Qivigy Drug Information
Generic name: HUMAN IMMUNOGLOBULIN G
Human Immunoglobulin G [EPC]
Uses of Qivigy
(immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for treatment of adults with primary humoral immunodeficiency (PI).
Dosage & Administration of Qivigy
| 300 - 800 mg/kg every 3-4 weeks | For the 1st infusion |
|---|---|
| 300 - 800 mg/kg every 3-4 weeks | From the 2nd infusion |
Side Effects of Qivigy
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described in this section reflects exposure to QIVIGY in one clinical study. A total of 47 patients with PI received intravenous infusion of QIVIGY at a dose range of 266 to 826 mg/kg every 3 or 4 weeks for up to 12 months . A total of 643 infusions of QIVIGY were administered, 136 in the every 3-week schedule and 507 in the 4-week schedule.
During the study, 4 out of 47 (9%) patients received premedication. The most common product-related adverse events observed in ≥ 5% of clinical study patients with PI were headache, infusion-related reaction, Coombs direct test positive, fatigue, and nausea. Table 2 lists the most common adverse reactions reported in ≥5% of patients.
Table 2: Adverse Reactions Adverse reactions were defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period. Occurring in ≥ 5% of Patients Adverse Reaction By Patients n (%) By Infusions n (%) Headache 14 26 Fatigue 7 10 Nausea 6 6 (<1) Infusion-related Reaction 5 7 Coombs Direct Test Positive 5 8 Sinusitis 3 3 (<1) Dizziness 3 3 (<1) Diarrhea 3 4 (<1)
Postmarketing Experience
Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified and reported during the post-approval use of IGIV products: Respiratory: Apnea, Acute Respiratory Distress Syndrome (ARDS), Transfusion-Related Acute Lung Injury (TRALI), respiratory failure, hypoxemia, pulmonary edema, dyspnea, wheezing, cough, bronchospasm, pulmonary embolism. Cardiovascular: Cardiac arrest, thromboembolism, vascular collapse, hypotension, phlebitis, pallor, angina, tachycardia, bradycardia, palpitations, myocardial infarction, cyanosis.
Neurological: Coma, loss of consciousness, seizures, (acute) encephalopathy, tremor, aseptic meningitis syndrome, migraine, speech disorder, paresthesia, hypoesthesia, photophobia. Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis, eczema, erythematous rash, dermatitis, pruritus, alopecia, urticaria. Gastrointestinal: Hepatic dysfunction, abdominal pain, diarrhea.
Renal: Acute renal failure, osmotic nephropathy, renal pain. Hematologic: Pancytopenia, leukopenia, hemolysis. Musculoskeletal: Musculoskeletal pain, muscle spasm, arthralgia, myalgia, muscle stiffness.
General disorders and administration site conditions: Pyrexia, rigors, injection-site reactions, chills, flushing, lethargy, malaise, burning sensation. Psychiatric disorders: Confusion, anxiety, agitation, nervousness. Metabolic and nutritional: Fluid overload, (pseudo) hyponatremia.
Immune system disorders: Hypersensitivity (e.g. anaphylaxis, allergic reaction), angioedema. Investigations: Falsely elevated erythrocyte sedimentation rate, positive direct antiglobulin (Coombs') test, increased hepatic enzymes.
Warnings & Cautions for Qivigy
Hypersensitivity Severe hypersensitivity reactions, including anaphylaxis, may occur with
QIVIGY In case of hypersensitivity, discontinue QIVIGY infusion immediately and institute appropriate treatment. Medications such as epinephrine should be available for immediate treatment of acute hypersensitivity reactions. QIVIGY contains IgA (≤ 50 mg/L) . Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
QIVIGY is contraindicated in IgA deficient patients with antibodies against IgA and patients with a history of hypersensitivity reaction .
Thrombosis Thrombosis may occur following treatment with immune globulin products, including
QIVIGY. 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 may occur in the absence of known risk factors. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia, high triacylglycerols (triglycerides), or monoclonal gammopathies.
