immune globulin SC (Rx)

Brand and Other Names:Hizentra, HyQvia, more...Cuvitru, Gammagard Liquid SC, Gamunex-C SC, Cutaquig, Xembify, immune globulin SC, human-kljw
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

subcutaneous injectable solution

  • 10% (100mg/mL) (Gamunex-C, Gammagard Liquid)
  • 10% (100mg/mL) duovial set with recombinant human hyaluronidase 160 units/mL (HyQvia)
  • 20% (200mg/mL) (Hizentra, Cuvitru, Xembify)

Primary Immune Deficiency

Indicated for primary immunodeficiency; this includes, but is not limited to, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies

Individualize the dose based on the patient’s clinical response and serum IgG trough levels; obtain baseline serum IgG trough level to guide subsequent dosage adjustments

Before initiating, ensure that patients have received IGIV treatment at regular intervals for at least 3 months

Hizentra

  • May be administered as a SC infusion at regular intervals as daily up to biweekly (ie, q2Weeks)
  • Before initiating, obtain serum IgG trough level to guide subsequent dose adjustments
  • Weekly dosing
    • Start 1 week after last IGIV infusion
    • Initial weekly dose: 1.37 x previous IVIG dose (in grams) divided by number of weeks between IVIG doses
  • Biweekly dosing (ie, q2week)
    • Start treatment 1 or 2 weeks after the last IGIV infusion or 1 week after that last weekly Hizentra infusion
    • Administer twice the calculated weekly dose
  • Frequent dosing (2-7 times/week)
    • Divide the calculated weekly dose by the desired number of dosage times per week

Gamunex-C

  • Administered as weekly SC infusion
  • Initial SC dose: 1.37 x current IVIG dose in mg/kg divided by number of weeks between IV doses
  • Not to exceed 20 mL/hr/infusion site

Gammagard Liquid

  • Administered as weekly SC infusion
  • Initial SC dose: Initial SC dose: 1.37 x current IVIG dose in mg/kg divided by number of weeks between IV doses
  • ≥40 kg: Not to exceed 30 mL/infusion site at rate of 20 mL/hr/site; for maintenance dose, may increase to 30 mL/hr site
  • <40 kg: Not to exceed 20 mL/infusion site at rate of 15 mL/hr site; for maintenance dose, may increase to 20 mL/hr site

HyQvia

  • Initiating
    • For patients previously on another IgG treatment, administer the first dose approximately 1 week after the last infusion of their previous treatment
    • Increase the dose and frequency from a 1-week dose to a 3- or 4-week dose (see titration schedule)
    • Initiating treatment at a full monthly dose was not evaluated in clinical trials
  • Titration schedule
    • Titrate to dosage interval of every 3-4 weeks
    • Week 1: 1st infusion (weekly dose) at 25% of targeted dose
    • Week 2: 2nd infusion (q2week dose) at 50% of targeted dose
    • Week 3: No infusion
    • Week 4: 3rd infusion (q3week dose) at 75% of targeted dose
    • Week 5: No infusion
    • Week 6: No infusion
    • Week 7: 4th infusion (q4week dose) at 100% of targeted dose (if required)
  • Switching from IVIG
    • Administer HyQvia at the same dose and frequency as the previous IV treatment, after the initial dose titration
  • Patients naïve to IgG treatment or switching from immune globulin human SC
    • 300-600 mg/kg SC at 3 to 4 week intervals, after initial titration

Cuvitru

  • Can be administered at regular intervals from daily up to q2weeks
  • Initiating
    • Individualize the dose based on the patient’s pharmacokinetic and clinical response
    • Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed
  • Switching from IVIG or adults switching from HyQvia
    • Begin Cuvitru 1 week after the patient’s last IGIV or HyQvia infusion
    • Establish the initial weekly dose by converting the monthly IGIV or HyQvia dose into an equivalent weekly dose and increasing it using a dose adjustment factor
    • To calculate the initial weekly dose, divide the previous IGIV or HyQvia dose in grams by the number of weeks between IV doses; then multiply this dose by the dose adjustment factor of 1.3
  • Switching from another immune globulin human SC (IGSC)
    • Cuvitru weekly dose (in grams) is recommended to be the same as the weekly dose of prior IGSC treatment (in grams)
    • Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state

