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 Prolia (Denosumab).
Calcium and vitamin D: While using Prolia (Denosumab), you need to receive 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. Contact your doctor immediately or get immediate medical attention if you develop symptoms of low blood calcium levels while using Prolia (Denosumab) (muscle spasms, twitches, or cramps; numbness or tingling in the fingers, toes, or around the mouth).
Fractures: As with other medications in this class, Prolia (Denosumab) may contribute to a type of rare fracture of the long bone in the thigh (femur) without any form of trauma. If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Infections: Prolia (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 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., Tacrolimus, prednisone, Azathioprine, anticancer medications) or who have a suppressed immune system may be more at risk of developing infections.
Latex allergy: The needle cap on the pre-filled syringe contains a latex derivative and should not be handled by people who are allergic to latex.
Severe jawbone problems: Prolia (Denosumab) may cause problems with your upper and 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 Prolia (Denosumab). It is important to practice good oral hygiene while taking Prolia (Denosumab).
Pregnancy: Prolia (Denosumab) is only recommended for postmenopausal women and has not been studied for use during pregnancy. If you become pregnant while using Prolia (Denosumab), contact your doctor immediately.
Male partners of females who are or may become pregnant should use a barrier method of birth control (i.e., condoms).
Breast-feeding: Prolia (Denosumab) has not been studied for use by breast-feeding mothers. It is not known if Prolia (Denosumab) passes into breast milk. If you are a breast-feeding mother and are taking Prolia (Denosumab), it may affect your baby. Prolia (Denosumab) is not recommended for use by women who are breast-feeding.
Children and adolescents: The safety and effectiveness of using Prolia (Denosumab) have not been established for children.
