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Generic Name: romosozumab-aqqg
Dosage Form: Injection, for Subcutaneous Use
Date of Approval: April 9, 2019
Company: Amgen Inc.

Treatment for: Osteoporosis

Medically reviewed by J. Stewart, BPharm. Last updated on Apr 18, 2019.

Medication Guide

See also: Prolia

Read this Medication Guide before you start treatment. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important 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 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 Evenity side effects below for a list of other side effects.

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 this medicine is safe and effective in children.

Who should not receive 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 other ingredients. See the end of this Medication Guide for a complete list of ingredients.

Before receiving 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 will I receive Evenity?

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

Evenity side effects

Evenity may cause serious side effects, including:
See Important information.

  • 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 start treatment. 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 treatment.
    • Your healthcare provider may tell you to see your dentist before you start treatment. 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.

Common side effects include:

  • joint pain
  • headache

These are not all the possible side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Evenity if I need to pick it up from a pharmacy?

  • 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.
  • Do not shake.
  • When you remove Evenity from the refrigerator, the injection 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 the injection works.

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

General information about 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 that is written for health professionals.

What are the ingredients in Evenity?

Active ingredient: romosozumab-aqqg

Inactive ingredients: acetate, calcium, polysorbate 20, sodium hydroxide, sucrose and water for injection.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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