Allergy & Immunology
Our world-leading immunoglobulin (Ig) franchise is the cornerstone of the immunology therapeutic area. Our efforts in this area focus on bringing trusted products and technologies to serve patients with a range of rare and serious diseases, including Primary Immunodeficiencies (PID) and Hereditary Angioedema (HAE).
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Primary Immune Deficiency (PID)
Hereditary Angioedema (HAE)
Important Safety Information for Hizentra
WARNING: Thrombosis may occur with immune globulin products, including Hizentra. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
For patients at risk of thrombosis, administer Hizentra 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.
Hizentra is contraindicated in patients with a history of anaphylactic or severe systemic reaction to human immune globulin (Ig) or components of Hizentra (eg, polysorbate 80), as well as in patients with immunoglobulin A deficiency with antibodies against IgA and a history of hypersensitivity. Because Hizentra contains L-proline as stabilizer, use in patients with hyperprolinemia is contraindicated.
IgA-deficient patients with anti-IgA antibodies are at greater risk of severe hypersensitivity and anaphylactic reactions. Thrombosis may occur following treatment with Ig products, including Hizentra.
Monitor patients for aseptic meningitis syndrome (AMS), which may occur following treatment with Ig products, including Hizentra. In patients at risk of acute renal failure, monitor renal function, including blood urea nitrogen, serum creatinine and urine output. In addition, monitor patients for clinical signs of hemolysis or pulmonary adverse reactions (eg, transfusion-related acute lung injury [TRALI]).
Hizentra is derived from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
The most common adverse reactions (observed in ≥5% of study subjects) were local infusion-site reactions, as well as headache, diarrhea, fatigue, back pain, nausea, extremity pain, cough, upper respiratory tract infection, rash, pruritus, vomiting, upper abdominal pain, migraine, arthralgia, pain, fall, and nasopharyngitis.
The passive transfer of antibodies can interfere with response to live virus vaccines and lead to misinterpretation of serologic test results.
Indications for Hizentra
Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is indicated for:
- Treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years and older.
- Maintenance therapy in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment.
- Limitation of Use: Maintenance therapy in CIDP has been systematically studied for 6 months and for a further 12 months in a follow-up study. Continued maintenance beyond these periods should be individualized based on patient response and need for continued therapy.
For subcutaneous infusion only.
Please see full prescribing information for Hizentra including boxed warning.
Important Safety Information for Rhophylac
Rhophylac®, Rho(D) Immune Globulin Intravenous (Human), is a blood-derived injection given to women with an Rh-negative who might have an incompatible pregnancy—that is, who may be carrying an unborn child with Rh-positive blood. If a woman in such a pregnancy is not treated, the result could be “isoimmunization,” a condition in which the mother’s Rh-negative blood produces antibodies that could attack the unborn child’s Rh-positive blood cells, potentially creating serious health problems for the unborn child and any future children of the mother.
Rhophylac is given by physicians as routine protection against immunization, typically as administration during pregnancy, often with readministration within 72 hours following childbirth. It is also given in cases of obstetric complications, invasive procedures during pregnancies, incomplete pregnancies, and obstetric manipulative procedures in certain non-pregnant women. Rhophylac is also used in Rh-negative individuals who have received blood components containg Rh(D)-positive red blood cells. For suppression of Rh isoimmunization, Rhophylac can be administered intravenously or intramuscularly, but must not be given to newborn infant.
You should not receive Rhophylac if you have had a previous serious allergic reaction to Rhophylac or other human blood products. It should not be given if your blood has an insufficient quantity of a protein called IgA, has produced antibodies to IgA, or you have known hypersensititivy to IgA. Your physician will do a blood test to assess your situation regarding IgA.
Some women have experienced mild and temporary actions after receiving Rhophylac, such as fever; overall discomfort or uneasiness; headache; skin reactions (like hives or welts); and chills. If you received Rhophylac as a shot (intramuscularly), you could experience pain or tenderness at the injection site. Adverse reactions to Rhophylac typically do not last long. Discuss with your doctor any reaction or symptom you experience after administration of Rhophylac that concerns you.
Rhophylac is made from donated human blood. The risk of transmission of infections agents, including viruses, cannot be completely eliminated.
Immunoglobulin administration can transiently interfere with your response to live vaccines, such as measles, mumps and rubella. (Note that most influenza vaccines are not “live” vaccines.) Tell your doctor if you plan to receive a vaccine after receiving Rhophylac.
Please see full prescribing information for Rhophylac, which includes a boxed warning that does not apply to use of Rhophylac in pregnancy or in cases of incompatible transfusions.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.
Important Safety Information for Privigen
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
- Thrombosis may occur with immune globulin products, including Privigen. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
- Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products that contain sucrose. Privigen does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction or renal failure, administer Privigen 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 complete boxed warning.
Privigen is contraindicated in patients with history of anaphylactic or severe systemic reaction to human immune globulin, in patients with hyperprolinemia, and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
In patients at risk of developing acute renal failure, monitor urine output and renal function, including blood urea nitrogen and serum creatinine.
Hyperproteinemia, increased serum viscosity, or hyponatremia can occur with Privigen. Infrequently, aseptic meningitis syndrome (AMS) may occur—especially with high doses or rapid infusion.
Hemolysis, either intravascular or due to enhanced red blood cell sequestration, may occur. Risk factors include non-O blood group and high doses. Closely monitor patients for hemolysis and hemolytic anemia.
