Denosumab belongs to a family of medications known as monoclonal antibodies. Specifically, it is a RANK ligand inhibitor. It is used to decrease the risk of fractures or bone pain as a result of certain cancers spreading into the bone. Denosumab is also used to treat a type of bone tumour called giant cell tumour of bone, which cannot be treated by surgery or where surgery is not the best option, for adults and adolescents (aged 13 to 17 years) whose bones have stopped growing.
This medication may also be used to treat hypercalcemia (high levels of calcium in the blood) for people with cancer that has not responded to treatment with bisphosphonates.
Denosumab works by reducing the amount of bone your body breaks down, making your bones less likely to break. In people with hypercalcemia, this medication decreases the amount of calcium in the blood by reducing the breakdown of bones.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.
Each single-use vial containing 1.7 mL of a sterile, preservative-free, clear, colourless-to-slightly yellow solution, formulated at pH 5.2, contains 120 mg of denosumab. Nonmedicinal ingredients: sorbitol, acetate, water for injection (USP), and sodium hydroxide to a pH of 5.2.
The recommended dose for preventing fractures or bone pain for adults with cancer is 120 mg injected subcutaneously (under the skin) every 4 weeks.
For adults or adolescents who are being treated for giant cell tumour of bone, or for treatment of hypercalcemia, the recommended dose is 120 mg injected subcutaneously every 4 weeks, with an additional dose being given 1 week and 2 weeks after the first dose during the first month of treatment only. This medication is injected under the skin of the upper arm, upper thigh, or abdomen. Your doctor may show you how to give yourself the injections, or a health care professional will inject the medication for you.
The solution for injection should be clear and colourless-to-slightly-yellow. If it is cloudy or you can see particles in the solution, do not use it. Allow the medication to warm to room temperature for 15 – 30 minutes before you inject it. Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
It is important that this medication be used exactly as recommended by your doctor. If you miss an appointment to receive denosumab, contact your doctor as soon as possible to reschedule your appointment. If you are injecting this medication yourself and miss a dose, use it as soon as you remember. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
This medication is stored in the refrigerator, protected from light and temperatures above 25°C. Do not allow this medication to freeze. Keep it out of the reach of children. When removed from the refrigerator, it can also be stored at room temperature for 30 days. It should be allowed to reach room temperature before injecting. Do not shake denosumab.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not use denosumab if you:
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Calcium and vitamin D: While using this medication, it is important that you are receiving enough calcium and vitamin D to maintain blood calcium levels. Your doctor will recommend a dose of calcium and vitamin D based on your needs. If you develop symptoms of low blood calcium levels (muscle spasms, twitches, or cramps; numbness or tingling in the fingers, toes, or around the mouth) while using this medication, contact your doctor immediately or get immediate medical attention.
Fractures: As with other medications in this class, denosumab may contribute to a type of rare fracture of the long bone in the thigh (femur). If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Fractures of the bones in the spine (vertebra) have been reported after stopping this medication. Do not stop treatment with this medication without checking with your doctor first.
Infections: This medication may cause infections that in some cases are serious and require hospitalization. Contact your doctor at once if you develop signs of an infection such as fever, abdominal pain, earache, painful urination, or blood in the urine, or if you notice a red, swollen, or tender area on the skin. People who are taking medications that suppress the immune system (e.g., prednisone, azathioprine, anticancer medications) or who have a suppressed immune system may be more at risk of developing infections.
Severe jawbone problems: Denosumab may cause problems with your upper or lower jaw. You may be at a higher risk of these problems if you have cancer that has spread to the bones, are taking certain medications (e.g., prednisone, anticancer medications), are having radiation treatments, have poor oral hygiene, or are having a tooth extracted. Your doctor may recommend that you see a dentist before starting this medication. It is important to practice good oral hygiene while taking this medication.
Pregnancy: The safety of denosumab for use during pregnancy has not been established. Denosumab is not recommended for use during pregnancy. If you become pregnant while using this medication, contact your doctor immediately. For women taking denosumab, an effective form of birth control should be used during treatment and for at least 5 months after the last dose of denosumab.
Breast-feeding: Denosumab has not been studied for use by breast-feeding mothers. It is not known if denosumab passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Denosumab is not recommended for use by women who are breast-feeding.
Children and adolescents: The safety and effectiveness of using this medication have not been established for children. Denosumab is only recommended for adolescents with giant cell tumour of bone whose bones have stopped growing. Denosumab has not been studied in children and adolescents with other cancers that have spread to bone.
There may be an interaction between denosumab and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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