Inhalational anthrax

Active Ingredient: Obiltoxaximab

Indication for Obiltoxaximab

Population group: only minors (0 - 18 years old) , adults (18 years old or older)
Therapeutic intent: Preventive action

Obiltoxaximab is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available.

For this indication, competent medicine agencies globally authorize below treatments:

16 mg/kg body weight once for patients weighing ≥40 kg and 24 mg/kg body weight once for patients weighing <40 kg

For:

Dosage regimens

Regimen A: In case that patient weight is ≥ 40 kg, intravenous, 16 milligrams obiltoxaximab per kilogram of body weight, one dose.

Regimen B: In case that patient weight is ≤ 40 kg, intravenous, 24 milligrams obiltoxaximab per kilogram of body weight, one dose.

Detailed description

The recommended dosage of obiltoxaximab in adult patients weighing at least 40 kg is a single intravenous infusion of 16 mg/kg body weight (bw). The recommended dosage of obiltoxaximab in adult patients weighing less than 40 kg is a single intravenous infusion of 24 mg/kg bw.

Premedication with an antihistamine is recommended before administration of obiltoxaximab.

For dose modifications in case of infusion-related reactions (IRR) see the following table.

Obiltoxaximab dose modifications for infusion-related reactions:

Severity of IRR Dose modification
Grade 1–3
Infusion-related
reaction
Obiltoxaximab infusion should be interrupted and supportive treatment should
be given.

For the first instance of Grade 3 wheezing, bronchospasm, or generalized
urticaria, obiltoxaximab should be permanently discontinued.

For recurrent Grade 2 wheezing or urticaria, or for recurrence of any Grade 3
symptoms, obiltoxaximab should be permanently discontinued.

Otherwise, upon complete resolution of symptoms, infusion may be resumed at
50% of the rate achieved prior to interruption. In the absence of infusion-related
symptoms, the rate of infusion is described in table 3.

Premedication should be administered.
Grade 4
Infusion-related
reaction
Obiltoxaximab infusion should be stopped immediately.
Supportive treatment should be given.
Obiltoxaximab should be permanently discontinued.

Dosage considerations

Obiltoxaximab must be administered via intravenous infusion over 90 minutes.

16 mg/kg/bw once for patients weighting ≥40 kg, 24 mg/kg/bw once for patients weighting 15-40 kg, 32 mg/kg/bw once for patients weighting ≤15 kg

For:

Dosage regimens

Regimen A: In case that patient weight is ≥ 40 kg, intravenous, 16 milligrams obiltoxaximab per kilogram of body weight, one dose.

Regimen B: In case that patient weight is ≥ 15 kg and patient weight is ≤ 40 kg, intravenous, 24 milligrams obiltoxaximab per kilogram of body weight, one dose.

Regimen C: In case that patient weight is ≤ 15 kg, intravenous, 32 milligrams obiltoxaximab per kilogram of body weight, one dose.

Detailed description

The recommended dose for paediatric patients is based on weight as shown in the table below.

Recommended paediatric dose of obiltoxaximab (weight-based dosing):

Body weight [kg] Dose [mg/kg bw]
>40 16
>15 to 40 24
15 or less 32

Dosage considerations

Obiltoxaximab must be administered via intravenous infusion over 90 minutes.

Active ingredient

Obiltoxaximab

Obiltoxaximab is a monoclonal antibody that binds the protective antigen (PA) of B. anthracis. Obiltoxaximab inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the anthrax lethal factor and oedema factor, the enzymatic toxin components responsible for the pathogenic effects of anthrax toxin.

Read more about Obiltoxaximab

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