Monograph Details
|
|
Hematology
> Bleeding disorders
|
|
GAMUNEX |
| Manufacturer |
|
Talecris Biotherapeutics, Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
IVIG. |
| Generic Name |
|
Immune Globulin (human) 1g/10mL, 2.5g/25mL, 5g/50mL, 10g/100mL, 20g/200mL; soln for IV infusion; preservative- and sucrose-free. |
| Indications |
|
Idiopathic Thrombocytopenic Purpura (ITP). |
| Adults and Children |
|
Give by IV infusion at a rate of 1mg/kg/min for first 30 minutes, if tolerated may increase to max 8mg/kg/min. 1g/kg once daily given on 2 consecutive days or 0.4g/kg once daily given on 5 consecutive days. If adequate response after first 1g/kg dose may withhold second dose. Risk of renal dysfunction or thrombotic event: infuse at a rate <8mg/kg/min. Expanded fluid volumes: high dose regimen not recommended. |
| Contraindications |
|
Severe selective IgA deficiency (serum IgA <0.05g/L) with known antibody against IgA. |
| Precautions |
|
Renal insufficiency, diabetes, >65yrs, volume depletion, sepsis, paraproteinemia: increased risk of renal dysfunction or acute renal failure; monitor urine output, BUN before and during treatment; consider discontinuing if renal dysfunction develops. Correct hypovolemia before starting treatment. Contains human plasma; monitor for possible infection transmission. Monitor for hemolysis. Hyperviscosity (perform baseline assessment of blood viscosity). High dose (2g/kg) and/or rapid infusion may increase risk of aseptic meningitis syndrome. Monitor for pulmonary dysfunction; perform test for anti-neutrophil antibodies if transfusion-related acute lung injury (TRALI) suspected. Pregnancy (Cat.C). |
| Interactions |
|
Avoid live viral vaccines for ≥6 months. Concomitant nephrotoxic drugs: increased risk of acute renal failure. May contain low levels of anti-Blood Group A and B antibodies of IgG4; direct antiglobin tests may be false-positive. |
| Adverse Reactions |
|
Headache, ecchymosis, purpura, hemorrhage, epistaxis, petechiae, fever, GI upset, thrombocytopenia, rash, asthenia, pruritus, arthralgia, dizziness, renal dysfunction (may be fatal); rare: hemolytic anemia, aseptic meningitis syndrome, TRALI, thrombosis. |
| Extra Text |
|
Note: Report all infections suspected to be transmitted by Gamunex to (800) 520-2807. |
| How Supplied |
|
Vials—1 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
