Sotrovimab - Injection

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

Sotrovimab is a medication that has been used to treat COVID-19 on an emergency/interim use basis. It is used by people 12 years of age and older who have recently tested positive for coronavirus, have had mild to moderate symptoms for no more than 7 days, and are not hospitalized. To receive sotrovimab, you must also be at high risk for COVID-19 complications due to older age, obesity, or ongoing medical conditions (such as lung, kidney, or heart disease, diabetes). Talk to your doctor about the risks and benefits of treatment with sotrovimab.

Sotrovimab is an antibody which, when given soon after infection, can neutralize the coronavirus and may prevent worsening of COVID-19 symptoms. More information about sotrovimab is available from the patient information sheet provided by your health care professional. If you are enrolled in a study, information should be provided by the doctor via the Informed Consent Form.

There is limited information about how safe and effective sotrovimab is for treating COVID-19. Study results show that sotrovimab may help people who have recently tested positive for coronavirus stay out of the hospital. Sotrovimab is not for use by people who are hospitalized due to COVID-19, or who need supplemental oxygen or a ventilator due to COVID-19.

The information in this document reflects emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of sotrovimab, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.

How To Use

Sotrovimab is given one time by injection into a vein by a health care professional. A health care professional will observe you during your infusion and for at least another hour after your treatment in case you have serious side effects.

Tell your doctor if your condition does not get better or if it gets worse.

Side Effects

Pain, soreness, swelling, or bruising at the injection site may occur. If you notice any of these effects, tell your health care professional promptly.

An infusion reaction may occur while this product is being given and up to 24 hours after infusion, causing symptoms such as low or high blood pressure, dizziness, slow/fast/irregular heartbeat, chest pain, trouble breathing, fever, chills, nausea, headache, confusion, sweating, or muscle pain. Get medical help right away if you notice any of these symptoms. A slower rate of infusion may help to lessen the risk of this reaction.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

Information is limited and it is unknown at this time if sotrovimab causes other serious side effects. This is not necessarily a complete list of possible side effects.

Contact your doctor for medical advice about side effects.

Precautions

Before using this medication, tell your doctor if you have any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems.

Limited information is known at this time about other medical conditions that may affect how sotrovimab works, or if sotrovimab may affect other medical conditions.

Before using this medication, tell your doctor your medical history.

To avoid spreading the virus, you should continue to take precautions such as self-isolation, wearing a mask, social distancing (physical distancing), washing hands, and not sharing personal items.

Tell your doctor if you are pregnant or think you are pregnant. Sotrovimab should be used during pregnancy only if the possible benefits are greater than the possible risks.

It is unknown if sotrovimab passes into breast milk. The risks of breast-feeding while infected with COVID-19 and while using this product should be discussed with the doctor.

Drug Interactions

Drug interactions may change how medications work or increase your risk for serious side effects. Information is limited and it is unknown at this time if sotrovimab has drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

Overdose information is not available at this time.

Notes

Not applicable.

Missed Dose

Not applicable.

Storage

Not applicable. This product is not stored at home.