Pemivibart

Renal Impairment PEMGARDA is not eliminated intact in the urine, thus renal impairment is not expected to affect the exposure of pemivibart. Similarly, dialysis is not expected to impact the PK of pemivibart.

Renal Impairment PEMGARDA is not eliminated intact in the urine, thus renal impairment is not expected to affect the exposure of pemivibart. Similarly, dialysis is not expected to impact the PK of pemivibart.

Hepatic Impairment The effect of hepatic impairment on the PK of pemivibart is unknown.

Hepatic Impairment The effect of hepatic impairment on the PK of pemivibart is unknown.

2 DOSAGE AND ADMINISTRATION 2.1 Dosage for Emergency Use of PEMGARDA Initial Dosing : The initial dosage of PEMGARDA in adults and adolescents (12 years of age and older weighing at least 40 kg) is 4500 mg administered as a single intravenous (IV) infusion [see Clinical Pharmacology (1 2.3 ) ]. Repeat Dose : The repeat dosage is 4500 mg of PEMGARDA administered as a single IV infusion every 3 months.

Vials of PEMGARDA are for one-time use only. Visually inspect the vials for particulate matter and discoloration. PEMGARDA is a clear to slightly opalescent, colorless to yellow solution. Discard the vial if the solution is cloudy, discolored, or if visible particles are observed. PEMGARDA should be administered as an IV infusion diluted with 0.9% sodium chloride.

Materials Needed: 9 single-dose vials of PEMGARDA (125 mg/mL) 50 mL prefilled bag of 0.9% sodium chloride (normal saline) for IV injection IV extension set with inline 0.2-micron filter Infusion pump or gravity infusion set 0.9% sodium chloride injection for flushing Preparation : Remove PEMGARDA vials from refrigerated storage and allow to equilibrate to room temperature (18℃ to 26℃ [64℉ to 79℉]) for 10 minutes before preparation.

The final product for administration will contain 50 mL: 36 mL of PEMGARDA and 14 mL of 0.9% sodium chloride. This product is preservative-free and therefore should be administered immediately. If immediate administration is not possible, the diluted solution may be stored at room temperature under ambient light for up to 4 hours.

Do not shake the diluted solution. Administration: PEMGARDA should only be administered in settings in which healthcare providers have immediate access to medications to treat a severe hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary [see Warnings and Precautions ] .

Attach infusion set including inline 0.2-micron filter to prepared IV bag, then prime the infusion set. Administer the entire 50 mL infusion using infusion pump or gravity infusion set over a minimum of 60 minutes. Due to potential overfill, the entire contents of prepared IV bag should be administered to avoid underdosing.

Once infusion is complete, flush line with 0.9% sodium chloride. Clinically monitor patients during infusion and observe patients for at least 2 hours after infusion is complete [see Warnings and Precautions ] . 2.1 Dosage for Emergency Use of PEMGARDA Initial Dosing : The initial dosage of PEMGARDA in adults and adolescents (12 years of age and older weighing at least 40 kg) is 4500 mg administered as a single intravenous (IV) infusion [see Clinical Pharmacology (1 2.3 ) ].

Repeat Dose : The repeat dosage is 4500 mg of PEMGARDA administered as a single IV infusion every 3 months. Repeat dosing should be timed from the date of the most recent PEMGARDA dose. The recommendations for dosing are based on the totality of the scientific evidence including clinical pharmacology data, antiviral activity data, and clinical study data [see Clinical Pharmacology , Microbiology, and Clinical Studies ] . 2.2 Dosage Adjustment in Specific Populations No dosage adjustment is recommended in pregnant or lactating individuals, in geriatrics, or in individuals with renal or hepatic impairment [see Use in Specific Populations ] . 2.3Dose Preparation and Administration General Information : PEMGARDA should be prepared and administered by a qualified healthcare provider using aseptic technique .

Vials of PEMGARDA are for one-time use only. Visually inspect the vials for particulate matter and discoloration. PEMGARDA is a clear to slightly opalescent, colorless to yellow solution. Discard the vial if the solution is cloudy, discolored, or if visible particles are observed. PEMGARDA should be administered as an IV infusion diluted with 0.9% sodium chloride.

Materials Needed: 9 single-dose vials of PEMGARDA (125 mg/mL) 50 mL prefilled bag of 0.9% sodium chloride (normal saline) for IV injection IV extension set with inline 0.2-micron filter Infusion pump or gravity infusion set 0.9% sodium chloride injection for flushing Preparation : Remove PEMGARDA vials from refrigerated storage and allow to equilibrate to room temperature (18℃ to 26℃ [64℉ to 79℉]) for 10 minutes before preparation.

The final product for administration will contain 50 mL: 36 mL of PEMGARDA and 14 mL of 0.9% sodium chloride. This product is preservative-free and therefore should be administered immediately. If immediate administration is not possible, the diluted solution may be stored at room temperature under ambient light for up to 4 hours.

Do not shake the diluted solution. Administration: PEMGARDA should only be administered in settings in which healthcare providers have immediate access to medications to treat a severe hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary [see Warnings and Precautions ] .

Attach infusion set including inline 0.2-micron filter to prepared IV bag, then prime the infusion set. Administer the entire 50 mL infusion using infusion pump or gravity infusion set over a minimum of 60 minutes. Due to potential overfill, the entire contents of prepared IV bag should be administered to avoid underdosing.

Once infusion is complete, flush line with 0.9% sodium chloride. Clinically monitor patients during infusion and observe patients for at least 2 hours after infusion is complete [see Warnings and Precautions ] .