bamlanivimab

Pronunciation: BAM la NIV i mab

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

Bamlanivimab 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 bamlanivimab only in people with COVID-19 who are not in a hospital or using supplemental oxygen.

What is bamlanivimab?

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

The US Food and Drug Administration (FDA) has authorized emergency use of bamlanivimab to treat mild to moderate COVID-19 in adults and children at least 12 years old and weighing at least 88 pounds (40 kilograms). Bamlanivimab 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).

Bamlanivimab 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. Bamlanivimab is not authorized for use in people who are already in the hospital or receiving supplemental oxygen for COVID-19.

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

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

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 bamlanivimab given?

Bamlanivimab is given as an infusion into a vein. A healthcare provider will give you this injection.

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

Bamlanivimab is usually given 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 bamlanivimab 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.

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

What happens if I miss a dose?

Bamlanivimab 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 bamlanivimab?

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

What are the possible side effects of bamlanivimab?

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, bleeding, 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 bamlanivimab?

Other drugs may affect bamlanivimab, 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 bamlanivimab.

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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bamlanivimab