Immunoglobulin G (Cutaquig)

Trade Name : Cutaquig

Pfizer Laboratories Div Pfizer Inc

SOLUTION, PLASMA DERIVATIVE

Strength 165 mg/mL

HUMAN IMMUNOGLOBULIN G Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Immunoglobulin G (Cutaquig) which is also known as Cutaquig and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 165 mg/mL per ml. Read more

Immunoglobulin G (Cutaquig) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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nCUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp)
n16.5% solution

nWARNING: THROMBOSIS
nWARNING: THROMBOSIS
nSee full prescribing information for complete boxed warning
nThrombosis may occur with immune globulin products, including CUTAQUIG. 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. n
nFor patients at risk of thrombosis, administer CUTAQUIG 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 of hyperviscosity.

nCUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion (IGSC), indicated as replacement therapy for primary humoral immunodeficiency (PI) in adults. This includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
nCUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp) is a 16.5% immune globulin solution for subcutaneous infusion indicated for treatment of primary humoral immunodeficiency (PI) in adults. (n)

nFor subcutaneous use only
nFor subcutaneous use only
nBefore switching to CUTAQUIG, obtain the patientu2019s serum IgG trough level to guide subsequent dose adjustments.
nDose
nSwitching from IGIV to CUTAQUIG: calculate the dosing by using a dose conversion factor (1.40); Switching from other IGSC: dosing should be the same as for previous IGSC.
nWeekly
nAdjust dosing according to patientu2019s pharmacokinetics and clinical response. (n)
nAdministration
nAdminister at regular weekly interval.
n* As tolerated
nInfusion sites: up to 6 infusion sites simultaneously, with at least 2 inches between sites. Rotate sites for each administration. (n)

nCUTAQUIG is a solution containing 16.5% IgG (165 mg/mL).
nCUTAQUIG is a solution containing 16.5% IgG (165 mg/mL) for subcutaneous infusion. (n)

nCUTAQUIG is contraindicated:
nHistory of anaphylactic or severe systemic reaction to human immune globulin or other components of CUTAQUIG (Polysorbate 80). (n)
nIgA deficient patients with antibodies against IgA and a history of hypersensitivity. (n)

nHypersensitivity and anaphylactic reactions can occur with CUTAQUIG. IgA-deficient patients with anti-IgA antibodies are at greater risk of severe reactions. (n)
nThrombosis may occur with CUTAQUIG. (n)
nFalsely elevated blood glucose readings may occur during and after the infusion of CUTAQUIG with some glucometer and test strip systems. (n)
nAseptic meningitis syndrome (AMS) may occur within 2 days of treatment. (n)
nMonitor patients for signs and symptoms of renal dysfunction. Monitor blood urea nitrogen, serum creatinine, and urine output in patients at risk of acute renal failure. (n)
nMonitor for clinical signs and symptoms of hemolysis, especially in patients with pre-existing anemia and/or cardiovascular or pulmonary compromise. (n)
nMonitor for pulmonary adverse reactions (transfusion-related acute lung injury, TRALI). (n)
nCUTAQUIG is made from human plasma and 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. (n)

nThe most common adverse reactions (AR) observed in u2265 5% of study subjects were local infusion site adverse reactions (such as redness, swelling, and itching), and, as systemic adverse reactions, headache, fever, diarrhea, dermatitis, asthma, and skin abrasion.
nThe most common adverse reactions (u2265 5% of study subjects) were local infusion site reactions (such as redness, swelling, itching), headache, fever, diarrhea, dermatitis, asthma, and skin abrasion. (n)
nTo report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.n

nThe passive transfer of antibodies may transiently interfere with the immune response to live virus vaccines, such as measles, mumps, varicella and rubella (n) and may lead to misinterpretation of the results of serological testing. (n)n
n_________________________________________________________________________________________________________________________

