Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Lörrach, Germany
NYXTHRACIS is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis (see section 5.1).
NYXTHRACIS is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.1).
NYXTHRACIS should be given as soon as it is clinically indicated.
Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of NYXTHRACIS.
The recommended dosage of NYXTHRACIS in adult patients weighing at least 40 kg is a single intravenous infusion of 16 mg/kg body weight (bw). The recommended dosage of NYXTHRACIS 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 NYXTHRACIS (see sections 4.4 and 4.8).
For dose modifications in case of infusion-related reactions (IRR) see table 1.
Table 1. 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. |
No dosage adjustment is needed for patients ≥65 years of age (see section 5.2).
The recommended dose for paediatric patients is based on weight as shown in table 2 below.
Table 2. 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.
The vial should not be shaken. Obiltoxaximab must be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection prior to administration as an intravenous infusion (see section 6.6).
The diluted obiltoxaximab intravenous infusion must be infused over 90 minutes with the infusion rate described in table 3, using an infusion bag or syringe for infusion and a 0.22 micron inline filter.
Patients need to be monitored closely for signs and symptoms of hypersensitivity throughout the infusion and for at least one hour after administration (see section 4.4). Infusion related reactions should be managed as outlined in table 1.
The line is to be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection at the end of the intravenous infusion.
Table 3. Obiltoxaximab dose, total infusion volume and infusion rate by body weight:
| Body weight [kg] (weight-based dosing) | Total infusion volume [mL] [infusion bag or syringe]* | Infusion rate [mL/h] |
|---|---|---|
| >40 kg or adult (16 mg/kg bw) | ||
| >40 | 250 | 167 |
| >15 kg to 40 kg (24 mg/kg bw) | ||
| 31 to 40 | 250 | 167 |
| 16 to 30 | 100 | 67 |
| 15 kg or less (32 mg/kg bw) | ||
| 11 to 15 | 100 | 67 |
| 5 to 10 | 50 | 33.3 |
| 3.1 to 4.9 | 25 | 17 |
| 2.1 to 3 | 20 | 13.3 |
| 1.1 to 2 | 15 | 10 |
| 1 or less | 7 | 4.7 |
* For instructions on dilution of the medicinal product and use of infusion bag or syringe before administration, see section 6.6.
In case of overdose, patients should be monitored for any signs or symptoms of adverse effects.
Unopened vial:
7 years.
Diluted solution in infusion bag:
After dilution in infusion bag, chemical, physical and microbial in-use stability has been demonstrated for 8 hours at room temperature (20°C–25°C) or in the refrigerator (2°C–8°C).
From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Diluted solution in syringe for infusion:
Once a diluted solution of NYXTHRACIS has been prepared, it should be administered immediately and not stored. Any unused product should be discarded.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original packaging in order to protect from light.
For storage conditions after dilution of the medicinal product, see section 6.3.
600 mg/6 mL of concentrate in vial (type I glass) with rubber stopper and a polypropylene cap with aluminium seal.
Pack contains 1 vial.
Important preparation instructions:
Preparation and dilution in infusion bag:
1. Calculate the milligrams of obiltoxaximab needed by multiplying the recommended mg/kg dose in table 2 (see section 4.2) by the individual patient’s body weight in kilograms.
2. Calculate the required volume in millilitres of obiltoxaximab concentrate for solution for infusion and number of vials needed for the dose by dividing the calculated dose in milligrams (step 1) by the concentration, 100 mg/mL. Each single vial allows delivery of 6 mL of obiltoxaximab concentrate for solution for infusion.
3. Select an appropriate size infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection. Withdraw a volume of solution from the infusion bag equal to the calculated volume in millilitres of obiltoxaximab in step 2 above. Discard the solution that was withdrawn from the infusion bag.
4. Withdraw the required volume of obiltoxaximab concentrate for solution for infusion (calculated from step 2) from the NYXTHRACIS vial(s). Discard any unused portion remaining in the NYXTHRACIS vial(s).
5. Transfer the required volume of obiltoxaximab concentrate for solution for infusion to the selected infusion bag.
6. Gently invert the infusion bag to mix the solution. Do not shake.
7. The infusion must be administered over 90 minutes with the infusion rate described in table 3 (see section 4.2), using a 0.22 micron inline filter.
8. The prepared solution is stable for 8 hours stored at room temperature 20°C to 25°C or 8 hours stored in the refrigerator at 2°C to 8°C.
Preparation and dilution in syringe for infusion:
1. Calculate the milligrams of obiltoxaximab needed by multiplying the recommended mg/kg dose in table 2 (see section 4.2) by the individual patient’s body weight in kilograms.
2. Calculate the required volume in millilitres of obiltoxaximab concentrate for solution for infusion and number of vials needed for the dose by dividing the calculated dose in milligrams (step 1) by the concentration, 100 mg/mL. Each single vial allows delivery of 6 mL of NYXTHRACIS concentrate for solution for infusion.
3. Select an appropriate size syringe for the total volume of infusion to be administered.
4. Using the selected syringe and a 0.22 micron inline filter, withdraw the required volume of obiltoxaximab concentrate for solution for infusion (calculated from step 2). Discard any unused portion remaining in the NYXTHRACIS vial(s).
5. Withdraw an appropriate amount of sodium chloride 9 mg/mL (0.9%) solution for injection to prepare the total infusion volume specified in table 2.
6. Gently mix the solution. Do not shake.
7. Once a diluted solution of obiltoxaximab has been prepared, administer immediately. Do not store solution in syringe. Discard unused product.
Disposal:
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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