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Denosumab Injection

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Why is this medication prescribed?

Denosumab injection (Prolia) is used

  • To treat osteoporosis (a condition where the bones thin out and weaken, breaking easily) in women who have experienced menopause (the “change of life” or the end of menstrual cycles), who have an increased risk for fractures (broken bones), or who cannot take other medication treatments for osteoporosis or did not respond to them.
  • To treat males who have a greater risk of fractures (broken bones), who are unable to take conventional drug therapies for osteoporosis, or who did not react to such treatments.
  • Men and women who will be taking corticosteroid medications for at least 6 months, who have an elevated risk of fractures, who are unable to take or who did not react to existing pharmacological treatments for osteoporosis should be treated for osteoporosis that is caused by corticosteroid medications.
  • Males undergoing specific drugs for prostate cancer treatment who are experiencing bone loss should be treated,
  • To treat bone loss in breast cancer patients who are taking drugs that make them more likely to fracture their bones.

Use of denosumab injection (Xgeva) RANK ligand inhibitors are a group of drugs that includes denosumab injection. It stops bone breakdown by inhibiting a specific receptor in the body, preventing bone loss. By preventing a specific receptor from functioning in the tumour cells, the treatment for GCTB reduces the growth of the tumour. By reducing bone breakdown, which releases calcium as bones break down, it reduces excessive calcium levels.

  • To lower the risk of fractures in patients with multiple myeloma, a disease that damages the bones by starting in the plasma cells, as well as in those with certain cancers that started in another region of the body but have moved to the bones.
  • To treat giant cell tumours of the bone (GCTB; a form of bone tumour) in adults and some adolescents when surgery is ineffective.
  • To treat those who did not react to conventional drugs for excessive calcium levels brought on by cancer.

How should this medicine be used?

Denosumab injection comes as a solution (liquid) to be injected subcutaneously (under the skin) in your upper arm, upper thigh, or stomach area. In a hospital or medical office, it is typically injected by a nurse or doctor. Typically, Prolia (denosumab injection) is administered once every six months. Denosumab injection (Xgeva) is typically administered once every four weeks when used to lower the risk of fractures from multiple myeloma or cancer that has spread to the bones. Denosumab injection (Xgeva) is typically administered every 7 days for the first three doses (on days 1, 8, and 15) and then once every 4 weeks beginning two weeks following the first three doses to treat giant cell tumour of the bone or elevated calcium levels brought on by cancer.

While receiving denosumab injectable therapy, your doctor will advise you to take calcium and vitamin D supplements. Follow the directions on the bottle for these vitamins.

Your doctor or pharmacist will provide you the manufacturer’s patient information sheet (Medication Guide) when you start treatment with denosumab injection (Prolia) for osteoporosis or bone loss, as well as each time you refill your prescription. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving denosumab injection,

