Are There Alternatives To Reclast And Prolia For Osteoporosis
There are several other medications that can be used to treat and/or prevent osteoporosis, such as:
Other bisphosphonates besides Reclast: Examples of others include ibandronate and alendronate .
Raloxifene : Raloxifene changes the way your body processes estrogen, and is therefore used to prevent or treat osteoporosis in women after menopause.
Calcitonin : Calcitonin is another treatment option thats derived from salmon. It is prescribed for women with osteoporosis who are at least 5 years post-menopause and who cant take the other medications.
Teriparatide and abaloparatide : These medications are based on the parathyroid hormone you make in your body. This hormone helps control calcium metabolism. Unlike other osteoporosis treatment options, these two focus on promoting new bone growth instead of limiting bone breakdown.
Romosozumab : This is a newer osteoporosis drug. It mainly helps you build new bone but also helps reduce breakdown of your existing bone. Right now, its only FDA-approved for use in postmenopausal women who have a high risk of fractures, or as an alternative for people who have tried other options that havent worked for them.
Prolia For Men With Osteoporosis
Prolia is approved to treat osteoporosis in men. With osteoporosis, your bones become weak and brittle. In men, osteoporosis can be caused by decreased production of hormones, such as testosterone. The condition can also be genetic. And as men age, their risk of osteoporosis increases.
Effectiveness in men with osteoporosis
In clinical trials, Prolia was effective in treating osteoporosis in men. In one trial, the mens bone mineral density was measured. Some men were given injections of Prolia, while other men were given injections of a placebo .
After 1 year of treatment, when compared with men taking the placebo, men taking Prolia had an increased BMD of:
- 4.8% in their spine
- 2% in their hip
- 2.2% in their femoral neck
How Long Do Side Effects Of Prolia Last
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. This includes side effects that affect your teeth.
If youre having side effects from Prolia that are bothersome and arent getting better, talk with your doctor. They may be able to recommend ways to reduce your side effects. Or your doctor may recommend a medication other than Prolia to treat your condition.
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What Other Drugs Interact With Denosumab
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
- Denosumab has no known severe interactions with other drugs.
- Serious interactions of denosumab include:
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.
Changes To The Product Information
The precaution in the Xgeva Product Information regarding hypocalcaemia has been updated to advise health professionals that severe symptomatic hypocalcaemia has been reported in the postmarketing setting. Similar text has also been added to the adverse effects section.
The adverse effects section of the Prolia PI has been updated to advise health professionals that rare events of severe symptomatic hypocalcaemia have been reported in patients at increased risk of hypocalcaemia. The PI was also updated to specify that atypical femoral fractures have been reported in patients being treated with Prolia.
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How Long Can I Take Prolia
You can use Prolia over a long period of time. In fact, if your osteoporosis is under control while youre taking Prolia, and youre not having severe or bothersome side effects, you should continue taking the drug for as long as your doctor recommends.
Clinical trials have shown that the drug is effective when its used over a 3-year period. But it may be effective when used for longer periods of time as well.
If you have severe or bothersome side effects from Prolia, or youd like to stop using Prolia for other reasons, talk with your doctor. They can discuss with you other treatment options to help increase your bone density.
Low Calcium In The Blood
If you have muscle spasms, twitching or cramps, tell your doctor straight away. This also includes any tingling feeling around your mouth , or in your fingers and toes.
These signs can mean that the calcium level in your blood is lower than normal. Your doctor will take regular blood tests to check your calcium levels. If it is low, your doctor will prescribe calcium and vitamin D supplements for you.
Occasionally, if calcium levels become very low, symptoms include feeling drowsy or confused. Let your doctor know if you, or other people, notice this.
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What Are Warnings And Precautions For Denosumab
This medication contains denosumab. Do not take Prolia or Xgeva if you are allergic to denosumab or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
History of systemic hypersensitivity, including anaphylaxis, facial swelling, and urticaria
- See “What Are Side Effects Associated with Using Denosumab?”
- See “What Are Side Effects Associated with Using Denosumab?”
Does Prolia Cause Weight Gain
Studies of Prolia didnt report weight gain as a side effect of the drug. But weight gain may occur with other medications you take or other health conditions you have.
If youre concerned about weight gain with Prolia, talk with your doctor. They may give you tips on managing a body weight thats healthy for you.
