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Prolia (Denosumab) belongs to a family of medications known as monoclonal antibodies. Specifically, it inhibits a protein that your body uses to signal for removing old bone tissue.
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Prolia (Denosumab) belongs to a family of medications known as monoclonal antibodies. Specifically, it inhibits a protein that your body uses to signal for removing old bone tissue. Prolia (Denosumab) works by reducing the amount of bone your body breaks down, making your bones less likely to break.
Prolia (Denosumab) is used to treat Osteoporosis for postmenopausal women who have a high risk of fracture or who have not tolerated or responded to other osteoporosis medications. It is also used to increase bone mass in men who have osteoporosis and are at high risk of having a fracture, have a history of osteoporotic fracture, or have not tolerated or responded to other osteoporosis medications.
Prolia (Denosumab) is also is also used to increase bone mass in women who are being treated with an aromatase inhibitor for Breast Cancer that has not spread to other parts of the body. It is also used to increase bone mass and reduce fractures in men who have Prostate Cancer that has not spread to other parts of the body and who are receiving medication to reduce testosterone levels.
Prolia (Denosumab) may be available under multiple brand names and/or in several different forms. Any specific brand name of Prolia (Denosumab) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Prolia (Denosumab) may not be used for all of the conditions discussed here.
Your doctor may have suggested Prolia (Denosumab) 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 Prolia (Denosumab), speak to your doctor. Do not stop using Prolia (Denosumab) without consulting your doctor.
Do not give Prolia (Denosumab) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use Prolia (Denosumab) if their doctor has not prescribed it.
The recommended dose of Prolia (Denosumab) is 60 mg injected once every 6 months. It is injected subcutaneously (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.
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 Prolia (Denosumab) be used exactly as recommended by your doctor. If you miss an appointment to receive Prolia (Denosumab), contact your doctor as soon as possible to reschedule your appointment. If you are injecting Prolia (Denosumab) 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.
Prolia (Denosumab) is stored in the refrigerator. Protect it from light and do not allow Prolia (Denosumab) 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 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.
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 Prolia (Denosumab). If you are concerned about side effects, discuss the risks and benefits of Prolia (Denosumab) with your doctor.
The following side effects have been reported by at least 1% of people taking Prolia (Denosumab). 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 Prolia (Denosumab).
Each 1 mL single use prefilled syringe of sterile, preservative-free, clear, colourless to slightly yellow solution contains 60 mg of Prolia (Denosumab). Nonmedicinal ingredients: sorbitol, acetate, polysorbate 20, water for injection (USP), and sodium hydroxide to adjust for pH.
Do not use Prolia (Denosumab) if you:
There may be an interaction between Prolia (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 Prolia (Denosumab). 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.
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 Prolia (Denosumab).
Calcium and vitamin D: While using Prolia (Denosumab), you need to receive 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. Contact your doctor immediately or get immediate medical attention if you develop symptoms of low blood calcium levels while using Prolia (Denosumab) (muscle spasms, twitches, or cramps; numbness or tingling in the fingers, toes, or around the mouth).
Fractures: As with other medications in this class, Prolia (Denosumab) may contribute to a type of rare fracture of the long bone in the thigh (femur) without any form of trauma. If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Infections: Prolia (Denosumab) 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 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., Tacrolimus, prednisone, Azathioprine, anticancer medications) or who have a suppressed immune system may be more at risk of developing infections.
Latex allergy: The needle cap on the pre-filled syringe contains a latex derivative and should not be handled by people who are allergic to latex.
Severe jawbone problems: Prolia (Denosumab) may cause problems with your upper and 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 Prolia (Denosumab). It is important to practice good oral hygiene while taking Prolia (Denosumab).
Pregnancy: Prolia (Denosumab) is only recommended for postmenopausal women and has not been studied for use during pregnancy. If you become pregnant while using Prolia (Denosumab), contact your doctor immediately.
Male partners of females who are or may become pregnant should use a barrier method of birth control (i.e., condoms).
Breast-feeding: Prolia (Denosumab) has not been studied for use by breast-feeding mothers. It is not known if Prolia (Denosumab) passes into breast milk. If you are a breast-feeding mother and are taking Prolia (Denosumab), it may affect your baby. Prolia (Denosumab) is not recommended for use by women who are breast-feeding.
Children and adolescents: The safety and effectiveness of using Prolia (Denosumab) have not been established for children.
All material © 1996-2021 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health providers with any questions you may have regarding a medical condition.
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