EVENITY DIALOGUE TOOL - evenityhcp.com€¦ · EVENITY® DIALOGUE TOOL Tap anywhere to start INDICATION EVENITY® is a prescription medicine used to treat osteoporosis in women after

EVENITY®

DIALOGUE TOOL

Tap anywhere to start

INDICATION

EVENITY® is a prescription medicine used to treat osteoporosis in women after menopause who are at high risk of fracture, or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

IMPORTANT SAFETY INFORMATION

EVENITY® can cause serious side effects, including increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem. Call your healthcare provider or get emergency help right away if you have any of these symptoms: symptoms of heart attack, which may include: chest pain or pressure; shortness of breath; feeling light-headed or dizzy; or symptoms of stroke, which may include: headache; numbness or weakness in face, arm, or legs; difficulty talking; changes in vision or loss of balance. Before you receive EVENITY®, tell your healthcare provider if you have had a heart attack or stroke, especially if it has happened in the past year. Please see additional Important Safety Information on pages 14-15.

Use the EVENITY® Dialogue Tool to guide your conversation and help you answer any questions and concerns.

• Move through the tool with the arrows and the navigation bar on the bottom of the screen

• Tapping a letter will bring you to a specific section of the tool

• Use the toggle at the top of the screen to switch between information for your patients (the PT side) and content for you (the HCP side)

• The Virtual Visit Checkpoint can help you keep the conversation on track by providing examples of potential thoughts patients may have and suggesting ways to help them better understand the need for this bone-building treatment


POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued.

Please see additional Important Safety Information by clicking the button below.

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What is the most important information I should know about EVENITY®?

EVENITY® can cause serious side effects, including increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem. Call your healthcare provider or get emergency help right away if you have any of these symptoms: symptoms of heart attack, which may include: chest pain or pressure; shortness of breath; feeling light-headed or dizzy; or symptoms of stroke, which may include: headache; numbness or weakness in face, arm, or legs; difficulty talking; changes in vision or loss of balance. Before you receive EVENITY®, tell your healthcare provider if you have had a heart attack or stroke, especially if it has happened in the past year.


what to expect while on treatment with EVENITY®

what your previous fracture was like

the formation of new bone

yourself about important information regarding EVENITY®

EVENITY®–the RAPID response you need to reduce your risk of spine fracture in 12 months

Help protect yourself against the increased risk of fracture


Visit EVENITY.com

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Which challenges impacted you most and how?

How long did it take for you to get back to your normal activities?

what your previous fracture was like


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Explain to patients why you are talking about this treatment option for them.

• Help contextualize the importance of osteoporosis treatment by discussing their last fracture

• Explore their feelings about the experience

• Remind them of what is at stake as you discuss their increased risk of fracturing again

“Why are we talking about starting a new treatment?” POTENTIAL PATIENT THOUGHT

HCP PTVIRTUAL VISIT CHECKPOINT


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the formation of new bone

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EVENITY® may cause serious side effects. Possible serious side effects include serious allergic reactions, low blood calcium, severe jaw bone problems, and unusual thigh bone fractures.


Q: How likely are you to suffer another fracture in the next year?

EVENITY® is the FIRST AND ONLY OSTEOPOROSIS treatment that works in 2 WAYS

EVENITY® increases bone formation and, to a lesser extent, decreases bone loss.

Image is for explanation only and is not meant to imply benefits.


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“What if I fracture again?”

• Patients may not know what high risk means, or even recognize that they have osteoporosis. A simple question about their risk for another fracture in the year after the latest one will highlight the urgent need for treatment

• Use the up/down arrows to explain to patients how EVENITY® works differently

• EVENITY® increases bone formation and, to a lesser extent, decreases bone resorption

POTENTIAL PATIENT THOUGHT


Hypersensitivity reactions have occurred in EVENITY®-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY®.


VIRTUAL VISIT CHECKPOINT


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QUESTION FOR PATIENT: How likely are you to suffer another fracture in the next year?

A: 5 times more likely

In the same clinical study, women on EVENITY® rapidly increased the bone mineral density of their lower spine,

hip, and femoral neck (thighbone) at 12 months.

For illustrative purposes only. Bone samples were taken from 2 different women from a sub study consisting of 139 women with postmenopausal osteoporosis. Images selected are

from women who were close to the group average.

