Eculizumab (Injection)

Introduction

Eculizumab (e-kue-LIZ-oo-mab)

Treats a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH).

Brand Name(s)

There may be other brand names for this medicine.

Soliris

When This Medicine Should Not Be Used

You should not receive this medicine if you have had an allergic reaction to eculizumab, if you have an active infection caused by meningococcus bacteria, or if you have not received a vaccine to prevent meningococcus infections.

How to Use This Medicine

Injectable

  • Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
  • A nurse or other trained health professional will give you this medicine.
  • This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.

If a dose is missed:

  • Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

  • Make sure your doctor knows if you are pregnant or breastfeeding, or if you have any kind of infection.
  • Eculizumab may increase your chance of having serious infections, including a meningococcal infection. Avoid people who are sick or have infections. Tell your doctor right away if you develop headaches, nausea, vomiting, fever, a stiff neck or back, a rash, confusion, muscle aches, or if your eyes have become sensitive to light. Make sure you have received a vaccine to prevent meningococcus infections at least two weeks before you receive this medicine. If you have already received the meningococcal vaccine in the past, your doctor will decide if you need another dose.
  • Ask your doctor for a patient safety card. This card will list the symptoms of meningococcus infections and what to do if you have them. Carry the card with you at all times. You will need to show the card to any doctor who treats you.
  • When this medicine is stopped you could have red blood cell destruction or breakdown (hemolysis). Your doctor will need to monitor you closely for at least eight weeks after you stop using this medicine. Be sure to keep all appointments.
  • This medicine may cause chest pain, fever, chills, itching, hives, flushing of the face, rash, dizziness, troubled breathing, or swelling of the face, tongue, and throat within a few hours after you receive it. Check with your doctor or nurse right away if you have any of these symptoms.
  • Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing.
  • Back pain, or pain in your arms or legs.
  • Burning or stinging of the skin.
  • Fever, chills, cough, sore throat, and body aches.
  • Headache, runny or stuffy nose.
  • Nausea or vomiting.
  • Painful cold sores or blisters on the lips, nose, eyes, or genitals.
  • Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

  • Constipation.
  • Pain, itching, burning, swelling, or a lump under your skin where the needle is placed.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Review Date: 2011-02-04 Reviewed By: Keywords: ,
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