Prolia® (Denosumab Injection)
This product requires a prescription.
This is a brand name product.
Prolia® (PRÃ“-lee-a) is used to treat bone loss (osteoporosis) in people at high risk of fractures. As a result of osteoporosis, bones become thinner and more prone to breaking. The risk of developing osteoporosis increases after menopause (in women), as you age, if you have a family member with osteoporosis, or if you take medications for an extended period of time (such as prednisone).
A medication called RANK ligand inhibitors, denosumab injection (Prolia®) is used to treat RA. In order to prevent bone loss, it blocks a certain receptor in the body that decreases bone breakdown. By blocking a certain receptor in tumor cells, it slows the growth of GCTB. As calcium is released from bones during bone breakdown, it treats high calcium levels.
Prolia® is effective in managing osteoporosis caused by corticosteroid medications in men and women who will be taking these medications for at least 6 months. It can be used to treat bone loss in men being treated for prostate cancer. In addition, it can be used to prevent bone loss in women with breast cancer receiving certain medications that increase their fracture risk.
Prolia® is not insulin or considered a diabetic medication.
In order to prevent broken bones (fractures), this medication slows bone loss and helps maintain strong bones. Known as a monoclonal antibody, denosumab belongs to a class of drugs called monoclonal antibodies. Osteoclasts, which break down bone, are prevented from doing so by it.
There is constant change in bone. Osteoclasts are cells in the body whose primary function is to remove bone. Osteoblasts are bone-forming cells, which are another type of cell. There is a balance between the actions of these two cells in normal bone. Osteoporosis destroys this balance. Instead, the cells that remove bone work overtime, removing bone faster than it can be replaced. Consequently, the bone becomes thinner, weaker, and more prone to breaking. Pain or other symptoms may not accompany osteoporosis. A fragility fracture, a broken bone caused by a minor fall or simple activities such as getting up, is sometimes the first symptom of osteoporosis. Future fractures can be significantly increased by a fragility fracture. Your doctor can guide you in other ways to manage your bone health besides prescribing Prolia®. Treatments for breast or prostate cancer that stop the production of estrogen or testosterone can also cause bone loss. As a result, some bones may become weaker and more prone to breaking.
You are more likely to break a bone if you are taking corticosteroids, such as prednisone.
● Any allergy to denosumab (Prolia®), any other medication, latex, or any of the ingredients in denosumab injection should be reported to your doctor and pharmacist. Check the Medication Guide or ask your pharmacist for a list of ingredients.
● Prolia and Xgeva are brands of denosumab injection. At the same time, you should not receive more than one product containing denosumab. Neither of these medications should be taken without telling your doctor.
● Prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or intend to take should be disclosed to your doctor and pharmacist. Be sure to mention any of the following: angiogenesis inhibitors such as axitinib (Inlyta), bevacizumab (Avastin), everolimus (Afinitor, Zortress), pazopanib (Votrient), sorafenib (Nexavar), or sunitinib (Sutent); semaglutide (Ozempic) bisphosphonates such as alendronate (Binosto, Fosamax), etidronate, ibandronate (Boniva), pamidronate, risedronate (Actonel, Atelvia), zoledronic acid (Reclast); cancer chemotherapy medications; medications that suppress the immune system such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), sirolimus (Rapamune), and tacrolimus (Astagraf XL, Envarsus, Prograf); steroids such as dexamethasone, methylprednisolone (A-Methapred, Depo-Medrol, Medrol, Solu-Medrol), and prednisone (Rayos); or medications used to lower your calcium levels, such as cinacalcet (Sensipar). In some cases, your doctor may need to adjust the dose of your medication or monitor you carefully for side effects.
● If you have a low calcium level in your blood or have ever had one, inform your doctor. During treatment, your doctor will likely check your calcium level and will probably tell you not to receive denosumab injection if the level is too low.
