"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"...
- Patient Information:
Details with Side Effects
(denosumab) Injection, for Subcutaneous Use
Read the Medication Guide that comes with Prolia before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about Prolia.
What is the most important information I should know about Prolia?
If you receive Prolia, you should not receive XGEVA® . Prolia contains the same medicine as Xgeva (denosumab).
Prolia can cause serious side effects including:
- Serious allergic reactions.
Serious allergic reactions have happened in people who take Prolia. Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction. Symptoms of a serious allergic reaction may include:
- Low calcium levels in your blood (hypocalcemia).
Prolia may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Prolia, it may get worse during treatment. Your low blood calcium must be treated before you receive Prolia. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as:
- Spasms, twitches, or cramps in your muscles
- Numbness or tingling in your fingers, toes, or around your mouth
Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Prolia. Take calcium and vitamin D as your doctor tells you to.
- Severe jaw bone problems (osteonecrosis).
Severe jaw bone problems may happen when you take Prolia. Your doctor should examine your mouth before you start Prolia. Your doctor may tell you to see your dentist before you start Prolia. It is important for you to practice good mouth care during treatment with Prolia. Ask your doctor or dentist about good mouth care if you have any questions
- Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
- Serious infections. Serious infections in your
skin, lower stomach area (abdomen), bladder, or ear may happen if you take
Prolia. Inflammation of the inner lining of the heart (endocarditis) due to an
infection also may happen more often in people who take Prolia. You may need to
go to the hospital for treatment if you develop an infection.
Prolia is a medicine that may affect the ability of your body to fight infections. People who have weakened immune system or take medicines that affect the immune system may have an increased risk for developing serious infections.
Call your doctor right away if you have any of the following symptoms of infection:
- Fever or chills
- Skin that looks red or swollen and is hot or tender to touch
- Fever, shortness of breath, cough that will not go away
- Severe abdominal pain
- Frequent or urgent need to urinate or burning feeling when you urinate
- Skin problems.
Skin problems such as inflammation of your skin (dermatitis), rash, and eczema may happen if you take Prolia. Call your doctor if you have any of the following symptoms of skin problems that do not go away or get worse:
- Small bumps or patches (rash)
- Your skin is dry or feels like leather
- Blisters that ooze or become crusty
- Skin peeling
- Bone, joint, or muscle pain.
Some people who take Prolia develop severe bone, joint, or muscle pain.
Call your doctor right away if you have any of these side effects.
What is Prolia?
Prolia is a prescription medicine used to:
- Treat osteoporosis (thinning and weakening of bone) in
women after menopause (“change of life”) who:
- are at high risk for fracture (broken bone)
- cannot use another osteoporosis medicine or other osteoporosis medicines did not work well
- Increase bone mass in men with osteoporosis who are at high risk for fracture
- 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
- Treat bone loss in women who are at high risk for fracture receiving certain treatments for breast cancer that has not spread to other parts of the body
It is not known if Prolia is safe and effective in children.
Who should not take Prolia?
Do not take Prolia if you:
- have been told by your doctor that your blood calcium level is too low.
- are pregnant or plan to become pregnant
- are allergic to denosumab or any of the ingredients in Prolia. See the end of this leaflet for a complete list of ingredients in Prolia.
What should I tell my doctor before taking Prolia?
Before taking Prolia, tell your doctor if you:
- Are taking a medicine called Xgeva (denosumab). Xgeva contains the same medicine as Prolia.
- Have low blood calcium
- Cannot take daily calcium and vitamin D
- Had parathyroid or thyroid surgery (glands located in your neck)
- Have been told you have trouble absorbing minerals in your stomach or intestines (malabsorption syndrome)
- Have kidney problems or are on kidney dialysis
- Plan to have dental surgery or teeth removed.
- Are pregnant or plan to become pregnant. Prolia may harm
your unborn baby. Tell your doctor right away if you become pregnant while
- Pregnancy Surveillance Program: Prolia is not intended for use in pregnant women. If you become pregnant while taking Prolia, talk to your doctor about enrolling in Amgen's Pregnancy Surveillance Program or call 1-800-772-6436 (1-800-77-AMGEN). The purpose of this program is to collect information about women who have become pregnant while taking Prolia.
- If you are a man and you receive Prolia: Small amounts of Prolia may be in semen. If your sexual partner is pregnant, some Prolia from your semen may reach the unborn baby. While the risk is likely to be low, it is important to talk to your doctor if your partner becomes pregnant while you are taking Prolia.
- Are breastfeeding or plan to breastfeed. It is not known if Prolia passes into your breast milk. You and your doctor should decide if you will take Prolia or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and nonprescription drugs, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of medicines with you to show to your doctor or pharmacist when you get a new medicine.
How will I receive Prolia?
- Prolia is an injection that will be given to you by a healthcare professional. Prolia is injected under your skin (subcutaneous).
- You will receive Prolia 1 time every 6 months.
- You should take calcium and vitamin D as your doctor tells you to while you receive Prolia.
- If you miss a dose of Prolia, you should receive your injection as soon as you can.
- Take good care of your teeth and gums while you receive Prolia. Brush and floss your teeth regularly.
- Tell your dentist that you are receiving Prolia before you have dental work.
What are the possible side effects of Prolia?
Prolia may cause serious side effects.
- See “What is the most important information I should know about Prolia?”
- It is not known if the use of Prolia over a long period of time may cause slow healing of broken bones.
The most common side effects of Prolia in women who are being treated for osteoporosis after menopause are:
The most common side effects of Prolia in men with osteoporosis are:
The most common side effects of Prolia in patients receiving certain treatments for prostate or breast cancer are:
- joint pain
- back pain
- pain in your arms and legs
- muscle pain
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Prolia. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Prolia if I need to pick it up from a pharmacy?
- Keep Prolia in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton.
- Do not freeze Prolia.
- When you remove Prolia from the refrigerator, Prolia must be kept at room temperature [up to 77°F (25°C)] in the original carton and must be used within 14 days.
- Do not keep Prolia at temperatures above 77°F (25°C). Warm temperatures will affect how Prolia works.
- Do not shake Prolia.
- Keep Prolia in the original carton to protect from light.
Keep Prolia and all medicines out of reach of children.
General information about Prolia.
Do not give Prolia to other people even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Prolia. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Prolia that is written for health professionals.
For more information, go to www.Prolia.com or call Amgen at 1-800-772-6436.
What are the ingredients in Prolia?
Active ingredient: denosumab
Inactive ingredients: sorbitol, acetate, polysorbate 20 (prefilled syringe only), Water for Injection (USP), and sodium hydroxide
RISK EVALUATION AND MITIGATION STRATEGY (REMS)
To inform healthcare providers (HCP) and patients about the risks of hypocalcemia, serious infections, dermatologic adverse reactions, and suppression of bone turnover, including osteonecrosis of the jaw and atypical femoral fractures, associated with Prolia® (denosumab).
Amgen will ensure the Prolia Medication Guide is distributed in accordance with 21CFR 208.24.
The Medication Guide is part of the REMS and is appended.
Amgen will implement a communication plan (CP) to inform Healthcare Providers (HCP) about the risks of hypocalcemia, serious infections, dermatologic adverse reactions, and suppression of bone turnover, including osteonecrosis of the jaw and atypical femoral fractures, associated with Prolia.
The CP consists of a Dear Healthcare Provider (DHCP) Letter, which will be sent by electronic mailing or mass mailing within 60 days of the most recent REMS approval to endocrinologists; rheumatologists; obstetricians/gynecologists; primary care physicians who received the first DHCP letter or had written at least 1 prescription for an osteoporosis medication since the launch of Prolia; oncologists and urologists who are likely to prescribe or have prescribed hormone ablation as a method of treatment for patients with prostate or breast cancer; and to any known new prescribers of Prolia who were not previously sent the DHCP Letter. If a targeted HCP's email address is not available, or if an email is undeliverable, the provider will receive the letter through the mail. The DHCP Letter will be sent to the following professional societies within 60 days of the most recent REMS approval requesting they provide this letter to their members: National Osteoporosis Foundation, American Society of Bone Mineral Research, American College of Rheumatology, American Association of Clinical Endocrinologists, the American College of Physicians, the American Academy of Family Physicians, the Endocrine Society, and the American Society of Clinical Oncology. A copy of the US Prescribing Information and Medication Guide will accompany the DHCP Letter.
Amgen will resend the DHCP Letter to the following professional societies annually from the date of the initial REMS approval (6/2010) for 3 years: National Osteoporosis Foundation, American Society of Bone Mineral Research, American College of Rheumatology, American Association of Clinical Endocrinologists, the American College of Physicians, the American Academy of Family Physicians, the Endocrine Society, and the American Society of Clinical Oncology.
The DHCP Letter, US Prescribing Information, and Medication Guide will also be distributed to HCPs via sales representatives and medical science liaisons at the time of initial contact, when inquired about the risks outlined in the REMS, or upon request; through the Amgen toll-free medical information line (1-800-772-6436); and through a REMS-dedicated link [www.proliahcp.com] from the website.
The Medication Guide, DHCP Letter, and web page are part of the REMS and are appended.
Timetable for Submission
Amgen will submit REMS Assessments to FDA at 18 months, 3 years, and 7 years from the date of the initial approval (01 June 2010) of the REMS. To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 days before the submission date for that assessment. Amgen will submit each assessment so that it will be received by the FDA on or before the due date.
Last reviewed on RxList: 6/30/2014
This monograph has been modified to include the generic and brand name in many instances.
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