Obiltoxaximab

Obiltoxaximab is a monoclonal antibody that binds the PA of B. anthracis [see Microbiology ( 12.4 )] .

• ANTHIM ® is a monoclonal antibody directed against the protective antigen of Bacillus anthracis . It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B.

• None.contraindicated

Pre-medicate with diphenhydramine. ( 2.1 , 5.1 ) Recommended Dosage of ANTHIM: Adult Patients: 16 mg/kg. ( 2.1 ) Pediatric Patients: ( 2.2 ) ➢ Greater than 40 kg: 16 mg/kg ➢ Greater than 15 kg to 40 kg: 24 mg/kg ➢ Less than or equal to 15 kg: 32 mg/kg Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous (IV) infusion over 1 hour and 30 minutes. ( 2.3 ) Administer ANTHIM in a monitored setting equipped to manage anaphylaxis. ( 2.4 , 5.1 ) See Full Prescribing Information for instructions on preparation, dilution and administration of ANTHIM injection. ( 2.3 , 2.4 ) 2.1 Dosage for Adult Patients Pre-medicate with diphenhydramine prior to administering ANTHIM [see Warnings and Precautions ( 5.1 )] . Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion [see Dosage and Administration ( 2.3 )] . The recommended dosage of ANTHIM in adult patients is a single dose of 16 mg/kg administered intravenously over 90 minutes (1 hour and 30 minutes) [see Dosage and Administration ( 2.4 )] . For adult patients weighing less than 40 kg, see Table 1 below. 2.2 Dosage for Pediatric Patients Pre-medicate with diphenhydramine prior to administering ANTHIM [see Warnings and Precautions ( 5.1 )]. Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion [see Dosage and Administration ( 2.3 )]. The recommended dose for pediatric patients is based on weight as shown in Table 1 below. Table 1.

Hypersensitivity reactions, including anaphylaxis ( Boxed Warning , 1.2 , 2.1 , 12.4 , 5.1 ) 5.1 Hypersensitivity and Anaphylaxis Hypersensitivity reactions were the most common adverse reactions in the safety trials of ANTHIM, occurring in 34/320 healthy subjects (10.6%). Three (0.9%) cases of anaphylaxis occurred during or immediately after the infusion. In clinical trials, manifestations of anaphylaxis were rash/urticaria, cough, dyspnea, cyanosis, postural dizziness and chest discomfort. ANTHIM infusion was discontinued in 8 (2.5%) subjects due to hypersensitivity or anaphylaxis. The adverse reactions reported in these 8 subjects included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnea and chest discomfort. The remaining subjects with hypersensitivity had predominantly skin-related symptoms such as pruritus and rash, and 6 subjects reported cough [see Adverse Reactions 6.1 ]. Due to the risk of anaphylaxis, ANTHIM 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 a period of time after administration [see Patient Counseling Information ( 17 )]. If anaphylaxis or hypersensitivity reactions occur, stop the infusion immediately and treat appropriately. Premedication with diphenhydramine is recommended prior to administration of ANTHIM [see Dosage and Administration ( 2.1 ) and Adverse Reactions ( 6.1 )] .

The following clinically important adverse reactions are described elsewhere in the labeling: Hypersensitivity and Anaphylaxis [see Warnings and Precautions ( 5.1 )]. Most frequently reported adverse reactions in healthy adult subjects (≥1.5%) were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, nasal congestion, infusion site pain, urticaria and pain in extremity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Elusys Therapeutics, Inc. at 1-844-808-0222 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The safety of ANTHIM was evaluated in 320 healthy subjects treated with one or more 16 mg/kg IV doses in three clinical studies. Study 1 was a placebo-controlled study evaluating a single dose of ANTHIM vs. placebo (210 subjects received ANTHIM, 70 received placebo). Study 2 was a repeat-dose study in which 70 subjects received the first dose, but 34 and 31 subjects received a second dose of ANTHIM in sequences A (2 weeks apart) and B (≥ 4 months apart), respectively.

Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population. ( 1.2 , 8.4 ) 8.1 Pregnancy Risk Summary There are no data on the use of ANTHIM in pregnant women to inform on drug-associated risk. There are adverse effects on maternal and fetal outcomes associated with anthrax in pregnancy (see Clinical Considerations ). In pregnant rabbits, intravenous administration of obiltoxaximab during organogenesis was not associated with adverse developmental outcomes at up to 0.62 times the human systemic exposure at the maximum recommended adult dose (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Limited data in the form of case reports of anthrax infection in pregnant women indicate that maternal infection is associated with a high risk of maternal, fetal, and neonatal deaths, particularly in the absence of treatment.

Metabolism

The PK of obiltoxaximab are linear over the dose range of 4 mg/kg (0.25 times the lowest recommended dose) to 16 mg/kg following single IV administration in healthy subjects. Following single IV administration of ANTHIM 16 mg/kg in healthy, male and female human subjects, the mean C max and AUC inf were 400 ± 91.2 mcg/mL and 5170 ± 1360 mcg•day/mL, respectively.

There is no clinical experience with overdosage of ANTHIM. In case of overdosage, monitor patients for any signs or symptoms of adverse effects.

• Mar 18, 2016BLABLA125509Elusys Therapeutics Inc

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The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Obiltoxaximab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• An Open Label Field Study of Anthim (Obiltoxaximab) in Subjects Exposed to B. Anthracis
  Unknown · Phase 4 · Interventional · 100 enrolled · Elusys Therapeutics
  NCT03088111updated 2023-07-14
• Safety, Tolerability and PK of Repeat Administration of Intravenous ETI-204 in Adult Volunteers
  Completed · Phase 1 · Interventional · 70 enrolled · Elusys Therapeutics
  NCT01932242updated 2019-05-14
• Intramuscular Dose-Escalation Study With ETI-204 in Adult Volunteers
  Completed · Phase 1 · Interventional · 36 enrolled · Elusys Therapeutics
  NCT01932437updated 2019-05-06
• Safety, Tolerability and PK of Intravenous (IV) ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
  Completed · Phase 1 · Interventional · 40 enrolled · Elusys Therapeutics
  NCT01952444updated 2019-04-16
• Safety, Tolerability, and PK of a Single Intravenous Dose of ETI-204 in Adult Volunteers
  Completed · Phase 1 · Interventional · 280 enrolled · Elusys Therapeutics
  NCT01929226updated 2019-04-08
• Intravenous Dose-Escalation Study With ETI-204 in Adult Volunteers
  Completed · Phase 1 · Interventional · 45 enrolled · Elusys Therapeutics
  NCT00829582updated 2017-11-14
• Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers
  Completed · Phase 1 · Interventional · 108 enrolled · Elusys Therapeutics
  NCT01453907updated 2017-11-14
• Monoclonal Antibody for Treatment of Inhalation Anthrax
  Completed · Phase 1 · Interventional · 36 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT00138411updated 2010-08-27

Frequently asked questions

How does Obiltoxaximab work?

Obiltoxaximab is a monoclonal antibody that binds the PA of B. anthracis [see Microbiology ( 12.4 )] .

What is Obiltoxaximab used for?

According to FDA labeling, Obiltoxaximab carries indications including: ANTHIM ® is a monoclonal antibody directed against the protective antigen of Bacillus anthracis . It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Obiltoxaximab?

Obiltoxaximab is classified as Antibacterial monoclonal antibodies, Anthrax Protective Antigen-directed Antibody, Anthrax Protective Antigen-directed Antibody Interactions.

What are the brand names for Obiltoxaximab?

Obiltoxaximab is marketed under brand names including Anthim.

What are the contraindications for Obiltoxaximab?

Obiltoxaximab labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.