No data

nCUTAQUIG (Immune Globulin Subcutaneous (Human) - hipp), is a solvent/detergent (S/D)-treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. CUTAQUIG is a solution for injection to be administered subcutaneously.
nThis preparation contains approximately 165 mg of protein per mL (16.5%), of which not less than 96% is normal human immunoglobulin G. CUTAQUIG contains not more than 3% aggregates, not less than 94% monomers and dimers, and not more than 3% fragments. On average, the product contains u2264u00a00.6u00a0mg of IgA /mL.
nThe sodium content of the final solution is not more than 30 mmol/L and the pH is between 5.0 and 5.5. The osmolality is 310 - 380 mOsmol/kg.
nThe manufacturing process for CUTAQUIG isolates IgG without additional chemical or enzymatic modification, and the Fc portion is maintained intact. CUTAQUIG contains the IgG antibody activities present in the donor population. IgG subclasses are fully represented with the following approximate percents of total IgG: IgG1 is 70%, IgG2 is 25%, IgG3 is 3% and IgG4 is 2%.
nCUTAQUIG contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of opsonization and neutralization of microbes and toxins. It contains maltose (79 mg/mL), but no preservatives or sucrose.
nAll units of human plasma used in the manufacture of CUTAQUIG are provided by FDA-approved blood and plasma establishments, and are tested by FDA-licensed serological tests for HBsAg, antibodies to HCV and HIV and Nucleic Acid Test (NAT) for HCV and HIV-1 and found to be non-reactive (negative).
nThe product is manufactured by the cold ethanol fractionation process followed by ultrafiltration and chromatography. The manufacturing process includes treatment with an organic S/D mixture composed of tri-n-butyl phosphate (TNBP) and Octoxynol. The CUTAQUIG manufacturing process shows significant viral reduction in in vitro studies (n). These reductions are achieved through a combination of process steps including cold ethanol fractionation, S/D treatment and pH 4 treatment.
nTable 5 Pathogen Reduction During CUTAQUIG Manufacturing
n* Not calculated for global LRF
nHIV-1: Human Immunodeficiency Virus - 1
nPRV: Pseudorabies Virus, model virus for e.g. Hepatitis B Virus (HBV)
nSBV: Sindbis Virus model virus for Hepatitis C Virus (HCV)
nMEV: Mouse Encephalomyelitis Virus, model virus for Human Parvovirus B19
nPPV: Porcine Parvovirus, model virus for Hepatitis A Virus (HAV)
nn.a.: not applicable

No data

No data

nThe study was a prospective, open-label, non-controlled, single-arm, multicenter study to evaluate the pharmacokinetics (PK), efficacy, tolerability and safety of subcutaneous human immunoglobulin (CUTAQUIG) in subjects with primary humoral immunodeficiency (PI).
nThe study was conducted in 61 subjects (38 adult and 23 pediatric subjects < 16 years of age) who received weekly SC infusions with CUTAQUIG during a 12-week wash-in/wash-out period followed by a 12-month efficacy period during which efficacy, pharmacokinetics, safety, tolerability, and quality of life (QoL) parameters of CUTAQUIG were evaluated. At the time of data analysis, 47 subjects (35 adults; 12 pediatric subjects) had completed the study, 8 pediatric subjects were continuing in the study, and 6 subjects (3 adults; 3 pediatric subjects) had discontinued the study prematurely at the time of data analysis.
nDuring the efficacy period the mean weekly dose was 175 mg/kg BW, with individual doses ranging from 60 to 390 mg/kg BW. The median duration of infusion per week was 1.5 hours.
nAll enrolled subjects (n=61) were included in the Safety Analysis Set and the Full Analysis Set (FAS). Four subjects were excluded from the Per-Protocol (PP) Set because they terminated early before the start of the primary treatment period.
nOverall, 33 female subjects and 28 male subjects participated in this study. The youngest subject enrolled in the study was 2 years old and the oldest was 73 years old. The mean age in the adult group (16u201375 yrs) was 46.6 years. Reported race was white for all but one subject, and all subjects were of not Hispanic/Latino ethnicity.
nThe main objective of the study was to assess the efficacy of CUTAQUIG in preventing serious bacterial infections (SBI defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess). This endpoint was considered successful if the upper bound of the 99% confidence interval for the rate of SBIs was < 1.0 per subject-year of follow up. This criterion was met, as no SBIs were reported at any time during the study.
nOther endpoints of the study included, but were not limited to: the number of episodes of any other infections, along with type and severity of infection and time to resolution; number of days of use and annual rate of antibiotics; absence and number of days of absence from work/school/ kindergarten/day care; and hospitalisations due to infections and number of days and annual rate of hospitalisation.
nEfficacy results are summarized in n.
nTable 7 Summary of efficacy results (FAS set).
n* Defined as bacterial pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, and visceral abscess.

