Pronunciation: soe TROE vi mab

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

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

Sotrovimab 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.

What is sotrovimab?

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

The US Food and Drug Administration (FDA) has authorized emergency use of sotrovimab to treat mild to moderate COVID-19 in adults and children at least 12 years old and weighing at least 88 pounds (40 kilograms). Sotrovimab 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 25 or higher;
  • chronic kidney disease;
  • diabetes;
  • a weak immune system (caused by disease or by using certain medicine);
  • heart disease, high blood pressure;
  • lung disease such as asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, or pulmonary hypertension;
  • sickle cell disease;
  • a neurodevelopmental disorder such as cerebral palsy; or
  • a tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).

There also may be a higher risk of severe COVID-19 symptoms in adults who are 65 years of age or older.

There also may be a higher risk of severe COVID-19 symptoms in children (12 to 17 years old) who have a BMI at or above the 85th percentile for age and gender.

Sotrovimab has not been approved to treat coronavirus or COVID-19. However, this medicine may help prevent the need for emergency medical care or admission to a hospital because of COVID-19. Sotrovimab is not authorized for use in people who are already in the hospital or receiving supplemental oxygen for COVID-19.

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

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

Tell your doctor if you have ever had:

  • any serious or chronic illness;
  • any allergies; or
  • if you are pregnant or breastfeeding.

COVID-19 is more likely to cause serious illness or death in a pregnant woman. Not all risks are known yet, but being treated with sotrovimab is likely to be less harmful than being infected with COVID-19 during pregnancy.

How is sotrovimab given?

Sotrovimab is usually given as only one dose as soon as possible after you test positive for COVID-19, or within 10 days after the start of symptoms.

Sotrovimab is injected into a vein by a healthcare provider.

Sotrovimab is injected slowly over 30 minutes. You will be watched for a short time to make sure you do not have an allergic reaction.

Being treated with sotrovimab 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.

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

What happens if I miss a dose?

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

What happens if I overdose?

In a medical setting an overdose would be treated quickly.

What should I avoid while receiving sotrovimab?

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

What are the possible side effects of sotrovimab?

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

Some side effects may occur during or up to 24 hours after the injection. Tell your caregiver right away if you have:

  • throat irritation, swelling in your face or throat;
  • fast, slow, or uneven heart rate;
  • confusion, dizziness, a light-headed feeling (like you might pass out);
  • chest pain, wheezing, shortness of breath;
  • fever, chills, sweating, nausea, weakness, tiredness;
  • pounding in your neck or ears;
  • rash, itching; or
  • headache, muscle pain.

Call your doctor if you have new or worsening symptoms after the infusion, such as fever, confusion, tiredness, feeling light-headed, irregular heartbeats, or trouble breathing.

Common side effects may include:

  • diarrhea; or
  • rash.

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 sotrovimab?

Other drugs may affect sotrovimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about sotrovimab.

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