For patients at risk of thrombosis, administer QIVIGY at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis .
Renal Injury Renal injury including acute renal dysfunction, acute renal failure, acute
tubular necrosis, proximal tubular nephropathy, and, osmotic nephrosis may occur after treatment with immune globulin products including QIVIGY. Ensure that patients are not volume depleted prior to the initiation of the infusion of QIVIGY. For patients judged to be at risk for developing renal dysfunction because of pre-existing renal insufficiency or predisposition to acute renal failure (such as diabetes mellitus, hypovolemia, overweight, use of concomitant nephrotoxic drugs, or age over 65 years), administer QIVIGY at the minimum infusion rate practicable . The risk of renal dysfunction and acute renal failure is greater in products that contain sucrose, though may still occur in products without sucrose. QIVIGY does not contain sucrose. Conduct periodic monitoring of renal function and urine output in patients judged to be at increased risk of developing acute renal failure.
Assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before the initial infusion of QIVIGY and at appropriate intervals thereafter. If renal function deteriorates, consider discontinuing QIVIGY.
Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia Hyperproteinemia, hyperviscosity, and hyponatremia may occur
in patients receiving immune globulin treatment, including QIVIGY. It is critical to clinically distinguish true hyponatremia from a pseudohyponatremia that is associated with or causally related to hyperproteinemia with concomitant decreased calculated serum osmolality or elevated osmolar gap, because treatment aimed at decreasing serum free water in patients with pseudohyponatremia may lead to volume depletion, a further increase in serum viscosity and a possible predisposition to thromboembolic events.
Aseptic Meningitis Syndrome Aseptic meningitis syndrome (AMS) may occur in patients following
immune globulin treatment, including QIVIGY. The risk of AMS may be higher with high doses (2 g/kg) and/or rapid infusion of immune globulin products. AMS usually begins within several hours to two days following immune globulin treatment and is characterized by the following symptoms and signs: severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea and vomiting. Cerebrospinal fluid (CSF) studies frequently reveal pleocytosis up to several thousand cells per cubic millimeter, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL, but negative culture results.
Conduct a thorough neurological examination on patients exhibiting symptoms and signs of AMS, including CSF studies, to rule out other causes of meningitis. Discontinuation of immune globulin treatment has resulted in remission of AMS within several days without sequelae.
Hemolysis Hemolysis may occur after administration of immune globulin products, including
QIVIGY due to the presence of blood group antibodies that can act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immune globulin, causing a positive direct antiglobulin test and hemolysis. Delayed hemolytic anemia can develop after immune globulin treatment due to enhanced RBC sequestration, and acute hemolysis consistent with intravascular hemolysis has been reported. The risk factors for hemolysis include high doses (e.g., ≥ 2 g/kg) given either as a single administration or divided over several days, non-O blood group, and an underlying inflammatory disease condition.
Monitor patients for clinical signs and symptoms of hemolysis. Consider appropriate laboratory testing in higher risk patients, including measurement of hemoglobin or hematocrit prior to infusion and within approximately 36 hours and again 7 to 10 days post infusion. If clinical signs and symptoms of hemolysis or a significant drop in hemoglobin or hematocrit are observed after QIVIGY infusion, perform confirmatory laboratory testing.
Transfusion-related Acute Lung Injury Transfusion-Related Acute Lung Injury (TRALI) may occur in
patients following immune globulin treatment, including QIVIGY. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Symptoms typically appear within 1 to 6 hours after treatment. Monitor patients for pulmonary adverse reactions.
If TRALI is suspected, immediately stop QIVIGY infusion, and perform appropriate tests for the presence of anti-neutrophil antibodies and anti-human leukocyte antigen (HLA) antibodies in both the product and patient's serum. Manage patients using oxygen therapy with adequate ventilatory support as appropriate.
