imdevimab

Pronunciation: im DEV i mab

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

Imdevimab has not been approved to treat coronavirus or COVID-19. It is not yet known if this medicine is an effective treatment for any condition.

The FDA has authorized emergency use of imdevimab in combination with casirivimab only in people with COVID-19 who are not in a hospital or using supplemental oxygen.

What is imdevimab?

Imdevimab is an experimental medicine being studied for use in treating conditions caused by coronavirus. It is not yet known if imdevimab is a safe and effective treatment for any condition.

The US Food and Drug Administration (FDA) has authorized emergency use of imdevimab in combination with another medicine called casirivimab to treat mild to moderate COVID-19 in adults and children at least 12 years old and weighing at least 88 pounds (40 kilograms). Imdevimab with casirivimab is for use only in people who test positive for COVID-19 and have a high risk of symptoms becoming severe enough to need treatment in a hospital or with supplemental oxygen.

The risk of COVID-19 symptoms becoming severe may be higher in people with:

  • a body mass index (BMI) of 35 or higher;
  • chronic kidney disease;
  • diabetes; or
  • a weak immune system (caused by disease or by using certain medicine).

There also may be a higher risk of severe COVID-19 symptoms in adults who are:

  • 65 years of age or older; or
  • 55 years of age or older AND have heart disease, high blood pressure, or lung disease such as chronic obstructive pulmonary disease (COPD).

There also may be a higher risk of severe COVID-19 symptoms in children (12 and older weighing at least 88 lbs or 40 kg) who have:

  • a BMI at or above the 85th percentile for age and gender;
  • sickle cell disease;
  • a heart problem;
  • a neurodevelopmental disorder such as cerebral palsy;
  • asthma or other chronic breathing disorder needing daily medication to control; or
  • a tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).

Imdevimab and casirivimab have not been approved to treat coronavirus or COVID-19. However, these medicines may help prevent the need for emergency medical care or admission to a hospital because of COVID-19. This drug combination is not authorized for use in people who are already in the hospital or receiving supplemental oxygen for COVID-19.

Imdevimab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving imdevimab?

Tell your doctor if you have ever had:

  • any allergies; or
  • any serious or chronic illness.

Tell your doctor if you are pregnant or breastfeeding.

How is imdevimab given?

Imdevimab must be given in combination with casirivimab and should not be used alone.

Imdevimab and casirivimab are given as an infusion into a vein. A healthcare provider will give you this injection.

These medicines must be given slowly, and the infusion can take at least 1 hour to complete.

Imdevimab and casirivimab are usually given together as only one dose. The injection should be given within 10 days of when you first started having symptoms of COVID-19.

You will be watched closely for at least 1 hour after the injection, to make sure you do not have an allergic reaction.

Being treated with imdevimab and casirivimab will not make you less contagious to other people. Keep using infection control methods such as self-isolation, social distancing, hand-washing, using protective face covering, disinfecting surfaces you touch a lot, and not sharing personal items with others.

Imdevimab and casirivimab also may not keep you from becoming infected with coronavirus again. Being treated with this drug combination could also affect your body's immune response to a coronavirus vaccine. Imdevimab and casirivimab are still being studied and all of their risks are not yet known.

What happens if I miss a dose?

Imdevimab is given in a single dose and does not have a daily dosing schedule.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid after receiving imdevimab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of imdevimab?

Get emergency medical help if you have signs of an allergic reaction: hives, itching; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fever, chills, sweating, shivering;
  • a light-headed feeling, like you might pass out;
  • wheezing, shortness of breath;
  • nausea, vomiting;
  • changes in your heart rate;
  • headache, muscle pain; or
  • pain, bruising, swelling, or skin changes where the medicine was injected.

Less serious side effects may also occur, or you may have none at all. Not all possible side effects are known.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect imdevimab?

Other drugs may affect imdevimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about imdevimab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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imdevimab