General MedicationsINTRAVENOUSGeneric

Anthim

obiltoxaximab

Standard Dose

Refer to label-specific dosage instructions.

Max Dose

See product label

Primary Use

Marketed solution containing OBILTOXAXIMAB.

Summary

Product profile Marketed solution containing OBILTOXAXIMAB.

Dose form and route SOLUTION · INTRAVENOUS

Structured Monograph

Clinical summary

Product profile Marketed solution containing OBILTOXAXIMAB. Dose form and route SOLUTION · INTRAVENOUS

Boxed Warning

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS 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 [see Indications and Usage ( 1.2 ), Dosage and Administration ( 2.4 ) and Warnings and Precautions ( 5.1 )]. WARNING: HYPERSENSITIVITY and ANAPHYLAXIS See full prescribing information for complete boxed warning. Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion ( 5.1 ) ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis ( 1.2 , 2.4 , 5.1 ) Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs ( 2.4 , 5.1 )

Monitoring

• 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.
• Review the product-specific label before prescribing.