Author: Charles Frank

How Does Prolia® denosumab Work?

When compared to placebo, treatment with Prolia resulted in markedly reduced bone formation rates. However, the long-term consequences of this degree of suppression of bone remodeling are unknown. Denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause (in women), as you age, if someone in your family has osteoporosis, or if you take certain medications (such as prednisone) for long periods.

Read the Medication Guide provided by your pharmacist before you start using denosumab and before each injection. Serious allergic reactions have happened in people who take Prolia. Call your doctor if you have any unusual problems while receiving this medication. This medicine is only given in a clinic, doctor’s office, or other health care setting and will not be stored at home.

Side Effects for Prolia

And be sure to let your doctor know about all the medications you’re currently taking. Here’s a list of some of the mild side effects that Prolia can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Prolia’s prescribing information.

Discontinuation of Prolia therapy should be considered based on individual benefit-risk assessment. For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit-risk assessment. The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. For these reasons, comparison of antibodies to denosumab with the incidence of antibodies to other products may be misleading. Serious infection was reported in 15 patients (3.9%) in the active-control group and 17 patients (4.3%) in the Prolia group.

1. In these patients Prolia also reduced the incidence of vertebral fractures [see Clinical Studies].
2. You should use effective birth control while you’re taking Prolia.
3. Verify the pregnancy status of females of reproductive potential prior to initiating Prolia treatment.
4. If Prolia treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy [see ADVERSE REACTIONS].

It is unlikely to be used during pregnancy or breastfeeding. If you’d like more information about Prolia treatment during pregnancy or while breastfeeding, talk with your doctor. If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist. Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works.

What does Prolia cost?

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at FDA-1088 or at /medwatch. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

If you notice other effects not listed above, contact your doctor or pharmacist. Take calcium and vitamin D as directed by your doctor, usually 1000 milligrams of calcium and at least 400 IU of vitamin D daily. Prolia® is an injection that works with your body to help stop the development ofbone-removing cells.

Prolia binds to RANKL, a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. Prolia prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone. Pre-existing hypocalcemia must be corrected prior to initiating therapy with Prolia [see WARNINGS AND PRECAUTIONS]. No clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of Prolia.

Our review of interim results from an ongoing safety study of Prolia suggests an increased risk of hypocalcemia, or low calcium levels in the blood, in patients with advanced kidney disease. Preliminary results from a separate internal FDA study further investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death. Prolia® is a prescription medicine used to treat bone loss in men who are at high risk for fracture receiving certain treatments for prostate cancer that has not spread to other parts of the body.

For more information about how these medications compare with each other, ask your doctor. They can tell you more about benefits and risks of Prolia and Forteo. Your doctor can help you decide which drug is better for your needs. Specifically, Prolia is a monoclonal antibody (a lab-made protein). It works with your immune system to help prevent bone loss.

How it’s administered

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to be sure it is safe for you to receive denosumab injection and to check your body’s response to denosumab injection. Visit your doctor or health care professional for regular checks on your progress.

These supplements help to prevent a low calcium level while you’re using Prolia. Your doctor will recommend the dosage of Prolia that’s right for you. Below are commonly used dosages, but the dosage you receive will be determined by your doctor. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing. Serious side effects from Prolia can occur, but they aren’t common.

Epidermal and dermal adverse events (such as dermatitis, eczema, and rashes) were reported in 4 patients (3.3%) in the placebo group and 5 patients (4.2%) in the Prolia group. The overall incidence of new malignancies was 4.3% in the placebo and 4.8% in the Prolia groups. New malignancies related to the breast (0.7% placebo vs. 0.9% Prolia), reproductive system (0.2% placebo vs. 0.5% Prolia), and gastrointestinal system (0.6% placebo vs. 0.9% Prolia) were reported. A causal relationship to drug exposure has not been established. Before starting Prolia treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take.

How does Prolia work? And how long does it stay in your system?

Prior to administration, Prolia may be allowed to reach room temperature (up to 25°C/77°F) in the original container. Once removed from the refrigerator, Prolia must not be exposed to temperatures above 25°C/77°F and must be used within 14 days. If not used within the 14 days, Prolia should be discarded. Do not use Prolia after the expiry date printed on the label. The gray needle cap on the single-dose prefilled syringe contains dry natural rubber (a derivative of latex); people sensitive to latex should not handle the cap. Prolia (denosumab) is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand).

Evaluation of full quantitative histomorphometry including bone remodeling rates was not possible in the glucocorticoid-induced osteoporosis population treated with Prolia. The long-term consequences of this degree of suppression of bone remodeling in glucocorticoid-treated patients is unknown. A total of 29 transiliac crest bone biopsy specimens were obtained from men with osteoporosis at 12 months (17 specimens in Prolia group, 12 specimens in placebo group).