What is the most important information I should know about Conexxence?
If you receive Conexxence, you should not receive other denosumab products at the same time.
Conexxence can cause serious side effects including:

• Increased risk of severe low calcium levels in your blood (hypocalcemia). Conexxence may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Conexxence, it may get worse during treatment. Your low blood calcium must be treated before you receive Conexxence. Talk to your doctor before starting Conexxence. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Conexxence. Take calcium and vitamin D as your doctor tells you to.
  If you have advanced chronic kidney disease (may or may not be on kidney dialysis), Conexxence may increase your risk for severe low calcium levels in your blood, which could result in hospitalization, life-threatening events and death. A mineral and bone disorder associated with kidney disease called chronic kidney disease-mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start Conexxence and during treatment, your doctor may need to do certain blood tests to check for CKD-MBD.
  Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
  • spasms, twitches, or cramps in your muscles
  • numbness or tingling in your fingers, toes, or around your mouth
• Serious allergic reactions. Serious allergic reactions have happened in people who take denosumab products. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction. Symptoms of a serious allergic reaction may include:

  low blood pressure (hypotension) trouble breathing throat tightness swelling of your face, lips, or tongue

  rash itching hives

• Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take Conexxence. Your doctor should examine your mouth before you start Conexxence. Your doctor may tell you to see your dentist before you start Conexxence. It is important for you to practice good mouth care during treatment with Conexxence. Ask your doctor or dentist about good mouth care if you have any questions.
• Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
• Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Conexxence. Talk with your doctor before starting Conexxence treatment. After your treatment with Conexxence is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip or delay taking Conexxence without first talking with your doctor. If your Conexxence treatment is stopped, talk to your doctor about other medicine that you can take.
• Serious infections. Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take Conexxence. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Conexxence. You may need to go to the hospital for treatment if you develop an infection.
  Conexxence is a medicine that may affect the ability of your body to fight infections. People who have a weakened immune system or take medicines that affect the immune system may have an increased risk for developing serious infections. Call your doctor right away if you have any of the following symptoms of infection:
  • fever or chills
  • skin that looks red or swollen and is hot or tender to touch
  • fever, shortness of breath, cough that will not go away
  • severe abdominal pain
  • frequent or urgent need to urinate or burning feeling when you urinate
• Skin problems. Skin problems such as inflammation of your skin (dermatitis), rash, and eczema may happen if you take Conexxence. Call your doctor if you have any of the following symptoms of skin problems that do not go away or get worse:

  redness itching small bumps or patches (rash)

  your skin is dry or feels like leather blisters that ooze or become crusty skin peeling

• Bone, joint, or muscle pain. Some people who take denosumab products develop severe bone, joint, or muscle pain.
  

• Treat osteoporosis (thinning and weakening of bone) in women after menopause (“change of life”) who:
  • are at high risk for fracture (broken bone)
  • cannot use another osteoporosis medicine or other osteoporosis medicines did not work well
• Increase bone mass in men with osteoporosis who are at high risk for fracture.
• Treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least 6 months and are at high risk for fracture.
• Treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.
• Treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body.

• are taking other denosumab products.
• have low blood calcium.
• cannot take daily calcium and vitamin D.
• had parathyroid or thyroid surgery (glands located in your neck).
• have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome).
• have kidney problems or are on kidney dialysis.
• are taking medicine that can lower your blood calcium levels.
• plan to have dental surgery or teeth removed.
• are pregnant or plan to become pregnant. Conexxence may harm your unborn baby.
  Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment with Conexxence.
  • You should use an effective method of birth control (contraception) during treatment with Conexxence and for at least 5 months after your last dose of Conexxence.
  • Tell your doctor right away if you become pregnant while taking Conexxence.
• are breastfeeding or plan to breastfeed. It is not known if Conexxence passes into your breast milk. You and your doctor should decide if you will take Conexxence or breastfeed. You should not do both.

• See “What is the most important information I should know about Conexxence?”
• It is not known if the use of Conexxence over a long period of time may cause slow healing of broken bones.

• Keep Conexxence in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton.
• Do not freeze Conexxence.
• When you remove Conexxence from the refrigerator, Conexxence must be kept at room temperature [up to 77°F (25°C)] in the original carton and must be used within 14 days.
• Do not keep Conexxence at temperatures above 77°F (25°C). Warm temperatures will affect how Conexxence works.
• Do not shake Conexxence.
• Keep Conexxence in the original carton to protect from light.