Pronunciation:

e-kue-LIZ-oo-mab

Brand Names:

• Soliris

Dosage Forms:

• Solution

Warnings:

Eculizumab, a complement inhibitor, increases the risk of serious infections caused by neisseria meningitidis. Life-threatening and fatal meningococcal infections have occurred in patients treated with complement inhibitors. These infections may become rapidly life-threatening or fatal if not recognized and treated early. Complete or update vaccination for meningococcal bacteria (for serogroups A, C, W, Y, and B) at least 2 weeks prior to the first dose of eculizumab, unless the risks of delaying therapy with eculizumab outweigh the risk of developing a serious infection. Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinations against meningococcal bacteria in patients receiving a complement inhibitor. See Warnings and Precautions (5.1) for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving eculizumab are at increased risk for invasive disease caused by Neisseria meningitidis, even if they develop antibodies following vaccination. Monitor patients for early signs and symptoms of serious meningococcal infections and evaluate immediately if infection is suspected. Because of the risk of serious meningococcal infections, eculizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called SOLIRIS REMS .

Classifications:

Therapeutic—

Blood Modifier Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Eculizumab injection 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).

Eculizumab injection is also used to treat a nerve and muscle disease called generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive.

Eculizumab injection is also used to treat neuromyelitis optica spectrum disorder (NMOSD), a rare disorder that causes inflammation of the nerves of the eyes and spinal cord. It is used in patients who are anti-aquaporin-4 (AQP4) antibody positive.

Eculizumab injection is a monoclonal antibody that works on the immune system.

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

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of eculizumab injection to treat atypical hemolytic uremic syndrome in children. However, safety and efficacy of eculizumab injection to treat other conditions have not been established in children.

Older adults—

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

Breast-feeding—

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.

Other medicines—

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.

• Neutropenia (low white blood cells) or
• Weak immune system—Use with caution. May cause side effects to become worse and increase risks for infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV will need to stay in place for at least 35 minutes in adults and 1 to 4 hours in children.

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 While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine 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 2 weeks before you receive this medicine. You may also be given antibiotic medicines to prevent infections if you are to use this medicine right away. 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 during treatment and for 3 months after your last dose. 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 for blood clots in your small blood vessels, called thrombotic microangiopathy (TMA) for at least 12 weeks after stopping treatment with this medicine. 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 infusion-related reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, chest pain, trouble breathing, itching or rash, lightheadedness, fainting, or swelling of the face, tongue, or throat after receiving this medicine.

Side Effects of This Medicine:

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:

More common

Back pain

black, tarry stools

bladder pain

blindness

bloody or cloudy urine

blurred vision

body aches or pain

burning or stinging of the skin

burning, dry, or itching eyes

chest pain or tightness

chills

cough

cough producing mucus

diarrhea

difficult, burning, or painful urination

difficulty breathing or swallowing

difficulty with moving

dizziness

ear congestion

fast heartbeat

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

hives, itching, skin rash

joint pain or swelling

loss of appetite

loss of voice

lower back or side pain

muscle ache, cramp, pain, 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

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

shivering

slow or fast heartbeat

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stuffy or runny nose

sweating

swollen glands

trouble breathing

trouble sleeping

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Less common

General feeling of discomfort or illness

hoarseness

itching, pain, redness, swelling, tenderness, or warmth on the skin

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:

More common

Bone pain

constipation

difficulty having a bowel movement

difficulty in moving

mouth or throat pain

pain in the arms or legs

More common

Bruise

hair loss or thinning of hair

lack or loss of strength

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.