Evenity

What is Evenity?

Evenity is a prescription medicine used to treat osteoporosis (thinning and weakening of bone) in women after menopause (“change of life”) who are at high risk of fracture (broken bone), or cannot use another osteoporosis medicine or other osteoporosis medicines did not work well.

It is not known if Evenity is safe and effective in children.

Description

Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa.

EVENITY (romosozumab-aqqg) injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to light yellow solution for subcutaneous injection in a single-use prefilled syringe.

Two 105 mg/1.17 mL single-use prefilled syringes are required to administer the recommended 210 mg dose of EVENITY [see Dosage and Administration (2.1)]. Each single-use prefilled syringe delivers 1.17 mL of solution containing 105 mg of romosozumab-aqqg, acetate (3.8 mg), calcium (0.61 mg), polysorbate 20 (0.07 mg) and sucrose (70 mg) in Water for Injection, USP, and sodium hydroxide to a pH of 5.2.

  Mechanism of Action

EVENITY inhibits the action of sclerostin, a regulatory factor in bone metabolism. EVENITY increases bone formation and, to a lesser extent, decreases bone resorption. Animal studies showed that romosozumab-aqqg stimulates new bone formation on trabecular and cortical bone surfaces by stimulating osteoblastic activity resulting in increases in trabecular and cortical bone mass and improvements in bone structure and strength [see Nonclinical Toxicology.

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 the symptoms listed below.
  • Symptoms of heart attack may include:
    • chest pain or pressure
    • shortness of breath
    • feeling light-headed or dizzy
  • Symptoms of stroke 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.
See “What are the possible side effects of Evenity?” below for other side effects of Evenity.

Who should not use Evenity?

Do not receive Evenity if you:

• have been told by your healthcare provider that your blood calcium level is too low.
• are allergic to romosozumab or any of the ingredients in Evenity. See the end of this Medication Guide for a complete list of ingredients in Evenity.

What should I tell my healthcare provider before using 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

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Evenity?

• Evenity is an injection that will be given to you by your healthcare provider. Evenity is injected under your skin (subcutaneous).
• You will receive an Evenity dose (2 injections) 1 time every month for 12 doses.
• You should take calcium and vitamin D while you receive Evenity.
• If you miss a dose of Evenity, contact your healthcare provider as soon as possible to schedule your next dose. Your next dose of Evenity should then be scheduled every month from the date of the last injection.
• You should take good care of your teeth and gums while you receive Evenity. You should tell your dentist that you are receiving Evenity before you have dental work.

What are the possible side effects of Evenity?

Evenity may cause serious side effects, including:
See “What is the most important information I should know about Evenity?”

• Serious allergic reactions. 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. Symptoms of a serious allergic reaction may include:
  • 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). Severe jaw bone problems may happen when you take Evenity. Your healthcare provider should examine your mouth before you start Evenity.
  • Your healthcare provider may tell you to see your dentist before you start Evenity. 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
• headache

These are not all the possible side effects of Evenity. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Evenity

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about Evenity that is written for health professionals.

How should I store Evenity?

• Keep Evenity in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect it from light.
• Do not freeze Evenity.
• Do not shake Evenity.
• When you remove Evenity from the refrigerator, Evenity must be kept at room temperature up to 77°F (25°C) in the original carton and must be used within 30 days. Evenity should be thrown away if taken out of the refrigerator and not used within 30 days.
• Do not keep Evenity at temperatures above 77°F (25°C). Warm temperatures will affect how Evenity works.

Keep Evenity and all medicines out of the reach of children.

What are the ingredients in Evenity?

Active ingredient: romosozumab-aqqg
Inactive ingredients: acetate, calcium, polysorbate 20, sodium hydroxide, sucrose and water for injection.

Label

PRINCIPAL DISPLAY PANEL

• 2 x 105 mg/1.17 mL Single-Use Prefilled Syringe
• NDC 55513-880-02
• EVENITY®
• (romosozumab-aqqg)
• injection
• For Healthcare
• Provider Use Only
• 105 mg/1.17 mL + 105 mg/1.17 mL = 1 Dose
• 210 mg/2.34 mL
• 2 x 105 mg/1.17 mL
• 105 mg/1.17 mL
• For Subcutaneous Use Only
• Sterile Solution – No Preservative
• Store Refrigerated at 2°C to 8°C (36°F to 46°F). Do not Freeze or Shake.
• Store in carton to protect from light.
• Keep out of the sight and reach of children.
• ATTENTION: Provide the enclosed Medication
• Guide to each patient. For more copies
• see EVENITY.com or call 1-800-77AMGEN.
• 2 syringes must be administered for
• a full 210 mg/2.34 mL dose
• Rx Only
• AMGEN® ucb
•