Pronunciation:

e-kue-LIZ-oo-mab - aeeb

Brand Names:

• Bkemv

Warnings:

Eculizumab products, complement inhibitors, 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-aeeb, unless the risks of delaying therapy with eculizumab-aeeb 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 for additional guidance on the management of the risk of serious infections caused by meningococcal bacteria. Patients receiving eculizumab products 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-aeeb is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called BKEMV REMS .

Classifications:

Pharmacologic—

Eculizumab

Uses of This Medicine:

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

This medicine is available only under a restricted distribution program called BKEMV™ 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 have not been performed on the relationship of age to the effects of eculizumab-aeeb injection to treat PNH in children. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of eculizumab-aeeb injection to treat aHUS in children. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eculizumab-aeeb 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Efgartigimod Alfa-fcab
• Rozanolixizumab-noli

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:

• Meningococcal infection, serious and unresolved—Should not be used in patients with this condition.

• Infection or
• Neutropenia (low white blood cells) or
• Weak immune system—Use with caution. May increase risk of serious infections.

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 BKEMV™ REMS program, and become familiar with the BKEMV™ 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.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your 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-aeeb 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 meningococcal infections at least 2 weeks before you receive this medicine. You may also be given antibiotic medicine 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 a meningococcal infection 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 may develop hemolysis (red blood cell breakdown). 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: When this medicine is stopped, you may develop a type of blood clot called thrombotic microangiopathy (TMA). Your doctor will need to monitor you closely for at least 12 weeks after you stop using this medicine. The signs and symptoms of TMA include chest pain, trouble breathing, or seizures. Call your doctor right away if you notice any of these signs and symptoms.

Eculizumab-aeeb 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

Black, tarry stools

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

body aches or pain

burning or stinging of the skin

chest pain

chills

confusion

cough

decreased amount of urine

diarrhea

difficult, burning, or painful urination

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

ear congestion

fast, pounding, or irregular heartbeat or pulse

fever

frequent urge to urinate

general feeling of discomfort or illness

headache

increased blood pressure

increased thirst

joint pain

loss of voice

lower back or side pain

mood changes

muscle aches, cramps, and pains

nausea

nervousness

numbness or tingling in the hands, feet, or lips

painful cold sores or blisters on the lips, nose, eyes, or genitals

pale skin

pounding in the ears

rapid weight gain

seizures

shivering

slow or fast heartbeat

sore throat

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

sneezing

stuffy or runny nose

sweating

swelling of the face, fingers, or lower legs

swollen glands

trouble breathing

trouble sleeping

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain

Incidence not known

Back pain

chest tightness

cough or hoarseness

difficulty swallowing

flushing

hives, itching, skin rash

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

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

Arm or leg pain

constipation

diarrhea

difficulty in moving

joint pain

lack or loss of strength

muscle spasm

pain or tenderness around eyes and cheekbones

swollen joints

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.