Medications


Ultomiris Injection 100 mg/mL

Uses

For blood cell disorders.

Instructions

This is an IV medicine. It is given through a sterile tube directly into the vein by a healthcare provider.

This medicine is given gradually through the IV line.

This medicine should be given by a trained health care provider.

You must be monitored by a healthcare professional for at least 1 hour after each dose is given.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you miss a dose, contact your doctor for instructions.

Please tell your doctor and pharmacist about all the medicines you take. Include both prescription and over-the-counter medicines. Also tell them about any vitamins, herbal medicines, or anything else you take for your health.

If your symptoms do not improve or they worsen while on this medicine, contact your doctor.

It is very important that you continue using this medicine for the full number of days that it is prescribed. Please do not stop the medicine even if you start to feel better after the first few days.

It is very important that you follow your doctor's instructions for all blood tests.

It is very important that you keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine. Symptoms of an allergic reaction can include trouble breathing, skin rash, itching, swelling, or severe dizziness.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Tell your doctor or nurse right away if high fever, chills, severe headache, nausea or vomiting that doesn't stop, stiff neck, confusion or sensitivity to light develop while the medicine is being given. The medicine may need to be stopped or given at a slower rate.

This medicine may reduce your body's ability to fight infections. Try to avoid contact with people with colds, flu or other infections.

Contact your doctor if you develop any signs of a new infection such as fever, cough, sore throat, or chills.

Wash your hands often and avoid close contact with people with infections such as colds and flu.

Meningitis vaccine should be given at least two weeks before starting this medicine. Talk with your doctor about this and other vaccines that may be needed.

Speak with your health care provider before receiving any vaccinations.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not breastfeed while on this medicine. You may safely start breastfeeding 8 months after stopping treatment.

Ask your pharmacist if this medicine can interact with any of your other medicines. Be sure to tell them about all the medicines you take.

Always carry an ID card or wear a medical alert bracelet indicating your medical condition.

Always carry the patient safety card with you during treatment with this medicine and for 8 months after your last dose.

Please tell all your doctors and dentists that you are on this medicine before they provide care.

Do not start or stop any other medicines without first speaking to your doctor or pharmacist.

To receive this medicine, patients in the US, their doctors and their pharmacists must agree to follow the requirements of the Ultomiris REMS program.

This medicine can cause serious side effects in some patients. Important information from the U.S. Food and Drug Administration (FDA) is available from your pharmacist. Please review it carefully with your pharmacist to understand the risks associated with this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • diarrhea
  • dizziness
  • headaches
  • pain in the joints
  • muscle pain
  • nausea

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • confusion
  • cough that does not go away
  • fainting
  • fever or chills
  • high fever
  • severe or persistent headache
  • neck pain or stiffness
  • sensitivity to light
  • shortness of breath

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Extra

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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IMPORTANT NOTE: This document tells you briefly how to take your medicine, but it does not tell you all there is to know about it.Your doctor or pharmacist may give you other documents about your medicine. Please talk to them if you have any questions.Always follow their advice. There is a more complete description of this medicine available in English.Scan this code on your smartphone or tablet or use the web address below. You can also ask your pharmacist for a printout. If you have any questions, please ask your pharmacist.


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