Prolia (Denosumab Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Prolia

Osteoporosis »

Osteoporosis facts

Osteoporosis is a condition of increased susceptibility to fracture due to fragile bone.
Osteoporosis weakens bone and increases risk of bone fracture.
Bone mass (bone density) decreases after 35 years of age and decreases more rapidly in women after menopause.
Key risk factors for osteoporosis include genetics, lack of exercise, lack of calcium and vitamin D, personal history of fracture as an adult, cigarette smoking, excessive alcohol consumption, history of rheumatoid arthritis, low body weight, and family history of osteoporosis.
Patients with osteoporosis have no symptoms until bone fractures occur.
The diagnosis of osteoporosis can be suggested by X-rays and confirmed by tests to measure bone density.
Treatments for osteoporosis, in addition to prescription osteoporosis medications, include stopping use of alcohol and cigarettes, and assur...

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Prolia®
(denosumab)

DRUG DESCRIPTION

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 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...

Read All Potential Precautions of Prolia »

Last reviewed on RxList: 5/24/2012
This monograph has been modified to include the generic and brand name in many instances.