Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of obiltoxaximab. Due to the risk of hypersensitivity and anaphylaxis, obiltoxaximab should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive obiltoxaximab closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop obiltoxaximab infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.
Note: Premedicate with diphenhydramine prior to infusion.
Anthrax, inhalational; treatment and prophylaxis: IV: 32 mg/kg as a single dose
Note: Premedicate with diphenhydramine prior to infusion.
Anthrax, inhalational; treatment and prophylaxis: Infants, Children, and Adolescents:
≤15 kg: IV: 32 mg/kg as a single dose
>15 kg to 40 kg: IV: 24 mg/kg as a single dose
>40 kg: IV: 16 mg/kg as a single dose
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Obiltoxaximab (United States: Availability limited to Strategic National Stockpile distribution): Drug information")
Anthrax, inhalational (treatment and prophylaxis): IV: Note: Premedicate with diphenhydramine prior to infusion.
≤40 kg: 24 mg/kg/dose as a single dose.
>40 kg: 16 mg/kg/dose as a single dose.
There are no dosage adjustments provided in the manufacturer's labeling; however, a small clearance rate (L/day) suggests that there is minimal renal clearance (Hou 2017).
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. Adverse reactions reported in adults.
>10%:
Hypersensitivity: Hypersensitivity reaction (11%)
Nervous system: Headache (8% to 16%)
1% to 10%:
Cardiovascular: Chest discomfort (<2%), chest pain (<2%), palpitations (<2%)
Dermatologic: Pruritus (4%), skin rash (7%), urticaria (2%)
Gastrointestinal: Vomiting (<2%), xerostomia (<2%)
Hematologic & oncologic: Abnormal lymphocytes (decreased: <2%), decreased neutrophils (<2%), decreased white blood cell count (<2%)
Immunologic: Antibody development (3%)
Local: Bruising at injection site (3%), erythema at injection site (4%), infusion-site pain (2%), skin discoloration at injection site (<2%), swelling at injection site (3%)
Nervous system: Dizziness (<2%), fatigue (<2%), voice disorder (<2%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (<2%), limb pain (2%), musculoskeletal pain (<2%), myalgia (<2%)
Respiratory: Cough (3% to 8%), cyanosis (<2%), dyspnea (<2%), nasal congestion (2%), oropharyngeal pain (<2%), paranasal sinus congestion (<2%), rhinorrhea (3%), throat irritation (3%), upper respiratory tract infection (5%)
Miscellaneous: Fever (<2%)
<1%: Hypersensitivity: Anaphylaxis
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: [US Boxed Warning]: Hypersensitivity or anaphylactic reactions (eg, rash/urticaria, cough, dyspnea, cyanosis, postural dizziness, chest discomfort) may occur. Administer in a monitored setting; monitor patients closely for signs and symptoms of hypersensitivity during and after the infusion. If hypersensitivity or anaphylaxis occurs, discontinue the infusion immediately and treat appropriately.
Dosage form specific issues:
• 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). Refer to manufacturer's labeling.
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Anthim: 600 mg/6 mL (6 mL) [contains polysorbate 80]
Obiltoxaximab (ANTHIM) is not available for general public use. All supplies are currently owned by the federal government for inclusion in the Strategic National Stockpile and for use by the US military.
IV: Must be diluted prior to administration. Administer over 90 minutes using a 0.22 micron inline filter. Flush the line with NS at the end of the infusion. Premedication with diphenhydramine is recommended.
IV: Premedication with diphenhydramine is recommended. Administer prepared solution (IV infusion bag or syringe) using a 0.22 micron inline filter over 1 hour and 30 minutes. Flush the line with NS at the end of the infusion.
Store in refrigerator at 2°C to 8°C (36°F to 46°F); protect from light. Do not freeze or shake. Prepared solution in NS in an IV bag for infusion is stable at room temperature or refrigerated for up to 8 hours after admixture. Prepared solution in a syringe for infusion should be administered immediately; do not store.
Treatment of inhalational anthrax in combination with appropriate antibacterial drugs and prophylaxis of inhalational anthrax when alternative therapies are not available or not appropriate (FDA approved in pediatric patients [age not specified] and adults)
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
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Obiltoxaximab is a chimeric monoclonal antibody (IgG1). Placental transfer of human IgG is dependent upon the IgG subclass, maternal serum concentrations, birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis (Palmeira 2012; Pentsuk 2009).
Untreated maternal anthrax infection has a high risk of maternal, fetal, and neonatal death. In general, guidelines for the prophylaxis and treatment of inhalational anthrax following exposure to Bacillus anthracis in pregnant and postpartum women are the same as nonpregnant adults (Meaney-Delman 2014).
Monitor patients closely for signs and symptoms of hypersensitivity during and after the infusion.
Obiltoxaximab is a monoclonal antibody that binds the free protective antigen component of B. anthracis toxin thereby preventing the intracellular entry of the anthrax lethal factor and edema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin.
Distribution: Greater than plasma volume (eg, some tissue distribution).
Excretion: Minimal renal elimination
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