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Patient Authorization and Consent

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Authorization for Use and Disclosure of Protected Health Information

Uses and Disclosure of Protected Health Information

I authorize Amgen and its data processors (collectively, “Amgen”) to collect, use, and disclose my protected health information for the following purposes:

To operate, administer, enroll me in, and/or continue my participation in Amgen'sBone Matters^® program or any other Amgen-affiliated patient support services and activities related to my condition or treatment (for example, co-pay card programs, reimbursement assistance programs, drug coverage verification, nurse partner services, adherence program and disease management support);
To contact, with my permission, my doctor and the rest of my health care team and share with them my health information that may be useful for my care;
To provide me with informational and promotional materials relating to Amgen products and services, and/or my condition or treatment; and/or
To improve, develop, and evaluate Amgen’s products, services, materials and programs related to my condition or treatment.

In order for Amgen to provide me with the services and/or programs described above, Amgen needs to collect and use my personal information, including my protected health information. I understand that my protected health information may include any information, in electronic or physical form, in the possession of or derived from a health care provider, health care plan, pharmacy, pharmaceutical company, laboratory and/or their contractor (each, a “Health Care Provider”). This may include select information from or about my medical history and general health, my health care plan benefits, payment limits or restrictions covered by my health care plan policy, and/or my adherence to my treatment.

I authorize my Health Care Providers to disclose my protected health information to Amgen, and between themselves, as necessary, but only for the purposes stated above in this Authorization. I understand that certain of my Health Care Providers (such as pharmacies and specialty pharmacies) may receive remuneration from Amgen in exchange for disclosing my protected health information and/or for using my information to contact me with communications about Amgen products which have been prescribed to me (for example, medication reminder programs and other patient support services).

Expiration, Right to Obtain a Copy, and Right to Cancel

I understand that by signing this form, I authorize my Health Care Providers or others who might hold my health information to disclose it to Amgen. I also understand I am authorizing my personal information, including my protected health information, to be used for the purposes described above. I understand and agree that by signing below, I am authorizing those who rely on this Authorization to disclose my protected health information for the earlier of five (5) years or until my participation in Amgen'sBone Matters^® program ends through my cancellation, unless a shorter time period is required by state law.

I understand that I can obtain a copy of this Authorization or cancel this Authorization at any time by calling Amgen at 1-888-231-5663 or by writing to PO Box 781046, Indianapolis, IN 46278. If I cancel this Authorization, I will no longer qualify for the services described. I also understand that if a Health Care Provider is disclosing my protected health information to Amgen in reliance on this Authorization on an on-going basis, my cancellation with Amgen will be effective with respect to any such Health Care Providers as soon as they receive notice of my cancellation.

No Effect on Treatment

I understand I do not have to sign this Authorization and that my enrollment in any of the services and/or programs described above is entirely voluntary. I understand that Amgen, as well as Health Care Providers, cannot require me, as a condition of having access to medications, prescription drugs, treatment or other care, to sign this Authorization. Federal Law (including HIPAA) requires a signed authorization in order for Amgen to collect my protected health information from my Health Care Providers. I understand I cannot participate in the listed services and/or programs without signing this Authorization or an equivalent authorization with my Health Care Providers.

Information Received from Health Care Providers

I understand that once my protected health information has been disclosed to Amgen, federal privacy laws may no longer apply and may no longer protect it from further disclosure, and that Amgen may disclose my protected health information to its data processors, contractors, and business partners for its business purposes. Amgen agrees, however, to protect my protected health information by only using and disclosing it as stated in the Authorization or as otherwise allowed or required by law.

By clicking the “I consent” button, I am electronically indicating that I have read and understood the above Authorization for Use and Disclosure of Protected Health Information (above in its full text), that I am legally authorized to consent, and that I am providing my consent as the patient or the patient’s legal representative for Amgen to collect, use, and disclose my protected health information for the purposes described within this Authorization. By clicking “I do not consent” below, my activation and enrollment into Bone Matters^® will be discontinued.

I consent
I do not consent

By selecting "I do not consent," you will not be able to continue enrolling in Bone Matters^®

Step 2 Of 2

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Consent to Health Data Processing for Bone Matters^®

I consent to Amgen processing my Health Data for the following purposes:

To enroll me and manage my participation in Amgen'sBone Matters^® program, which includes activities related to my condition or treatment (for example, co-pay card programs, payer medication coverage verification, nurse partner support, disease management support), and to manage Amgen’s products, services, and programs related to my condition or treatment.