Your doctor will explain how Prolia will be given to you. They will also explain how much youll be given and how often. Below are commonly used dosages, but the dosage you receive will be determined by your doctor.
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Thank You For Reporting
Figure. Sources of adverse event reports made to the TGA in 2012
The TGA received approximately 14 500 adverse event reports during 2012. This was a similar number to those received during the previous year.
In recent years, sponsors have become the predominant reporter of adverse events. In 2012, sponsors were responsible for approximately 8350 reports – demonstrating their commitment to meeting pharmacovigilance requirements, which support the TGA’s mission to ensure ongoing medicine, vaccine and medical device safety in Australia.
Meanwhile, general practitioners and consumers made a comparatively small number of reports in 2012. GPs contributed 5% of reports received last year, which was a decrease on the 7% they contributed in 2011.
The TGA aims to stimulate greater reporting from GPs and consumers in the future, with greater promotion of reporting avenues and other initiatives under the TGA’s blueprint reforms that will support easier reporting. As part of the TGA’s aim to increase transparency, it is working towards making information about medicines and medical devices that are being monitored publicly available. Further information about these activities will be provided as they develop.
- to 6232 8392
For more information about reporting, visit www.tga.gov.au or contact the TGA’s Office of Product Review on 1800 044 114.
How Long Prolias Side Effects Last
For most people, Prolias side effects are mild and go away after a few days to a few weeks.
Its important to tell your doctor if you have serious or ongoing side effects.
For example, if you have a serious UTI or other infection, call your doctor right away. They can treat the infection as needed. Your risk for infection with Prolia may be higher if you have a weakened immune system. So be sure to tell your doctor about all your health conditions before taking Prolia.
Certain side effects of Prolia that may last longer than others include:
- jaw or dental side effects*
- low calcium level
- unusual thigh bone fractures
Ask your doctor about serious or long-lasting side effects of Prolia and what you should know before starting this drug. Your doctor can discuss with you how to manage side effects and whether youll need to stop taking Prolia due to side effects.
* For more information on this side effect, see the Side effect focus section below.
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Unprecedented Push To Promote Flu Vaccination
As flu season has just begun in the Northern Hemisphere, health officials, including Health & Human Services Secretary Tom Price, have released statements urging people and health care providers to get vaccinated against influenza.
At a press conference hosted by the National Foundation for Infectious Diseases on September 28th, Secretary Price was joined by a panel of experts including a professor of preventative medicine at Vanderbilt University School of Medicine, the director of the Center for Vaccine Development at the University of Maryland School of Medicine and other professionals specializing in fighting infectious diseases.
They strongly urged that people get the flu shot this year, further reinforcing the Center for Disease Controls recommendation that everyone aged six months or older receive the vaccine.
In Secretary Prices own words:
While we dont know what this season has in store, the science on flu vaccination is clear Vaccination can help prevent you or someone you love from becoming sick and missing school or work, or worse, becoming severely ill or being hospitalized or even dying from the flu.1
The overall vaccination rate in the United States rose from 45.6% in the 2015-2016 flu season to 46.8% in the 2016-2017 season. The rate for those below 17 years of age remained roughly the same, while the rates for those 18 and above rose from 41.7% to 43.3%.
Use Of 2013 Seasonal Influenza Vaccines In Children
The TGA advises health professionals that, for the 2013 influenza season, there are four influenza vaccines registered for use in children from the age of 6 months – Agrippal, Fluarix, Influvac and Vaxigrip. An additional influenza vaccine, Fluvax, is registered for use in children from the age of 5 years. Fluvax should not be used in children under 5 years and should only be used in children aged 5 to under 9 years based on careful consideration of potential benefits and risks in the individual child.
During the 2010 influenza season, an excess number of febrile reactions and febrile convulsions occurred in children under 5 years after immunisation with one of the registered seasonal influenza vaccines, Fluvax.1 As a result, the approved indication for Fluvax was changed to 5 years and over, with special precautions in children aged 5 to under 9 years.
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Doctors Support The Change
Richard Watkins, MD, an infectious disease physician and a professor of internal medicine at the Northeast Ohio Medical University, tells Verywell that there was never any compelling evidence for the previous recommendation, adding, I am glad it has been changed.
Watkins says that the move may help more children get vaccinated, noting the convenience factor. Under the updated guidance, families only have to make one trip to get vaccinated instead of several under the previous recommendations, he says.
