EVENITY contains the active ingredient romosozumab-aqqg, a monoclonal antibody that inhibits sclerostin. It is available as a sterile, preservative-free solution for subcutaneous injection, delivered from two prefilled syringes, each containing 105 mg of the drug. Key inactive ingredients include acetate, calcium, polysorbate 20, and sucrose. Romosozumab-aqqg is designed to be administered in a 210 mg dose through two injections.

How should I use this medication?

This medication is injected under the skin. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Low calcium level—muscle pain or cramps, confusion, tingling, or numbness in the hands or feet
• Osteonecrosis of the jaw—pain, swelling, or redness in the mouth, numbness of the jaw, poor healing after dental work, unusual discharge from the mouth, visible bones in the mouth
• Severe bone, joint, or muscle pain
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Headache
• Joint pain
• Muscle spasms
• Pain, redness, or irritation at injection site
• Swelling of the ankles, hands, or feet

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Dental disease
• Heart attack
• Heart disease
• Kidney problems
• Low levels of calcium in the blood
• On dialysis
• Stroke
• Wear dentures
• An unusual or allergic reaction to romosozumab, other medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need bloodwork while taking this medication.

You should make sure you get enough calcium and vitamin D while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

Some people who take this medication have severe bone, joint, or muscle pain. This medication may also increase your risk for jaw problems or a broken thigh bone. Tell your care team right away if you have severe pain in your jaw, bones, joints, or muscles. Tell you care team if you have any pain that does not go away or that gets worse.

Tell your dentist and dental surgeon that you are taking this medication. You should not have major dental surgery while on this medication. See your dentist to have a dental exam and fix any dental problems before starting this medication. Take good care of your teeth while on this medication. Make sure you see your dentist for regular follow-up appointments.

What are the most serious risks of this medication?

This medicine can increase the risk of having a heart attack or stroke.