Xembify

  • Before initiating, obtain serum IgG trough level to guide subsequent dose adjustments
  • Doses divided over the course of a week or qWeek achieve similar exposure when administered regularly at steady-state
  • For frequent dosing (2-7 times/week), divide the calculated weekly dose by the desired number of dosage times per week
  • Monitor IgG trough level every 2-3 months to determine subsequent dose adjustments and dosing intervals as needed
  • Consider patient’s clinical response in dose adjustment; if an adequate clinical response or a serum IgG trough level equivalent to that of a previous treatment is not maintained, adjust dose accordingly; refer to the prescribing information for further information
  • Switching from IVIG
    • Start 1 week after last IGIV infusion
    • Initial weekly dose: 1.37 x previous IVIG dose (in grams) divided by number of weeks between IVIG doses
  • Switching from another IGSC
    • Administer same weekly dose of Xembify (in grams) as the weekly dose of prior IGSC treatment (in grams)

Chronic Inflammatory Demyelinating Polyneuropathy

Hizentra only

Indicated for chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment

Maintenance therapy in CIDP systematically studied for 6 mo and for a further 12 mo in a follow-up study; individualize maintenance therapy beyond these periods based upon the patient’s response and need for continued therapy

Initiate weekly dosing 1 week after patient’s last IGIV dose

Initial dose

  • 0.2 g/kg (1 mL/kg) SC per week, administered in 1 or 2 sessions over 1 or 2 consecutive days

If CDIP symptoms worsens

  • If CIDP symptoms worsen, consider reinitiating treatment with an IGIV-approved for CIDP, while discontinuing Hizentra
  • If improvement and stabilization are observed during IGIV treatment, consider reinitiating Hizentra at 0.4 g/kg/week, administered in 2 sessions per week over 1 or 2 consecutive days, while discontinuing IGIV
  • If CIDP symptoms worsen on the 0.4 g/kg/wk, consider reinitiating therapy with an IGIV product approved for treatment of CIDP, while discontinuing Hizentra
  • Monitor the patient’s clinical response and adjust the duration of therapy based on patient need
  • Also see Administration

Dosing Considerations

Adjust dose by measuring serum trough IgG trough levels and calculating difference from baseline IVIG trough levels, then refer to dosage adjustment tables listed within prescribing information for particular product

Dermatomyositis (Orphan)

Hizentra: Orphan designation for treatment of dermatomyositis

Orphan sponsor

  • CSL Behring LLC; 1020 First Ave, PO Box 61501; King of Prussia, PA

Dosage Forms & Strengths

subcutaneous injectable solution

  • 10% (100mg/mL) (Gamunex-C, Gammagard Liquid)
  • 20% (200mg/mL) (Hizentra, Cuvitru, Xembify)

Primary Immune Deficiency

<2 years: Safety and efficacy not established

Individualize the dose based on the patient’s clinical response and serum IgG trough levels; obtain baseline serum IgG trough level to guide subsequent dosage adjustments

Before initiating, ensure that patients have received IGIV treatment at regular intervals for at least 3 months

Hizentra

  • May be administered as weekly or biweekly (ie, q2Weeks) SC infusion
  • Initial SC weekly dose: 1.53 x current IVIG dose in mg/kg divided by number of weeks between IV doses
  • Initial SC biweekly dose: For biweekly dosing, start treatment 1 or 2 weeks after the last IGIV infusion or 1 week after that last weekly Hizentra infusion
  • SC infusion volume: Not to exceed 15 mL/infusion site; for maintenance dose, may increase to 20 mL/site after 4th infusion, and then 25 mL/site as tolerated
  • SC infusion rate: Not to exceed 15 mL/hr/site for 1st dose; may increase to 25 mL/hr/site for subsequent infusions