nCUTAQUIG is supplied in 1 g, 1.65 g, 2 g, 3.3 g, 4 g or 8 g single-use vials.

nAdvise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
nInform patients to immediately report the following signs and symptoms to their healthcare provider:
nInform patients to be tested periodically to make sure they have the appropriate levels of IgG in their blood. These tests may result in adjustments to the CUTAQUIG dose.
nInform patients/caregivers that because CUTAQUIG is made from human blood, it 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 [see n (n), n (n)].
nInform patients that CUTAQUIG may interfere with the response to live virus vaccines (e.g., measles, mumps, rubella, and varicella) and to notify their immunizing physician of recent therapy with CUTAQUIG [see n (n)].
Arrayn- nHome treatment/Self administration
nManufactured by:
nOctapharma Pharmazeutika Produktionsges.m.b.H.
nOberlaaer Strasse 235
n1100 Vienna, Austria
nU.S. License No. 1646
nDistributed by:
nPfizer Labs
nDivision of Pfizer Inc.
nNY, NY 10017

nPatient Information
nCUTAQUIG
n(kew' ta kwig)
nImmune Globulin Subcutaneous (Human) - hipp, 16.5% solution
nInformation for Patients
nThe following summarizes important information about CUTAQUIG. Please read it carefully before using CUTAQUIG and each time you get a refill, as there may be new information. This Patient Information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions after reading this, ask your healthcare provider.
nWhat is CUTAQUIG?
nCUTAQUIG is a ready-to-use liquid solution of Immunoglobulin G (IgG), also called antibodies, which protect the body against infection. CUTAQUIG is used to treat patients with primary humoral immunodeficiency (PI).
nThere are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. Regular administration of CUTAQUIG will help your body to fight bacteria and viruses that cause infections. CUTAQUIG is made from human plasma that is donated by healthy people. CUTAQUIG contains antibodies collected from these healthy people; these antibodies replace the missing antibodies in PI patients.
nWho should NOT use CUTAQUIG?
nDo not use CUTAQUIG if you have ever had a severe allergic reaction to immune globulin or other blood products.
nTell your healthcare provider if you:
nWhat should I tell my healthcare provider before using CUTAQUIG?
nTalk to your healthcare provider about any medical conditions that you have or have had.
nTell your healthcare provider that you are taking CUTAQUIG before you get vaccination as vaccines may not work while you are taking CUTAQUIG.
nTell your healthcare provider about all of the prescription and non-prescription medicines you take, including over-the-counter medicines, dietary supplements, or herbal medicines.
nTell your healthcare provider if you are pregnant or plan to get pregnant, or if you are nursing because CUTAQUIG might not be right for you.
nTell your healthcare provider if you have diabetes. If you need to do glucose testing, your healthcare provider may tell you to use a different way to monitor your blood sugar levels on the day that you receive a CUTAQUIG infusion. Some types of blood glucose testing systems (so called glucometers) falsely interpret the maltose contained in CUTAQUIG as glucose. If you are uncertain ask your healthcare provider which glucose testing system you can use while using CUTAQUIG.
nHow should I use CUTAQUIG?
nCUTAQUIG is given under the skin (subcutaneously). This type of infusion can be given at home by yourself or by your caretaker after appropriate training. Administration of CUTAQUIG should be done at regular weekly intervals. A detailed description for giving CUTAQUIG under the skin is given in the Instructions for Use at the end of this package insert. Only use CUTAQUIG by yourself after you have been instructed by your healthcare provider.
nWhat are the possible or reasonably likely side effects of CUTAQUIG?
nThe most common side effects of CUTAQUIG are:
nCall your healthcare provider or emergency department immediately if you have any of the following symptoms: difficulty breathing, chest tightness, itching, swelling of the face, rash, hives or dizziness. These could be signs of a serious allergic reaction.
nTell your healthcare provider immediately if you have any of the following symptoms. They could be signs of a serious drug reaction:
nThese are not all of the possible side effects from CUTAQUIG. Ask your healthcare provider for more information. You are encouraged to report side effects to Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088.
