WARNING

Taking Xgeva (denosumab) comes with certain risks, and it’s important for individuals to be aware of these potential risks before starting the medication. Some key risks associated with Xgeva include:

• Hypocalcemia: Xgeva can lower calcium levels in the blood, leading to symptoms such as muscle spasms or twitches, numbness or tingling, and seizures.
• Osteonecrosis of the Jaw (ONJ): This is a rare but serious condition where the bone tissue in the jaw fails to heal after minor trauma, often associated with dental procedures.
• Atypical Femoral Fractures: Unusual fractures of the thigh bone may occur with minimal or no trauma in individuals taking Xgeva.
• Infections: Xgeva has been associated with an increased risk of infections, including skin infections, urinary tract infections, and upper respiratory tract infections.
• Dermatologic Reactions: Skin reactions such as dermatitis, rash, and eczema are potential side effects of Xgeva.
• Allergic Reactions: While severe allergic reactions are rare, they can occur and may include difficulty breathing, swelling of the face or throat, and severe rash.
• Hypersensitivity: Some individuals may develop hypersensitivity reactions.
• Bone Pain: Musculoskeletal pain and pain in the extremities have been reported as common side effects.

It’s crucial to discuss these risks with your healthcare provider before starting Xgeva. The decision to use this medication is often based on a careful assessment of the potential benefits and risks for an individual. Healthcare providers will closely monitor patients on Xgeva and may adjust the treatment plan as needed.

Individual responses to medications can vary, and some people may experience side effects while others may not. If you are prescribed Xgeva, it’s essential to communicate with your healthcare provider about any concerns, symptoms, or changes in your health during the course of treatment. Regular follow-up appointments and monitoring are typically part of the treatment plan to manage and mitigate potential risks.

Why is this medication prescribed?

Xgeva (denosumab) is a medication used for the treatment of certain bone-related conditions. It is primarily prescribed for:

• Osteoporosis: Xgeva is used to treat osteoporosis in postmenopausal women and in men at high risk of fractures.
• Bone Metastases: It is also prescribed to prevent skeletal-related events (such as fractures or the need for radiation or surgery to the bone) in patients with bone metastases from solid tumors.
• Giant Cell Tumor of Bone: Xgeva is used to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
• Hypercalcemia of Malignancy: Xgeva can be used for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

How should this medicine be used?

Xgeva is usually given as an injection under the skin (subcutaneously) every four weeks. The dosage and schedule may vary depending on the specific condition being treated. It’s important to follow your healthcare provider’s instructions and the prescribed dosing schedule.

Here are general guidelines for using Xgeva:

• Administration: Xgeva is typically administered by a healthcare professional in a clinic or healthcare setting.
• Subcutaneous Injection: The medication is given as a subcutaneous injection, usually in the upper arm, thigh, or abdomen.
• Dosage: The recommended dosage and frequency will be determined by your healthcare provider based on your specific medical condition.
• Monitoring: Regular monitoring may be necessary during treatment to assess the response to Xgeva and to check for any potential side effects.
• Calcium and Vitamin D Supplementation: It is often recommended to take calcium and vitamin D supplements during Xgeva treatment to help maintain normal calcium levels in the blood.

It’s crucial to communicate with your healthcare provider about any concerns, side effects, or changes in your health during Xgeva treatment. Additionally, inform your healthcare provider about any other medications or supplements you are taking, as they may interact with Xgeva. Always follow your healthcare provider’s recommendations for the proper use of this medication.

Other uses for this medicine

While the primary uses of Xgeva are related to bone health and the prevention of skeletal-related events, researchers and healthcare providers may explore other potential applications. However, any off-label use should only be considered under the guidance of a healthcare professional.

What special precautions should I follow?

When using Xgeva, certain precautions should be taken to ensure the safety and effectiveness of the treatment. It’s important to discuss these precautions with your healthcare provider. Here are some general precautions associated with Xgeva:

• Hypocalcemia Monitoring: Xgeva may lower blood calcium levels. Patients should have their calcium levels monitored, and calcium and vitamin D supplementation may be necessary.
• Renal Impairment: Xgeva is primarily excreted through the kidneys. Caution is advised in patients with severe renal impairment. Adjustments to the dosage may be needed in these cases.
• Infections: Xgeva has been associated with an increased risk of infections, including skin infections, urinary tract infections, and upper respiratory tract infections. Patients should be monitored for signs of infection during treatment.
• Atypical Femoral Fractures: Xgeva has been associated with an increased risk of atypical femoral fractures. Patients on Xgeva should be monitored for any signs of unusual thigh or groin pain, as this may be an indication of a possible fracture.
• Osteonecrosis of the Jaw (ONJ): Osteonecrosis of the jaw has been reported in patients receiving Xgeva. Dental examinations and appropriate preventive measures are recommended before starting treatment.
• Pregnancy and Breastfeeding: The safety of Xgeva during pregnancy and breastfeeding is not well-established. It should be used during pregnancy only if the potential benefits justify the potential risks.
• Allergic Reactions: Patients should be monitored for signs of allergic reactions, and the medication should be discontinued if a serious allergic reaction occurs.
• Drug Interactions: Inform your healthcare provider about all medications, including over-the-counter drugs and supplements, that you are taking, as Xgeva may interact with other medications.

