ВУЗ: Казахский национальный медицинский университет им. С.Д. Асфендиярова
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17.8
Musculoskeletal Pain
Inform patients that severe bone, joint, and/or muscle pain have been reported in patients taking Prolia.
Patients should report severe symptoms if they develop [see Warnings and Precautions (5.8)].
17.9
Embryo-Fetal Toxicity
Pregnancy
Advise patients that Prolia is contraindicated in women who are pregnant and may cause fetal harm
[see Contraindications (4.2), Use in Specific Populations (8.1)].
17.10 Nursing Mothers
Advise patients that because many drugs are excreted in human milk and because of the potential for
serious adverse reactions in nursing infants from Prolia, a decision should be made whether to discontinue
nursing or discontinue the drug, taking into account the importance of the drug to the mother [see Use in
Specific Populations (8.3)].
17.11 Schedule of Administration
If a dose of Prolia is missed, administer the injection as soon as convenient. Thereafter, schedule
injections every 6 months from the date of the last injection.
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
Patent: http://pat.amgen.com/prolia/
© 2010-2015 Amgen Inc. All rights reserved.
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MEDICATION GUIDE
Prolia
®
(PRÓ-lee-a)
(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 blood pressure (hypotension)
trouble breathing
throat tightness
swelling of your face, lips, or tongue
rash
itching
hives
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
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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:
Redness
Itching
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.
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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:
o are at high risk for fracture (broken bone)
o 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 taking Prolia.
o 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.
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.
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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:
back pain
pain in your arms and legs
high cholesterol
muscle pain
bladder infection
The most common side effects of Prolia in men with osteoporosis are:
back pain
joint pain
common cold (runny nose or sore throat)
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.