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Description

Eculizumab injection is a monoclonal antibody. It is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH.

This medicine is also used to treat a serious kidney disorder called atypical hemolytic uremic syndrome (aHUS).

This medicine is available only under a restricted distribution program called Soliris® REMS (Risk Evaluation and Mitigation Strategy) Program.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of eculizumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eculizumab injection in the elderly.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—Use with caution. This medicine may decrease your body’s ability to fight infection.

• Meningococcal infection—Should not be given to patients with this condition.

Proper Use

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 35 minutes.

It is very important that you understand the requirements of the Soliris® REMS program, and become familiar with the Soliris® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

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.

Eculizumab 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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Back pain
• Black, tarry stools
• Bladder pain
• Bloody or cloudy urine
• Blurred vision
• Burning or stinging of the skin
• Chest pain
• Cough
• Difficult, burning, or painful urination
• Difficulty with moving
• Dizziness
• Fever
• Headache
• Joint pain
• Lower back or side pain
• Muscle aching or cramping
• Muscle pains or stiffness
• Nausea
• Nervousness
• Pain or tenderness around the eyes and cheekbones
• Painful cold sores or blisters on the lips, nose, eyes, or genitals
• Pale skin
• Pounding in the ears
• Shortness of breath or troubled breathing
• Slow or fast heartbeat
• Sneezing
• Sore throat
• Sores, ulcers, or white spots on lips or in the mouth
• Stuffy or runny nose
• Swollen glands
• Swollen joints
• Tightness of the chest or wheezing
• Troubled breathing with exertion
• Unusual bleeding or bruising
• Unusual tiredness or weakness

• Chills
• Diarrhea
• General feeling of discomfort or illness
• Loss of appetite
• Shivering
• Sweating
• Trouble sleeping
• Vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty having a bowel movement (stool)
• Pain in the arms or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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