Obiltoxaximab

Indications

Obiltoxaximab is used for: Inhalation Anthrax

Adult Dose

Inhalation Anthrax Indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs It is also indicated for prophylaxis of inhalational anthrax due to B anthracis when alternative therapies are not available or not appropriate Weight ?40 kg: 16 mg/kg IV as a single dose Weight <40 kg: 24 mg/kg IV as a single dose Infuse IV over 90 minutes

Child Dose

Inhalation Anthrax Indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs It is also indicated for prophylaxis of inhalational anthrax due to B anthracis when alternative therapies are not available or not appropriate Weight-based dosing Administer as a single IV dose infused over 90 minutes (see Administration) >40 kg: 16 mg/kg IV 15-40 kg: 24 mg/kg IV <15 kg: 32 mg/kg IV

Renal Dose

Administration

IV Preparation Solution should appear clear to opalescent, colorless to pale yellow to pale brownish-yellow that may contain few translucent-to-white proteinaceous particulates Discard vial if the solution is discolored or contains extraneous particles other than a few translucent-to-white, proteinaceous particles Do not shake the vial IV Administration Premedicate with diphenhydramine before administering obiltoxaximab Administer obiltoxaximab in appropriately monitored settings equipped to manage anaphylaxis Dilute injection before administering IV using the bag or syringe for infusion After preparation of the bag or syringe for infusion, administer the infusion solution using a 0.22-micron inline filter with the infusion rate described (see IV preparation) Administer diluted IV infusion over 90 minutes Monitor patients closely for signs and symptoms of hypersensitivity throughout the infusion and for a period of time after administration Stop infusion immediately and treat appropriately, if hypersensitivity or anaphylaxis occurs Flush IV line with 0.9% NaCl at the end of infusion

Contra Indications

Precautions

Hypersensitivity reactions were the most common adverse reactions in the safety trials (see Black Box Warnings) Premedication with diphenhydramine is recommended prior to administration; diphenhydramine does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity

Pregnancy-Lactation

Pregnancy Pregnancy category B; no adequate and well-controlled studies in pregnant women were conducted; use only if clearly needed Animal study: No evidence of harm to the pregnant New Zealand White (NZW) rabbit dam or the fetuses was observed at ~2-fold the human dose Lactation Unknown if distributed in human breast milk Although human immunoglobulins are excreted in human milk, published data suggest that neonatal consumption of human milk does not result in substantial absorption of these maternal immunoglobulins into circulation Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Interactions

Side Effects

Side effects of Obiltoxaximab : >10% Hypersensitivity (10.6%) 1-10% Headache (8%) Upper respiratory tract infections (5%) Pruritus (4%) Cough (3%) Vessel puncture site bruise (3%) Infusion site swelling (3%) Nasal congestion (2%) Infusion site pain (2%) Urticaria (2%) Pain in extremity (2%) <1% Anaphylaxis (0.9%)

Mode of Action

Monoclonal antibody that binds to the protective antigen of B anthracis and prevents the formation of the anthrax toxin that directly damages cells; disrupts cell defense mechanisms that lead to organ injury, uncontrolled bacterial growth, and death