DRUG INTERACTIONS-(summary)-

1 Interference with RT-PCR or Rapid Antigen Detection RSV Diagnostic Assays Nirsevimab-alip does not interfere with reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen detection RSV diagnostic assays that employ commercially available antibodies targeting antigenic site I, II, or IV on the RSV fusion (F) protein.

For immunological assay results which are negative when clinical observations are consistent with RSV infection, it is recommended to confirm using an RT-PCR-based assay.

BRIEF SUMMARY

NIRSEVIMAB-(July 2023)

Indication-  prevent respiratory tract syncytial virus  (RSV) disorder 

Dosage-  intramuscular injection. Recommended dosage: Neonates and infants born during  their first RSV season:  50 mg if less than 5 kg in body weight.                         100 mg if greater than or equal to 5 kg in body weight.

ADR- t common adverse reactions were rash) and injection site

CI-  contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis

Pat Inform- Advise the caregiver that the child will receive one dose of BEYFORTUS by IM injection.  If the child remains at increased risk for RSV, they may receive a second dose 

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U.S.  APPROVED DRUGS DURING 2023                                        

Serial No 27

Name-                       BEYFORTUS

Acive  Ingredient -  Nirsevimab-alip

Pharmacological clssificiation-        To prevent respiratory tract syncytial virus                                                                      (RSV) disorder                                                                                                                     

 Date of Approval-         7/17/2023

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use BEYFORTUS™ safely and effectively.

See full prescribing information for BEYFORTUS. BEYFORTUS (nirsevimab-alip) injection, for intramuscular use

Initial U.S. Approval: 2023

 INDICATIONS AND USAGE -

 BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in: ? Neonates and infants born during or entering their first RSV season

 Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

 ADVERSE REACTIONS-

 Most common adverse reactions were rash (0.9%) and injection site reactions (0.3%). 

CONTRAINDICATIONS -

 BEYFORTUS is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients. 

 WARNINGS AND PRECAUTIONS -

Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human IgG1 monoclonal antibodies. Initiate appropriate medications and/or supportive therapy.

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DOSAGE AND ADMINISTRATION

Administer as an intramuscular injection. (2.1) Recommended dosage: Neonates and infants born during or entering their first RSV season: ? 50 mg if less than 5 kg in body weight.  100 mg if greater than or equal to 5 kg in body weight.

Children who remain vulnerable through their second RSV season: ? 200 mg (2 x 100 mg injections).

 DOSAGE FORMS AND STRENGTHS -

 Injection: 50 mg/0.5 mL in a single-dose pre-filled syringe. 

100 mg/mL in a single-dose pre-filled syringe.

 PATIENT COUNSELING INFORMATION

Advise the child’s caregiver to read the FDA-approved patient labeling (Patient Information).

Dosage and Administration-

Advise the caregiver that the child will receive one dose of BEYFORTUS by IM injection by a healthcare provider. If the child remains at increased risk for RSV, they may receive a second dose in the second RSV season

Manufactured by: AstraZeneca AB, Södertälje, Sweden SE-15185 US License No. 2059 Distributed by: Sanofi Pasteur, Inc., Swiftwater, PA 18370 USA BEYFORTUS is a trademark of the Sanofi group of companies. ©AstraZeneca 2023

CLINICAL PHARMACOLOGY

1. Mechanism of Action

BEYFORTUS is a monoclonal antibody with anti-RSV activity [see Microbiology (12.4)].

2. Pharmacodynamics -

There is a positive correlation between a serum nirsevimab-alip AUC (based on clearance at baseline) above 12.8 mg*day/mL and a lower incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI).

Following IM administration of nirsevimab-alip in adults, RSV neutralizing antibody levels in serum were approximately 4 times higher than baseline at 8 hours after nirsevimab-alip dosing, and maximum levels were reached by day 6 following IM administration of nirsevimab-alip in adults.

The safety and effectiveness of BEYFORTUS have not been established in adults. 

3. Pharmacokinetics-

 The PK of nirsevimab-alip is dose-proportional following a single IM administration of doses ranging from 25 mg (0.5 times the lowest approved recommended dosage) to 200 mg in pediatric subjects.

 Distribution-

The estimated nirsevimab-alip total volume of distribution is 477 mL, for an infant weighing 5 kg.

Elimination-

The nirsevimab-alip terminal half-life is approximately 71 days and the estimated clearance is 3.42 mL/day for an infant weighing 5 kg.

Metabolism-

 Nirsevimab-alip is degraded into small peptides by catabolic pathways.

Specific Populations-

 No clinically significant differences in the pharmacokinetics of nirsevimab-alip were observed based on race or vulnerability to severe RSV disease (i.e., CLD, CHD, GA <29 weeks, or immunocompromised states). An effect of renal or hepatic impairment on nirsevimab-alip pharmacokinetics is not expected.

Drug Interaction Studies -

No formal drug interaction studies have been performed with BEYFORTUS. Nirsevimab-alip is not predicted to be a substrate of, inhibitor or inducer of cytochrome P450 enzymes or transporter systems based on a mechanistic understanding of monoclonal antibodies.

Clinical Studies Vaccines:

There is limited experience with co-administration of BEYFORTUS with vaccines. In clinical trials, when BEYFORTUS was given concomitantly with routine childhood vaccines, the safety and reactogenicity profile of the coadministered regimen was similar to the childhood vaccines given alone.

USE IN SPECIFIC POPULATIONS

1 Pregnancy-

BEYFORTUS is not indicated for use in females of reproductive potential.

2. Lactation-

BEYFORTUS is not indicated for use in females of reproductive potential.

3. Pediatric Use-

The safety and effectiveness of BEYFORTUS have been established for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

The safety and efficacy of BEYFORTUS for this indication and populations are discussed throughout the labeling.

Use of BEYFORTUS for this indication is supported by evidence from adequate and well-controlled studies in neonates and infants from birth up to 12 months of age with additional pharmacokinetic and safety data in children up to 24 months of age

The safety and effectiveness of BEYFORTUS have not been established in children older than 24 months of age.

 OVERDOSAGE-

There is limited experience of overdose with BEYFORTUS. There is no specific treatment for an overdose with BEYFORTUS. In the event of an overdose, the individual should be monitored for the occurrence of adverse reactions and provided with symptomatic treatment as appropriate.