Description
Eculizumab-aagh 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-aagh injection is a monoclonal antibody that works on the immune system.
This medicine is available only under a restricted distribution program called EPYSQLI® 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-aagh 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-aagh injection to treat aHUS in children. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eculizumab-aagh injection in the elderly.
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. 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
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 EPYSQLI® REMS program, and become familiar with the EPYSQLI® 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
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-aagh 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 meningococcal vaccine at least 2 weeks before you receive this medicine. If you have not completed your meningococcal vaccine and you need this medicine right away, you may be given the vaccine and antibiotic medicine to prevent infection. 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-aagh 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
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 appetite
- 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
- 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.
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