nTalk to your healthcare provider about any side effect that bothers you or that does not go away. You can ask your healthcare provider for more information on possible side effects.
nWhenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help if you have a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine. If prescribed epinephrine for severe allergic reactions, make sure you receive adequate training from a healthcare provider for its proper use.
nHow should I store CUTAQUIG?
nKeep CUTAQUIG in the outer carton to protect it from exposure to light.
nDo not freeze CUTAQUIG.
nYou can store CUTAQUIG at 36u00b0F- 46u00b0F (+2u00b0C to +8u00b0C) for up to 24 months from the date of manufacture. Within its shelf-life, the product may be stored at room temperature up to 77u00b0F (up to +25u00b0C) for up to 6 months without being refrigerated again during this period, and must be discarded if not used after this.
nDo not use CUTAQUIG after the expiration date printed on the vial.
nDispose all materials, including any unused CUTAQUIG, in an appropriate container.
nWhat else should I know about CUTAQUIG?
nDo not use CUTAQUIG for a medical condition for which it was not prescribed. Do not share CUTAQUIG with other people, even if they have the same diagnosis and symptoms that you have.
nResources at Octapharma available to patients
nFor more product information on CUTAQUIG, please visit www.cutaquig.com.
nFor more information on patient assistance programs that are available to you, please contact the Octapharma Patient Support Center at 1-800-554-4440.
nManufactured by
nOctapharma Pharmazeutika Produktionsges.m.b.H.
nOberlaaer Strasse 235
n1100 Vienna, Austria
nU.S. License No. 1646
nDistributed by
nPfizer Labs
nDivision of Pfizer Inc.
nNY, NY 10017
ncutaquign is a registered trademark of Octapharma.
nInstructions for Use
nCUTAQUIG
nImmune Globulin Subcutaneous (Human) - hipp, 16.5% solution
nDetailed patient handling instructions for administration of CUTAQUIG
nCUTAQUIG is for subcutaneous use only.
nUse CUTAQUIG only after you have been properly instructed and trained by your healthcare provider.
nFollow the administration guidance below step by step and use aseptic/sterile technique when administrating CUTAQUIG. Use gloves if you have been told to do so when preparing the infusion.
n8. Starting the infusion
n- Start the infusion. Follow infusion pump manufactureru2019s instructions.
n9. Recording the infusion
n- On each vial of CUTAQUIG, you will find a peel-off portion of the label with the batch number details. Stick this label in your patientu2019s treatment diary or infusion log book. Record details of the dose, date, time, infusion site location and any infections, side effects or other comments in connection with this infusion.
n10. After infusion is complete
n- Gently remove the dressing and the needle(s) and immediately place into the sharps bin.
n- Press a small piece of gauze on the needle site and apply a dressing.
n- Discard all used disposable supplies as well as any unused product and the empty vial(s) as recommended by your healthcare provider and according to local requirements.
n- Tidy up and securely store all the reusable equipment (e.g., pump) until the next infusion.
nIf you encounter any problems or experience side effects during or after the infusion, contact your healthcare provider. When doing so, keep your treatment diary or log book with you to be able to give all necessary information.
nYou can also report side effects to the FDA at 1-800-FDA-1088 or online under www.fda.gov/medwatch.
nFor more product information on CUTAQUIG, please visit www.cutaquig.com
nManufactured by
nOctapharma Pharmazeutika Produktionsges.m.b.H.
nOberlaaer Strasse 235
n1100 Vienna, Austria
nU.S. License No. 1646
nDistributed by
nPfizer Labs
nDivision of Pfizer Inc.
nNY, NY 10017
ncutaquign is a registered trademark of Octapharma.
nIssued 11 2019.

nImmune Globulin Subcutaneous (Human) - hipp, 16.5%
nCutaquig
n6 mL
nNDC 0069-1061-02
nCutaquig
n10 mL
nNDC 0069-1802-02
nCutaquig
n12 mL
nNDC 0069-1476-02
nCutaquig
n20 mL
nNDC 0069-1960-02
nCutaquig
n24 mL
nNDC 0069-1509-02
nCutaquig
n48 mL
nNDC 0069-1965-02

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Immunoglobulin G (Cutaquig)

Trade Name : Cutaquig

SOLUTION, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Immunoglobulin G (Cutaquig)

Trade Name : Cutaquig

SOLUTION, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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