Medical Editor: John P. Cunha, DO, FACOEP
Carimune NF, Nanofiltered, Immune Globulin Intravenous (Human), is an antibody product indicated for the maintenance treatment of patients with primary immunodeficiencies (PID), e.g., common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency. Carimune NF is preferable to intramuscular Immune Globulin (Human) preparations in treating patients who require an immediate and large increase in the intravascular immunoglobulin level, in patients with limited muscle mass, and in patients with bleeding tendencies for whom intramuscular injections are contraindicated. Common side effects of Carimune NF include:
- flushing of the face
- feelings of tightness in the chest
- low or high blood pressure (hypotension or hypertension)
- joint pain
- muscle pain and
- temporary skin reactions (rash, swelling, itching, hives, eczema, or dermatitis)
The recommended dose of Carimune NF for the treatment of ITP is 0.4g/kg of body weight on 2–5 consecutive days. Carimune NF may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Carimune NF should be administered only if prescribed. Consult your doctor before breastfeeding.
Our Carimune NF, Nanofiltered, Immune Globulin Intravenous (Human) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Increases in creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following infusion. Progression to oliguria or anuria, requiring dialysis has been observed. Types of severe renal adverse events that have been seen following IGIV therapy include: acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis.9-14,64,71–73
Inflammatory adverse reactions have been described in agammaglobulinemic and hypogammaglobulinemic patients who have never received immunoglobulin substitution therapy before or in patients whose time from last treatment is greater than 8 weeks and whose initial infusion rate exceeds 2 mg/kg/min.
This occurs in approximately 10% of such cases. Such reactions may also be observed in some patients during chronic substitution therapy.
Reactions, which may become apparent only 30 minutes to 1 hour after the beginning of the infusion, are as follows: flushing of the face, feelings of tightness in the chest, chills, fever, dizziness, nausea, diaphoresis, and hypotension or hypertension. In such cases, the infusion should be slowed or temporarily stopped until the symptoms subside. The infusion may then be resumed at a lower rate that is comfortable for the patient. If anaphylaxis or other severe reactions occur, the infusion should be stopped immediately.
Immediate anaphylactoid and hypersensitivity reactions due to previous sensitization of the recipient to certain antigens, most commonly IgA, may be observed in exceptional cases, described under CONTRAINDICATIONS.30,31,65 In patients with ITP, who receive higher doses (0.4 g/kg/day or greater), 2.9% of infusions may result in adverse reactions.21 Headache, generally mild, is the most common symptom noted, occurring during or following 2% of infusions. A few cases of usually mild hemolysis have been reported after infusion of intravenous immunoglobulin products.59–61 These were attributed to transferal of blood group (e.g., anti-D) antibodies.
The following adverse reactions have been identified and reported during the post-approval use of IGIV products:
Cardiac arrest, thromboembolism, vascular collapse, hypotension
Coma, loss of consciousness, seizures, tremor
Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis
General/Body as a Whole
Hepatic dysfunction, abdominal pain
Because postmarketing reporting of these reactions is voluntary and the at-risk populations are of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to exposure to the product. Such is also the case with literature reports authored independently.66
Read the entire FDA prescribing information for Carimune (Immune Globulin Intravenous (Human) Nanofiltered Lyophilized Preparation)