Active Ingredient: Obiltoxaximab
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:
For:
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.
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. |
Obiltoxaximab must be administered via intravenous infusion over 90 minutes.
For:
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.
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 |
Obiltoxaximab must be administered via intravenous infusion over 90 minutes.
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