This medicine is a RANK ligand (RANKL) inhibitor used to treat osteoporosis (weak bones) in certain women who have gone through menopause. It is also used to help build bone in certain men with osteoporosis. It is used to treat bone loss in certain men receiving treatment for prostate cancer, and in certain women receiving treatment for breast cancer. It may also be used for other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine is given as an injection every 6 months at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions. THIS MEDICINE IS A COLORLESS TO PALE YELLOW SOLUTION that may contain a very small amount of clear to white particles. Do NOT use this medicine if it contains many particles or any foreign matter. Do NOT use it if the solution is cloudy or discolored, or if the vial or syringe is cracked or damaged. STORE THIS MEDICINE in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C) in the original container. Do not freeze. Do not shake this medicine. This medicine may also be stored at room temperature, up to 77 degrees F (25 degrees C), for up to 14 days. Do not expose this medicine to temperatures above 77 degrees F (25 degrees C). KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, contact your doctor right away.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also using another medicine that contains denosumab. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking a corticosteroid (eg, prednisone) or medicine to suppress your immune system. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of low blood calcium levels, high cholesterol, blood clotting problems, anemia, bone infection, pancreas problems, recent broken bone, thyroid or parathyroid problems (including thyroid or parathyroid surgery), allergies, pregnancy or if you are able to become pregnant, or breast-feeding. Tell your doctor if you have a history of kidney problems or you are on dialysis, if you have had part of your small intestine removed, or if you have problems absorbing nutrients from food (malabsorption syndrome). Tell your doctor if you have immune system problems, cancer, or if you have had or will be having radiation or chemotherapy. Tell your doctor if you cannot take daily calcium or vitamin D supplements, if you have poor dental hygiene or other dental problems, or if you plan to have dental surgery or teeth removed. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have low calcium levels in your blood or if you are pregnant or planning to become pregnant. Use of this medicine in CHILDREN is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include back pain; mild joint pain; mild muscle pain; mild skin inflammation (eg, red, dry, itchy, or flaky skin); mild sore throat; pain in the arms or legs; or runny nose. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; ear pain; irregular heartbeat; new or unusual hip, groin, or thigh pain; red, swollen, blistered, or peeling skin; severe or persistent stomach or back pain (with or without nausea or vomiting); signs of infection (eg, fever, persistent sore throat, chills) or skin infection (eg, warm, red, swollen, or painful skin); symptoms of low blood calcium (eg, muscle stiffness, spasms, twitches, or cramps; numbness or tingling in your fingers, toes, or around your mouth; seizures); swelling of the hands, ankles, or feet; symptoms of bladder or urinary tract infection (eg, frequent or urgent need to urinate, burning during urination, difficult or painful urination); symptoms of jaw bone problems (eg, jaw swelling, pain, or numbness; drainage from the mouth or teeth; sores in the mouth); unusual tiredness or weakness; or vision changes (eg, cloudy or blurred vision). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If overdose is suspected, contact your local poison control center or emergency room immediately.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.