Cuvitru

  • Can be administered at regular intervals from daily up to q2weeks
  • Initiating
    • Individualize the dose based on the patient’s pharmacokinetic and clinical response
    • Monitor serum IgG trough levels regularly to guide subsequent dose adjustments and dosing intervals as needed
  • Switching from IVIG or adults switching from HyQvia
    • Begin Cuvitru 1 week after the patient’s last IGIV or HyQvia infusion
    • Establish the initial weekly dose by converting the monthly IGIV or HyQvia dose into an equivalent weekly dose and increasing it using a dose adjustment factor
    • To calculate the initial weekly dose, divide the previous IGIV or HyQvia dose in grams by the number of weeks between IV doses; then multiply this dose by the dose adjustment factor of 1.3
  • Switching from another immune globulin human SC
    • Cuvitru weekly dose (in grams) is recommended to be the same as the weekly dose of prior IGSC treatment (in grams)
    • Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state

Gamunex-C

  • Administered as weekly SC infusion
  • Initial weekly SC dose: 1.37 x current IVIG dose in mg/kg divided by number of weeks between IV doses

Gammagard Liquid

  • Administered as weekly SC infusion
  • Initial SC dose: Initial SC dose: 1.37 x current IVIG dose in mg/kg divided by number of weeks between IV doses
  • ≥40 kg: Not to exceed 30 mL/infusion site at rate of 20 mL/hr/site; for maintenance dose, may increase to 30 mL/hr site
  • <40 kg: Not to exceed 20 mL/infusion site at rate of 15 mL/hr site; for maintenance dose, may increase to 20 mL/hr site

Xembify

  • Before initiating, obtain serum IgG trough level to guide subsequent dose adjustments
  • Doses divided over the course of a week or qWeek achieve similar exposure when administered regularly at steady-state
  • For frequent dosing (2-7 times/week), divide the calculated weekly dose by the desired number of dosage times per week
  • Monitor IgG trough level every 2-3 months to determine subsequent dose adjustments and dosing intervals as needed
  • Consider patient’s clinical response in dose adjustment; if an adequate clinical response or a serum IgG trough level equivalent to that of a previous treatment is not maintained, adjust dose accordingly; refer to the prescribing information for further information
  • Switching from IVIG
    • Start 1 week after last IGIV infusion
    • Initial weekly dose: 1.37 x previous IVIG dose (in grams) divided by number of weeks between IVIG doses
  • Switching from another IGSC
    • Administer same weekly dose of Xembify (in grams) as the weekly dose of prior IGSC treatment (in grams)

Dosing Considerations

Adjust dose by measuring serum trough IgG trough levels and calculating difference from baseline IVIG trough levels, then refer to dosage adjustment tables listed within prescribing information for particular product

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Interactions

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            Adverse Effects

            >10%

            Injection site reactions (92-100%)

            Headache (26.5-48%)

            GI disorder (37%)

            Fever (25%)

            Sore throat (8.2-17%)

            Rash (10.2-17%)

            Cough (16.3%)

            Diarrhea (10-14.3%)

            Fatigue (12.2%)

            Allergic reaction (11%)

            Abdominal pain (10.2%)

            Pain (8.2-10%)

            1-10%

            Arthralgia (8.2%)

            Migraine (8.2%)

            Epistaxis (8.2%)

            Nausea (4.1%)

            Rash (4.1%)

            Postmarketing Reports

            General disorders and administration site conditions: Infusion-site ulcer, infusion-site necrosis

            Infusion reactions: Wheezing, rigors, myalgia

            Renal: Osmotic nephropathy

            Respiratory: Pulmonary edema, dyspnea, oxygen saturation decreased, cyanosis, Hypoxemia, bronchospasm, apnea, acute respiratory distress syndrome (ARDS)

            Cardiovascular: Hypotension, hypertension, myocardial infarction, chest pain, cardiac arrest, vascular collapse

            Neurological: Coma, loss of consciousness, seizures, aseptic meningitis syndrome

            Integumentary: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, dermatitis (eg, bullous dermatitis)

