Patient Support Program Privacy Policy

This Privacy Policy describes how North 53, LLC and its subsidiary and affiliated companies (“we,” “our,” or “us”) collects Personal Information from and about you, including through your interactions with us https://ospomyv.com (the “Site”). We refer to these collectively as the “Services.” It also describes the types of Personal Information we collect, how we may use and disclose such information, and your choices and legal rights with respect to such information.

By using our Services, you agree to the collection, use, and disclosure of your information as described in this Privacy Policy. If you do not agree, please do not use our Services.

Contents:

1. Personal Information We Collect

There are several ways we may collect Personal Information about you, including through information you provide to us; information we collect through your use of the Services and interactions with us; information we receive from third parties; and by combining information from different sources. This includes data that identifies you personally, whether directly or indirectly. For purposes of this Privacy Policy, “Personal Information” refers to information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, to you, and includes “personal data” or similar terms as defined in applicable law.

a) Categories of Information We May Collect
We may collect certain categories of Personal Information, such as:

  • Identifiers/demographic information, such as name, age, date of birth, sex, gender, postal and email address, phone number, and online identifiers, Internet Protocol (“IP”) address, and other similar identifiers.
  • Commercial information, such as products or services purchased, obtained, or considered and other purchasing or consuming histories or tendencies.
  • Internet or other electronic network activity information.
  • Geolocation data (non-precise).
  • Sensitive Personal Information as defined by applicable laws, including Personal Information collected and analyzed concerning a consumer’s health.

b) Information You May Provide
When you use our Services, we may collect Personal Information from you, such as when you enroll in a patient support program or call into the medical information center.

c) Information We May Automatically Collect
When you visit and interact with our Services, we or our service providers do not use first or third-party cookies or any tracking technologies on our website.

d) Information We May Receive from Third Parties
We may receive Personal Information from other sources. Our third-party sources may include:

  • Providers, such as a prescriber of your medication.

e) Combination of Information
We may combine Personal Information that we receive from various sources. For example, we may combine Personal Information that we receive from third parties with Personal Information we already have about you. We use, disclose, and protect combined Personal Information as described in this Privacy Policy.

f) Retention
We will retain your Personal Information for as long as reasonably necessary to provide you with our Services that you request or otherwise where permitted or required in accordance with applicable law. We will retain and use your Personal Information as necessary to comply with our legal obligations, resolve disputes, and enforce our agreements. What this means in practice will vary between different types of information, and when we consider our approach, we take into account ongoing business or legal needs for the information, for example in relation to tax, health and safety, and potential or actual disputes or investigations.

2. Purposes for Processing Your Personal Information

We may use the Personal Information we collect about you for the purposes listed below:

  • To provide you with our Services, including to enroll you in a patient support program.
  • To communicate with you, including to respond to your inquiries/requests and request feedback from you, and to send you important updates and messages about changes to our Services, our Privacy Policy, and/or other applicable terms and conditions.
  • To review the usage and maintain the operation of our Services.
  • To conduct analysis and develop and/or improve our Services.
  • To monitor, protect, and maintain the security and integrity of our Services and our business, such as protecting against and preventing fraud, unauthorized transactions, claims and other liabilities.
  • To comply with applicable laws and regulations and respond to lawful requests and communications from law enforcement and other government officials.
  • To carry out sales and business transactions in which information held by us is among the assets transferred or is otherwise relevant to the evaluation, negotiation, or completion of the transaction.
  • To protect our rights, privacy, safety, property and/or those of others.
  • To fulfill any other purpose for which you provide your Personal Information or as explained to you at the point of information collection.

3. How We May Disclose Your Personal Information

We may disclose Personal Information that we collect to the following categories of recipients:

  • Our Service Providers. We disclose your Personal Information to our service providers that provide business, professional, or technical support services to us, help us operate our business and the Services, or administer activities on our behalf. We require our service providers to only use your Personal Information in connection with providing services to us.
  • Commercial information, such as products or services purchased, obtained, or considered and other purchasing or consuming histories or tendencies.

In certain circumstances, we may disclose each category of your Personal Information to:

  • Competent Governmental, Regulatory, and Public Authorities. We may disclose your Personal Information only as permitted or if required to do so by government and law enforcement authorities. We disclose Personal Information in matters involving claims of personal or public safety, or in litigation. This may include disclosure of your Personal Information to allow us to pursue remedies or to limit the damages we may sustain. We may also use or disclose your information to enforce our terms and conditions, to protect our operations or those of any of our affiliates, to prevent misuse of our Services, or to protect our rights, privacy, safety or property and/or that of our affiliates, you, or others.
  • Relevant Third Parties as Part of a Corporate Transaction. In the event of a reorganization, merger, sale, joint venture, assignment, transfer, or other disposition of all or any portion of our business, assets, or stock (including in connection with a bankruptcy or similar proceeding), we may disclose or transfer your Personal Information to certain third parties, such as the acquiring entity and its advisers.
  • Other Third Parties. We will disclose your Personal Information to other third parties at your direction or with your consent. Additionally, we will disclose your Personal Information as we believe necessary or appropriate to: (a) comply with applicable law; (b) enforce our terms and conditions; (c) protect our operations; (d) protect our rights, privacy, safety, or property, and/or those of you or others; and (e) allow us to pursue available remedies or limit damages that we may sustain.