Always follow your healthcare provider’s instructions and communicate any concerns or side effects promptly. This information is not exhaustive, and individual patient circumstances may warrant additional precautions. Consult with your healthcare provider for personalized advice based on your health condition.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Xgeva. However, it’s generally important to maintain a balanced and healthy diet to support overall well-being.

What should I do if I forget a dose?

If you miss a dose of Xgeva, contact your healthcare provider to discuss the appropriate course of action. It’s important not to double up on doses to make up for a missed one. Your healthcare provider will guide you on how to proceed based on your specific situation.

What side effects can this medication cause?

Xgeva (denosumab) may cause side effects, and it’s important to be aware of potential reactions. Not everyone will experience these side effects, and their severity can vary from person to person. Common side effects and less common but serious side effects associated with Xgeva include:

Common Side Effects:

• Pain in the Extremities: This may include pain in the arms or legs.
• Fatigue: Feeling tired or weak is a common side effect.
• Musculoskeletal Pain: Pain in the muscles or joints may occur.
• Back Pain: Pain in the back is a reported side effect.
• Headache: Some individuals may experience headaches.
• Nausea: Feeling nauseous or having an upset stomach.
• Peripheral Edema: Swelling in the hands, arms, legs, or feet.
• Hypophosphatemia: Low levels of phosphate in the blood.

Less Common but Serious Side Effects:

• Hypocalcemia: Low levels of calcium in the blood, which can lead to symptoms such as muscle spasms or twitches, numbness or tingling, and seizures.
• Osteonecrosis of the Jaw (ONJ): A rare but serious condition involving the death of jawbone tissue, often associated with dental procedures.
• Atypical Femoral Fractures: Unusual fractures of the thigh bone that may occur with minimal or no trauma.
• Infections: Xgeva has been associated with an increased risk of infections.
• Dermatologic Reactions: Skin reactions, including dermatitis, rash, and eczema.
• Allergic Reactions: Severe allergic reactions are rare but can occur. Signs include difficulty breathing, swelling of the face or throat, and severe rash.
• Hypersensitivity: Some individuals may develop hypersensitivity reactions.

It’s crucial to report any unusual or severe symptoms to your healthcare provider promptly. Additionally, inform your healthcare provider about any pre-existing medical conditions and medications you are taking, as they may influence the likelihood or severity of side effects.

This list is not exhaustive, and individuals may experience different side effects. Always consult with your healthcare provider for personalized information and guidance regarding the use of Xgeva and the management of potential side effects.

What should I know about storage and disposal of this medication?

Storage of Xgeva:

Follow the storage instructions provided by your healthcare provider or pharmacist. In general:

• Refrigeration: Xgeva is often stored in the refrigerator. Keep it refrigerated until the time of use.
• Protection from Light: Protect the medication from light. Keep it in the original carton until you are ready to use it.
• Do Not Freeze: Do not freeze Xgeva.

Always check the specific storage instructions on the medication packaging or consult with your healthcare provider.

Disposal of Xgeva:

Follow proper disposal guidelines to ensure the safe disposal of Xgeva:

• Unused Medication: Return any unused medication to your healthcare provider or a designated collection site.
• Dispose of Sharps Safely: If your Xgeva is administered as an injection with a needle, dispose of used needles in a sharps container. Do not throw them in the regular trash.
• Local Regulations: Follow local regulations for the disposal of medications. Some areas have specific guidelines for medication disposal.
• Ask Your Pharmacist: If you are unsure about how to dispose of Xgeva, ask your pharmacist for guidance.

In case of emergency/overdose

In case of an emergency or overdose, seek medical attention immediately. Symptoms of overdose may include severe dizziness, weakness, or fainting.

What other information should I know?

• Follow-up Appointments: Regularly attend follow-up appointments with your healthcare provider to monitor your response to treatment and assess for any potential side effects.
• Inform Healthcare Providers: Keep your healthcare provider informed about all medications, supplements, and over-the-counter drugs you are taking, as well as any changes in your health.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, inform your healthcare provider. The use of Xgeva during pregnancy and breastfeeding should be discussed, as the potential risks and benefits need to be considered.
• Dental Care: Inform your dentist that you are taking Xgeva. Dental examinations and appropriate preventive measures are recommended before starting treatment.
• Regular Monitoring: Your healthcare provider may perform regular blood tests, imaging studies, or other assessments to monitor your response to Xgeva and to check for any potential complications.

Always follow your healthcare provider’s instructions and contact them if you have any questions or concerns regarding Xgeva or your treatment plan. The information provided here is general, and individual circumstances may warrant specific considerations.