Omisirge Side Effects

Generic name: omidubicel

Medically reviewed by Drugs.com. Last updated on Jul 9, 2024.

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

Applies to omidubicel: intravenous suspension.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Tell your doctor right away think you have become pregnant.

This medicine may cause serious allergic reactions (eg, anaphylaxis, angioedema, bronchospasm), which can be life-threatening and require immediate medical attention. Check with your doctor right away if you or your child have a chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, rash, itching, trouble breathing, or unusual tiredness or weakness after using this medicine.

This medicine may cause infusion reaction, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have black, tarry stools, blurred vision, colicky or burning stomach pain, constipation, cracked lips, diarrhea, difficulty in swallowing, dizziness, facial swelling, fever or chills, headache, loss of appetite, nausea or vomiting, pain in the back of throat or chest when swallowing, skin rash, slow or fast heartbeat, sores, ulcers, or white spots on the lips, tongue, or inside the mouth, trouble breathing, vomiting blood or material that looks like coffee grounds, or weakness while you are receiving this medicine.

Check with your doctor right away if you have diarrhea, fever, rash, unexplained weight gain, or yellow eyes. These maybe symptoms of serious conditions called graft-versus-host-disease or engraftment syndrome.

This medicine may cause secondary cancer (eg, post-transplant lymphoproliferative disorder). Check with your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, or yellow skin and eyes.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, HIV, hepatitis B or C) or genetic diseases to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

Serious side effects of Omisirge

Along with its needed effects, omidubicel (the active ingredient contained in Omisirge) 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 omidubicel:

Other side effects of Omisirge

Some side effects of omidubicel 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 omidubicel: intravenous suspension.

General adverse events

The most common adverse reactions (incidence greater than 20%) were infections, GvHD, and infusion reactions.^[Ref]

Gastrointestinal

• Very common (10% or more): Gastrointestinal toxicity (19%), dysphagia (12%)^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (25%)^[Ref]

Hematologic

• Very common (10% or more): Hemorrhage (12%)^[Ref]

Hemorrhage includes cystitis hemorrhagic, epistaxis, gastrointestinal bleeding, pulmonary alveolar hemorrhage, subarachnoid hemorrhage, and upper gastrointestinal hemorrhage.^[Ref]

Immunologic

• Very common (10% or more): Infusion reactions (any severity: 56%, Grade 3: 17% and 4: 21%), GvHD (acute up to 58%, chronic 35%)
• Common (1% to 10%): Primary graft failure^[Ref]

The most common infusion reactions were hypertension, mucosal inflammation, arrythmia, and fatigue. The most common Grade 3 to 4 infusion reaction was hypertension, reported in 6% of the patients.^[Ref]

Local

• Very common (10% or more): Pain (33%), mucosal inflammation (31%)^[Ref]

Metabolic

• Very common (10% or more): Magnesium decreased (94%), aspartate aminotransferase increased (56%), alanine aminotransferase (56%), alkaline phosphatase increased (42%), magnesium increased (15%)^[Ref]

Other

• Very common (10% or more): Viral infections (75%), bacterial infections (65%), fungal infections (21%)
• Common (1% to 10%): Fatigue, fever^[Ref]

Renal

• Very common (10% or more): Creatinine increased (50%), renal impairment (12%)^[Ref]

Respiratory

• Very common (10% or more): Respiratory failure (12%)
• Common (1% to 10%): Dyspnea (8%)^[Ref]

Respiratory failure includes acute respiratory distress syndrome, acute respiratory failure, hypoxia, and respiratory failure.^[Ref]

Hepatic

• Very common (10% or more): Bilirubin increased (42%)^[Ref]

See also:

Further information

Omisirge 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