This medicine is a RANK ligand (RANKL) inhibitor used to prevent certain bone-related events in patients who have a certain type of tumor that has spread to the bones (bone metastases).
Follow the directions for using this medicine provided by your doctor. THIS MEDICINE IS USUALLY ADMINISTERED as an injection at your doctor's office, hospital, or clinic. This medicine is sometimes used at home as an injection. If you are using this medicine at home, a healthcare professional will provide detailed instructions for its appropriate use. Ask any questions that you may have about this medicine or giving injections. USE THE PROPER TECHNIQUE taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle. 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 is cracked or damaged. Do NOT vigorously shake this medicine. 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). 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, 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 multiple myeloma (a certain type of cancer), 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 cannot take daily calcium or vitamin D supplements, if you have had or will be receiving radiation or chemotherapy, 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. Use of this medicine in CHILDREN is not recommended. This medicine may affect bone growth and tooth development in children. 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 using this medicine include diarrhea, headache, nausea, tiredness, or weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience cough; shortness of breath; symptoms of low blood calcium levels (eg, muscle stiffness, spasms, twitches, or cramps; burning, numbness, or tingling in your fingers, toes, or around your mouth; seizures); symptoms of low blood phosphate levels (eg, new or worsening loss of appetite, muscle weakness or pain, seizures); or symptoms of jaw bone problems (eg, jaw swelling, pain, or numbness; drainage from the mouth or teeth; sores in the mouth). 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; or 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.