  • If you have an allergy to denosumab (Prolia, Xgeva), any other drugs, latex, or any of the ingredients in denosumab injection, inform your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • You should be aware that the brand names Prolia and Xgeva are used to market denosumab injection. You shouldn’t get more than one denosumab-containing product at once. If one of these medications is being used to treat you, be sure to let your doctor know.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: axitinib (Inlyta), bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), or sunitinib (Sutent) are examples of angiogenesis inhibitors; bisphosphonates such zoledronic acid (Reclast), alendronate (Binosto, Fosamax), etidronate, ibandronate (Boniva), pamidronate, and risedronate (Actonel, Atelvia); chemotherapeutic drugs for cancer; immunosuppressive drugs such tacrolimus (Astagraf XL, Envarsus, Prograf), azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall), sirolimus (Rapamune), and cyclosporine (Azasan, Imuran); steroids like prednisone (Rayos), dexamethasone (A-Methapred, Depo-Medrol, Medrol, and Solu-Medrol), and methylprednisolone (A-Methapred); or medicines that lower the levels of calcium in your body, such cinacalcet (Sensipar). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If your blood calcium level is low or has ever been, let your doctor know. Prior to starting treatment, your doctor will likely examine your blood calcium levels and advise against receiving denosumab injection if the levels are too low.
  • Inform your doctor if you have ever experienced anaemia (a condition in which the red blood cells do not carry enough oxygen throughout the body) or are now undergoing dialysis; a condition that prevents your blood from clotting normally; cancer; any kind of infection, particularly in your mouth; issues with your mouth, teeth, gums, or dentures; dental or oral surgery (teeth removed, dental implants); any illness that impairs your immune system’s performance; surgery to remove a portion of your small intestine; thyroid or parathyroid gland (a tiny gland in the neck) surgery; gastrointestinal issues that make it challenging for your body to absorb nutrition; Diabetes, parathyroid, kidney, or polymyalgia rheumatica (a disorder that causes muscular discomfort and weakness).
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Before beginning denosumab injectable therapy, a pregnancy test must be negative. Pregnancy should not occur while a patient is getting a denosumab injection. During the course of your denosumab injection and for at least five months following the end of your treatment, you should use a trustworthy method of birth control to avoid getting pregnant. Call your doctor right away if you find out you’re pregnant while getting a denosumab injection or within five months of finishing your treatment. The foetus could suffer from denosumab.
  • You should be aware that denosumab injection can lead to osteonecrosis of the jaw (ONJ), a dangerous disorder of the jaw bone, particularly if you receive this medicine and then undergo dental surgery or therapy. Before beginning to receive denosumab injections, a dentist should check your teeth and carry out any necessary procedures, such as cleaning or repairing ill-fitting dentures. While having a denosumab injection, make sure to properly brush your teeth and clean out your mouth. Before getting any dental work done while taking this medication, see your doctor.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Call your doctor as soon as you can if you are going to be late for a denosumab injection visit. As soon as a new appointment can be made, the missing dose should be administered. While using denosumab injection (Prolia) for osteoporosis or bone loss, you should wait six months after receiving the missing dosage before scheduling your subsequent injection.

What side effects can this medication cause?

Denosumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • Irritated, dry, or rosy skin
  • Oozing or crusted skin blisters
  • Sloughing skin
  • Back ache
  • Suffering in your arms
  • Edoema in the legs or arms
  • Joint or muscle ache
  • Nausea
  • Diarrhea
  • Constipation
  • Abdominal pain
  • Headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

  • Muscle twitching, cramping, or stiffness
  • Tingling or numbness in your mouth, toes, or fingers
  • Swelling of the face, eyes, throat, tongue, or lips; hives; rash; itching; trouble breathing or swallowing
  • Cold or fever
  • Skin that is irritated, sensitive, swollen, or heated in any way
  • Cough, loss of breath, and fever
  • Severe ear ache or ear leakage
  • Urinary incontinence, the need to urinate frequently or urgently
  • Acute stomach discomfort
  • Gums that are sore or inflamed, teeth that are loosening, jaw pain or heaviness, and poor healing are all signs of gum disease
  • Uncommon bruising or bleeding
  • Upon discontinuation of denosumab and for up to a year afterward, nausea, vomiting, headache, and decreased alertness may occur

The risk that you will shatter your thigh bone may increase after receiving a denosumab injection (s) Before the bone(s) break, you may suffer discomfort in your hips, groyne, or thighs for a few weeks or months. You may also discover that one or both of your thigh bones have broken even though you haven’t fallen or been in any other kind of accident. In healthy individuals, it is uncommon for the thigh bone to break, but individuals with osteoporosis have the risk of doing so even if they do not receive a denosumab injection. Moreover, denosumab injection may inhibit the healing of fractured bones, hinder bone growth, and stop children’s teeth from erupting properly. Discuss the dangers of receiving an injection of denosumab with your doctor.

Further adverse effects after denosumab injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Don’t shake the injection of denosumab. Protect it from light and keep it in the refrigerator. Avoid freezing. For up to 14 days, denosumab injection can be stored at room temperature.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at for additional information.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

What other information should I know?

Keep all of your appointments with your physician and the lab. To ensure that receiving denosumab injection is safe for you and to monitor your body’s reaction to denosumab injection, your doctor will request a number of tests.

Do not share your medication with anybody else. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Prolia®
  • Xgeva®
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