John Schreiber, MD, a pediatric infectious disease specialist at Connecticut Children’s Medical Center, tells Verywell that the changed guidance seems like a reasonable thing to do.
Schreiber anticipates that some parents may still be wary to give their children other vaccines at the same time as the COVID-19 vaccine, but say that new recommendations are sound.
I dont have any concerns with this, Schreiber says. But, he adds, the CDC and AAP will monitor children to see what happens next. If it turns out that children are complaining about more side effects after getting vaccinated, Im sure the recommendations can be modified.”
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.
How Is Prolia Given
Prolia is injected under the skin of your stomach, upper thigh, or upper arm. A healthcare provider will give you this injection.
Prolia is usually given once every 6 months.
Your doctor may have you take extra calcium and vitamin D while you are being treated with Prolia. Take only the amount of calcium and vitamin D that your doctor has prescribed.
If you need to have any dental work , tell the dentist ahead of time that you are using Prolia.
Pay special attention to your dental hygiene. Brush and floss your teeth regularly while using this medication. You may need to have a dental exam before you begin treatment with Prolia. Follow your doctor’s instructions.
Your risk of bone fractures can increase when you stop using Prolia. Do not stop using this medicine without first talking to your doctor.
If you keep this medicine at home, store it in the original container in a refrigerator. Protect from light and do not freeze.
You may take Prolia syringe out of the refrigerator and allow it to reach room temperature before the injection is given. Do not heat the medicine before using.
Do not shake the the prefilled syringe or you may ruin the medicine. Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for a new prescription.
Each prefilled syringe of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.
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How Does Prolia Work
is the brand name for the generic drug denosumab. It inhibits a protein called RANKL. The cells responsible for breaking down bone need RANKL in order to work and survive. By keeping RANKL from binding to its receptor, Prolia limits the ability of these cells to break down bone.
As a result, Prolia helps strengthen bone and increase bone mass. Like Reclast, Prolia also helps reduce the occurrence of various fractures, including vertebral, nonvertebral, and hip fractures in postmenopausal women with osteoporosis.
Prolia is also approved to treat several different groups of people:
Men and postmenopausal women with osteoporosis who are at high risk for bone fractures, including those with osteoporosis caused by steroids
Men who are at high risk for bone fractures and are receiving androgen deprivation therapy like or for nonmetastatic prostate cancer treatment
Women who are at high risk for bone fractures and are receiving adjuvant aromatase inhibitor therapy like for breast cancer treatment
How Should I Use This Medication
The recommended dose of denosumab is 60 mg injected once every 6 months. It is injected subcutaneously of the upper arm, upper thigh, or abdomen. Your doctor may show you how to give yourself the injections, or a health care professional will inject the medication for you.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
It is important that this medication be used exactly as recommended by your doctor. If you miss an appointment to receive denosumab, contact your doctor as soon as possible to reschedule your appointment. If you are injecting this medication yourself and miss a dose, use it as soon as you remember. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
This medication is stored in the refrigerator. Protect it from light and do not allow this medication to freeze. Keep it out of the reach of children. When removed from the refrigerator, it can also be stored at room temperature for 30 days. It should be allowed to reach room temperature before injecting.
Do not dispose of medications in wastewater or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
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Should Pharmacologic Osteoporosis Treatment Be Continued Before And After Covid
To date, there is no evidence that any osteoporosis therapy either increases the risk or severity of COVID-19 infection, alters the disease course , or interferes with the efficacy or side effect profile of COVID-19 vaccination. On the other hand, depending on the pharmacologic agent utilized, disruption of osteoporosis treatment could have significant implications on fragility fracture risk. Osteoporotic fractures continue to occur unabated throughout the COVID-19 pandemic, with fragility fractures comprising an even higher proportion of fractures than prior to the pandemic. Thus, as a general rule, therapeutic regimens should not be permanently discontinued or indefinitely delayed because of vaccination. However, we acknowledge that depending on the specific profile of each anti-osteoporosis drug category, special adjustments may need to be considered with respect to vaccination timing. Accordingly, considerations related to each class of medications commonly utilized for the treatment of osteoporosis are discussed in the following sections. In the absence of clear data, these recommendations should be considered as suggestions, and not guidelines. Furthermore, in light of the current scarcity in vaccine availability, we recognize that vaccine dosing may need to be prioritized over potential slight alterations in standard osteoporosis regimens.