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Here is important safety information regarding the use of this medication. Please review these points and discuss any concerns with your healthcare provider.

• Low Calcium Levels: Xgeva (denosumab) can lead to dangerously low calcium levels, particularly in individuals with kidney issues or those taking medications like cinacalcet (Sensipar) and Parsabiv (etelcalcetide) for high parathyroid levels. Factors that increase risk include serious kidney problems, not taking calcium supplements, medications that lower calcium levels, mineral absorption disorders, previous small intestine surgery, and a history of hypoparathyroidism or thyroid surgery.

• High Calcium Levels After Discontinuation: Ceasing Xgeva (denosumab) can cause high calcium levels in individuals treated for giant cell tumor of bone and those whose bones are still growing, especially within the first year of stopping the medication. Report symptoms like appetite loss, stomach upset, nausea, vomiting, and constipation to your prescriber immediately. Risk factors include a history of giant cell tumor of bone and being in an age group where bones are still developing.

• Jaw Bone Problems (Osteonecrosis): Xgeva (denosumab) may rarely cause osteonecrosis of the jaw, a condition where the jaw bone deteriorates, resulting in jaw pain, infections, or slow healing post-dental procedures. Risks are heightened by prolonged use, dental procedures, use of dental devices, steroid medications, certain tumor-inhibiting drugs, chemotherapy, poor oral hygiene, gum infections, or diabetes history.

• Unusual Thigh Bone Fractures: Some individuals on Xgeva (denosumab) have experienced atypical thigh fractures without injury. Contact your healthcare team if you experience new or unusual hip, thigh, or groin pain.

• Spine Fractures After Stopping Treatment: Halting or missing doses of Xgeva (denosumab) can increase the risk of spine fractures. Inform your prescriber if you have a history of spine fractures before starting treatment. To mitigate spine fracture risks, an alternative osteoporosis medication may be recommended after discontinuation.

• Risk to Unborn Babies: Xgeva (denosumab) poses a serious risk to unborn babies. Do not use if pregnant. A pregnancy test may be requested before starting treatment, and reliable birth control should be used during and for at least 5 months after stopping the medication.

• Serious Allergic Reactions: Some individuals have experienced severe allergic reactions, including breathing difficulties, throat and lip swelling, and hives. Seek immediate medical attention if these occur, and inform your healthcare provider to discuss alternative treatments.

Contraindications:

• Untreated low calcium levels.
• Current pregnancy.

Consult your healthcare provider if any of these conditions apply to you before using this medication.

When using this medication, some individuals may experience common side effects such as tiredness, weakness, headache, back pain, diarrhea, and nausea. These effects are generally mild, but if they persist or worsen, it is advisable to consult a healthcare provider. Additionally, some patients may experience fatigue, low blood phosphorus levels, shortness of breath, or a cough. These effects, while common, are usually not severe.

There are also other side effects that may occur, including skin rash, hair loss, and muscle pain. If you experience these symptoms, particularly if they are severe, it's important to contact your healthcare provider. Serious side effects, although rare, require urgent medical attention. These include severe allergic reactions characterized by dizziness, trouble breathing, swelling of the face and throat, and severe rash. Additionally, dangerously low calcium levels can manifest as tingling, numbness, muscle cramps, irregular heart rhythms, or seizures.

A rare but serious condition known as osteonecrosis of the jaw may occur, presenting with symptoms such as jaw pain, swelling, exposed bone, and gum infection. Low calcium levels in the blood, which can be very serious, may also occur, especially in individuals with kidney problems. Symptoms include severe muscle spasms, mood changes, numbness, and severe dizziness. If you stop using the medication, be aware that there may be a risk of bone fractures in the spine, particularly if you have osteoporosis or a history of broken bones. Always seek medical help if you notice unusual symptoms or if you have concerns about side effects.