Epysqli Side Effects

Generic name: eculizumab

Medically reviewed by Drugs.com. Last updated on Apr 11, 2024.

Note: This document provides detailed information about Epysqli Side Effects associated with eculizumab. Some dosage forms listed on this page may not apply specifically to the brand name Epysqli.

Applies to eculizumab: intravenous solution.

Precautions

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 for 2 weeks 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.

Serious side effects of Epysqli

Along with its needed effects, eculizumab (the active ingredient contained in Epysqli) 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 while taking eculizumab:

Other side effects of Epysqli

Some side effects of eculizumab 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:

For healthcare professionals

Applies to eculizumab: intravenous solution.

General adverse events

The most common adverse reaction was headache (occurred mostly in the initial phase) and the most serious adverse reaction was meningococcal sepsis.^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, bronchitis, dyspnea, cough, nasal congestion, pharyngolaryngeal pain, rhinorrhea, pneumonia
• Uncommon (0.1% to 1%): Lower respiratory tract infection, sinusitis, epistaxis, throat irritation^[Ref]

Musculoskeletal

• Very common (10% or more): Back pain (15%), arthralgia (17%)
• Common (1% to 10%): Myalgia, muscle spasms, bone pain, neck pain, pain in extremity
• Uncommon (0.1% to 1%): Trismus, joint swelling^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, vomiting, nausea, abdominal pain, constipation, dyspepsia
• Uncommon (0.1% to 1%): Gastrointestinal infection, peritonitis, gastroesophageal reflux disease, abdominal distension, gingival pain
• Rare (0.01% to 0.1%): Gingivitis^[Ref]

Hematologic

• Common (1% to 10%): Thrombocytopenia, leukopenia, anemia, hemolysis
• Uncommon (0.1% to 1%): Coagulopathy, red blood cell agglutination, abnormal clotting factor, anemia, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyltransferase increased, hematocrit decreased, hemoglobin decreased, thrombocytopenia, lymphopenia
• Rare (0.01% to 0.1%): Hemolysis, abnormal clotting factor, red blood cell agglutination, coagulopathy^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (33%), hypotension (17%)
• Uncommon (0.1% to 1%): Palpitation, accelerated hypertension, hematoma, hot flush, vein disorder^[Ref]

Nervous system

• Very common (10% or more): Headache (41%)
• Common (1% to 10%): Dizziness, dysgeusia
• Uncommon (0.1% to 1%): Syncope, tremor, paresthesia^[Ref]

Immunologic

• Common (1% to 10%): Meningococcal sepsis, aspergillus infection, arthritis bacterial, oral herpes, viral infection
• Uncommon (0.1% to 1%): Meningococcal meningitis, Neisseria infection, sepsis, septic shock, fungal infection, Haemophilus influenza infection, abscess, cellulitis, influenza, cystitis, gingival infection, impetigo, tooth infection
• Rare (0.01% to 0.1%): Aspergillus infection, bacterial arthritis, impetigo^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Depression, anxiety, insomnia, sleep disorder, abnormal dreams, mood swings^[Ref]

Genitourinary

• Common (1% to 10%): Proteinuria, urinary tract infection
• Uncommon (0.1% to 1%): Hematuria, dysuria, spontaneous penile erection, menstrual disorder
• Rare (0.01% to 0.1%): Genitourinary tract gonococcal infection^[Ref]

Dermatologic

• Very common (10% or more): Rash (15%), pruritus (10%)
• Common (1% to 10%): Alopecia
• Uncommon (0.1% to 1%): Urticaria, dermatitis, erythema, petechiae, skin depigmentation, hyperhidrosis, dry skin^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Grave's disease^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Jaundice^[Ref]

Hypersensitivity

• Common (1% to 10%): Anaphylactic reaction
• Uncommon (0.1% to 1%): Hypersensitivity^[Ref]

Local

• Uncommon (0.1% to 1%): Infusion site paresthesia, infusion site pain, extravasation^[Ref]

Metabolic

• Very common (10% or more): Hypokalemia (18%)
• Common (1% to 10%): Decreased appetite
• Uncommon (0.1% to 1%): Anorexia^[Ref]

Ocular

• Uncommon (0.1% to 1%): Vision blurred, conjunctival irritation^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Malignant melanoma, myelodysplastic syndrome^[Ref]

Other

• Common (1% to 10%): Edema, chest discomfort, pyrexia, chills, fatigue, asthenia, influenza like illness
• Uncommon (0.1% to 1%): Tinnitus, vertigo, feeling hot^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal impairment^[Ref]

See also:

Frequently asked questions

• What are biosimilar drugs and how do they compare to biologics?
• How does Ultomiris compare to Soliris for PNH?
• How does Soliris work for PNH?
• What biosimilars have been approved in the United States?
• How does Empaveli compare to Soliris?

Further information

Epysqli side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer