Prolia® (Denosumab Injection)

Prolia can cause serious infections, including skin infections and endocarditis, as well as hypocalcemia, which can be severe and life-threatening. Patients should be monitored for signs of infection and calcium levels before and during treatment. Osteonecrosis of the jaw has also been reported, requiring dental examination prior to initiation.

● 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.

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

● Diarrhea

● Constipation

● Pain in the abdomen

● Experiencing headaches

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.

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.

At Insulin Outlet, we ensure the safety and quality of our medications, meeting all federal legislation standards. Your order will be dispatched from a reputable licensed Canadian pharmacy, guaranteeing the highest standards of reliability and authenticity. This medication has been approved by Health Canada (Canada's FDA) and is identical to what you would receive in the US, only with Canadian labeling and packaging. We do not sell counterfeit or unauthorized medications. Our discounted medications are shipped directly from Canada to your doorstep, providing a fast and secure delivery experience. To conveniently buy Prolia online at a significant discount, place your order above or call us at 1-888-238-0872.