Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Bkemv

Descriptions


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

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-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.

Geriatric

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

  • 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 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

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

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

  1. Black, tarry stools
  2. bladder pain
  3. bloating or swelling of the face, arms, hands, lower legs, or feet
  4. bloody or cloudy urine
  5. blurred vision
  6. body aches or pain
  7. burning or stinging of the skin
  8. chest pain
  9. chills
  10. confusion
  11. cough
  12. decreased amount of urine
  13. diarrhea
  14. difficult, burning, or painful urination
  15. dizziness
  16. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  17. ear congestion
  18. fast, pounding, or irregular heartbeat or pulse
  19. fever
  20. frequent urge to urinate
  21. general feeling of discomfort or illness
  22. headache
  23. increased blood pressure
  24. increased thirst
  25. joint pain
  26. loss of voice
  27. lower back or side pain
  28. mood changes
  29. muscle aches, cramps, and pains
  30. nausea
  31. nervousness
  32. numbness or tingling in the hands, feet, or lips
  33. painful cold sores or blisters on the lips, nose, eyes, or genitals
  34. pale skin
  35. pounding in the ears
  36. rapid weight gain
  37. seizures
  38. shivering
  39. slow or fast heartbeat
  40. sore throat
  41. sores, ulcers, or white spots on the lips or in the mouth
  42. sneezing
  43. stuffy or runny nose
  44. sweating
  45. swelling of the face, fingers, or lower legs
  46. swollen glands
  47. trouble breathing
  48. trouble sleeping
  49. unusual bleeding or bruising
  50. unusual tiredness or weakness
  51. vomiting
  52. weight gain

Incidence not known

  1. Back pain
  2. chest tightness
  3. cough or hoarseness
  4. difficulty swallowing
  5. flushing
  6. hives, itching, skin rash
  7. 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

  1. Arm or leg pain
  2. constipation
  3. diarrhea
  4. difficulty in moving
  5. joint pain
  6. lack or loss of strength
  7. muscle spasm
  8. pain or tenderness around eyes and cheekbones
  9. 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.

Portions of this document last updated: July 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/eculizumab-aeeb-intravenous-route/precautions/drg-20569879