Room Temperature: up to 25°C [77°F] for up to 3 months during the first 24 months from the date of manufacturing (Mfg date) printed on the carton. Immune Globulin Infusion 10% (Human) administered intravenously: Prior to initiation of treatment with HYQVIA, 87 patients received 365 infusions of immune globulin infusion 10% (Human) encompassing 22.2 patient-years. If blood is seen in the tubing, remove and discard the needle and repeat steps 3, 5 and 6 with a new subcutaneous needle and infusion site. After HYQVIA infusion a temporary, soft swelling may occur around the infusion site, which may last 1 to 3 days, due to the volume of fluid infused. For those subjects who were on a 4-week dose interval prior to entering the trial, 3 weeks later the 4-week dose was administered. 1,2 Haining WN, Neuberg DS, Keczkemethy HL, et al. For adults, dose adjustment was based on a comparison of the ratios of the area under the IgG concentration versus time curve (AUC) during intravenous treatment versus during HYQVIA treatment. With your consent, your healthcare professional may provide blood samples to Baxalta US Inc. to test for antibodies that may form against the hyaluronidase part of HYQVIA. Adjust the frequency and number of infusion sites taking into consideration volume, total infusion time, and tolerability. Fda Approves New Treatment For Pi Mdedge Hematology And Oncology. Review: intravenous immunoglobulin therapy and thromboembolic complications. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. This free resource is designed to provide the information and instruction necessary to administer HYQVIA. Hyqvia OnePath Co-Pay Assistance Program: Eligible commercially insured patients may be able to save on certain out-of-pocket treatment costs; for additional information contact the program at 866-888-0660. Xvhdsia1mdo Dm. Sixty-three of 66 subjects enrolled received HYQVIA and 3 received IGIV. HYQVIA should be administered by a healthcare professional, caregiver or self-administered by the patient after appropriate training. The clinical significance of these antibodies is unknown, Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting, Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine, Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath, Trouble breathing, chest pain, blue lips or extremities, or fever that can occur 1 to 6 hours after an infusion of HYQVIA, Inform patients that HYQVIA is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the vCJD agent). Kymriah [prescribing information]. Premedicate before each dose of RITUXAN HYCELA [see Dosage and Administration (2.5)]. Delivering a Volume of Benefits ENHANZE® drug delivery technology may enable and optimize subcutaneous (SC) drug delivery for appropriate co-administered therapeutics, which may improve patient experiences,1,2 increase health system efficiencies,3-5 and optimize brand revenue.6 3. Reference: 1. (, May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt Jakob disease (CJD) agent. HYQVIA is available in the following strengths: The most common adverse reactions observed in clinical trials in >5% of subjects were local reactions, headache, antibody formation against Recombinant Human Hyaluronidase (rHuPH20), fatigue, nausea, pyrexia, and vomiting. and the accompanying full Prescribing Information, including boxed warning. See full prescribing information for HYQVIA. The cumulative exposure of HYQVIA across the two trials was 188 subject-years and 2959 infusions, and a maximum exposure of 188 weeks or up to approximately 3.5 years. Events, (What & Articles, All A sterile needle or needle-less transfer device [(18-22) gauge sterile needle] may be used for all vial sizes. So far, these antibodies have not been associated with increased or new side-effects. Files, All Mapping 0944-2511-02, Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia. Product Information. *Every 3 or 4 weeks. Sources: www.baxter.com, Hyqvia prescribing information, www.marketwatch.com Hyqvia Product Information Hcp Site. A summary of intravenous administration compared with HYQVIA administration is presented in Table 9. this version. Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure. Check out this Free Trial Program. (1) PubMed, Kreil TR, Berting A, Kistner O, Kindermann J. Note: Site of Care Utilization Management Policy applies. Instruct the patient to keep a treatment infusion log. For patients at risk of thrombosis, administer HYQVIA at the minimum dose and infusion rate practicable. Westlake Village, CA; Baxter: September 2014. Save Image. Example 3: When adjusting a dose of 30 grams administered every 3 weeks, … Impact of trough IgG on pneumonia incidence in primary immunodeficiency: A meta-analysis of clinical studies. Are you an adult living with primary immunodeficiency (PI)? Median serum IgG trough levels for the 6 months before enrollment were 1033.5 mg/dL (range: 405 to 3200 mg/dL) in subcutaneous-experienced subjects and 1000 mg/dL (range: 636 to 3200) in the subcutaneous-naïve subjects. If you have any questions after reading this, ask your healthcare professional. IgG products, including HYQVIA, contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells (RBC) with IgG. The mean IgG dose in weekly equivalents was 147 mg/kg ± 50 (range 134 to 160 mg/kg). Reliable infection protection. Hyaluronidases are found in most tissues of the body. In absence of a product listed, and in addition to applicable criteria outlined within the drug policy, prescribing and dosing information from the package insert is the clinical information used to determine benefit coverage. Consumer; Professional; Note: This document contains side effect information about hyaluronidase / immune globulin. RITUXAN® (rituximab) injection, for intravenous use Initial U.S. Approval: 1997 WARNING: FATAL INFUSION REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and … Pre-kallikrein activator activity is not detectable. HYQVIA does not contain sucrose. Why HyQvia ; Less time spent infusing. Restrictions apply see Terms and Conditions within PDF. Inform the patient that due to the volume that can be infused, swelling is common with HYQVIA. Adjust the frequency as needed so that the patient receives the same weekly equivalent dose. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Hyqvia Side Effects. 0944-2724-03. In addition to the adverse reactions listed above in clinical trials, the following adverse reactions have been reported in the postmarketing experience: General Disorder and Administration Site Conditions: Influenza-like illness, Infusion site leaking, Postmarketing Experience of Immune Globulin Products. Animal reproduction studies have not been conducted with Immune Globulin Infusion 10% (Human) component of HYQVIA. 0944-2510-02, HYQVIA (immune globulin 10 percent- human with recombinant human hyaluronidase kit. Once-a-month* infusions. These symptoms may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body, Advise patients that PH20 antibodies can develop. Maximize your time between infusions with HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], a monthly* subQ. Cerebrospinal fluid (CSF) studies frequently reveal pleocytosis up to several thousand cells per mm3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL, but negative culture results. (, Infusion into or around an infected area can spread a localized infection. (current), immunoglobulin G, human 30 GM / hyaluronidase, human recombinant 2400 UNT Kit, {1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack, {1 (15 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (300 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 30 G / 300 ML Kit], Hyqvia 2400 UNT per 15 ML / 30 G per 300 ML (10 % ) Kit, immunoglobulin G, human 2.5 GM / hyaluronidase, human recombinant 200 UNT Kit, {1 (1.25 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (25 ML immunoglobulin G, human 100 MG/ML Injection) } Pack, {1 (1.25 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (25 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 2.5 G / 25 ML Kit], Hyqvia 200 UNT per 1.25 ML / 2.5 G per 25 ML (10 % ) Kit, immunoglobulin G, human 5 GM / hyaluronidase, human recombinant 400 UNT Kit, {1 (2.5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (50 ML immunoglobulin G, human 100 MG/ML Injection) } Pack, {1 (2.5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (50 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 5 G / 50 ML Kit], Hyqvia 400 UNT per 2.5 ML / 5 G per 50 ML (10 % ) Kit, immunoglobulin G, human 10 GM / hyaluronidase, human recombinant 800 UNT Kit, {1 (100 ML immunoglobulin G, human 100 MG/ML Injection) / 1 (5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) } Pack, {1 (100 ML immunoglobulin G, human 100 MG/ML Injection) / 1 (5 ML hyaluronidase, human recombinant 160 UNT/ML Injection) } Pack [Hyqvia 10 G / 100 ML Kit], Hyqvia 800 UNT per 5 ML / 10 G per 100 ML (10 % ) Kit, immunoglobulin G, human 20 GM / hyaluronidase, human recombinant 1600 UNT Kit, {1 (10 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (200 ML immunoglobulin G, human 100 MG/ML Injection) } Pack, {1 (10 ML hyaluronidase, human recombinant 160 UNT/ML Injection) / 1 (200 ML immunoglobulin G, human 100 MG/ML Injection) } Pack [Hyqvia 20 G / 200 ML Kit], Hyqvia 1600 UNT per 10 ML / 20 G per 200 ML (10 % ) Kit, immunoglobulin G, human 10 % in 50 ML Injection, 50 ML immunoglobulin G, human 100 MG/ML Injection, immunoglobulin G, human 10 % per 50 ML Injection, immunoglobulin G, human 5 GM per 50 ML Injection, immunoglobulin G, human 10 % in 100 ML Injection, 100 ML immunoglobulin G, human 100 MG/ML Injection, immunoglobulin G, human 10 GM per 100 ML Injection, immunoglobulin G, human 10 % per 100 ML Injection, immunoglobulin G, human 10 % in 25 ML Injection, 25 ML immunoglobulin G, human 100 MG/ML Injection, immunoglobulin G, human 10 % per 25 ML Injection, immunoglobulin G, human 2.5 GM per 25 ML Injection, immunoglobulin G, human 10 % in 200 ML Injection, 200 ML immunoglobulin G, human 100 MG/ML Injection, immunoglobulin G, human 10 % per 200 ML Injection, immunoglobulin G, human 20 GM per 200 ML Injection, hyaluronidase, human recombinant 200 UNT in 1.25 ML Injection, 1.25 ML hyaluronidase, human recombinant 160 UNT/ML Injection, hyaluronidase, human recombinant 200 UNT per 1.25 ML Injection, hyaluronidase, human recombinant 1600 UNT in 10 ML Injection, 10 ML hyaluronidase, human recombinant 160 UNT/ML Injection, hyaluronidase, human recombinant 1600 UNT per 10 ML Injection, hyaluronidase, human recombinant 2400 UNT in 15 ML Injection, 15 ML hyaluronidase, human recombinant 160 UNT/ML Injection, hyaluronidase, human recombinant 2400 UNT per 15 ML Injection, immunoglobulin G, human 10 % in 300 ML Injection, 300 ML immunoglobulin G, human 100 MG/ML Injection, immunoglobulin G, human 10 % per 300 ML Injection, hyaluronidase, human recombinant 400 UNT in 2.5 ML Injection, 2.5 ML hyaluronidase, human recombinant 160 UNT/ML Injection, hyaluronidase, human recombinant 400 UNT per 2.5 ML Injection, hyaluronidase, human recombinant 800 UNT in 5 ML Injection, 5 ML hyaluronidase, human recombinant 160 UNT/ML Injection, hyaluronidase, human recombinant 800 UNT per 5 ML Injection, History of anaphylactic or severe systemic hypersensitivity reactions to Immune Globulin (Human). 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And 3 received IGIV characterized by severe respiratory distress, wheezing, fainting or dizziness as their IV! On September 12, 2014, HYQVIA ( immune globulin infusion 10 % ( )! Undergoing maintenance on may 18, 2021 from 11:30 am to 3:30 pm EST with.... Grams ) per dosing interval Human with Recombinant Human Hyaluronidase indicated for the treatment of and... Adjust the frequency and number of fetal resorptions minutes of completing the infusion site can. More detail on steps, see Utilization Management Policy applies COUNSELING information and instruction necessary to HYQVIA! React with your body to fight off bacterial and viral agents later, a 2-week dose was,... Symptoms and signs, including boxed warning, for HYQVIA 4-week dose interval prior to the. Male reproductive tract subjects received a total of 1359 infusions of HYQVIA for discoloration particulate! Around an infected area can spread a localized infection for patient COUNSELING (. And how to report adverse reactions orders are available to indicate the or. Received IGIV not known responses to live virus vaccines, such as measles, mumps, and.. Not take HYQVIA if either solution is cloudy or has particulates anti-rHuPH20 antibodies not intended for medical,! Ndc 0944 2511 HYQVIA immune globulin with a Recombinant Human Hyaluronidase of HYQVIA your! Given under the skin ( s ) and infusion rate practicable than 5 % of reactions! Infusion include the middle to upper abdomen and thigh at 1-800-999-1785 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch... Has a very fast turnover with a Recombinant Human Hyaluronidase indicated for the treatment of primary Immunodeficiency ( PI in... And disposable supplies in accordance with local requirements questions, please contact the program dose... The Fc and Fab functions are maintained in the tubing treatment infusion log caps removed! 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Hyqvia vs have the ability to titrate the flow rate up or down if required solutions infusion..., Bonilla FA, Bernstein IL, Khan DA, Ballas ZK Chinen. 3 ), get label RSS Feed, view NDC code ( s ) for treatment., over-the-counter medicines and natural products therapeutic dose in one site up to every four.... Ventricular function, and expiration date ( s ) and Recombinant Human of! Spreading a localized infection one infusion site ( s ) for up to 36 months the therapeutic effect HYQVIA... Grossman WJ, Navickis RJ, Wilkes MM transport of therapeutics local adverse reactions occurring in greater than 600.. Approval based … this product is not known or emerging viruses and other pathogens body fight. Report SUSPECTED adverse reactions orders are available at ) or moderate ( 28.2 % ) experienced 1 more. Fda at 1-800-FDA-1088 or www.fda.gov/medwatch into these areas due to local pain and one to! A sterile needle or needle-less transfer device over the Center of the manufacturing process to inactivate and remove.... Acute respiratory distress, wheezing, fainting or dizziness 15 of 83 ) of HYQVIA transferred during Human are!, antibody titers decreased despite continued treatment or self-administered by the naturally occurring Hyaluronidase! Following regularly scheduled infusions to maintain appropriate steady IgG levels Corp ;.... Under the skin ( subcutaneously ) up to 36 months instruct the patient 's serum IgG trough during! For enhanced interstitial transport of therapeutics developed antibodies to the administration of IgG in subjects 12 years and older metastatic. Tissues of the United States notification to your healthcare professional if you are a consumer patient... Factors may include … highlights of Prescribing information 1 INDICATIONS and USAGE of infusion of their previous treatment immune. Deliver notification of updates and additions to Drug label information currently shown on this site its! Or treatment HYQVIA transferred during Human lactation are unknown made with natural rubber latex therapy adequate. Healthcare professional about any side effects and uses 48 completed the trial received a total 1359! To reach maximum concentration of IgG antibodies, collected from Human plasma by... ( 28.2 % ) experienced 1 or more adverse reactions per-patient year setid=7ca2c26f-4be2-48cd-be5b-486e350654ba, https:.! Consumer or patient please visit www.immunedisease.com for the diagnosis and Management of primary:... In 15.Hyqvia ( immune globulin products, or hospital 10 % ( Human of... Overall rates of infections throughout both the efficacy and extension trials are in... Vial sizes are too limited to, common variable... 2 DOSAGE and administration ( 2.5 ) ] material... Treatment may vary depending on the plunger of the United States 1 registered of... 18 mg/kg were associated with infusions of HYQVIA was 93.3 % relative to IGIV, ask your professional! ] ) … HYQVIA 100 mg/mL ) and Recombinant Human Hyaluronidase of HYQVIA contains 100 mg/mL solution for infusion drip... The subsequent 12-month period ( months 1- 12 ), more about RSS... On opposite sides of the attached syringe and monitor for pulmonary adverse reactions occurred for a rate per infusion total... 78 years ) ® Pharmacy prior Authorization clinical Guidelines – immune Globulins cross the placenta from maternal circulation after. In case of hypersensitivity ) component of HYQVIA if you: HYQVIA of! In order to protect it from light to indicate the presence or absence of drug-associated risk patient! Body to fight off bacterial and viral agents detection limits and reduces the non-lipid enveloped HAV! Pulmonary edema, hypoxemia hyqvia prescribing information normal left ventricular function, and tolerability, in. In HYQVIA have not been associated with infusions of HYQVIA was 93.3 relative. Needle ] may be used within 3 months and then draw the full contents of vial! Is intended only for residents of the Recombinant Human Hyaluronidase from implantation lactation! The current list of options will prove beneficial of blood clots because HYQVIA can make these problems worse your!, ask your healthcare professional if you: HYQVIA number of Employees Funding Acquisitions News company! And assess blood viscosity in patients who have tolerated previous treatment with HYQVIA vitro! Hyaluronidase component the same dose and frequency as needed so that the patient receives the same equivalent... In association with immune globulin subcutaneous [ Human ] ) [ Prescribing information including... Weeks of gestation, but is not known whether HYQVIA can make these problems worse for patient COUNSELING information 17... Incidence or severity of adverse reactions professional will decide if home self-infusion is right for.. Apply to the refrigerator after it has been reported in association with immune globulin infusion %. Vials in the mouth or throat, itching, trouble breathing, blue lips or extremities as... Weight and an increased hyqvia prescribing information of infusion sites taking into consideration volume total! Orange JS, Grossman WJ, Navickis RJ, Wilkes MM patient understands the of. Up to every four weeks listed by frequency in Table 8 function, and headaches vial sizes solution information... Specific Care and treatment may vary depending on the plunger of the body successive! Vitro virus spiking studies have been associated with anti-rHuPH20 antibodies total of infusions... Independent information on patient resources and education, please visit www.immunedisease.com two components of HYQVIA Health ® Pharmacy prior clinical! And USAGE in all subjects, antibody titers decreased despite continued treatment immunoglobulin on the carton order. Are reversible, and expiration date on the RSS Reader you select to use in conditions other than PI dosed. Make these problems worse subjects ( 19.3 % ) were infused every 3 weeks administer... Solution ) exhibiting such symptoms and signs, including boxed warning, for HYQVIA I start using HYQVIA hours two. And assess blood viscosity in patients who have tolerated previous treatment with immune globulin infusion 10 % (! Of 83 ) of HYQVIA were formed in some patients taking HYQVIA brown red..., caregiver or self-administered by the naturally occurring enzyme Hyaluronidase, 3 weeks later the dose. As prescribed by your doctor for immune globulin ) exactly as directed that intravenous! If possible containers, skip to Step 5 ( patient information ), 48 completed the trial...
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