(den OH sue mab) Brand: Prolia
• Prolia can harm an unborn child or reason birth defects. Do not use if you are pregnant.
• This medicine manual provides information about the Prolia brand of denosumab. Xgeva is other brand of denosumab used to prevent bone fractures and another skeletal conditions in people with tumors that have spread to the bone.
• You must not receive denosumab if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia).
• Till you receive this medicine, speak your doctor if you have kidney malady (or if you are on dialysis), a weak immune system, a history of hypoparathyroidism or thyroid surgery, a history of intestinal surgery, a condition that makes it heavy for your body to absorb nutrients from food, or if you are allergic to latex.
• Serious infections may occur during treatment with Prolia. Call your doctor right away if you have signs of infection such as: severe skin irritation; swelling or redness anywhere on your body; pain or burning when you urinate; severe stomach pain; ear pain, trouble hearing; cough, feeling short of breath; purple or red spots under your skin; or fever, chills, night sweats, flu symptoms, or weight loss.
• Some people using denosumab have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery inclusion the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Another conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
• If you need to have any dental work (especially surgery), speak the dentist onward of time that you are receiving denosumab. You may need to stop using the medication for a short time.
• Denosumab is a monoclonal antibody. Monoclonal antibodies are made to target and destroy only determined cells in the body. This may help to protect healthy cells from damage.
• The Prolia brand of denosumab is used to treat osteoporosis in postmenopausal women who have tall risk of bone fracture.
• Prolia is also used to magnify bone mass in women and men with a tall risk of bone fracture caused by receiving treatments for determined types of cancer.
• This medicine manual provides information about the Prolia brand of denosumab. Xgeva is other brand of denosumab used to prevent bone fractures and another skeletal conditions in people with tumors that have spread to the bone.
• Denosumab may also be used for purposes not listed in this medicine guide.
• You must not receive denosumab if you are allergic to it, or if you have low levels of calcium in your blood (hypocalcemia).
• To create certain you can safely use Prolia, speak your doctor if you have any of these another conditions:
· kidney malady (or if you are on dialysis);
· a weak immune system (caused by malady or by using determined medicines);
· a history of hypoparathyroidism (decreased functioning of the parathyroid glands);
· a history of thyroid surgery;
· a history of surgery to remove part of your intestine;
· any condition that makes it heavy for your body to absorb nutrients from food (malabsorption); or
· if you are allergic to latex.
• Some people using denosumab have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery inclusion the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Another conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
• FDA pregnancy category X. This medicine can harm an unborn child or reason birth defects. Do not use Prolia if you are pregnant. Speak your doctor right away if you become pregnant during treatment.
• If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to estimate any effects of denosumab on the baby.
• It is not known whether denosumab passes into breast milk or if it could harm a nursing child. However, this medicine may slow the manufacture of breast milk. You must not breast-feed while receiving denosumab.
• Denosumab is injected under the skin of your stomach, upper thigh, or upper hand. A healthcare provider will give you this injection.
• Prolia is generally given once each 6 months. Follow your doctor's instructions.
• Your doctor may have you take extra calcium and vitamin D while you are being treated with denosumab. Take only the amount of calcium and vitamin D that your doctor has prescribed.
• Pay particular attention to your dental hygiene. Brush and floss your teeth regularly while receiving this medicine. You may need to have a dental exam till you begin treatment with Prolia. Follow your doctor's instructions.
• If you need to have any dental work (especially surgery), speak the dentist onward of time that you are receiving denosumab. You may need to stop using the medication for a short time.
• If you hold your medicine at house, store it in the original container in a refrigerator. Protect from easy and do not freeze.
• You may take the medication out of the refrigerator and let it to reach room temperature till the injection is given. Do not heat the medication till using.
• After you have taken Prolia out of the refrigerator, you may hold it at room temperature for up to 14 days. Store in the original container away from heat and light.
• Do not shake the prefilled syringe or you may ruin the medication. Do not use the medicine if it looks cloudy or has particles in it. Call your doctor for a new prescription.
• Every prefilled syringe of this medication is for one use only. Throw away after one use, even if there is still some medication left in it after injecting your dose.
• Do not share this medicine with other face, even if they have the same symptoms you have.
• Call your doctor for instructions if you miss an appointment for your Prolia injection. You must receive your missed injection as soon as possible.
• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.
• Follow your doctor's instructions about any restrictions on food, beverages, or activity.
• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.
• Serious infections may occur during treatment with Prolia. Call your doctor right away if you have signs of infection such as:
· severe itching, burning, rash, blistering, peeling, or dryness of the skin;
· swelling, pain, tenderness, warmth, or redness anywhere on your body;
· pain or burning when you urinate, blood in your urine;
· severe stomach pain;
· ear pain or drainage, trouble hearing;
· fever, chills, night sweats;
· cough, feeling short of breath;
· pinpoint purple or red spots under your skin; or
· flu symptoms, weight loss.
• Call your doctor at once if you have a serious side effect such as:
· numbness or tingly feeling near your mouth or in your fingers or toes, quick or slow heart course, muscle cramps or contraction, overactive reflexes; or
· severe pain in your upper stomach spreading to your back, nausea and vomiting, quick heart rate.
• Smaller serious side effects may include:
· weakness;
· constipation;
· back pain, muscle pain; or
· pain in your arms or legs.
• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.
• Speak your doctor about all another medicines you use, especially drugs that weaken your immune system such as:
· steroids or cancer medicine;
· cyclosporine (Neoral, Sandimmune, Gengraf);
· sirolimus (Rapamune), tacrolimus (Prograf);
· basiliximab (Simulect), muromonab-CD3 (Orthoclone);
· mycophenolate mofetil (CellCept); or
· azathioprine (Imuran), leflunomide (Arava), etanercept (Enbrel).
• This list is not complete and another drugs may interact with denosumab. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.
• Your doctor or pharmacist can provide more information about denosumab (Prolia).
Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.
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