            Hematologic: Pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs’) test

            Gastrointestinal: Hepatic dysfunction

            Hizentra

            • Infusion reactions: Allergic-anaphylactic reactions (eg, swollen face,tongue and pharyngeal edema, pyrexia, chills, dizziness, hypertension/changes in blood pressure, malaise, tachycardia, flushing)
            • Cardiovascular: Chest discomfort (eg, chest pain)
            • Respiratory: Dyspnea
            • Neurological: Tremor, burning sensation
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            Warnings

            Black Box Warnings

            Thrombosis

            • Thrombosis may occur with immune globulin products
            • Risk factors include advanced age, prolonged immobilization, hypercoagulable conditions, history of thrombosis, estrogen use, indwelling central vascular catheters, hyperviscosity, and CV risk factors
            • For at risk patients, use lowest possible dose and infusion rate, ensure adequate hydration before administration, assess blood viscosity, and monitor for signs and symptoms of thrombosis

            Contraindications

            Hypersensitivity to immune globulins or solution components

            Selected IgA deficiency with known antibody against IgA

            Severe thrombocytopenia or coagulation disorders

            Hyperprolinemia (Hizentra contains the stabilizer L-proline)

            Cautions

            Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG (see Contraindications)

            Thrombosis may occur following treatment with immune globulin products; risk factors 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; monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity

            Aseptic meningitis syndrome (AMS) reported to occur with IgG products; discontinuation of IgG treatment resulted in remission of AMS within several days without sequelae; syndrome usually begins within several hours to 2 days following IV administered IgG, perhaps more frequently in association with high dose (2 g/kg) IV administered IgG

            Infusion into or around an infected area can spread a localized infection; do not infuse HyQvia into these areas due to potential risk of spreading a localized infection Initial treatment should be done in clinical setting (due to possibility of anaphylactic reactions)

            Products made from human plasma can contain infectious agents (eg, viruses and, theoretically, Creutzfeldt-Jakob disease [CJD])

            Subcutaneous administration associated with increased risk of hematoma

            Hemolytic anemia reported (monitor)

            Renal dysfunction or renal failure has been associated with IG therapy; monitor renal function and urine output

            Hyperproteinemia and hyponatremia may occur

            In clinical studies, eighteen percent of subjects receiving HyQvia developed nonneutralizing antibodies to the recombinant human hyaluronidase component; potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male testes, epididymis, and sperm; unknown whether these antibodies may interfere with fertilization in humans or its clinical significance

            Noncardiogenic pulmonary edema may occur in patients following treatment with human immune globulin products

            Drug interactions overview

            • Live virus vaccines
              • Passive transfer of antibodies with immunoglobulin administration may interfere with response to live virus vaccines (eg, measles, mumps, rubella, varicella) HyQvia may impair immune response to live attenuated virus vaccines (eg, mumps, rubella, varicella) for up 6 months and for a year or more to measles
            • Interference with laboratory tests
              • Various passively transferred antibodies in immunoglobulin preparations may lead to misinterpretation of the results of serological testing
              • Passive transmission of antibodies to erythrocyte antigens (eg, A, B, and D) may cause a positive direct or indirect antiglobulin (Coombs’) test
              • Administration of Cuvitru can lead to false positive readings in assays that depend on detection of beta-D-glucans for diagnosis of fungal infections; this may persist during the weeks following infusion of the product
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            Pregnancy & Lactation

            Pregnancy

            No human data are available to indicate the presence or absence of drug-associated risk

            Unknown whether immune globulin SC can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity

            Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation; therefore, drug should be given to pregnant women only if clearly needed

            Lactation

            No human data are available to indicate the presence or absence of drug-associated risk

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for immune globulin SC and any potential adverse effects on the breastfed infant from immune globulin SC or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Pooled human immune globulins from donors used as replacement therapy for primary and secondary immunodeficiencies, and IgG antibodies against viral, bacteria, parasitic, and mycoplasma antigens; provides passive immunity through an increase in antibody titer and antigen-antibody reaction potential

            Absorption

            Peak plasma concentration: 1607 mg/dL (HyQvia); 1809 mg/dL (Cuvitru); 14 mg/mL (Xembify)

            Peak plasma time: 5 days (HyQvia); 105 hr (Cuvitru); 76 hr (Xembify)

