Sotrovimab

Generic name: Sotrovimab
Dosage form: intravenous solution (500 mg/8 mL)
Drug class: Miscellaneous antivirals

Usage of Sotrovimab

Due to the high frequency of the Omicron BA.2 sub-variant, this drug is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.

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.

Sotrovimab is for use in adults and children at least 12 years old who weigh at least 88 pounds (40 kilograms).

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

  • are overweight;
  • have chronic kidney disease;
  • have diabetes;
  • have a weak immune system (caused by disease or by using certain medicine);
  • have sickle cell disease;
  • have a heart problem or high blood pressure;
  • have a neurodevelopmental disorder such as cerebral palsy;
  • have asthma or other chronic breathing disorder; or
  • have 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 pregnant women and in adults who are 65 and older.

    Sotrovimab has not been approved to treat coronavirus or COVID-19. However, sotrovimab 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.

    Sotrovimab side effects

    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 medical caregivers 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, weakness, tiredness, trouble breathing, or fast or slow heartbeats.

    Common side effects of sotrovimab 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.

    Before taking Sotrovimab

    You should not use sotrovimab if you are allergic to it, or 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.

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    How to use Sotrovimab

    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 sotrovimab 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.

    Warnings

    Due to the high frequency of the Omicron BA.2 sub-variant, this drug is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.

    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.

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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