WITHOUT TREATMENT

IMAGES OF BONE SAMPLES

A pelvis bone sample taken at month 12 from a woman with postmenopausal

osteoporosis receiving placebo

WITH EVENITY®

A pelvis bone sample taken at month 12 from a woman with postmenopausal

osteoporosis receiving EVENITY®This study followed 7180 women with postmenopausal osteoporosis receiving EVENITY® or placebo (a treatment without medicine) for

12 months. Women receiving EVENITY® had fewer new spine fractures (0.5%) than women receiving placebo (1.8%) at 12 months. Reductions

in fractures other than the spine were not significant at 12 months.

Help protect yourself against the increased risk of fracture

EVENITY® may help reduce your risk of spinal fracture in just 12 months


You should take calcium and vitamin D as your doctor tells you to while you receive EVENITY®.


Fracture risk reduction after 12 months

After 12 months, women on EVENITY® significantly reduced their risk of spine fractures.

73%


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EVENITY® REDUCED RISK of SPINE

FRACTURES by

• Use the bone biopsy images to discuss the bone-building effect of this treatment

• Seeing the images may help patients better understand osteoporosis, as well as potential impact of treatment

“Why is this the right choice for me?”POTENTIAL PATIENT THOUGHT


Hypocalcemia has occurred in patients receiving EVENITY®. Correct hypocalcemia prior to initiating EVENITY®. Adequately supplement patients with calcium and vitamin D while on EVENITY®.




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yourself about important information regarding EVENITY®

Across 2 large clinical trials, EVENITY® was studied in over 11,000 postmenopausal women with osteoporosis. The most common side effects seen with EVENITY® were joint pain and headaches.

EVENITY® can cause serious side effects, including:

• Increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem

• Serious allergic reactions

The following are the percentage of women within each treatment group who experienced a MACE event (either a heart attack, stroke or death due to a cardiovascular problem):

Study 1

Placebo AlendronateEVENITY® EVENITY®

Study 2

25%

20%

15%

10%

5%

0%

25%

20%

15%

10%

5%

0%0.8% 1.1%0.8% 2.0%

% o

f Tria

l Pat

ient

s

% o

f Tria

l Pat

ient

s

Talk with your doctor about the risks of possible side effects vs. risks of not getting treated with EVENITY®.

These are not all the side effects of EVENITY®.


• Low calcium levels in your blood (hypocalcemia) • Severe jaw bone problems (osteonecrosis) • Unusual thigh bone fractures

• Study 1 followed 7,180 women with postmenopausal osteoporosis receiving EVENITY®

or placebo for 12 months

• This study showed a Hazard Ratio of 1.03 for EVENITY® compared to placebo

• Study 2 followed 4,093 women with postmenopausal osteoporosis receiving EVENITY® or alendronate for 12 months

• This study showed a Hazard Ratio of 1.87 for EVENITY® compared to alendronate

• 30 women out of 3,581 (0.8%) in the EVENITY® arm experienced a MACE event

• 41 women out of 2,014 (2.0%) in the EVENITY® arm experienced a MACE event


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“Are the benefits worth the risks for me personally?”POTENTIAL PATIENT THOUGHT

• Talk about individual needs and medical history

• EVENITY® should not be started in patients who have had a heart attack or stroke within the past year. Discuss their individual risks as they relate to possible benefits of treating with EVENITY® (decreased fracture risk) and the possible risks of treatment with EVENITY® (possible side effects)

• Explain the safety data shown across both studies

• Study 1 followed 7,180 women with postmenopausal osteoporosis receiving EVENITY® or placebo for 12 months. This study showed the number of women with positively adjudicated MACE was 30 (0.8%) in the EVENITY® group and 29 (0.8%) in the placebo group

• Study 2 followed 4,093 women with postmenopausal osteoporosis receiving EVENITY® first followed by alendronate vs alendronate alone. This study showed the number of women with positively adjudicated MACE was 41 (2.0%) in the EVENITY® group and 22 (1.1%) in the alendronate group

• The hazard ratio is a comparison between the probability of events in the EVENITY® group compared to the probability of events in the control group

• The hazard ratio at 12 months in FRAME was 1.03 (0.62, 1.72) for EVENITY® compared to placebo. This means there was a 3% higher relative risk

• The hazard ratio at 12 months in ARCH was 1.87 (1.11, 3.14) for EVENITY® compared to alendronate. This means there was an 87% higher relative risk

• Make sure to clearly communicate the possible side effects and that your patient understands the signs and symptoms of heart attack and stroke and to seek medical treatment if the patient has any symptoms of heart attack or stroke



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what to expect while on treatment with EVENITY®

Resources to help you stay on track

ENROLL TODAY AT EVENITY.COM/SIGNUP OR TEXT ENROLL TO 89183

®

Talk to your healthcare professional about the importance of transitioning to an antiresorptive after 12 monthly doses of EVENITY®.