            Mean AUC: 10,560 day·mg/dL (Hizentra); 115 g·day/L (Cuvitru); 91.4 g·day/L (HyQvia); 2183 mg·hr/mL (Xembify)

            Excretion

            Half-life: 59.3 days (HyQvia)

            Clearance: 2.2 mL/day/kg (Hizentra); 1.86 mL/kg/day (Cuvitru); 1.6 mL/kg/day (HyQvia)

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            Administration

            SC Preparation (Xembify)

            Prior to use, allow solution to come to room temperature (68-77°F or 20-25°C); may take 60 minutes or longer

            Do not apply heat or place in the microwave

            Visually inspect for particulate matter and discoloration prior to administration; SC injection should appear clear to slightly opalescent, and colorless or pale yellow solution

            Do not use if solution is cloudy or turbid; do not shake or dilute

            Vials are single-use only; do not store punctured, partially used, or opened vials

            Administer within 8 hr after beginning preparation (ie, once vial contents is transferred into a syringe)

            Administer separately from other drugs or medications that the patient may be receiving

            Do not mix with other medications including immune globulins from other manufacturers; discard unused portion

            SC Administration

            For multiple site SC infusion, divide sites at least 2 inches apart

            For weekly dosing, use up to 4 sites simultaneously or 12 sites consecutively per infusion

            Infusion sites include abdomen, thighs, upper arm, lateral hip; rotate injection sites every week

            Hizentra

            • For SC administration using an infusion pump
            • Infusion sites
              • Administer in abdomen, thigh, upper arm, and/or lateral hip
              • Dose may be infused into multiple infusion sites simultaneously; use up to 8 infusion sites in parallel
              • More than one infusion device can be used simultaneously
              • Infusion sites should be at least 2 inches apart
              • Change the actual site of infusion with each administration
            • Volume and infusion rate per site
              • PI: Not to exceed 15 mL/hr/infusion site for 1st dose; for subsequent infusions, do not exceed 25 mL/hr/site as tolerated
              • CIDP: Not to exceed 20 mL/hr/infusion site for 1st dose; for subsequent infusions, do not exceed 50 mL/hr/site as tolerated

            HyQvia

            • Administer by a healthcare professional, caregiver or self-administered by the patient after appropriate training
            • Infusion requires an infusion pump capable of infusion rates up to 300 mL/hr/site; to ensure maximum flow rates, use a SC set that is 24 gauge and labeled for high flow rates
            • Infuse the 2 components sequentially, beginning with the recombinant human hyaluronidase
            • Initiate the infusion of the full dose of the IG 10% through the same SC needle set within ~10 minutes of the hyaluronidase infusion
            • For each full or partial vial of IG 10% used, administer the entire contents of the hyaluronidase vial
            • Infusion site(s): Infuse in abdomen or thighs; if 2 sites are used, give on opposite sides of body and administer half of total volume of hyaluronidase in each site
            • Volume per site: Up to 600 mL/site for patients ≥40 kg and up to 300 mL/site for patients <40 kg
            • Infusion rate
              • Hyaluronidase: 1-2 mL/min SC (as tolerated)
              • Immune globulin, first 2 infusions (<40 kg): 5 mL/hr initially; double infusion rate every 5-15 minutes until 80 mL/hr for remainder of infusion
              • Immune globulin, first 2 infusions (≥40 kg): 10 mL/hr initially; after 5-10 minutes increase to 30 mL/min, and then double infusion rate every 5-15 minutes until 240 mL/hr for remainder of infusion
              • Immune globulin, subsequent 2-3 infusions (<40 kg): 10 mL/hr initially; after 5-10 minutes increase to 30 mL/min, and then double infusion rate every 5-15 minutes until 240 mL/hr for remainder of infusion
              • Immune globulin, subsequent 2-3 infusions (≥40 kg): Beginning with 10 mL/hr, increase every 5-15 minutes to 30 mL/hr, 120 mL/hr, 240 mL/hr, and finally 300 mL/hr for remainder of infusion