● Tell your doctor if you are receiving dialysis treatments or if you have or have ever had anemia (a condition in which the red blood cells do not provide enough oxygen to all parts of the body); cancer; any type of infection, particularly in your mouth; problems with your mouth, teeth, gums, or dentures; any type of surgery (teeth extracted, dental implants); any condition that prevents your blood from clotting normally; any condition that diminishes your immune system; surgery on your thyroid gland or parathyroid gland (small gland in your neck); surgery to remove part of your small intestine; stomach or intestinal problems that prevent your body from absorbing nutrients ; polymyalgia rheumatica (disorder that causes muscle pain and weakness); diabetes, or parathyroid or kidney disease.
● If you are pregnant, planning to become pregnant, or breastfeeding, tell your doctor. Prior to starting denosumab injection treatment, you must have a negative pregnancy test. While receiving denosumab injections, you should not become pregnant. When receiving denosumab injections and for at least five months after completing treatment, you should use reliable birth control methods to prevent pregnancy. Contact your doctor immediately if you become pregnant while receiving denosumab injection, or within five months of treatment. Fetuses may be harmed by denosumab. Please see the pregnancy tab for more information.
● Having dental surgery or receiving treatment while receiving denosumab injection may result in osteonecrosis of the jaw (ONJ), a serious condition of the jaw bone. Before receiving denosumab injections, a dentist should examine your teeth and perform any necessary treatments, such as cleaning or repairing ill-fitting dentures. While receiving denosumab injections, brush your teeth and clean your mouth properly. If you are receiving this medication, talk to your doctor before having any dental work done.
Osteoporosis Treatment in Postmenopausal Women
It is indicated for postmenopausal women with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture or multiple risk factors for fracture; or for those who have failed or are intolerant to other available osteoporosis therapies. Prolia® reduces the incidence of vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis.
Osteoporosis Treatment To Increase Bone Mass
This drug is indicated for increasing bone mass in men with osteoporosis who have a history of osteoporotic fractures or multiple risk factors for fractures; or for patients who have not responded to other therapies for osteoporosis.
Treatment of Osteoporosis Induced by Glucocorticoids
A patient at high risk of fracture who is either initiating or continuing systemic glucocorticoids equivalent to 7.5 mg or greater of prednisone a day and is expected to remain on these glucocorticoids for at least 6 months can receive Prolia® for the treatment of glucocorticoid-induced osteoporosis. Patients at high risk of fracture are those who have had osteoporotic fractures in the past, who have multiple risk factors for fracture, or who have failed or are intolerant to other osteoporosis treatments.
Treatment Of Bone Loss In Men Receiving Androgen Deprivation Therapy For Prostate Cancer
Prolia® is indicated to increase bone mass in men at high risk for fractures receiving androgen deprivation therapy for nonmetastatic prostate cancer. Prolia® also reduced the incidence of vertebral fractures in these patients.
Adjuvant Aromatase Inhibitor Therapy and Bone Loss in Breast Cancer Patients
Breast cancer patients receiving adjuvant aromatase inhibitor therapy may benefit from Prolia® for increasing bone mass.
Subcutaneous (under the skin) injections of denosumab are administered by injecting a solution (liquid) under your arm, thigh, or stomach. Typically, the injection is performed in a medical office or clinic by a doctor or nurse. Denosumab injections (Prolia) are typically administered every six months. It is usually given once every four weeks to reduce the risk of fractures from multiple myeloma, or cancer that has spread to the bones. The first three doses of denosumab injection are usually given every 7 days (on day 1, day 8, and day 15) and then every 4 weeks starting 2 weeks after the first three doses.
While receiving denosumab injections, your doctor will advise you to take calcium and vitamin D supplements. When taking these supplements, follow the directions exactly.
You will receive the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with denosumab injection (Prolia) and every time you refill your prescription for denosumab injection. Ask your doctor or we can set up a consultation with one of our pharmacists. To obtain a Medication Guide, you can also visit the FDA’s website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website.
