Eculizumab (Injection)

Introduction

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

Treats a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). It is also used to treat a serious kidney disorder called atypical hemolytic uremic syndrome (aHUS).

Brand Name(s)

Soliris

When This Medicine Should Not Be Used

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.
• The medicine must be injected slowly, so your IV tube will need to stay in place for at least 35 minutes.
• 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.
• This medicine is available only under a registered distribution program called Soliris® REMS (Risk Evaluation and Mitigation Strategy) Program. You will be asked to sign an agreement form before you take this medicine. This form tells you about the benefits and risks of using this medicine. Make sure you understand what is on the form before you sign it.

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.
• For patients with PNH: 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 8 weeks after you stop using this medicine. Be sure to keep all appointments.
• For patients with aHUS: Your doctor may also need to check you for at least 12 weeks after stopping treatment with this medicine for blood clots in your small blood vessels called thrombotic microangiopathy (TMA). The signs and symptoms of TMA include chest pain, difficulty with breathing, mental depression or anxiety, or seizures. Call your doctor right away if you notice any of these signs and symptoms.
• This medicine may cause a serious side effect called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have 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.
• 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.
• Black, tarry stools.
• Bladder pain; bloody or cloudy urine; difficult, burning, or painful urination; and lower back or side pain.
• Blurred vision, dizziness, nervousness, pounding in the ears, and slow or fast heartbeat.
• Burning or stinging of the skin.
• Chest pain, shortness of breath.
• 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.
• Pale skin, troubled breathing with exertion, and unusual bleeding or bruising.
• Sores, ulcers, or white spots on lips or in the mouth, and swollen glands.
• 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