Nyxthracis (Previously Obiltoxaximab SFL)

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. Posology 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. 8). Medicinal product no longer authorised 3 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. 2). Paediatric population 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 Method of administration Obiltoxaximab must be administered via intravenous infusion over 90 minutes.

Precautions to be taken before handling or administering the medicinal product The vial should not be shaken. 6). 22 micron inline filter. 4). Infusion related reactions should be managed as outlined in table 1. 9%) solution for injection at the end of the intravenous infusion.

Summary of the safety profile The safety of obiltoxaximab has been studied only in healthy adult subjects. The safety of obiltoxaximab was evaluated in 320 healthy subjects (aged 18 to 79 years old) treated with one or two 16 mg/kg intravenous doses in three clinical studies.

Overall 250 of the 320 subjects received a single dose of 16 mg/kg obiltoxaximab. Hypersensitivity related adverse reactions (including rash) occurred in 9% (22/250) of these subjects, with one case of anaphylaxis that occurred during the infusion.

The infusion was discontinued in 3% (8/250) due to hypersensitivity or anaphylaxis. The most frequently reported adverse reactions were headache (4%, 9/250), pruritus (4%, 9/250), and urticaria (2%, 6/250). 2%) (includes dizziness and dizziness postural).

4%). 2%). Tabulated list of adverse reactions Table 4 presents adverse reactions observed with obiltoxaximab in the 250 healthy human subjects that received a single intravenous dose of 16 mg/kg obiltoxaximab, by System Organ Class and frequency.

The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); and uncommon (≥1/1,000 to <1/100). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Table 4:

Adverse reactions reported in healthy adult subjects MedDRA System Organ Class Common Uncommon Immune system disorders Anaphylactic reaction Hypersensitivity Nervous system disorders Headache Dizziness Dizziness postural Hypoaesthesia Eye disorders Photophobia Ear and labyrinth disorders Ear discomfort Vascular disorders Phlebitis Medicinal product no longer authorised 7 MedDRA System Organ Class Common Uncommon Respiratory, thoracic, and mediastinal disorders Cough Throat irritation Dysphonia Sinus congestion Dyspnoea Gastrointestinal disorders Lip pain Skin and subcutaneous tissue disorders Pruritus, urticaria, rash Dermatitis allergic Rash generalised Skin exfoliation Musculoskeletal and connective tissue disorders Pain in extremity Muscle spasm Muscle twitching Pain in jaw General disorders and administration site conditions Infusion site pain Pain Chest discomfort Chills Fatigue Infusion site swelling Non-cardiac chest pain Tenderness Vessel puncture site pain Description of selected adverse reactions Hypersensitivity and anaphylaxis The adverse reactions reported in the 8 subjects in whom the obiltoxaximab infusion was discontinued for possible hypersensitivity included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnoea and chest discomfort.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Infusion-related reactions, hypersensitivity and anaphylaxis Infusion-related/hypersensitivity reactions were commonly observed during clinical trials with obiltoxaximab in healthy subjects.

Due to the risk of severe reactions or anaphylaxis, obiltoxaximab should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Patients should be monitored closely throughout the infusion period and for at least one hour after administration.

Since the clinical trials were conducted in healthy volunteers, obiltoxaximab infusions were stopped at the onset of any reaction. Based on experience with other monoclonal antibodies used in the treatment of serious medical conditions, infusions can generally be completed if managed appropriately.

Infusion-related reactions should be managed as outlined in table 1. g. 2). Diphenhydramine was administered 30 minutes prior to treatment with obiltoxaximab in clinical trials conducted with obiltoxaximab. Premedication with an antihistamine does not prevent anaphylaxis and may mask or delay onset of symptoms of hypersensitivity.

Anthrax meningitis Obiltoxaximab does not cross the blood-brain barrier and does not prevent or treat anthrax meningitis. 2). Laboratory test interactions Exposure to NYXTHRACIS may interfere with serological tests for anthrax. 1). Medicinal products containing sorbitol may be fatal if given intravenously to subjects with hereditary fructose intolerance (HFI).

Obiltotoxaximab should not be used in subjects with HFI unless there is an overwhelming clinical need and no alternatives are available. A detailed history with regard to HFI symptoms should be taken from each patient prior to being given this medicinal product.

1.