US residents only

Before you start STOBOCLO

Speak to your doctor about your medical history, especially if you are or may become pregnant, or if you have a history of kidney problems.

Your doctor may want to give you some tests to make sure STOBOCLO is right for you. These tests include: 

Calcium level test

Your doctor will give you a test to measure the amount of calcium in your blood. If the level is too low, you will probably need to take medicine to bring your calcium up to normal.

Pregnancy test

If you could become pregnant, your doctor will test to make sure you are not pregnant before starting STOBOCLO. Women should use birth control the entire time they are taking STOBOCLO and for 5 months after their last dose of STOBOCLO.

Make sure you tell your doctor if you are pregnant, are planning to get pregnant, think you may be pregnant, or are breastfeeding.

Dental evaluation

Your doctor will likely want you to have a dental exam before starting STOBOCLO.

Tell your doctor of any tooth pain or dental work you have had or are planning to have. In clinical studies, some patients taking denosumab experienced jawbone deterioration, a condition called osteonecrosis of the jaw.

Let your dentist know that you are taking STOBOCLO. Make sure you visit your dentist as your doctor recommends.

What to expect during STOBOCLO treatment

STOBOCLO is given as a shot under the skin by your healthcare provider. It does not require an infusion.

Your doctor will inject STOBOCLO in one of these 3 locations:

  • Upper arm
  • Upper thigh
  • Stomach area

Your doctor may test your blood calcium before you start STOBOCLO and while you are taking STOBOCLO.

Kidney function

You can take STOBOCLO even with lower kidney function. If your kidney function is lower than normal, you are at increased risk of low blood calcium levels. Consult your doctor on how best to manage your individual risk.

STOBOCLO dosing

Your doctor will administer STOBOCLO every 6 months.

  • You will receive a 60-mg, single subcutaneous injection
  • You may take 1000 mg of calcium and at least 400 IU of vitamin D daily, as directed by your doctor

Getting the most out of STOBOCLO

At your appointment

  • Wear loose, comfortable clothing
  • Schedule your next appointments in advance as instructed by your doctor

Things to do every day

  • Maintain good oral hygiene
    • Brush twice daily
    • Use a fluoride toothpaste
    • Brush for 2 minutes each time you brush
    • Floss your teeth every day
    • Eat a healthy diet and limit sugar
    • Visit your dentist regularly

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.