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RespiGam Side Effects

Generic name: respiratory syncytial virus immune globulin

Medically reviewed by Drugs.com. Last updated on Nov 24, 2023.

Note: This document provides detailed information about RespiGam Side Effects associated with respiratory syncytial virus immune globulin. Some dosage forms listed on this page may not apply specifically to the brand name RespiGam.

Applies to respiratory syncytial virus immune globulin: intravenous solution.

Important warnings This medicine can cause some serious health issues

RSV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease.

Although RSV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease.

Discuss with the doctor the risks and benefits of using RSV IG.

Treatment with immune globulin products such as RSV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death.

Notify the doctor immediately if symptoms such as decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath occur.

These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as RSV IG.

Notify the doctor immediately if symptoms such as severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting occur.

These may be signs of AMS.

Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems.

RSV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although RSV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with the doctor the risks and benefits of using RSV IG.

Treatment with immune globulin products such as RSV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify the doctor immediately if symptoms such as decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath occur. These may be signs of kidney problems.

Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as RSV IG. Notify the doctor immediately if symptoms such as severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting occur. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems.

Notify your doctor immediately if a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to RSV IG is experienced.

Other less serious side effects may also occur. Upon injection of the medication, some patients may experience the following side effects:

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For healthcare professionals

Applies to respiratory syncytial virus immune globulin: intravenous solution.

Renal

Renal side effects associated with sucrose-containing IGIV infusion have included increased serum creatinine, increased BUN level, oliguria, anuria, acute renal failure, acute tubular necrosis, proximal tubular nephropathy, and osmotic nephrosis.[Ref]

Other

Other side effects has included fever/pyrexia (6%) and overdose effect (1%). Pallor, cold/clammy skin, gagging, and fluid overload have been reported rarely.

Other side effects associated with other IGIV derivatives have included flushing. This effect is often related to the rate of infusion.[Ref]

Respiratory

Respiratory side effects have included respiratory distress (2%), wheezing (2%), rales (1%), tachypnea (1%), and hypoxia/hypoxemia (1%). Cyanosis, cough, and rhinorrhea have been reported rarely.

Respiratory side effects associated with other IGIV derivatives have included dyspnea. This effect is often related to the rate of infusion.[Ref]

Gastrointestinal

Gastrointestinal side effects have included vomiting (2%), diarrhea (1%), and gastroenteritis (1%).

Gastrointestinal side effects associated with other IGIV derivatives have included abdominal cramps. This effect is often related to the rate of infusion.[Ref]

Cardiovascular

Cardiovascular side effects reported in 1% of patients have included fluid overload, tachycardia, increased pulse rate, and hypertension. Edema, hypotension, and heart murmur have been reported rarely.

Cardiovascular side effects associated with other IGIV derivatives have included blood pressure changes, palpitations, and chest tightness. These effects are usually related to the rate of infusion.[Ref]

The CARDIAC study reported an increase in frequency of cardiac surgery in children with left and right shunts. All enrollees (n=429) had preexisting congenital heart disease of less than 48 months duration at time of enrollment. The study also reported a greater frequency of severe and life-threatening side effects associated with the cardiac surgery.[Ref]

Dermatologic

Dermatologic side effects have included rash (1%). Eczema has been reported rarely.

Dermatologic side effects associated with other IGIV derivatives have included pruritus. This effect is usually related to the rate of infusion.[Ref]

Local

Local side effects have included inflammation at injection site.[Ref]

Nervous system

Nervous system side effects have rarely included sleepiness.

Nervous system side effects associated with other IGIV derivatives have included dizziness and anxiety. These effects are often related to the rate of infusion.[Ref]

Ocular

Ocular side effects have rarely included conjunctival hemorrhage.[Ref]

Musculoskeletal

Musculoskeletal side effects associated with other IGIV derivatives have included myalgia and arthralgia. These effects are often related to the rate of infusion.[Ref]

Hypersensitivity

Hypersensitivity side effects, including anaphylactic reactions, have been associated with other IGIV derivatives.[Ref]

Immunologic

Immunologic side effects associated with other IGIV derivatives have rarely included aseptic meningitis syndrome.[Ref]

Aseptic meningitis syndrome has been associated with high doses (2 g/kg) of IGIV.

Aseptic meningitis of unknown etiology has been reported in three pediatric patients during RSV-IGIV therapy in the PREVENT trial. Subsequent findings reported one child to have a presumptive diagnosis of enteroviral infection, and another child to have an unconfirmed diagnosis of Herpes simplex meningitis related to treatment with acyclovir. The third child developed fever, vomiting, and malaise associated with 21 cells per mm3 in the cerebrospinal fluid.[Ref]

References

1. (2005) "Product Information. Respigam (respiratory syncytial virus immune globulin)." Medimmune Inc

More about RespiGam (respiratory syncytial virus immune globulin)

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Further information

RespiGam 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.

Some side effects may not be reported. You may report them to the FDA.