Version May 2024
Maltose in immune globulin products, including Anthrasil, may give falsely high blood glucose levels with some point-of-care blood glucose testings systems (for example those based on the GDH-PQQ or glucose-dye-oxidoreductase methods) resulting in inappropriate administration of insulin and life-threatening hypoglycemia. To avoid interference by maltose contained in Anthrasil, perform blood glucose measurement in patients receiving Anthrasil with a glucose-specific method (monitor and test strips).
Thrombosis may occur with immune globulin products, including Anthrasil. 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. Thrombosis may occur in the absence of known risk factors.
For patients at risk of thrombosis, administer Anthrasil at the minimum 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.
Anthrax (inhalational exposure), treatment: Note: Must be administered in combination with appropriate antimicrobial therapy. Not for use as postexposure prophylaxis in combination with vaccination; in animal models, anthrax immune globulin has been shown to reduce vaccine immunogenicity (Ref).
Initial dose: Dose may be doubled for severe cases in patients >5 kg. Without substantially delaying administration, consider therapeutic thoracentesis and/or abdominal paracentesis prior to or concurrently with administration.
Neonates: IV: 1 vial (~60 units).
Maintenance: Consider repeat dosing in patients experiencing substantial hemorrhage, patients with significant compartmental fluid losses, and in patients whose own immune response may be impaired or delayed. The interval between doses should take into account the magnitude of ongoing blood and fluid losses and the clinical status of the patient. Repeat dosing has not been evaluated in humans.
Anthrax (inhalational exposure), treatment: Note: Must be administered in combination with appropriate antimicrobial therapy. Not for use as postexposure prophylaxis in combination with vaccination; in animal models, anthrax immune globulin has been shown to reduce vaccine immunogenicity (Ref).
Initial dose: Select initial dose based on clinical severity. Dose may be doubled for severe cases in patients >5 kg. Single doses >840 units (14 vials) have not been evaluated in humans. Without substantially delaying administration, consider therapeutic thoracentesis and/or abdominal paracentesis prior to or concurrently with administration.
Infants, Children, and Adolescents <17 years:
<10 kg: IV: 1 vial (~60 units).
10 to <18 kg: IV: 2 vials (~120 units).
18 to <25 kg: IV: 3 vials (~180 units).
25 to <35 kg: IV: 4 vials (~240 units).
35 to <50 kg: IV: 5 vials (~300 units).
50 to <60 kg: IV: 6 vials (~360 units).
≥60 kg: IV: 7 vials (~420 units).
Adolescents ≥17 years: IV: 7 vials (~420 units).
Maintenance: Consider repeat dosing in patients experiencing substantial hemorrhage, patients with significant compartmental fluid losses, and in patients whose own immune response may be impaired or delayed. The interval between doses should take into account the magnitude of ongoing blood and fluid losses and the clinical status of the patient. Repeat dosing has not been evaluated in humans.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution; administer at the minimum rate of infusion practical; monitor closely.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Anthrax immunoglobulin (United States: Availability limited to Strategic National Stockpile distribution): Drug information")
Anthrax, inhalational exposure; anthrax, soft tissue infection (off-label use): IV: Note: Must be administered in combination with appropriate antimicrobial therapy. NOT for use as postexposure prophylaxis in combination with vaccination as anthrax immune globulin has been shown (in animal models) to reduce vaccine immunogenicity (Ref). Limited data exist for use in patients with skin and soft tissue infection (Ref).
Initial: 420 units (7 vials); select initial dose based on clinical severity. Dose may be doubled for severe cases. Single doses >840 units (14 vials) have not been evaluated in humans. Without substantially delaying administration, consider therapeutic thoracentesis and/or abdominal paracentesis prior to or concurrently with administration.
Maintenance: Consider repeat dosing in patients experiencing substantial hemorrhage, patients with significant compartmental fluid losses, and in patients whose own immune response may be impaired or delayed. The interval between doses should take into account the magnitude of ongoing blood and fluid losses and the clinical status of the patient. Repeat dosing has not been evaluated in humans.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Use with caution and infuse at the minimum rate possible; patients with preexisting renal impairment are at a higher risk of developing acute renal dysfunction.
