uses
What is denosumab used for?Denosumab (Prolia, Jubbonti, Stoboclo) is commonly used to treat osteoporosis, a condition in which the bones are thinner, weaker, and more prone to breakage. Denosumab may be prescribed for people at high risk for fractures in the following situations.Postmenopausal people with osteoporosisPeople who take a medicine called a corticosteroid such as prednisone Denosumab is also used to increase bone mass in people at high risk for fracture in men with osteoporosis and people who take certain medicines for either breast or prostate cancer.Denosumab may also be used for other conditions as determined by your healthcare provider.How does denosumab work (mechanism of action)?Denosumab helps to strengthen bone by preventing the breakdown of bone.How is denosumab supplied (dosage forms)?Denosumab is available as a 60 mg/mL prefilled syringe that is injected under the skin (subcutaneous).How should I store denosumab?Denosumab is usually given by a healthcare provider in a hospital or clinic. If you will store it at home, store it in the refrigerator at 36 F to 46 F (2 C to 8 C). It should be stored in the original container and away from light. Do not freeze denosumab. Denosumab can be kept up to 77 F (25 C) for up to 30 days. After 30 days, denosumab must be thrown away.Â
how to use
liquid that is injected under the skin
drug interactions
Does denosumab interact with foods or drinks?There are no known interactions between denosumab and foods or drinks.There are no known interactions between denosumab and alcohol. It is best to limit the amount of alcohol you drink.Does denosumab interact with other medicines (drug interactions)?Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.In particular, make sure that you discuss if you are using any of the following before using denosumab.A corticosteroid such as prednisone, which is a medicine used for certain inflammatory conditions.A medicine used to treat hyperparathyroidism and hypercalcemia (high levels of calcium) such as cinacalcet. A medicine that suppresses the immune system such as methotrexate or cyclosporine. A denosumab medicine such as Xgeva, Wyost, or Jubbonti. This may not be a complete list of medicines that can interact with denosumab. Always check with your healthcare provider.
side effects
What are the most common side effects of denosumab?The most common side effects of denosumab are listed below. Tell your healthcare provider if you have any of these side effects that bother you.Back pain, muscle pain, joint pain, or pain in the arms and legsHigh cholesterol levelsBladder infectionHigh blood pressureHeadacheBronchitisRunny nose or sore throatThere may be other side effects of denosumab that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.What are the serious side effects of denosumab?While less common, the most serious side effects of denosumab are described below, along with what to do if they happen.Severe Allergic Reactions. Denosumab may cause allergic reactions, which can be serious. Tell your healthcare provider right away if you have any of the following symptoms of a serious allergic reaction. Get emergency help if you are no longer where you received denosumab. Breathing problems or wheezingRacing heartFever or general ill feelingSwollen lymph nodesSwelling of the face, lips, mouth, tongue, or throatTrouble swallowing or throat tightnessItching, skin rash, or pale red bumps on the skin called hivesNausea or vomitingDizziness, feeling lightheaded, or faintingStomach crampsJoint painLow Calcium Level (Hypocalcemia). Denosumab can cause low calcium levels, which can be serious. Make sure that you take calcium and vitamin D that your healthcare provider may recommend. Keep all appointments to have your blood checked. Stop using denosumab and call your healthcare provider right away if you have any of the following symptoms.  Changes in your heart rate or rhythm, such as a fast or skipping heartbeatMuscle pain, twitches, or spasmsNumbness or tingling in your fingers, toes, or around your mouthSeizuresSevere Jawbone Problems (Osteonecrosis). Denosumab can cause severe jawbone problems, also called osteonecrosis of the jaw. In this condition, your jawbone may get damaged due to reduced blood flow. You may be at higher risk if you are undergoing certain dental procedures (such as a tooth extraction or dental implants), have poor oral health, or have cancer or certain other conditions. You may be told to see a dentist before starting denosumab and to practice good mouth care. Call your healthcare provider right away if you experience any of the following symptoms of jaw osteonecrosis.Jaw pain or discomfortMouth soresLoose teethUnusual Thigh Bone Fractures. Denosumab can cause