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Frequently Asked Questions

Here you can find answers to the most common questions about STOBOCLO.

What is STOBOCLO?

STOBOCLO is a biosimilar of Prolia® (denosumab). Like Prolia, STOBOCLO is used to strengthen and protect bones in conditions such as osteoporosis, osteoporosis from steroid use, and bone loss from cancer treatment. However, STOBOCLO may be more affordable than Prolia.

What is a biosimilar?

STOBOCLO is a prescription biosimilar of Prolia® (denosumab). 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.

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

FDA, Food and Drug Administration.

How is STOBOCLO administered?

STOBOCLO is given as an injection under the skin (subcutaneous injection) every 6 months by your healthcare provider.

What is the most important information I should know about STOBOCLO?

If you receive STOBOCLO, you should not receive other denosumab products.

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. If you have low blood calcium before you start receiving STOBOCLO, it may get worse during treatment. Your low blood calcium must be treated before you receive STOBOCLO. Talk to your doctor before starting STOBOCLO. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take STOBOCLO. Take calcium and vitamin D as your doctor tells you to.

    If you have advanced chronic kidney disease (may or may not be on kidney dialysis), STOBOCLO may increase your risk for severe low calcium levels in your blood, which could result in hospitalization, life-threatening events and death. A mineral and bone disorder associated with kidney disease called chronic kidney disease-mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start STOBOCLO and during treatment, your doctor may need to do certain blood tests to check for CKD-MBD.

    Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
    • spasms, twitches, or cramps in your muscles
    • numbness or tingling in your fingers, toes, or around your mouth
  • Serious allergic reactions. Serious allergic reactions have happened in people who take denosumab products. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction. Symptoms of a serious allergic reaction may include:
    • low blood pressure (hypotension)
    • trouble breathing
    • throat tightness
    • swelling of your face, lips, or tongue
    • rash
    • itching
    • hives
  • Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take STOBOCLO. Your doctor should examine your mouth before you start STOBOCLO. Your doctor may tell you to see your dentist before you start STOBOCLO. It is important for you to practice good mouth care during treatment with STOBOCLO. Ask your doctor or dentist about good mouth care if you have any questions.
  • Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture 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. After your treatment with STOBOCLO is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking STOBOCLO without first talking with your doctor. If your STOBOCLO treatment is stopped, talk to your doctor about other medicine that you can take.
  • Serious infections. Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take STOBOCLO. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take STOBOCLO. You may need to go to the hospital for treatment if you develop an infection.

    STOBOCLO is a medicine that may affect the ability of your body to fight infections. People who have a weakened immune system may have an increased risk for developing serious infections. Call your doctor right away if you have any of the following symptoms of infection:
    • fever or chills
    • skin that looks red or swollen and is hot or tender to touch
    • fever, shortness of breath, cough that will not go away
    • severe abdominal pain
    • frequent or urgent need to urinate or burning feeling when you urinate
  • Skin problems. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema may happen if you take STOBOCLO. Call your doctor if you have any of the following symptoms of skin problems that do not go away or get worse: 
    • redness
    • itching
    • small bumps or patches (rash)
    • your skin is dry or feels like leather
    • blisters that ooze or become crusty
    • skin peeling
  • Bone, joint, or muscle pain. Some people who take denosumab products develop severe bone, joint, or muscle pain.

Call your doctor right away if you have any of these side effects.

Ask your physician about the STOBOCLO Risk Evaluation and Mitigation Strategy program, or go to www.stoboclorems.com.

Be sure to review the Medication Guide carefully and talk with your healthcare provider before starting STOBOCLO.

What are the benefits of treatment with STOBOCLO?

In a clinical study of 479 postmenopausal women with osteoporosis, STOBOCLO was shown to be as effective as Prolia® (denosumab) in reducing fractures.

STOBOCLO may be prescribed for all the same conditions Prolia is approved to treat.

Is STOBOCLO safe?

Yes, STOBOCLO has been approved by the FDA, which means it has passed rigorous testing to ensure it is safe and effective for patients. Like any medicine, it may have side effects, so it’s important to talk to your doctor about any concerns.

FDA, Food and Drug Administration.

What are the side effects of STOBOCLO?

STOBOCLO may cause serious side effects.

The most common side effects of STOBOCLO in women who are being treated for osteoporosis after menopause are:

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

The most common side effects of STOBOCLO in men with osteoporosis are:

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

The most common side effects of STOBOCLO in patients with glucocorticoid-induced osteoporosis are:

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

The most common side effects of STOBOCLO in patients receiving certain treatments for prostate or breast cancer are:

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

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of STOBOCLO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.