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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.