Dosing & Uses
Dosage Forms & Strengths
SC injectable solution
- 10% (100mg/mL) (Gamunex-C, Gammagard Liquid)
- 10% (100mg/mL) duovial set with recombinant human hyaluronidase 160 units/mL (HyQvia)
- 16.5% (165mg/mL) (Cutaquig)
- 20% (200mg/mL) (Hizentra, Cuvitru, Xembify)
Primary Humoral Immunodeficiency
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 dose based on 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 or Cutaquig
- 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 1 week after 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 initial weekly dose, divide previous IGIV or HyQvia dose in grams by number of weeks between IV doses; then multiply this dose by the dose adjustment factor of 1.3
- Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state
-
Switching from another immune globulin human SC (IGSC)
- 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 CIDP symptoms worsens
- If CIDP symptoms worsen on 0.2 g/kg/week, consider increasing dose to 0.4 g/kg/week SC administered in 2 sessions per week over 1-2 consecutive days
- If CIDP symptoms worsen on 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
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
SC injectable solution
- 10% (100mg/mL) (Gamunex-C, Gammagard Liquid)
- 16.5% (165mg/mL) (Cutaquig)
- 20% (200mg/mL) (Hizentra, Cuvitru, Xembify)
Primary Humoral Immunodeficiency
<2 years: Safety and efficacy not established
Individualize dose based on 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 or Cutaquig
- 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 1 week after 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 initial weekly dose, divide previous IGIV or HyQvia dose in grams by number of weeks between IV doses; then multiply this dose by the dose adjustment factor of 1.3
- Doses divided over the course of a week, once weekly, or biweekly, achieve similar exposure when administered regularly at steady-state
-
Switching from another immune globulin human SC
- 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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (6)
- axicabtagene ciloleucel
immune globulin SC, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
immune globulin SC, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
immune globulin SC, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- idecabtagene vicleucel
immune globulin SC, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- lisocabtagene maraleucel
immune globulin SC, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tisagenlecleucel
immune globulin SC, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (10)
- BCG vaccine live
immune globulin SC decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor.
- efgartigimod alfa
efgartigimod alfa will decrease the level or effect of immune globulin SC by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- efgartigimod/hyaluronidase SC
efgartigimod/hyaluronidase SC will decrease the level or effect of immune globulin SC by receptor binding competition. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies.
- measles (rubeola) vaccine
immune globulin SC decreases effects of measles (rubeola) vaccine by pharmacodynamic antagonism. Use Caution/Monitor.
- measles mumps and rubella vaccine, live
immune globulin SC decreases effects of measles mumps and rubella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor.
- measles, mumps, rubella and varicella vaccine, live
immune globulin SC decreases effects of measles, mumps, rubella and varicella vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor.
- rozanolixizumab
rozanolixizumab will decrease the level or effect of immune globulin SC by receptor binding competition. Use Caution/Monitor. Coadministration of rozanolixizumab with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If long-term use of such medications is essential, consider discontinuing rozanolixizumab and using alternative therapies.
- rubella vaccine
immune globulin SC decreases effects of rubella vaccine by pharmacodynamic antagonism. Use Caution/Monitor.
- smallpox (vaccinia) vaccine, live
immune globulin SC decreases effects of smallpox (vaccinia) vaccine, live by pharmacodynamic antagonism. Use Caution/Monitor.
- varicella virus vaccine live
immune globulin SC decreases effects of varicella virus vaccine live by pharmacodynamic antagonism. Use Caution/Monitor.
Minor (4)
- ethotoin
ethotoin, immune globulin SC. Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis (theoretical interaction, based on IM and IV immune globulin).
- fosphenytoin
fosphenytoin, immune globulin SC. Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis (theoretical interaction, based on IM and IV immune globulin).
- phenytoin
phenytoin, immune globulin SC. Mechanism: unknown. Minor/Significance Unknown. Risk of hypersensitivity myocarditis (theoretical interaction, based on IM and IV immune globulin).
- protein a column
protein a column decreases levels of immune globulin SC by Other (see comment). Minor/Significance Unknown. Comment: Since Prosorba binds IgG, it could theoretically interfere with the levels and/or effects of pharmacologic immune globulins.
