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 this medication.
Calcium and vitamin D: While using this medication, 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 this medication, contact your doctor immediately or get immediate medical attention.
Fractures: As with other medications in this class, 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.
Infections: This medication 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, blood in 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 people who have a suppressed immune system may be more at risk of developing infections.
Severe jawbone problems: 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 this medication. It is important to practice good oral hygiene while taking this medication.
Pregnancy: The safety of denosumab for use during pregnancy has not been established. Denosumab is not recommended for use during pregnancy. If you become pregnant while using this medication, contact your doctor immediately. For women taking denosumab, an effective form of birth control should be used during treatment and for at least 5 months after the last dose of denosumab.
Breast-feeding: Denosumab has not been studied for use by breast-feeding mothers. It is not known if denosumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Denosumab is not recommended for use by women who are breast-feeding.
Children and adolescents: The safety and effectiveness of using this medication have not been established for children. Denosumab is only recommended for adolescents with giant cell tumour of bone whose bones have stopped growing. Denosumab has not been studied in children and adolescents with other cancers that have spread to bone.