WHAT IS BILDYOS? BILDYOS is a prescription medicine used: To treat osteoporosis (thinning and weakening of bone) in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about BILDYOS? If you receive BILDYOS, you should not receive other denosumab products at the same time. BILDYOS can cause serious side effects, including: Increased risk of severe low calcium levels in your blood (hypocalcemia) BILDYOS may lower the calcium levels in your blood. If you have low blood calcium before you start receiving BILDYOS, it may get worse during treatment. Your low blood calcium must be treated before you receive BILDYOS. Talk to your doctor before starting BILDYOS. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take BILDYOS. Take calcium and vitamin D as your doctor tells you to.
WHAT IS BILDYOS?
BILDYOS is a prescription medicine used:
To treat osteoporosis (thinning and weakening of bone) in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
To increase bone mass in men with osteoporosis who are at high risk for fracture.
To treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least 6 months and are at high risk for fracture.
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.
To 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.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about BILDYOS? If you receive BILDYOS, you should not receive other denosumab products at the same time. BILDYOS can cause serious side effects, including: Increased risk of severe low calcium levels in your blood (hypocalcemia) BILDYOS may lower the calcium levels in your blood. If you have low blood calcium before you start receiving BILDYOS, it may get worse during treatment. Your low blood calcium must be treated before you receive BILDYOS. Talk to your doctor before starting BILDYOS. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take BILDYOS. Take calcium and vitamin D as your doctor tells you to.
BILDYOS is administered the same way as PROLIA (denosumab)
An injection under your skin (subcutaneous) every 6 months
BILDYOS (like PROLIA)1 injection
given by your doctor every 6 months
Your doctor will give you an injection in the upper arm, upper thigh, or stomach area
Other osteoporosis treatments can have different dosing schedules
Once-a-month injections given by a doctor
Daily, weekly, or monthly oral tablets
Daily self-administered injections
Yearly IV infusions
IV, intravenous.
Important things to remember while on treatment with BILDYOS:
Take 1,000 mg of calcium daily and at least 400 IU of vitamin D daily, as directed by your doctor
Set up an injection reminder for every 6 months
Do not stop, skip, or delay a dose without speaking to your doctor*
BILDYOS syringe and vial stopper are not made with natural rubber latex
*Stopping, skipping, or delaying BILDYOS increases your risk of breaking bones, including bones in your spine.
IU, international units.
Talk to your doctor about what to expect during treatment
BILDYOS has the same most common side effects as PROLIA
In women being treated for osteoporosis after menopause: The most common side effects of BILDYOS are back pain, muscle pain, pain in your arms and legs, bladder infection, and high cholesterol.
In men with osteoporosis: The most common side effects of BILDYOS are back pain, common cold (runny nose or sore throat), and joint pain.
In patients with glucocorticoid-induced osteoporosis: The most common side effects of BILDYOS are back pain, lung infection, high blood pressure, and headache.
In patients receiving certain treatments for prostate or breast cancer: The most common side effects of BILDYOS are joint pain, pain in your arms and legs, back pain, and muscle pain.
Tell your doctor if you have any side effect that bothers you or does not go away
Possible serious side effects include:
Increased risk of severe low calcium levels in your blood (hypocalcemia)
You should take calcium and vitamin D as your doctor tells you to while receiving BILDYOS.
Serious allergic reactions
Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction.
Severe jawbone problems (osteonecrosis of the jaw)
It is important for you to practice good mouth care during treatment with BILDYOS. Ask your doctor or dentist about good mouth care if you have any questions.
Unusual thigh bone fractures
Symptoms of a fracture include new or unusual pain in your hip, groin, or thigh.
Serious infections
BILDYOS is a medicine that may affect the ability of your body to fight infections. Call your doctor right away if you have any symptoms of infection.
Increased risk of broken bones, including broken bones in the spine after stopping, skipping, or delaying BILDYOS
Do not stop, skip, or delay taking BILDYOS without first talking with your doctor. If your BILDYOS treatment is stopped, talk to your doctor about other medicine that you can take.
Skin problems
Call your doctor if you have any symptoms of skin problems that do not go away or get worse.
Bone, joint, or muscle pain
Some people who take denosumab products develop severe bone, joint, or muscle pain.
BILDYOS is not the same as BILPREVDA® (denosumab-nxxp), which is used to treat other conditions. Do not take other products that contain denosumab while on BILDYOS.
These are not all the possible side effects of BILDYOS
Be sure to talk to your doctor about any new or worsening side effects
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
*Cost savings may be available for eligible patients.