Amgen uses the following when it administers the Bone Matters^® program:

Health Data – my name (and the name of my caregiver if applicable), gender, date of birth, contact information and information relating to my health condition or treatment.

I understand that my consent to processing is required for me to participate in the Bone Matters^® program. I also understand that Amgen will not sell my Health Data to third parties, but Amgen may disclose my Health Data to Amgen’s data processors, contractors, and business partners for Amgen’s business purposes related to the Bone Matters^® program. I understand that Amgen may use my Health Data to contact me by mail, email, telephone, or text for the above purposes. I also understand that if I do not consent to the use of my Health Data for the above purposes, I will not be able to participate in the Bone Matters^® program. Finally, I understand that I may withdraw my consent to processing my Health Data for the above purposes at any time using one of the methods listed in the Additional Disclosures section below and that if I withdraw my consent, I will no longer be able to participate in the Bone Matters^® program.

I consent to the collection, processing, and disclosure of my Health Data for the above purposes
I do not consent to the collection, processing, or disclosure of my Health Data for the above purposes

By selecting “I do not consent to the collection, processing, or disclosure of my Health Data for the above purposes,” you will not be able to continue enrolling in Bone Matters^®

Additional Disclosures

I understand that participation in the Bone Matters program and, if I have consented, receipt of marketing communications are optional services at no cost to me. The consent(s) above in no way affects my right to obtain any medications and I do not have to provide consent to be able to receive any medications. To obtain a copy of the consent(s) above or to withdraw my consent to collection, processing, and/or disclosure of my Health Data for any of the above purposes to which I have consented, I can contact Amgen by visiting www.amgen.com/DataSubjectRights or calling 1-866-592-6436. For more information about Amgen’s privacy practices, Amgen’s Privacy Statement can be found at http://www.amgen.com/privacy.

Important Safety Information for Prolia^® (denosumab):

What is the most important information I should know about Prolia?

If you receive Prolia, you should not receive other denosumab products at the same time.

Prolia can cause serious side effects (including):

Increased risk of severe 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. Talk to your doctor before starting Prolia. 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.

If you have advanced chronic kidney disease (may or may not be on kidney dialysis), Prolia 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 Prolia 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 Prolia. 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) may occur. Your doctor should examine your mouth before you start Prolia and may tell you to see your dentist. It is important for you to practice good mouth care during treatment with Prolia.

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 Prolia. Talk with your doctor before starting Prolia treatment. After your treatment with Prolia 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 Prolia without first talking with your doctor. If your Prolia 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. Inflammation of the inner lining of the heart (endocarditis) due to an infection may also happen more often in people who take Prolia. You may need to go to the hospital for treatment.

Prolia 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.

Skin problems such as inflammation of your skin (dermatitis), rash, and eczema have been reported.

Bone, joint, or muscle pain. Some people who take Prolia develop severe bone, joint, or muscle pain.

Do not take Prolia if you: have low blood calcium; or are pregnant or plan to become pregnant, as Prolia may harm your unborn baby; or are allergic to denosumab or any ingredients in Prolia.

Before taking Prolia, tell your doctor about all of your medical conditions, including if you:

Take the medicine XGEVA (denosumab)
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
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with Prolia.
- You should use an effective method of birth control (contraception) during treatment with Prolia and for at least 5 months after your last dose of Prolia.
- Tell your doctor right away if you become pregnant while taking Prolia.
Are breast-feeding or plan to breast-feed

What are the possible side effects of 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 are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection.

These are not all the possible side effects of Prolia. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Approved Use:

Prolia is a prescription medicine used to treat 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.

Please see Prolia full Prescribing Information, including Medication Guide.

Important Safety Information for Prolia^® (denosumab):

What is the most important information I should know about Prolia?

If you receive Prolia, you should not receive other denosumab products at the same time...

If you receive Prolia, you should not receive...

Approved Use for Prolia^® (denosumab):

Approved Use for Prolia^® (denosumab):

Program Eligibility

Personal Information

Program Question(s)

Patient Authorization and Consent

Additional Disclosures

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