May 11, 2022

Alternatives, cost, side effects, dosage, etc.

Ultomiris can cause mild or severe side effects. The following lists contain some of the main side effects that can occur during treatment with Ultomiris. These lists do not include all possible side effects.

For more information about the possible side effects of Ultomiris, talk to your doctor or pharmacist. They can give you advice on how to deal with side effects that may be concerning or bothersome.

To note: The Food and Drug Administration (FDA) tracks the side effects of drugs it has approved. If you would like to notify the FDA about an adverse reaction you have had with Ultomiris, you can do so via MedWatch.

Mild side effects

Mild side effects* of Ultomiris may include:

*This is a partial list of mild Ultomiris side effects. For more information about other mild side effects, talk to your doctor or pharmacist, or see prescribing information for Ultomiris.
† For more information on this side effect, see “Details of side effects” below.

Most of these side effects may disappear within a few days or weeks. But if they get worse or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Serious side effects from Ultomiris are not common, but they can occur. Call your doctor right away if you experience any serious side effects. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.

Serious side effects and their symptoms may include:

  • Serious infections, such as pneumonia or meningitis. Symptoms may include:
    • headache with nausea, vomiting, fever, stiff neck or stiff back
    • rash that does not fade when pressed
    • flu-like symptoms with muscle or joint pain
  • Infusion-related reactions.*
  • Serious meningococcal infections.†
  • Allergic reaction.*

* For more information on this side effect, see ‘Details of side effects’ below.
Ultomiris has a framed warning for this side effect. A boxed warning is the FDA’s most serious warning. For more information on this side effect, see “Details of side effects” below.

Details of side effects

Here are some details about some side effects that this drug can cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Ultomiris.

Infusion-related reactions

Ultomiris is administered by IV infusion. Therefore, some people may have infusion-related reactions with this medicine. These are side effects that occur during or shortly after your infusion. In clinical testsinfusion-related reactions were rare with Ultomiris treatment.

Symptoms of infusion-related reactions may include:

what you can do

Your doctor or other healthcare professional will monitor you for any infusion-related reactions during your Ultomiris infusion. They will also monitor you for at least 1 hour after your infusion.

If you experience symptoms of a reaction, tell your doctor immediately. They can give you medicine to treat your symptoms if needed. And they can slow or stop your infusion until your symptoms improve.

Upper respiratory tract infection

It is possible to get an upper respiratory tract infection, such as the common cold, during treatment with Ultomiris. In clinical teststhese infections were among the most common side effects reported with Ultomiris.

Symptoms of upper respiratory tract infections can include:

  • sore throat
  • runny or stuffy nose
  • cough
  • sneeze

what you can do

If your symptoms are bothersome, talk to your doctor or pharmacist. They can recommend appropriate over-the-counter medications to help relieve your symptoms.

To help prevent these upper respiratory infections, try to:

  • wash your hands often
  • avoid close contact with people with colds
  • eat lots of fruits and vegetables
  • Have plenty of sleep

Serious meningococcal infections

Ultomiris has a framed warning for the risk of serious meningococcal infections. A boxed warning alerts doctors and patients to potentially dangerous drug effects.

In clinical tests, serious meningococcal infections were rare with Ultomiris treatment. However, these infections can be deadly and even fatal if not recognized and treated promptly.

Ultomiris works by weakening part of your immune system. Thus, it can increase your risk of serious infections caused by meningococcal bacteria. Examples of these infections include bacterial meningitis and sepsis (severe immune response to infection).

Symptoms of serious meningococcal infections can include:

  • headache with nausea, vomiting, fever, stiff neck or stiff back
  • fever with or without rash
  • rash that does not fade when pressed
  • light sensitivity
  • confusion
  • feel like sleeping
  • cold hands and feet
  • flu-like symptoms with muscle or joint pain

You may also have an increased risk of this side effect for up to 8 months after your last dose of Ultomiris.

what you can do

Due to the risk of meningococcal infections, Ultomiris is only available under a Risk Evaluation and Mitigation Strategy (REMS) program. (For more information on the Ultomiris REMS program, see “Ultomiris REMS Program” in the “Uses of Ultomiris” section below.)

As part of the REMS programme, your doctor will ensure that you are up to date with the recommended meningococcal vaccines before starting treatment with Ultomiris. Otherwise, they will give you the vaccines at least 2 weeks before the start of treatment. This will give the vaccines time to work.

If you need urgent treatment with Ultomiris, your doctor may ask you to start Ultomiris earlier than 2 weeks after receiving the vaccines. In this case, you will probably also need to take antibiotics to help prevent meningococcal infections. You will take the antibiotics for the first 2 weeks after your first Ultomiris infusion.

Vaccines reduce the risk of serious meningococcal infections, but it is still possible to get these infections. If you experience symptoms of a serious meningococcal infection during treatment with Ultomiris or within 8 months of your last dose, see your doctor immediately. But if your symptoms are life-threatening, call 911 or your local emergency number.

If you have a serious meningococcal infection, your doctor will prescribe antibiotics to treat it. They may also recommend withholding treatment with Ultomiris until the infection improves.

Allergic reaction

As with most medicines, some people may have an allergic reaction after receiving Ultomiris.

Symptoms of a mild allergic reaction may include:

A more serious allergic reaction is rare but possible. Symptoms of a severe allergic reaction may include:

  • swelling under the skin, usually in the eyelids, lips, hands, or feet
  • swelling of the tongue, mouth or throat
  • difficulty breathing

Call your doctor right away if you have an allergic reaction to Ultomiris, as the reaction could become severe. Call 911 or your local emergency number if your symptoms are life-threatening or you think you have a medical emergency.


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