WHAT IS BILDYOS?
BILDYOS is a prescription medicine used:
To treat osteoporosis (thinning and weakening of bone) in women after menopause who are at high risk for fracture or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.
To increase bone mass in men with osteoporosis who are at high risk for fracture.
To treat osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least 6 months and are at high risk for fracture.
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.
To 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.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about BILDYOS?
If you receive BILDYOS, you should not receive other denosumab products at the same time.
BILDYOS can cause serious side effects, including:
Increased risk of severe low calcium levels in your blood (hypocalcemia) BILDYOS may lower the calcium levels in your blood. If you have low blood calcium before you start receiving BILDYOS, it may get worse during treatment. Your low blood calcium must be treated before you receive BILDYOS. Talk to your doctor before starting BILDYOS. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take BILDYOS. Take calcium and vitamin D as your doctor tells you to.
If you have advanced chronic kidney disease (may or may not be on kidney dialysis), BILDYOS may increase your risk for severe low calcium levels in your blood, which could result in hospitalization, life-threatening events, and death. A mineral and bone disorder associated with kidney disease called chronic kidney disease-mineral bone disorder (CKD-MBD) may increase your risk for severe low calcium levels in blood. Before you start BILDYOS and during treatment, your doctor may need to do certain blood tests to check for CKD-MBD.
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
Serious allergic reactions Call your doctor or go to your nearest emergency room right away if you have any symptoms of a serious allergic reaction, including low blood pressure (hypotension); trouble breathing; throat tightness; swelling of your face, lips, or tongue; rash; itching; or hives.
Severe jaw bone problems (osteonecrosis) Severe jaw bone problems may happen when you take BILDYOS. Your doctor should examine your mouth before you start BILDYOS. Your doctor may tell you to see your dentist before you start BILDYOS. It is important for you to practice good mouth care during treatment with BILDYOS. 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.
Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying BILDYOS Talk with your doctor before starting treatment. After your treatment with BILDYOS is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. Do not stop, skip, or delay taking BILDYOS without first talking with your doctor. If your BILDYOS treatment is stopped, talk to your doctor about other medicine that you can take.
Serious infections Serious infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take BILDYOS. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take BILDYOS. You may need to go to the hospital for treatment.
BILDYOS is a medicine that may affect the ability of your body to fight infections. People who have weakened immune systems 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 Inflammation of your skin (dermatitis), rash, and eczema may occur with use of BILDYOS. Call your doctor right away if you have any of the following 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 denosumab products develop severe bone, joint, or muscle pain.
Call your doctor right away if you have any of these side effects.
What should I tell my doctor BEFORE starting BILDYOS?
Tell your doctor about all of your medical conditions, including if you:
Are taking other denosumab products
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
Are taking medicine that can lower your blood calcium levels
Plan to have dental surgery or teeth removed
Are pregnant or plan to become pregnant. BILDYOS may harm your unborn baby.
Females who are able to become pregnant:
Your health care provider should do a pregnancy test before you start treatment.
You should use an effective method of birth control (contraception) during treatment and for at least 5 months after your last dose of BILDYOS.
Tell your doctor right away if you become pregnant while taking BILDYOS.
Are breastfeeding or plan to breastfeed. It is not known if BILDYOS passes into your breast milk. You and your doctor should decide if you will take BILDYOS or breastfeed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I watch for AFTER starting BILDYOS?
BILDYOS can cause serious side effects.
It is not known if the use of BILDYOS over a long period of time may cause slow healing of broken bones.
The most common side effects of BILDYOS in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.
The most common side effects of BILDYOS in men with osteoporosis are back pain, joint pain, and common cold (runny nose or sore throat).
The most common side effects of BILDYOS in patients with glucocorticosteroid-induced osteoporosis are back pain, high blood pressure, lung infection, and headache.
The most common side effects of BILDYOS in patients receiving certain treatments for prostate or breast cancer are joint pain, back pain, pain in your arms and legs, and muscle pain.
These are not all the possible side effects of BILDYOS. Call your doctor for medical advice about side effects. Tell your doctor if you have any side effect that bothers you or that does not go away.
BILDYOS is an injection that will be given to you by a health care professional. BILDYOS is injected under your skin (subcutaneous).
This is the most important information to know about BILDYOS. For more information, talk to your health care provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
Please read the Medication Guide for BILDYOS, including information about severe hypocalcemia, and discuss it with your doctor. The Physician Prescribing Information also is available.