Non-Severe Side Effects
There may be side effects associated with denosumab injection. If any of these symptoms persist or are severe, contact your doctor:
● Skin that is red, dry, or itchy
● Blisters that ooze or crust over
● Skin peeling
● Pain in the back
● Arm pain
● Swelling of the arms or legs
● Pain in the muscles or joints
● Feeling nauseated
● Pain in the abdomen
● Experiencing headaches
Severe Side Effects
There are some side effects that can be serious. Get emergency medical attention if you experience any of these symptoms:
● A stiff or twitching muscle, cramps, or spasms
● Feeling numb or tingly in your fingers, toes, or mouth
● Inflammation of the face, eyes, throat, tongue, or lips, hives, rash, itching, difficulty breathing or swallowing, symptoms of asthma,
● Chills or fever
● An area of skin that is red, tender, swollen, or warm
● Feeling sick, coughing, or having trouble breathing
● Ear pain or drainage
● Urination frequently or urgently, burning sensation when urinating
● Pain in the abdomen
● Swollen or painful gums, loose teeth, numbness or heavy feeling in the jaw, poor healing of the jaw
● Bleeding or bruising that is unusual
● For up to 1 year after stopping denosumab, you may experience nausea, vomiting, headaches, and decreased alertness
It is possible that you will break your thigh bone(s) after receiving the denosumab injection. In some cases, you may experience pain in your hips, groin, or thighs for several weeks or months before the bone(s) break. Even if you have not fallen or experienced another trauma, one or both of your thigh bones may break. Healthy people are unlikely to break their thigh bones, but people with osteoporosis may break them even without denosumab injections. The injection of denosumab may also slow down the healing of broken bones and prevent children from growing properly or having their teeth come in properly. Denosumab injections come with risks, so talk to your doctor about them.
There may be other side effects associated with denosumab injections. If you experience any unusual problems while taking this medication, contact your doctor.
If you are pregnant or plan to become pregnant, tell your doctor.
Pregnancy-safe medications are classified by the FDA. When a medication is taken during pregnancy, possible risks to an unborn baby are classified into five categories – A, B, C, D, and X.
Prolia® belongs to category X. Prolia® can cause problems for babies born to women who take it during pregnancy. Mothers cannot benefit from medication more than the risks of harm to their babies in any circumstance. Pregnant women should never take these medications.
Denosumab is not excreted in human milk. It has been suggested that absence of RANKL during pregnancy may interfere with the maturation of the mammary gland, resulting in impaired lactation post-partum in genetically engineered mice (a “knockout mouse”). Consider the benefits of breast-feeding to the newborn/infant and the benefits of Prolia® therapy for the mother before deciding whether to abstain from breast-feeding or Prolia therapy.
Medicinal ingredients: denosumab
Nonmedicinal ingredients: sorbitol, acetate, polysorbate 20, water for injection and sodium hydroxide.
Persons allergic to latex should not handle the needle cover on the single use prefilled syringe. The following dosage forms of Prolia® are available: Prolia® is a liquid for injection, available as a prefilled syringe. Prolia® is a clear solution that is colorless to slightly yellow in color. If the solution is cloudy, it should not be used.
Be sure to keep this medication in the original container, tightly closed, and out of reach of children. Denosumab injections should not be shaken. Protect it from light and store it in the refrigerator. Keep out of the freezer. Up to 14 days can be kept at room temperature when storing denosumab injection.
If a medication is no longer needed, it should be disposed of in a way that prevents pets, children, or other people from consuming it. It is not recommended to flush this medication. You should dispose of your medications through a medicine take-back program. Contact your pharmacist or local garbage/recycling department for information about take-back programs in your community.
Most medication containers (such as pill minders and containers for eye drops, creams, patches, and inhalers) aren’t childproof, so it’s very important to keep them out of sight and reach of children. Keep all medications out of sight and reach of young children by locking safety caps and storing them in a safe location.