stress fractures or tiny cracks in the thigh bones. Notify your healthcare provider right away if you develop new or unusual pain or swelling in your thigh, hip, or groin. Serious Infections. Denosumab may affect your immune system and the ability of your body to fight off infections. This can increase your risk of developing serious infections including infections of the skin, bladder, ear, and lower stomach area. denosumab may also cause endocarditis, an infection that affects the lining of the heart. Call your healthcare provider right away if you develop any of the following symptoms of an infection.Fever or chillsSkin that is red, swollen, or hotSevere abdominal painShortness of breath or coughBurning or stinging when you pee or frequent and urgent need to pee.Increased Risk of Broken Bones. If you stop taking denosumab or miss a dose, your risk of having a broken bone (including in the spine) increases. Talk to your healthcare provider if you missed a dose or plan on stopping denosumab. Skin Problems. You may get a skin problem such as dermatitis, eczema, or a rash when you use denosumab. Call your healthcare provider right away if you have any of the following symptoms that do not go away or get worse. Skin redness, dryness, peeling, or itchingSkin blisters that may ooze or become crustySkin rash that may look like small bumps or patchesBone, Joint, or Muscle Pain. Denosumab can cause severe bone, joint, or muscle pain. Talk to your healthcare provider right away if you have severe pain.Â
overdose and misseddose
What should I do if I accidentally use too much denosumab?If you or someone else has used too much denosumab, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.What should I do if I miss a dose of denosumab?Denosumab is usually given by a healthcare provider every 6 months. Your healthcare provider will make sure you are receiving denosumab as scheduled. If you miss your appointment to get denosumab, call to make an appointment as soon as possible.
warnings and Precautions
Who should not use denosumab?Allergies to Ingredients. People who are allergic to any of the following should not take denosumab.DenosumabProliaJubbontiStobocloAny of the ingredients in the specific product dispensedYour pharmacist can tell you all of the ingredients in denosumab. Pregnancy. Do not take denosumab if you are pregnant. If you become pregnant, tell your healthcare provider right away. See the Pregnancy section below for more details.Low Blood Calcium. People with hypocalcemia (low blood calcium) should not get denosumab until calcium levels have been corrected.  What should I know about denosumab before using it?Do not use denosumab unless it has been prescribed to you by a healthcare provider. Use it as prescribed.Do not share denosumab with other people, even if they have the same condition as you. It may harm them.Brush and floss your teeth daily. Tell your dentist you are using denosumab before having any dental work done. Talk to your healthcare provider if you plan on stopping denosumab. Your risk of having a broken bone increases if you stop denosumab and do not take another medicine. Keep denosumab out of the reach of children. Since this medicine must be kept in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.Talk to your doctor before starting denosumab. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels. What should I tell my healthcare provider before using denosumab?Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if denosumab is right for you.In particular, make sure that you discuss any of the following.Kidney Problems. If you have advanced chronic kidney disease or are receiving dialysis, you are at greater risk for low blood calcium. Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.Low blood calciumParathyroid or thyroid surgeryHypoparathyroidismPlan to have dental surgery or teeth removedHave been told you have trouble absorbing mineralsCannot take calcium and vitamin DImmune system problemsRemoval of part of your small intestineOther Medicines and Supplements. Denosumab may interact with other medicines and supplements. Before using denosumab, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.Pregnancy. Do not take denosumab, and tell your healthcare provider if you are or plan to become pregnant. denosumab may cause harm to your unborn baby. If you can become pregnant, you must use contraception during denosumab treatment and for 5 months after stopping denosumab. Your healthcare provider will make sure you have a negative pregnancy test before starting denosumab. Breastfeeding. Denosumab should not be used if you are breastfeeding. It is not known if denosumab passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop denosumab.