Meet
OSPOMYV®An FDA-approved biosimilar to Prolia® (denosumab)

A biosimilar is an almost identical version of an FDA-approved biologic medical product that is manufactured by a different company and may cost much less than the original.

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What is OSPOMYV?

A medicine that helps make bones stronger and helps stop them from breaking easily in patients at high risk

FDA approved for all the same indications as Prolia®

Thoroughly studied and proven to share the same safety and effectiveness profile as Prolia® and can be substituted for it at the pharmacy

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Actor Portrayal

OSPOMYV Co-Pay Program

The OSPOMYV Co-pay Program can help eligible patients reduce their out-of-pocket costs.

  • If you qualify, you can start using your co-pay card right away
  • Your card doesn’t expire—you’ll be automatically re-enrolled every year

See if you qualify

If you have any questions, please contact the Cordavis Help-Line at 1-833-378-3653.

Indications & Important Safety Information

Ospomyv is a prescription medicine indicated for treatment:

  • of osteoporosis 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.
  • of osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six 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.

What is the most important information I should know about Ospomyv?
If you receive Ospomyv, you should not receive other denosumab products at the same time.

Ospomyv can cause serious side effects including:
Increased risk of severe low calcium levels in your blood (hypocalcemia). Ospomyv may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Ospomyv, it may get worse during treatment. Your low blood calcium must be treated before you receive Ospomyv. Talk to your doctor before starting Ospomyv. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Ospomyv. 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), Ospomyv 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 Ospomyv 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 have happened in people who take denosumab products. 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

Severe jaw bone problems (osteonecrosis) may happen when you take Ospomyv. Your doctor should examine your mouth and may tell you to see your dentist before you start Ospomyv. It is important for you to practice good mouth care during treatment with Ospomyv.

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 Ospomyv. Talk with your doctor before staring Ospomyv treatment. After your treatment with Ospomyv 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 Ospomyv without first talking with your doctor. If your Ospomyv treatment is stopped, talk to your doctor about other medicine that you can take.

Serious Infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take Ospomyv. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Ospomyv. You may need to go to the hospital for treatment if you develop an infection.

Ospomyv is a medicine that may affect the ability of your body to fight infections. People who have a 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

Bone, joint, or muscle pains. Some people who take denosumab products develop severe bone, joint, or muscle pain.

Do not take Ospomyv 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 products or any of the ingredients in Ospomyv.

Before taking Ospomyv, 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. Ospomyv may harm your unborn baby.

Females who are able to become pregnant:

  • Your healthcare provider should do a pregnancy test before you start treatment with Ospomyv.
  • You should use an effective method of birth control (contraception) during treatment with Ospomyv and for at least 5 months after your last dose of Ospomyv.
  • Tell your doctor right away if you become pregnant while taking Ospomyv.
  • are breastfeeding or plan to breastfeed. It is not known if Ospomyv passes into your breast milk. You and your doctor should decide if you will take Ospomyv or breastfeed. You should not do both.

What are the possible side effects of Ospomyv?
It is not known if the use of Ospomyv over a long period of time may cause slow healing of broken bones.

The most common side effects of Ospomyv in women who are being treated for osteoporosis after menopause are back pain, muscle pain, pain in arms and legs, bladder infection, and high cholesterol.

The most common side effects of Ospomyv in men with osteoporosis are back pain, common cold (runny nose or sore throat), and joint pain.

The most common side effects of Ospomyv in patients with glucocorticoid-induced osteoporosis are back pain, lung infection (bronchitis), high blood pressure, and headache.

The most common side effects of Ospomyv in patients receiving certain treatments for prostate or breast cancer are joint pain, pain in arms and legs, back pain, and muscle pain. Additionally, in denosumab-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.

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 Ospomyv. Call your doctor for medical advice about side effects. You may report side effects to FDA by phone at 1-800-FDA-1088, or visit www.fda.gov/medwatch.

Please see Ospomyv full Prescribing Information and Medication Guide.

Indications & Important Safety Information

What is Ospomyv?

Ospomyv is a prescription medicine indicated for treatment:

  • of osteoporosis 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.
  • of osteoporosis in men and women who will be taking corticosteroid medicines (such as prednisone) for at least six 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 Ospomyv?
If you receive Ospomyv, you should not receive other denosumab products at the same time.

Ospomyv can cause serious side effects including:
Increased risk of severe low calcium levels in your blood (hypocalcemia). Ospomyv may lower the calcium levels in your blood. If you have low blood calcium before you start receiving Ospomyv, it may get worse during treatment. Your low blood calcium must be treated before you receive Ospomyv. Talk to your doctor before starting Ospomyv. Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood while you take Ospomyv. 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), Ospomyv 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 Ospomyv 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 have happened in people who take denosumab products. 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

Severe jaw bone problems (osteonecrosis) may happen when you take Ospomyv. Your doctor should examine your mouth and may tell you to see your dentist before you start Ospomyv. It is important for you to practice good mouth care during treatment with Ospomyv.

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 Ospomyv. Talk with your doctor before staring Ospomyv treatment. After your treatment with Ospomyv 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 Ospomyv without first talking with your doctor. If your Ospomyv treatment is stopped, talk to your doctor about other medicine that you can take.

Serious Infections in your skin, lower stomach area (abdomen), bladder, or ear may happen if you take Ospomyv. Inflammation of the inner lining of the heart (endocarditis) due to an infection also may happen more often in people who take Ospomyv. You may need to go to the hospital for treatment if you develop an infection.

Ospomyv is a medicine that may affect the ability of your body to fight infections. People who have a 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

Bone, joint, or muscle pains. Some people who take denosumab products develop severe bone, joint, or muscle pain.

Do not take Ospomyv 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 products or any of the ingredients in Ospomyv.

Before taking Ospomyv, 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. Ospomyv may harm your unborn baby.

Females who are able to become pregnant:

  • Your healthcare provider should do a pregnancy test before you start treatment with Ospomyv.
  • You should use an effective method of birth control (contraception) during treatment with Ospomyv and for at least 5 months after your last dose of Ospomyv.
  • Tell your doctor right away if you become pregnant while taking Ospomyv.
  • are breastfeeding or plan to breastfeed. It is not known if Ospomyv passes into your breast milk. You and your doctor should decide if you will take Ospomyv or breastfeed. You should not do both.

What are the possible side effects of Ospomyv?
It is not known if the use of Ospomyv over a long period of time may cause slow healing of broken bones.

The most common side effects of Ospomyv in women who are being treated for osteoporosis after menopause are back pain, muscle pain, pain in arms and legs, bladder infection, and high cholesterol.

The most common side effects of Ospomyv in men with osteoporosis are back pain, common cold (runny nose or sore throat), and joint pain.

The most common side effects of Ospomyv in patients with glucocorticoid-induced osteoporosis are back pain, lung infection (bronchitis), high blood pressure, and headache.

The most common side effects of Ospomyv in patients receiving certain treatments for prostate or breast cancer are joint pain, pain in arms and legs, back pain, and muscle pain. Additionally, in denosumab-treated men with nonmetastatic prostate cancer receiving ADT, a greater incidence of cataracts was observed.

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 Ospomyv. Call your doctor for medical advice about side effects. You may report side effects to FDA by phone at 1-800-FDA-1088, or visit www.fda.gov/medwatch.

Please see Ospomyv full Prescribing Information and Medication Guide.