We may disclose Personal Information for other reasons that we will describe at the time of information collection or prior to disclosing your information.

Please note that we may de-identify or aggregate Personal Information so that it will no longer be considered Personal Information and disclose such information to other parties for purposes consistent with those described in this Privacy Policy. Unless you take action to re-identify your de-identified information, we will not attempt to re-identify this information so that it may be associated with you.

4. Your Privacy Choices and Rights

You have the ability to make certain choices about how we use your Personal Information, as follows:

a) Privacy Rights and Requests

Depending on your U.S. state of residence, including California, Colorado, Connecticut, Delaware, Iowa, Maryland, Minnesota, Montana, Nebraska, New Hampshire, New Jersey, Oregon, Tennessee, Texas, Utah, Virginia, and such other states with privacy laws that are enacted, you may have certain rights in relation to your Personal Information, including:

  • Right to Know: You may have the right to know what Personal Information we have collected about you, including the categories of sources from which the Personal Information is collected, the business or commercial purpose for collecting, selling, or sharing Personal Information, the categories of third parties to whom we disclose Personal Information, the categories of Personal Information disclosed to third parties, and the specific pieces of Personal Information we have collected about you. Please note that we may not be required to respond to your requests “to know” or access specific pieces of Personal Information more than twice in any 12-month period.
  • Right to Request Specific List of Third Parties: We do not share or sell personal information to third parties, so we do not offer a method to request this information.
  • Right to Request a List of Categories of Third Parties: You may have the right to request a list of the categories of third parties to which we have disclosed Personal Information.
  • Right to Data Portability: You may have the right to access your information in a portable format.
  • Right to Delete: You may have the right to request that we delete Personal Information that we have collected from or about you, subject to certain exceptions.
  • Right to Correct: You may have the right to correct inaccurate Personal Information that we may maintain about you, subject to appropriate verification.
  • Right to Opt Out of Certain Types of Personal Information Uses and Disclosures: We do not use and disclose to third parties Personal Information for analytics and advertising purposes. Therefore, we do not offer an opt out of the “sale” or "sharing” of your Personal Information, or the use and disclosure of your Personal Information for “targeted advertising” (as these terms are defined under applicable law).

Please note that, where permitted under applicable law, we may decline a request if we are unable to verify your identity (or an agent’s authority to make the request) and confirm the Personal Information we maintain relates to you.

If you are interested in exercising one or more of the rights outlined above, please email us at ConsumerPrivacy@CVSHealth.com or call us at 1-833-533-0768. We may take steps to verify your identity before responding to your request by asking you a series of questions about you or your previous interactions with us. Submitting a privacy rights request does not require you to create an account with us.

We will not discriminate against you if you decide to exercise your privacy rights.

b) Agent Requests

Only you, or someone legally authorized to act on your behalf, may submit a request related to your Personal Information.

Depending on your U.S. state of residence, you may authorize someone to make a privacy rights request on your behalf (an authorized agent). Authorized agents will need to demonstrate that you’ve authorized them to act on your behalf. We retain the right to request confirmation directly from you confirming that the agent is authorized to make such a request, or to request additional information to confirm the agent’s identity.

c) Right to Appeal

Depending on your U.S. state of residence, you may have the right to appeal a decision we have made in connection with your privacy rights request. To appeal a decision, please contact us at ConsumerPrivacy@CVSHealth.com.

d) Notice of Financial Incentive

We do not offer financial incentives to promote our products and services.

5. External Links

Our Services may have links to third-party services, which may have privacy policies that differ from our own. We are not responsible for the practices of third-party services.

6. Children’s Privacy

Our Services are intended for a general audience. We do not direct our Services to individuals under eighteen (18), nor do we knowingly solicit or collect any Personal Information from individuals under eighteen (18).

7. Data Security

We have implemented physical, administrative, and technical safeguards to maintain the security, confidentiality, and integrity of your information. However, as no transmission of information over the internet is absolutely secure, we cannot guarantee the safety of your information.

8. Revisions To This Privacy Policy

We reserve the right, in our sole discretion, to change, modify, add, remove, or otherwise revise portions of this Privacy Policy at any time. When we do, we will post the change(s) to our Services. Your continued use of our Services following the posting of changes to these terms means you accept these changes. If we change the Privacy Policy in a material way, we will provide appropriate notice to you and seek your consent where required by applicable privacy laws. Notice may be provided via a temporary banner on our Site, an email sent to users for whom we have an email address, or by temporarily noting “UPDATED” next to the Privacy Policy link on the footer of our Site.

9. How To Contact Us

If you have any questions or concerns about this Privacy Policy or the practices described herein, you may contact us by email at ConsumerPrivacy@CVSHealth.com, by mail to 1 CVS Drive, Woonsocket, RI 02895, or by phone at 1-833-533-0768.

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.