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not always defined.
Cardiovascular: Cardiac arrest, edema, hypotension, peripheral edema
Central nervous system: Headache (20%; dose dependent)
Endocrine & metabolic: Glycosuria (dose related), hyperkalemia, metabolic acidosis
Gastrointestinal: Nausea (9%)
Hematologic & oncologic: Blood coagulation disorder
Hepatic: Ascites
Local: Pain at injection site (9%), swelling at injection site (7%)
Renal: Renal insufficiency
Respiratory: Acute respiratory distress, pleural effusion, pulmonary edema
History of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of anthrax immune globulin, other human immune globulin preparations, or any component of the formulation; IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity
Concerns related to adverse effects:
• Aseptic meningitis: Aseptic meningitis syndrome (AMS) has been reported with immune globulin administration; may occur with high doses (>2 g/kg). Syndrome usually appears within several hours to 2 days following treatment; usually resolves within several days after product is discontinued. Conduct a detailed neurological examination and CSF studies in patients exhibiting signs and symptoms of AMS (eg, severe headache, nuchal rigidity, drowsiness, fever, photophobia, painful eye movements, nausea, vomiting) to rule out other causes of meningitis, particularly anthrax meningitis.
• Hemolysis: Intravenous immune globulin products have been associated with antiglobulin hemolysis (acute or delayed); monitor for signs of hemolytic anemia. Cases of hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation (DIC) have been reported. Risk factors associated with hemolysis include high doses (>2 g/kg) given either as a single administration or divided over several days, underlying associated inflammatory conditions, and non-O blood type (FDA, 2012). Monitor for signs and symptoms of hemolysis and consider laboratory monitoring (eg, hemoglobin and hematocrit prior to initiation, 36 to 96 hours postinfusion, and 7 to 10 days postinfusion) in higher risk patients.
• Hypersensitivity: Hypersensitivity and anaphylactic reactions can occur; monitor all patients for acute allergic reactions during and following infusion. Administration should occur in a setting where appropriate treatment for hypersensitivity, anaphylaxis, or shock can be administered. Discontinue treatment in patients who develop a severe hypersensitivity reaction. Patients with known antibodies to IgA are at a greater risk of developing severe hypersensitivity; use in these patients is contraindicated.
• Infusion reactions: Patients should be monitored for adverse events, which may be related to the rate of infusion (eg, fever, chills, nausea, vomiting, headache), during and after the infusion; follow closely the recommended infusion rates.
• Pulmonary edema: Monitor for transfusion-related acute lung injury (TRALI); noncardiogenic pulmonary edema has been reported with immune globulin use. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, and fever in the presence of normal left ventricular function. Usually occurs within 1 to 6 hours after infusion.
• Renal impairment: Acute renal dysfunction, acute renal failure, osmotic nephropathy, acute tubular necrosis, and proximal tubular nephropathy can rarely occur with immune globulin IV products and has been associated with fatalities; more likely with products stabilized with sucrose (which does not include anthrax immune globulin). Use with caution in any patient with preexisting renal dysfunction and patients at risk of renal dysfunction (eg, elderly, diabetes mellitus, volume depletion, sepsis, paraproteinemia, nephrotoxic medications). In patients at risk of renal dysfunction, ensure adequate hydration prior to administration; the rate of infusion should be minimized. Monitor renal function prior to infusion and periodically thereafter; discontinue if renal function deteriorates.
• Thromboembolic events: [US Boxed Warning]: Thrombosis may occur with immune globulin products even in the absence of risk factors for thrombosis. For patients at risk of thrombosis (eg, advanced age, impaired cardiac output, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors), administer at the minimum infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity such as those with cryoglobulins, fasting chylomicronemia/severe hypertriglyceridemia, or monoclonal gammopathies.
Disease-related concerns:
• Hypovolemia: Patients should not be volume depleted prior to initiation of therapy.
• IgA deficiency: Increased risk of hypersensitivity, especially in patients with anti-IgA antibodies; use is contraindicated in patients with IgA deficiency with antibodies against IgA and history of IgA hypersensitivity
Special populations:
• Older adult: Use with caution in the elderly; may be at increased risk for renal dysfunction.
