Author: Alex Thompson

Prolia Denosumab Injection: Side Effects, Uses, Dosage, Interactions, Warnings

However, taking an equivalent of 2.5 mg of prednisone for 3 months or longer can put you at risk for fractures. If you need to take steroids long term, talk with your doctor about ways to lower your risk of fracture. They may suggest that you exercise or take supplements such as calcium or vitamin D. Or they may recommend a prescription medication, such as Prolia.

Taking certain steroids over a long period of time can cause osteoporosis. This is because some steroids, such as prednisone, can decrease the density of your bones. So if you’re taking certain steroids long term, your bones may become weaker, and you may have a higher risk of fractures. Prolia comes as a solution inside prefilled syringes that each hold 60 mg of the drug. Prolia is given as an injection under your skin (called a subcutaneous injection).

Prolia for men with osteoporosis

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. Continue to take other medications for your condition as directed by your doctor. Take calcium and vitamin D as directed by your doctor, usually 1000 milligrams of calcium and at least 400 IU of vitamin D daily. If you’d like more information about Prolia treatment during pregnancy or while breastfeeding, talk with your doctor.

And in trials of people taking cancer treatments that affect certain hormones (such as testosterone and estrogen), 6% of people who took Prolia had muscle or bone pain. In comparison, 3.8% of people who took a placebo had this type of pain. The risk of jaw necrosis may also be increased if you’ve had recent dental work. This could include having dental surgery, tooth extractions, or dental implants, such as implants with dental crowns.

Symptoms of serious allergic reaction, such as decreased blood pressure and trouble breathing, have been reported in people taking Prolia. However, it’s not known how many people taking Prolia during clinical trials had an allergic reaction to the drug. In clinical trials, Prolia was effective in treating osteoporosis and reducing bone loss. For information about Prolia’s effectiveness, see the “Prolia Uses” section below.

1. Prolia is used to treat osteoporosis in women after menopause and in men, and in people who are taking corticosteroids for 6 months or more.
2. Keep a list of medicines with you to show to your doctor or pharmacist when you get a new medicine.
3. Specifically, Prolia works by blocking a protein called RANK.
4. Vertebral fractures were diagnosed based on lateral spine radiographs (T4-L4) using a semiquantitative scoring method.

For these reasons, comparison of antibodies to denosumab with the incidence of antibodies to other products may be misleading. New malignancies were reported in no patients in the placebo group and 4 (3.3%) patients (3 prostate cancers, 1 basal cell carcinoma) in the Prolia group. 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. ONJ has been reported in the osteoporosis clinical trial program in patients treated with Prolia [see WARNINGS AND PRECAUTIONS]. It is unlikely to be used during pregnancy or breastfeeding. The recommended dose of Prolia is 60 mg administered as a single subcutaneous (under the skin) injection once every 6 months.

Prolia Images

Some cases required hospitalization and were complicated by acute renal injury [see WARNINGS AND PRECAUTIONS]. Based on results from animal studies, Prolia may negatively affect long-bone growth and dentition in pediatric patients below the age of 4 years. There was no evidence of maternal harm prior to labor; adverse maternal effects occurred infrequently during labor.

It binds to RANKL, which is a protein on the membrane of osteoclasts that is essential for their formation, function, and survival. This inhibits osteoclast formation, which decreases bone resorption and increases bone mass and strength in both cortical (hard bone) and trabecular (spongy bone) bone. Prolia is a monoclonal antibody that targets and inhibits RANK ligand (RANKL). Call your doctor or health care professional if you are unable to keep an appointment. For Prolia, talk to your pediatrician regarding the use of this medicine in children. For Xgeva, talk to your pediatrician regarding the use of this medicine in children.

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on some of the side effects this drug may or may not cause. For more information on the possible side effects of Prolia, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome. The following lists contain some of the key side effects that may occur while taking Prolia. RxList does not provide medical advice, diagnosis or treatment.

What is this medication?

If Prolia treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy [see ADVERSE REACTIONS]. Serious infection was reported in 1 patient (0.8%) in the placebo group and no patients in the Prolia group. Prolia is supplied in a single-dose prefilled syringe with a safety guard. The gray needle cap on the single-dose prefilled syringe contains dry natural rubber (a derivative of latex). 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. Our Prolia (denosumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Having an infection in your mouth can also increase your risk of jaw necrosis. Some side effects from Prolia may last only a few days, while others may last several months. Because the drug can stay in your body for up to 6 months, some side effects can still occur months after your last dose of Prolia. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Prolia for a condition for which it was not prescribed. Do not give Prolia to other people, even if they have the same symptoms that you have.

What is the most important information I should know about Prolia (Denosumab (Prolia))?

In patients treated with active-control, 100% of biopsies had tetracycline label. In patients treated with Prolia, 1 (33%) had tetracycline label and 2 (67%) had no tetracycline label present at the 12-month biopsy. Evaluation of full quantitative histomorphometry including bone remodeling rates was not possible in the glucocorticoid-induced osteoporosis population treated with Prolia.

But for those taking risedronate, their spinal BMD was only increased by 2.3%. For each of the uses described below, Prolia is given to people who are at high risk of a bone fracture. Prolia contains the active drug denosumab, while Reclast contains the active drug zoledronic acid. Your doctor will check to see what’s causing your skin problems, and they’ll recommend if any treatment is needed.

How to take Prolia (Denosumab (Prolia))?

In the osteoporosis clinical trial program, atypical femoral fractures were reported in patients treated with Prolia. The duration of Prolia exposure to time of atypical femoral fracture diagnosis was as early as 2½ years [see WARNINGS AND PRECAUTIONS]. Adverse reactions reported in ≥ 2% of postmenopausal women with osteoporosis and more frequently in the Prolia-treated women than in the placebo-treated women are shown in the table below.