| Privigen® | Immune Globulin Intravenous (Human) 10% Liquid |
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US Prescribing Information
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US Important Safety Information (Selected)
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WARNINGS:
Thrombosis (blood clotting) can occur with immune globulin products, including Privigen. Risk factors may include advanced age, prolonged immobilization, a history of blood clotting or hyperviscosity (thick blood), use of estrogens, installed vascular catheters, and cardiovascular risk factors.
In predisposed patients, kidney malfunction and acute kidney failure, potentially fatal, can occur with the administration of human immune globulin intravenous (IGIV) products. Kidney problems occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.
If you are at high risk of thrombosis or kidney problems, your doctor will prescribe and administer Privigen at the minimum dose and infusion rate practicable, and will monitor you for signs and symptoms of thrombosis and viscosity, as well as kidney function. Always drink sufficient fluids before administration.
See your doctor for a full explanation, and the full prescribing information for complete boxed warning.
In clinical trials of Privigen, headache was the most common side effect. Other common side effects that can be seen with treatment include fatigue, nausea, fever, and high blood pressure. These are not the only side effects possible; see the full prescribing information for a complete list of adverse reactions possible with treatment for each condition. Alert your physician to any side effect that bothers you or does not go away.
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| Rhophylac® | Rho(D), Immune Globulin Intravenous (Human) |
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US Prescribing Information
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US Important Safety Information (Selected)
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WARNING: INTRAVASCULAR HEMOLYSIS IN ITP
This warning does not apply to Rh0(D)-negative patients treated for the suppression of Rh isoimmunization.
Intravascular hemolysis leading to death has been reported in Rho(D)-positive patients treated for immune thrombocytopenic purpura (ITP) with Rho(D) Immune Globulin Intravenous (Human) products. Intravascular hemolysis can lead to clinically compromising anemia and multi-system organ failure, including acute respiratory distress syndrome (ARDS); acute renal insufficiency, renal failure, and disseminated intravascular coagulation (DIC) have also been reported. Monitor patients for signs and symptoms of intravascular hemolysis in a healthcare setting for at least 8 hours after administration. See full prescribing information for complete boxed warning.
The most common adverse reactions observed in the treatment of ITP (>14% of patients) are chills, pyrexia/increased body temperature, headache, and hemolysis. In patients with preexisting anemia, Rhophylac may increase the severity of anemia.
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| Carimune® NF | Nanofiltered, Immune Globulin Intravenous (Human) |
| Known outside the US as: Sandoglobulin®, Redimune®, and Sanglopor® |
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US Prescribing Information
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US Important Safety Information(Selected)
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WARNING: THROMBOSIS, RENAL DYSFUNCTION or ACUTE RENAL FAILURE
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- Thrombosis may occur with immune globulin products, including Carimune NF. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis can occur in absence of known risk factors.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death can occur in predisposed patients with immune globulin intravenous (IGIV) products, including Carimune NF. Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age over 65, volume depletion, sepsis, paraproteinemia, and those receiving known nephrotoxic drugs. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose, such as Carimune NF.
- For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer Carimune NF at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
- See full prescribing information for full boxed warning.
Slow or temporarily stop infusion if patient experiences facial flushing, tightness in chest, chills, fever, nausea, dizziness or other unusual response; stop infusion immediately if anaphylaxis or severe reaction occurs. Headache, usually mild, is the most common adverse reaction; mild hemolysis, arthralgia, myalgia, and transient skin reactions have also been reported.
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Full US Important Safety Information
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