or rash patches, or skin peeling worsen or do not resolve.

Severe bone, joint, or muscle pain. Some people who take denosumab products develop severe bone, joint, or muscle pain.

Do not take STOBOCLO if you have low blood calcium, are pregnant or planning pregnancy, or if you’re allergic to denosumab or any ingredients in STOBOCLO.

Before taking STOBOCLO, tell your doctor if you:

  • take other denosumab products
  • have low blood calcium
  • cannot take daily calcium and vitamin D supplements
  • have had parathyroid or thyroid surgery
  • have malabsorption syndrome (trouble absorbing minerals)
  • have kidney problems or receive dialysis
  • take medicines that can lower blood calcium
  • plan dental surgery or tooth removal
  • are pregnant, planning pregnancy, or breastfeeding. STOBOCLO may harm an unborn baby; a pregnancy test is required before treatment; use effective birth control during treatment and for 5 months after your last dose; inform your doctor immediately if pregnancy occurs. It is unknown if STOBOCLO passes into breast milk; do not breastfeed during treatment.

Tell your doctor of all medicines, vitamins, and herbal supplements you take. Keep an updated list to share with healthcare providers.

The most common side effects of STOBOCLO are:

For women with osteoporosis after menopause: back pain, muscle pain, pain in arms and legs, bladder infection, high cholesterol.

For men with osteoporosis: back pain, common cold (runny nose or sore throat), joint pain.

For patients with glucocorticoid-induced osteoporosis: back pain, lung infection (bronchitis), high blood pressure, headache.

For patients treated for prostate or breast cancer: joint pain, pain in arms and legs, back pain, muscle pain.

Tell your doctor if side effects are bothersome or persistent. These are not all possible side effects. Call your doctor for advice on side effects or report them to the FDA at 1‑800‑FDA‑1088.

Please see the Medication Guide and talk with your healthcare provider.

INDICATIONS

STOBOCLO (denosumab-bmwo) is a prescription medicine used to:

  • Treat osteoporosis in women after menopause who are at high risk for fracture or who cannot use or haven’t responded well to other osteoporosis medicines.
  • Increase bone mass in men with osteoporosis who are at high risk for fracture.
  • Treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least 6 months and are at high risk for fracture.
  • Treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
  • Treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

It is not known if STOBOCLO is safe and effective in children. STOBOCLO is not approved for use in children.