            Cuvitru

            • Infusion site
              • Areas of infusion include abdomen, thighs, upper arms, or lateral hip
              • May be infused into multiple infusion sites
              • Use up to 4 sites simultaneously
              • Infusion sites should be at least 4-inches apart, avoiding bony prominences
              • Rotate sites with each administration
            • Volume per site
              • To calculate the number of sites to be used, divide the total volume to be infused by the maximum volume/site (up to 60 mL/site) to be infused
              • Simultaneous SC infusion at multiple sites can be facilitated by use of a multineedle administration set
            • Infusion rate
              • First 2 infusions: 10-20 mL/hr/site
              • Subsequent infusions: May increase to 60 mL/hr/site as tolerated
              • If utilizing 4 infusion sites, the maximum infusion rate for all sites combined is 240 mL/hr

            Gamunex-C SC

            • SC preparation
              • Allow solution to reach ambient room temperature before use
              • Do not shake
              • Do not use of solution is cloudy or has particulates, or is beyond its expiration date
              • Prime tubing with Gamunex-C solution
            • SC infusion rate
              • Adults: 20 mL/hr per infusion site; up to 8 infusion sites may be used (most patients use 4 infusion sites)
              • Children and adolescents weighing ≥25 kg: 15 mg/hr per infusion site initially, may increase up to 20 mL/hr/infusion site
              • Children weighing <25 kg: 20 mL/hr per infusion site
              • In children up to 6 infusion sites simultaneously may be used
              • For patients of all ages ensure that the infusion sites are at least 2 inches (5 cm) apart

            Xembify

            • For SC administration using an infusion pump
            • Follow manufacturer’s instructions for preparing the pump and administration tubing; prime tubing with Xembify to ensure no air is left in the tubing or needle
            • Infusion sites
              • Administer in abdomen, thigh, upper arm, sides, back and/or lateral hip
              • Rotate sites of each administration; avoid bony areas, scars, areas of inflammation, superficial infection, or blood vessels
              • Dose may be infused into multiple infusion sites simultaneously; use up to 6 infusion sites
              • More than one infusion device can be used simultaneously Infusion sites should be at least 2 inches apart
              • Change the actual site of infusion with each administration
              • Children will require less total volume for a specific dose (mg/kg body weight) than adults
            • Volume and infusion rate per site
              • Not to exceed 25 mL/hr/infusion site
            • After infusion
              • Follow manufacturer’s instructions to turn off pump
              • Undo and discard any dressing or tape
              • Gently remove the inserted needle(s) or catheter(s)
              • Discard any unused solution and any used administration equipment in an appropriate waste container

            Storage

            Do not shake; do not freeze; do not use product that has been frozen

            Keep in its original carton to protect it from light

            Do not use after expiration date

            Hizentra

            • Store at room temperature (≤25°C [77°F])
            • Stable for up to 30 months, as indicated by the expiration date printed on the outer carton and vial label
            • Do not shake; do not freeze; do not use product that has been frozen

            HyQvia

            • Refrigerate at 2-8°C (36-46°F) for ≤36 months
            • Store at room temperature ≤25°C (77°F) for ≤3 months during the first 24 months from the date of manufacturing (Mfg date) printed on the carton
            • Drug must be used within 3 months after removal to room temperature
            • Do not return drug to the refrigerator after it has been stored at room temperature.

            Cuvitru

            • Refrigerate at 2-8°C (36-46°F) for ≤36 months
            • Store at room temperature ≤25°C (77°F) for ≤12 months
            • Do not return drug to refrigerator if you take it out to room temperature

            Gamunex-C

            • Refrigerate at 2-8°C (36-46°F) for ≤36 months
            • Store at room temperature ≤25°C (77°F) for ≤6 months during the 36 month shelf life, after which the product must be immediately used or discarded

            Xembify

            • Refrigerate at 2-8°C (36-46°F); do not freeze; do not use after expiration date
            • Store at room temperature ≤25°C (77°F) for ≤6 months during the 36 month shelf life, after which the product must be immediately used or discarded
            • Do not use solutions that have been frozen
            • Components used in the packaging are not made with natural rubber latex and contains no preservatives
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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