During and shortly following Privigen infusion, elevations of systolic and diastolic blood pressure (including cases of hypertensive urgency) have been observed. These elevations resolved or significantly improved within hours with oral anti-hypertensive therapy or observation alone. Check patients for a history of hypertension and monitor blood pressure during this period.
Consider relative risks and benefits before prescribing high-dose regimen for chronic ITP and CIDP in patients at increased risk of thrombosis, hemolysis, acute kidney injury or volume overload. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]).
Privigen is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
In clinical studies of patients with PI, the most common adverse reactions to Privigen, observed in >5% of subjects, were headache, fatigue, nausea, chills, vomiting, back pain, pain, elevated body temperature, abdominal pain, diarrhea, cough, stomach discomfort, chest pain, joint swelling/effusion, influenza-like illness, pharyngolaryngeal pain, urticaria, and dizziness. Serious adverse reactions were hypersensitivity, chills, fatigue, dizziness, and increased body temperature.
In clinical studies of patients being treated for chronic ITP, the most common adverse reactions, seen in >5% of subjects, were laboratory findings consistent with hemolysis, headache, elevated body temperature, anemia, nausea, and vomiting. A serious adverse reaction was aseptic meningitis syndrome.
In clinical studies of patients being treated for CIDP, the most common adverse reactions, observed in >5% of subjects, were headache, asthenia, hypertension, nausea, pain in extremity, hemolysis, influenza-like illness, leukopenia, and rash. Serious adverse reactions were hemolysis, exacerbation of CIDP, acute rash, increased diastolic blood pressure, hypersensitivity, pulmonary embolism, respiratory failure, and migraine.
Treatment with Privigen might interfere with a patient's response to live virus vaccines and could lead to misinterpretation of serologic testing. In patients over 65, do not exceed recommended dose and infuse at the minimum rate practicable.
Indications for Privigen
Privigen is indicated for the treatment of:
- Primary humoral immunodeficiency (PI)
- Chronic immune thrombocytopenic purpura (ITP) in patients age 15 years and older
- Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults
- Limitation of use: maintenance therapy in CIDP has not been studied for periods longer than 6 months. Individualize duration of treatment beyond 6 months based on patient response.
Please see full prescribing information for Privigen.
Important Safety Information for HAEGARDA
HAEGARDA®, C1 Esterase Inhibitor Subcutaneous (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older. HAEGARDA is for subcutaneous use after reconstitution only.
HAEGARDA is contraindicated in patients with a history of life-threatening hypersensitivity reactions, including anaphylaxis, to C1-INH preparations or their excipients.
Severe hypersensitivity reactions to HAEGARDA could occur. In such cases, discontinue administration and institute appropriate treatment. Epinephrine should be immediately available to treat hypersensitivity reactions.
At the recommended subcutaneous dose of HAEGARDA, no causal relationship to thromboembolic events (TEs) has been established. However, TEs have been reported with intravenous administration of C1-INH products, usually at high doses.
In clinical trials, adverse reactions observed in more than 4% of subjects treated with HAEGARDA were injection-site reactions, hypersensitivity, nasopharyngitis, and dizziness.
HAEGARDA is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
Please see full prescribing information for HAEGARDA.
Important Safety Information for BERINERT
BERINERT®, C1 Esterase Inhibitor (Human), is contraindicated in individuals with a history of life-threatening systemic reactions to C1 esterase inhibitor preparations (including anaphylaxis).
Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, chest tightness, wheezing, hypotension, and anaphylaxis). If hypersensitivity is suspected, immediately discontinue administration of BERINERT and initiate appropriate treatment. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reactions.
Serious arterial and venous thromboembolic (TE) events have been reported following administration of recommended doses of C1 Esterase Inhibitor (Human) products to patients with HAE. Risk factors may include presence of an indwelling venous catheter/access device; prior history of thrombosis; underlying atherosclerosis; use of oral contraceptives or certain androgens; morbid obesity; and immobility. Weigh benefits/risks before administering to patients with known risk factors for TE events and closely monitor such patients during and after BERINERT administration. TE events also have been reported with C1 Esterase Inhibitor (Human) products when used for unapproved indications at higher than recommended doses.
Appropriately trained patients may self-administer BERINERT upon recognition of an HAE attack. Advise patients to seek medical attention immediately following self-administration for laryngeal attacks, and to seek medical attention if progress of any attack makes them unable to properly prepare or administer dose of BERINERT.
BERINERT is derived from human plasma. The risk of transmission of infectious agents, including viruses and theoretically, the agents of Creutzfeldt-Jakob Disease (CJD) and its variant form (vCJD), cannot be completely eliminated.
The most serious adverse reaction reported in subjects who received BERINERT in clinical studies was an increase in severity of pain associated with HAE. Dysgeusia was the most common adverse reaction reported in over 4% of subjects and more frequently than in the placebo group.
BERINERT has not been evaluated in pregnant women or nursing mothers, and should be used only if clearly needed. In clinical trials, the half-life of BERINERT was shorter and clearance was faster in children than in adults; the clinical implication of this difference is not known.
Indications for BERINERT
BERINERT is a plasma-derived concentrate of C1 Esterase Inhibitor (Human), indicated for the treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients. The safety and efficacy of BERINERT for prophylactic therapy have not been established.
Please see full prescribing information for BERINERT, including the patient product information.
To report SUSPECTED ADVERSE REACTIONS, contact the CSL Behring Pharmacovigilance Department at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.