Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Xgeva (Denosumab). If you are concerned about side effects, discuss the risks and benefits of Xgeva (Denosumab) with your doctor.

The following side effects have been reported by at least 1% of people taking Xgeva (Denosumab). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• Constipation
• Diarrhea
• dizziness
• fatigue
• headache
• nausea
• pain, redness, or swelling at the site of the injection
• pain in muscles, arms, legs, or back

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention. 

Check with your doctor as soon as possible if any of the following side effects occur:

• flu-like symptoms (e.g., sore throat, cough, runny nose)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, Fever, chills, rapid heartbeat, swollen abdomen)
• sores in mouth on the gums or jaw bone
• symptoms of a skin infection (e.g., redness, swelling, warmth, tenderness)
• symptoms of low blood calcium levels (e.g., muscle spasms, twitches, or cramps; numbness or tingling in the fingers, toes, or around the mouth)
• symptoms of low levels of phosphate in the blood (e.g., difficulty swallowing, weakness of the large muscles, tingling in the extremities, slowed breathing or heart beat)
• unusual pain in hip, groin, or thigh
• unusual tiredness or weakness
• wheezing or shortness of breath

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a Anaphylaxis (severe allergic reaction) (such as difficulty breathing, Hives, swelling of the face or throat)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• unusual pain and swelling of the jaw

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Xgeva (Denosumab).

Each single-use vial containing 1.7 mL of a sterile, preservative-free, clear, colourless-to-slightly yellow solution, formulated at pH 5.2, contains 120 mg of Xgeva (Denosumab). Nonmedicinal ingredients: sorbitol, acetate, water for injection (USP), and sodium hydroxide to a pH of 5.2.

Do not use Xgeva (Denosumab) if you:

• are allergic to Xgeva (Denosumab) or any ingredients of the medication
• have low blood calcium levels

There may be an interaction between Xgeva (Denosumab) and any of the following:

• azathioprine
• anticancer medications (e.g., Cyclophosphamide, Methotrexate, Bleomycin)
• Belimumab
• corticosteroids (e.g., prednisone, Dexamethasone, budesonide, Hydrocortisone)
• Cyclosporine
• Hydroxyurea
• Infliximab
• mycophenolate
• Rituximab
• Tacrolimus
• Tocilizumab

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Xgeva (Denosumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xgeva (Denosumab).

Calcium and vitamin D: While using Xgeva (Denosumab), it is important that you are receiving enough calcium and vitamin D to maintain blood calcium levels. Your doctor will recommend a dose of calcium and vitamin D based on your needs. If you develop symptoms of low blood calcium levels (muscle spasms, twitches, or cramps; numbness or tingling in the fingers, toes, or around the mouth) while using Xgeva (Denosumab), contact your doctor immediately or get immediate medical attention.

Fractures: As with other medications in this class, Xgeva (Denosumab) may contribute to a type of rare fracture of the long bone in the thigh (femur). If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.

Fractures of the bones in the spine (vertebra) have been reported after stopping Xgeva (Denosumab). Do not stop treatment with Xgeva (Denosumab) without checking with your doctor first.  

Infections: Xgeva (Denosumab) may cause infections that in some cases are serious and require hospitalization. Contact your doctor at once if you develop signs of an infection such as fever, abdominal pain, earache, painful urination, or blood in the urine, or if you notice a red, swollen, or tender area on the skin. People who are taking medications that suppress the immune system (e.g., Prednisone, Azathioprine, anticancer medications) or who have a suppressed immune system may be more at risk of developing infections.

Severe jawbone problems: Xgeva (Denosumab) may cause problems with your upper or lower jaw. You may be at a higher risk of these problems if you have cancer that has spread to the bones, are taking certain medications (e.g., prednisone, anticancer medications), are having radiation treatments, have poor oral hygiene, or are having a tooth extracted. Your doctor may recommend that you see a dentist before starting Xgeva (Denosumab). It is important to practice good oral hygiene while taking Xgeva (Denosumab).

Pregnancy: The safety of Xgeva (Denosumab) for use during pregnancy has not been established. Xgeva (Denosumab) is not recommended for use during pregnancy. If you become pregnant while using Xgeva (Denosumab), contact your doctor immediately. For women taking Xgeva (Denosumab), an effective form of birth control should be used during treatment and for at least 5 months after the last dose of Xgeva (Denosumab).

Breast-feeding: Xgeva (Denosumab) has not been studied for use by breast-feeding mothers. It is not known if Xgeva (Denosumab) passes into breast milk. If you are a breast-feeding mother and are taking Xgeva (Denosumab), it may affect your baby. Xgeva (Denosumab) is not recommended for use by women who are breast-feeding.

Children and adolescents: The safety and effectiveness of using Xgeva (Denosumab) have not been established for children. Xgeva (Denosumab) is only recommended for adolescents with giant cell tumour of bone whose bones have stopped growing. Xgeva (Denosumab) has not been studied in children and adolescents with other cancers that have spread to bone.