Dosage form specific issues:
• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease, including unknown or emerging viruses and other pathogens. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.
• Maltose: [US Boxed Warning]: Some products may contain maltose, which may result in falsely elevated blood glucose readings with some point-of-care blood glucose testings systems (eg, those based on the GDH-PQQ or glucose-dye-oxidoreductase methods), which may result in inappropriate administration of insulin and subsequent hypoglycemia. Blood glucose should be measured by a glucose-specific method (eg, monitor and test strips).
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
Anthrasil: FDA approved March 2015; availability is limited to the US Strategic National Stockpile
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Anthrasil: 60 units (50 mL) [contains polysorbate 80]
IV: For IV infusion only. Use of an in-line filter is optional.
Infusion rate: If adverse reactions occur (eg, flushing, headache, nausea, changes in heart rate or blood pressure), slow the rate of infusion or temporarily stop the infusion.
Neonates, Infants, Children, and Adolescents <17 years: Initiate infusion at 0.01 mL/kg/minute (maximum initial rate: 0.5 mL/minute) for 30 minutes; may increase the infusion rate by 0.02 mL/kg/minute (maximum rate increase: 1 mL/minute) every 30 minutes as tolerated. Maximum infusion rate: 0.04 mL/kg/minute or 2 mL/minute, whichever is less.
Adolescents ≥17 years: Initiate infusion at 0.5 mL/minute for 30 minutes; may increase the infusion rate by 1 mL/minute every 30 minutes as tolerated. Maximum infusion rate: 2 mL/minute
IV: For IV infusion only. Use of an in-line filter is optional.
Infusion rate: If adverse reactions occur (eg, flushing, headache, nausea, changes in heart rate or blood pressure), slow the rate of infusion or temporarily stop the infusion.
Initiate infusion at 0.5 mL/minute for 30 minutes; may increase the infusion rate by 1 mL/minute every 30 minutes as tolerated. Maximum infusion rate: 2 mL/minute.
Preexisting renal impairment or at risk of thrombosis: Administer at the minimum rate of infusion practicable; do not exceed the recommended infusion rate and follow the infusion schedule closely.
Store frozen at ≤–15°C (≤5°F) until required for use. Do not refreeze, reuse, or save for future use. Discard any partially used vials.
Treatment of inhalational anthrax in combination with appropriate antibacterial drugs (FDA approved in pediatric patients [age not specified] and adults)
Note: Effectiveness is based solely on efficacy studies conducted in animal models of inhalational anthrax. Anthrax immune globulin (human) (AIGIV) does not have direct antibacterial activity, does not cross the blood-brain barrier, and does not prevent or treat meningitis. There have been no studies in the pediatric, geriatric, or obese populations.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Estrogen Derivatives: May enhance the thrombogenic effect of Anthrax Immune Globulin (Human). Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification
Human data are not available related to the use of anthrax immune globulin in pregnancy. However, anthrax immune globulin is expected to cross the placenta. Anthrax infection is associated with maternal and fetal death. Criteria for treating pregnant and postpartum women should be the same as nonpregnant women unless other contraindications exist. Dosing of anthrax immune globulin in pregnancy should also follow the same weight-based dosing schedule (Meaney-Delman, 2014).
Renal function (BUN and serum creatinine) before initial infusion and at appropriate intervals thereafter; urine output periodically; baseline blood viscosity in patients at risk for hyperviscosity; signs and symptoms of hemolysis (hemoglobin and hematocrit prior to initiation, 36 to 96 hours postinfusion, and 7 to 10 days postinfusion in patients at high risk), aseptic meningitis syndrome, hypersensitivity reactions, infusion-related reactions, and transfusion-related acute lung injury
Antibodies obtained from pooled human plasma of individuals immunized with the anthrax vaccine provide passive immunity and neutralizes the anthrax toxin by binding to protective antigen (PA) to prevent PA-mediated cellular entry of anthrax edema factor and lethal factor.
Distribution: Vd: 5.7 to 6.8 L
Half-life elimination: 24 to 28 days
Time to peak : ~2.5 to 4 hours
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