Ablyze®


(Eculizumab)


What is it?

What is Ablyze®?

Ablyze® (Eculizumab) is a humanized monoclonal IgG antibody that binds to complement protein C5. This process prevents hemoglobin lysis and results in stabilization of hemoglobin and a reduction in the need for RBC transfusions.

Indications

What is Ablyze® used for?

Ablyze® is a prescription medicine that is used to treat:

  • Patients with a blood disease called Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • Adults and children with a blood and kidney disease called atypical Hemolytic Uremic Syndrome (aHUS).
  • Adults with a disease called generalized myasthenia gravis (gMG)
  • Adults with a disease called neuromyelitis optica spectrum disorder (NMOSD)

It is not known if Ablyze® is safe and effective in children with PNH, gMG, or NMOSD.

Contraindications

Who should not use Ablyze®?

Do not use Ablyze® if:

  • you are allergic to eculizumab, proteins derived from mouse products, other monoclonal antibodies, or any of the other ingredients of this medicine.
  • you have not been vaccinated against meningococcal infection unless you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
  • you have a meningococcal infection.

Important information

What should I tell my health care provider before using Ablyze®?

• If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

• If you did not get a meningococcal vaccine.

• If you have a meningococcal infection.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How should I use Ablyze®?

This drug is given as an infusion into a vein over a period of time by your physician. Read all information given to you. Follow all instructions closely.

Side Effects

What are the possible side effects of Ablyze®?

The most common side effects of Ablyze® may include:

 

  • headache
  • infection of the lung, common cold, infection of the urinary system
  • low white blood cell count, reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
  • inability to sleep
  • dizziness, taste disorders, high blood pressure
  • upper respiratory tract infection, cough, throat pain, bronchitis, cold sores (herpes simplex)
  • diarrhea, vomiting, nausea, abdominal pain, rash, hair loss, itchy skin
  • pain in the joints (arms and legs)
  • fever, feeling tired, influenza like illness

Ablyze® may cause serious side effects that you need to call your doctor about right away, including:

  •  Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  •  Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  •  Signs of a urinary tract infection like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  •  Signs of a meningococcal infection like very bad headache with or without upset stomach, throwing up, fever, or stiff neck or back; confusion; high fever; fever with a rash; if light bothers the eyes; or very bad muscle aches or pain with or without flu-like signs.
  •  Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  •  Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
  •  Not able to pass urine or change in how much urine is passed.
  •  A fast heartbeat.
  •  Swelling in the arms or legs.
  • Bruising.
  •  A burning, numbness, or tingling feeling that is not normal.
  •  Eye irritation.
  •  Cataracts have happened with this drug. Tell your doctor about any change in eyesight.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Storage

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
  • Store in a refrigerator (2°C – 8°C).
  • Do not freeze.
  • Store in the original package in order to protect from light.