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Anthim
Overview
What is Anthim?
Obiltoxaximab is a chimeric IgG1 kappa monoclonal antibody (mAb) that binds the PA component of toxin. It has an approximate molecular weight of 148 kDa.
ANTHIM injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates. ANTHIM is supplied as 600 mg/6 mL in single-dose vials for intravenous infusion. Each mL contains 100 mg obiltoxaximab in L-histidine (6.2 mg), polysorbate 80 (0.1 mg), sorbitol (36 mg) with a pH of 5.5.
What does Anthim look like?
What are the available doses of Anthim?
Injection: 600 mg/6 mL (100 mg/mL) solution in single-dose vial. ()
What should I talk to my health care provider before I take Anthim?
Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population. (, )
How should I use Anthim?
ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to in combination with appropriate antibacterial drugs.
ANTHIM is indicated for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate
Pre-medicate with diphenhydramine. (, )
Recommended Dosage of ANTHIM:
Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous (IV) infusion over 1 hour and 30 minutes. ()
Administer ANTHIM in a monitored setting equipped to manage anaphylaxis. (, )
See Full Prescribing Information for instructions on preparation, dilution and administration of ANTHIM injection. (, )
What interacts with Anthim?
Sorry No Records found
What are the warnings of Anthim?
Sorry No Records found
What are the precautions of Anthim?
Sorry No Records found
What are the side effects of Anthim?
Sorry No records found
What should I look out for while using Anthim?
None.
Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs
What might happen if I take too much Anthim?
There is no clinical experience with overdosage of ANTHIM. In case of overdosage, monitor patients for any signs or symptoms of adverse effects.
How should I store and handle Anthim?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; excursions permitted to 15°-30°C (59°-86°F).Dispense accompanying Medication Guide to each patient.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]; excursions permitted to 15°-30°C (59°-86°F).Dispense accompanying Medication Guide to each patient.ANTHIM injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates in single-dose vials containing 600 mg/6 mL (100 mg/mL) and is available in the following packaging configuration:Carton: Contains one (1) single-dose vial of ANTHIM 600 mg/6 mL (NDC 69604-204-02).Store in refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. ANTHIM injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates in single-dose vials containing 600 mg/6 mL (100 mg/mL) and is available in the following packaging configuration:Carton: Contains one (1) single-dose vial of ANTHIM 600 mg/6 mL (NDC 69604-204-02).Store in refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light. ANTHIM injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates in single-dose vials containing 600 mg/6 mL (100 mg/mL) and is available in the following packaging configuration:Carton: Contains one (1) single-dose vial of ANTHIM 600 mg/6 mL (NDC 69604-204-02).Store in refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Obiltoxaximab is a monoclonal antibody that binds the PA of
.
Non-Clinical Toxicology
None.Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs
Centrally Acting Agents
Alcohol
Antacids
Compounds Which Inhibit Certain Hepatic Enzymes
Phenytoin
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
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 If anaphylaxis or hypersensitivity reactions occur, stop the infusion immediately and treat appropriately.
Premedication with diphenhydramine is recommended prior to administration of ANTHIM Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
The following clinically important adverse reactions are described elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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