FOR12 OFFICE VISITS

1 DOSE(2 SHOTS)

GIVEN MONTHLY DURING THE SAME VISIT

Each EVENITY® dose consists of 2 shots given every month by your doctor or healthcare provider.

You should take calcium and vitamin D as your doctor tells you to while you receive EVENITY®.

If you miss an appointment, contact your doctor as soon as possible to reschedule. Starting a new treatment can leave you with a lot of questions.

BONE MATTERS® is a comprehensive support program designed to provide the answers you need as you begin and

continue with EVENITY®.

Important Safety InformationThe most common side effects of EVENITY® are joint pain and headaches.


EVENITY® is the only bone-building treatment given as 12 monthly doses


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EVENITY® is indicated for 12 monthly doses and patients should stay on treatment for the full 12 months as appropriate to get the full benefit of this treatment

• Following completion of EVENITY® treatment, continued therapy with an antiresorptive agent should be considered

• Inform patients about helpful resources available during their 12 months of treatment

• This page also informs patients about where they can go online for more information for the patient support program

“What happens after 12 months of treatment?”POTENTIAL PATIENT THOUGHT


ONJ and atypical femoral fracture have been reported in patients taking EVENITY®. Patients should be monitored for adverse outcomes.




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POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued. In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY® compared to those treated with alendronate.

Contraindications: EVENITY® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY®. EVENITY® is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria.

Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY®-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY®.

Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY®. Correct hypocalcemia prior to initiating EVENITY®. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement patients with calcium and vitamin D while on EVENITY®.

Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY®. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY®. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.

For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITY® should be considered based on benefit-risk assessment.

Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.

During EVENITY® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY® therapy should be considered based on benefit-risk assessment.

Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY® were arthralgia and headache.

EVENITY® is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Please see EVENITY® full Prescribing Information, including Medication Guide.



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What is the most important information I should know about EVENITY®?

EVENITY® can cause serious side effects, including increased risk of having a heart attack, stroke, or death from a cardiovascular (heart or blood vessel) problem. Call your healthcare provider or get emergency help right away if you have any of these symptoms: symptoms of heart attack, which may include: chest pain or pressure; shortness of breath; feeling light-headed or dizzy; or symptoms of stroke, which may include: headache; numbness or weakness in face, arm, or legs; difficulty talking; changes in vision or loss of balance. Before you receive EVENITY®, tell your healthcare provider if you have had a heart attack or stroke, especially if it has happened in the past year.

Do not receive EVENITY® if you: have low blood calcium; or are allergic to romosozumab or any of the ingredients in EVENITY®.

Before receiving EVENITY®, tell your healthcare provider about all your medical conditions, including if you: • have a history of other heart or blood vessel problems • have low blood calcium • cannot take daily calcium and vitamin D • have kidney problems or are on kidney dialysis • plan to have dental surgery or teeth removed

What are the possible side effects of EVENITY®?

EVENITY® may cause serious side effects, including:

Serious allergic reactions have happened in people who receive EVENITY®. Call your healthcare provider or go to the nearest emergency room right away if you have any symptoms of a serious allergic reaction including: rash; hives; swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in swallowing or breathing.

Low calcium levels in your blood (hypocalcemia). EVENITY® may lower the calcium levels in your blood. Your low blood calcium should be treated before you receive EVENITY®. Call your healthcare provider 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.

Severe jaw bone problems (osteonecrosis) may occur. Your healthcare provider should examine your mouth before you start EVENITY® and may tell you to see your dentist. Ask your healthcare provider or dentist about good mouth care.

Unusual thigh bone fractures. Symptoms of this type of fracture include new or unusual pain in your hip, groin, or thigh.

The most common side effects of EVENITY® include joint pain and headaches.

These are not all the possible side effects of EVENITY®. 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.

Please see EVENITY® full Prescribing Information, including Medication Guide.


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• Restate why you think EVENITY® is the appropriate treatment and how the benefits compare to the risks

• Visit EVENITY.com for more information

• Remind her that she can enroll in the BONE MATTERS® support program at EVENITY.com/signup or by texting ENROLL to 89183

Ending the Conversation

You should review the Indication and Important Safety Information with your patients.



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POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued.


© 2019–2020 Amgen Inc. All rights reserved. Not for reproduction. USA-785-81295 05/20

One Amgen Center Drive Thousand Oaks, CA 91320-1799 www.amgen.com


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EVENITY DIALOGUE TOOL - evenityhcp.com€¦ · EVENITY® DIALOGUE TOOL Tap anywhere to start INDICATION EVENITY® is a prescription medicine used to treat osteoporosis in women after