"March 7, 2013 -- An FDA panel voted to stop recommending calcitonin salmon for the treatment of osteoporosis in women who are at least five years past menopause.
The committee voted 12-9 against continued marketing of the drug, citing"...
(denosumab) Injection, for Subcutaneous Use
- Patient Information:
Details with Side Effects
Prolia (denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand). Denosumab has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.
Prolia is a sterile, preservative-free, clear, colorless to pale yellow solution.
Each 1 mL single-use prefilled syringe of Prolia contains 60 mg denosumab (60 mg/mL solution), 4.7% sorbitol, 17 mM acetate, 0.01% polysorbate 20, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.
Each 1 mL single-use vial of Prolia contains 60 mg denosumab (60 mg/mL solution), 4.7% sorbitol, 17 mM acetate, Water for Injection (USP), and sodium hydroxide to a pH of 5.2.
What are the possible side effects of Prolia (Prolia)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, 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...
What are the precautions when taking denosumab injection (Prolia)?
Before using denosumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood calcium levels (hypocalcemia), thyroid/parathyroid problems/surgery, stomach/intestinal problems (such as malabsorption, surgery), kidney problems, recent or planned dental surgery/tooth removal.
Infrequently, people taking medications for bone loss (including denosumab) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental...
Last reviewed on RxList: 7/22/2013
This monograph has been modified to include the generic and brand name in many instances.
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