Denosumab

What it is used for

Stoboclo is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Stoboclo is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

In postmenopausal women with osteoporosis, denosumab reduces the incidence of vertebral, nonvertebral, and hip fractures. 1.2 Treatment to Increase Bone Mass in Men with Osteoporosis Stoboclo is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

1.3 Treatment of Glucocorticoid-Induced Osteoporosis Stoboclo is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months.

High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. 1.4 Treatment of Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer Stoboclo is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer.

In these patients denosumab also reduced the incidence of vertebral fractures. 1.5 Treatment of Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer Stoboclo is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

The most important thing to know

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

Side effects, and when to stop

Conexxence may cause serious side effects. It is not known if the use of Conexxence over a long period of time may cause slow healing of broken bones. The most common side effects of Conexxence in women who are being treated for osteoporosis after menopause are: back pain pain in your arms and legs high cholesterol muscle pain bladder infection The most common side effects of Conexxence in men with osteoporosis are: back pain joint pain common cold (runny nose or sore throat) The most common side effects of Conexxence in patients with glucocorticoid-induced osteoporosis are: back pain high blood pressure lung infection (bronchitis) headache The most common side effects of Conexxence in patients receiving certain treatments for prostate or breast cancer are: joint pain back pain pain in your arms and legs muscle pain Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Conexxence. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take Conexxence if you: have been told by your doctor that your blood calcium level is too low. are pregnant or plan to become pregnant. are allergic to denosumab products or any of the ingredients in Conexxence. See the end of this Medication Guide for a complete list of ingredients in Conexxence. Before taking Conexxence, tell your doctor about all of your medical conditions, including if you: 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. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of medicines with you to show to your doctor or pharmacist when you get a new medicine. How will I receive Conexxence? Conexxence is an injection that will be given to you by a healthcare provider. Conexxence is injected under your skin (subcutaneous). You will receive Conexxence 1 time every 6 months.

You should take calcium and vitamin D as your doctor tells you to while you receive Conexxence. If you miss a dose of Conexxence, you should receive your injection as soon as you can. Take good care of your teeth and gums while you receive Conexxence. Brush and floss your teeth regularly. Tell your dentist that you are receiving Conexxence before you have dental work.

Storing it

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. Keep Conexxence and all medicines out of the reach of children.