Transmissible Infectious Agents
There is risk of transmission of infectious disease or agents including viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and the Creutzfeldt-Jakob disease agent with QIVIGY administration because it is manufactured using human blood. The risk of infectious agent transmission is minimized by plasma donor screening, donation testing, and manufacturing steps proven to inactivate and remove bloodborne pathogens. Any infection suspected to have been transmitted by this product should be reported by the physician or other healthcare provider to Kedrion Biopharma Inc. at 1-855-3KDRION (1-855-353-7466).
Monitoring Laboratory Tests Assess renal function, including measurement of
BUN and serum creatinine, before the initial infusion of QIVIGY and at appropriate intervals thereafter. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia, markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis. If signs and/or symptoms of hemolysis are present after an infusion of QIVIGY, perform appropriate laboratory testing for confirmation.
If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil antibodies and anti-HLA antibodies in both the product and the patient's serum. 5.10 Interference with Laboratory Tests After the administration of immune globulin, the transitory rise of the various passively transferred antibodies in the patients' blood may result in misleading positive results in serological testing. Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies for example the direct or indirect antiglobulin test (Coombs test).
Drug Interactions with Qivigy
Effect of
QIVIGY on Live attenuated virus vaccines Immune globulin administration may transiently impair the efficacy of live attenuated virus vaccines such as measles, mumps, rubella, s and varicella because the continued presence of high levels of passively acquired antibody may interfere with an active antibody response. Inform the immunizing physician of recent therapy with QIVIGY so that appropriate measures may be taken.
Effect of
QIVIGY on Serological Testing Passive transmission of antibodies through immune globulin administration may interfere with some serological testing.
Effect of Loop diuretics on
QIVIGY The use of loop diuretics should be avoided. Concomitant use of loop diuretics with IGIV may contribute to an increased blood viscosity and subsequently increase the risk of thromboembolic events.
Pregnancy Safety for Qivigy
Pregnancy Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with QIVIGY. It is not known whether QIVIGY can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation.
QIVIGY should be given to pregnant women only if clearly needed. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 - 4% and 15 - 20%, respectively.
Pediatric Use of Qivigy
Pediatric Use The safety and effectiveness of QIVIGY have not been established in pediatric patients.
Contraindications for Qivigy
is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. QIVIGY is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity . Patients with history of anaphylactic or severe systemic reactions to human immune globulins. IgA deficient patients with antibodies against IgA and a history of hypersensitivity.
Overdosage Information for Qivigy
Overdosage of QIVIGY may lead to fluid overload and hyperviscosity, particularly in the elderly and in patients with renal impairment.
Clinical Studies of Qivigy
The efficacy of QIVIGY was evaluated in an open-label, prospective clinical study in adult patients with primary humoral immunodeficiency (NCT03961009). A total of 47 patients received intravenous infusion of QIVIGY at the dose of 266 to 826 mg/kg every 3 or 4 weeks for 12 months. Thirty-nine and 8 patients were administered QIVIGY on a 4-week or a 3-week infusion cycle, respectively. The population characteristics were as follows: The median age was 56 years (range 20 to 70 years), 30 patients (64%) were female, 45 patients (96%) were White, and 2 patients (4%) were of "other" race.
The primary efficacy outcome was the incidence rate of acute serious bacterial infections (SBIs; bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, and osteomyelitis/septic arthritis). Secondary efficacy outcomes included the incidence rate of infections other than acute SBIs, patients hospitalized due to infection, number and duration of antibiotic treatment for any kind of infection, and missed work/school/other major activities due to infections. Table 5 summarizes the efficacy results. Table 5: Summary of QIVIGY Efficacy Results (N=47) Efficacy Outcome Result Annualized rate of acute SBIs 0 acute SBIs/person-year Annualized rate of other infections (not including acute SBIs) 2.1 infections per patient year Patients hospitalized due to infection 0 Antibiotics Number of antibiotics courses 113 Median duration of antibiotic use (min, max) 10 days Missed work/school/other major activities due to infections Number of patients 9 Median (min, max) 6 days
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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