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Carimune Nf Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 3g, 6g, 12g; per vial; pwd for IV infusion after reconstitution; contains sucrose and NaCl; preservative-free.
Pharmacological Class
Immune globulin.
How Supplied
Single-use vial—1
Manufacturer
Carimune Nf Indications
Indications
Immune thrombocytopenic purpura (ITP).
Carimune Nf Dosage and Administration
Adults and Children
Induction: give by IV infusion at a rate of 0.5mg/kg/min for first 30mins, if tolerated may increase to 1mg/kg/min up to max 3mg/kg/min in a stepwise manner. 0.4g/kg on 2–5 consecutive days. Use of 6% immunoglobulin solution is recommended. Acute childhood ITP: discontinue therapy after second day of 5 day course if platelet count response to first two doses is 30–50000/μL. Maintenance: If platelet count falls to <30000/μL and/or clinically significant bleed: give 0.4g/kg as a single infusion, may increase to 0.8–1g/kg as single infusion if inadequate response. Risk of renal dysfunction/failure or thrombosis: max infusion rate <2mg/kg/min.
Carimune Nf Contraindications
Contraindications
IgA-deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Carimune Nf Boxed Warnings
Not Applicable
Carimune Nf Warnings/Precautions
Warnings/Precautions
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Monitor for aseptic meningitis, hemolysis and delayed hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Contains human plasma; monitor for possible infection transmission. Have epinephrine inj available. Elderly. Pregnancy (Cat.C).
Carimune Nf Pharmacokinetics
See Literature
Carimune Nf Interactions
Interactions
Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines.
Carimune Nf Adverse Reactions
Adverse Reactions
Headache, arthralgia, myalgia, transient skin reactions, infusion reactions (eg, flushing, chills, fever), renal toxicities; aseptic meningitis syndrome (esp. high dose 2g/kg), TRALI, thrombosis.
Carimune Nf Clinical Trials
See Literature
Carimune Nf Note
Not Applicable
Carimune Nf Patient Counseling
See Literature
Carimune Nf Generic Name & Formulations
Legal Class
Rx
General Description
Immune globulin (human) 3g, 6g, 12g; per vial; pwd for IV infusion after reconstitution; contains sucrose and NaCl; preservative-free.
Pharmacological Class
Immune globulin.
How Supplied
Single-use vial—1
Manufacturer
Carimune Nf Indications
Indications
Primary immunodeficiency (eg, common variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency).
Carimune Nf Dosage and Administration
Adults and Children
Give by IV infusion at a rate of 0.5mg/kg/min for first 30mins, if tolerated may increase to 1mg/kg/min up to max 3mg/kg/min in a stepwise manner. 0.4–0.8g/kg once every 3–4 weeks. Previously untreated agammaglobulinemic or hypogammaglobulinemic patients: give 3% immunoglobulin solution for first infusion. Risk of renal dysfunction/failure or thrombosis: max infusion rate <2mg/kg/min.
Carimune Nf Contraindications
Contraindications
IgA-deficiency with antibodies against IgA. Previous severe reaction to human immune globulin.
Carimune Nf Boxed Warnings
Not Applicable
Carimune Nf Warnings/Precautions
Warnings/Precautions
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular risk factors: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output before and during therapy; discontinue if renal function deteriorates. Monitor for aseptic meningitis, hemolysis and delayed hemolytic anemia. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Contains human plasma; monitor for possible infection transmission. Have epinephrine inj available. Elderly. Pregnancy (Cat.C).
Carimune Nf Pharmacokinetics
See Literature
Carimune Nf Interactions
Interactions
Concomitant nephrotoxic drugs: increased risk of renal toxicity. May affect response to live virus vaccines.
Carimune Nf Adverse Reactions
Adverse Reactions
Headache, arthralgia, myalgia, transient skin reactions, infusion reactions (eg, flushing, chills, fever), renal toxicities; aseptic meningitis syndrome (esp. high dose 2g/kg), TRALI, thrombosis.
Carimune Nf Clinical Trials
See Literature
Carimune Nf Note
Not Applicable
Carimune Nf Patient Counseling
See Literature