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
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
IgA-deficiency with antibodies against IgA and history of hypersensitivity
Hyperprolinemia Type I or II
Cautions
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)
Subcutaneous administration associated with increased risk of hematoma
Hyperproteinemia and hyponatremia may occur
In clinical studies, eighteen percent of subjects receiving HyQvia developed non-neutralizing 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
Because this product is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, theCreutzfeldt-Jakob disease (CJD) agent; this also applies to unknown or emerging viruses and other pathogens; no cases of transmission of viral diseases or CJD have been associated with this therapy; all infections suspected by a physician possibly to have been transmitted by this product should be reported to CSL Behring Pharmacovigilance at 1-866-915-6958
Transfusion-related acute lung injury (TRALI)
- Noncardiogenic pulmonary edema may occur in patients administered human immune globulin products; TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever
- Typically, it occurs within 1-6 hours following transfusion; patients with TRALI may be managed using oxygen therapy with adequate ventilatory support
- Monitor therapy recipients for pulmonary adverse reactions; if TRALI suspected, perform appropriate tests for presence of anti-neutrophil antibodies in both the product and patient’s serum
Hypersensitivity
- Severe hypersensitivity reactions may occur, even in patients who have tolerated previous treatment with IgG
- If a hypersensitivity reaction occurs, discontinue therapy immediately and institute appropriate treatment
- Individuals with IgA deficiency can develop anti-IgA antibodies and anaphylactic reactions (including anaphylaxis and shock) after administration of blood components containing IgA
- Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions with administration of this medication, which contains ≤50 mcg/mL IgA
Thrombosis
- Thrombosis may occur; 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 absence of known risk factors;consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triglycerides, or monoclonal gammopathies
- For patients at risk of thrombosis, administer at a 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
Aseptic meningitis syndrome (AMS)
- AMS reported with use of IGIV4 or IGSC; the syndrome usually begins within several hours to 2 days following immune globulin treatment; AMS is characterized by severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting
- Cerebrospinal fluid (CSF) studies frequently show pleocytosis up to several thousand cells per cubic millimeter, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL; AMS may occur more frequently in association with high doses (≥2 g/kg) and/or rapid infusion of immune globulin product
- Patients exhibiting such signs and symptoms should receive a thorough neurological examination, 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
Renal dysfunction/failure
- Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with use of human immune globulin products, especially those containing sucrose; this product does not contain sucrose
- Ensure that patients are not volume depleted before administering this product
- For patients judged to be at risk for developing renal dysfunction, including patients with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs, monitor renal function and consider lower, more frequent dosing
- Periodic monitoring of renal function and urine output is particularly important in patients judged to have a potential increased risk of developing acute renal failure; assess renal function, including measurement of blood urea nitrogen (BUN) and serum creatinine, before initial infusion and at appropriate intervals thereafter; if renal function deteriorates, consider discontinuing therapy
Hemolysis
- This product can contain blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells (RBCs) with immunoglobulin, causing a positive direct antiglobulin(Coombs’) test result and hemolysis
- Delayed hemolytic anemia can develop subsequent to immune globulin therapy due to enhanced RBC sequestration, and acute hemolysis, consistent with intravascular hemolysis, reported
- Monitor recipients of this therapy for clinical signs and symptoms of hemolysis; if signs and/or symptoms of hemolysis are present after infusion, perform appropriate confirmatory laboratory testing
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
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.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)
Administration
SC Preparation
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 before administration; SC injection should appear clear to slightly opalescent, and colorless or pale-yellow solution
Discard 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
Infusion sites include abdomen, thighs, upper arm, lateral hip; rotate injection sites every week
Change infusion site with each administration
Hizentra
For SC administration using an infusion pump
May infuse into multiple infusion sites simultaneously; use up to 8 infusion sites in parallel
-
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
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
Cutaquig
Dose may be infused into multiple infusion sites, up to 8 infusion sites simultaneously
-
Volume per site
- Not already on IGSC: For first 2 infusions, do not exceed 25 mL/site (adults aged ≥17 yr), 15 mL/site (aged 7-17 yr), or 10 mL/site (aged 2-6 yr)
- Subsequent infusions, if tolerated: May gradually increase by 10 mL/site (adults aged ≥17 yr) or 5-10 mL/site (aged 2-17 yr) every 2-4 weeks
- Not to exceed 40 mL/site (adults aged ≥17 yr), 29 mL/site (aged 7-17 yr), or 15.5 mL/site (aged 2-6 yr)
-
Infusion rate
- Not already on IGSC: For first 2 infusions, do not exceed 20 mL/hr/site (adults aged ≥17 yr) or 15 mL/hr/site (aged 2-17 yr)
- Subsequent infusions, if tolerated: May gradually increase by ~10 mL/hr/site (adults aged ≥17 yr) or ~5-10 mL/hr/site (aged 2-17 yr) every 2-4 weeks
- Not to exceed 52 mL/hr/site (adults aged ≥17 yr) or 25 mL/hr/site (aged 2-17 yr)
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
Do not return drug to the refrigerator after it has been stored at room temperature
Hizentra
- Store at room temperature (≤25°C [77°F]) for up to 30 months
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 manufacturing date printed on the carton
- Drug must be used within 3 months after stored at to room temperature
Cuvitru
- Refrigerate at 2-8°C (36-46°F) for ≤36 months
- May store at room temperature ≤25°C (77°F) for ≤12 months during the 36-month shelf life, after which product must be immediately used or discarded
Gamunex-C, Xembify, Cutaquig
- Refrigerate at 2-8°C (36-46°F) for ≤36 months
- May store at room temperature ≤25°C (77°F) for ≤6 months during the 36-month shelf life, after which product must be immediately used or discarded
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| GamaSTAN S/D intramuscular - | 15-18 % range vial |  | |
| GamaSTAN S/D intramuscular - | 15-18 % range vial |  |
Copyright © 2010 First DataBank, Inc.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
