nirsevimab (Rx)

Brand and Other Names:Beyfortus, nirsevimab-alip

Dosing & Uses

AdultPediatric

Not indicated for adults, see Pediatric Dosing & Uses

Dosage Forms & Strengths

IM injection, solution

  • 50mg/0.5mL prefilled syringe
  • 100mg/mL prefilled syringe

Respiratory Syncytial Virus Prevention

Indicated for prevention of respiratory syncytial virus (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

Neonates and infants (first RSV season)

  • Dosage for neonates and infants born during or entering their first RSV season is based on body weight
  • <5 kg: 50 mg IM X 1 dose
  • ≥5 kg: 100 mg IM X 1 dose

Children who remain at increased risk for severe RSV disease (second RSV season)

  • Aged ≤24 months: 200 mg IM x 1 dose (ie, two 100-mg IM injections)

Children undergoing cardiac surgery with cardiopulmonary bypass

  • Additional dose recommended as soon as child is stable after surgery to ensure adequate nirsevimab serum levels
  • First RSV season
    • Surgery ≤90 days after receiving nirsevimab: Base additional dose on body weight at the time of additional dose; refer to above weight-based dosing
    • >90 days since receiving nirsevimab: Additional dose of 50 mg regardless of body weight
  • Second RSV season
    • Surgery ≤90 days after receiving nirsevimab: Additional dose of 200 mg, regardless of body weight
    • >90 days since receiving nirsevimab: Additional dose of 100 mg, regardless of body weight

Dosage Modifications

Renal or hepatic impairment

  • Prescribing information states an effect of renal or hepatic impairment on nirsevimab pharmacokinetics is not expected
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Adverse Effects

<1%

Rash within 14 days post-dose (0.9%); placebo (0.6%)

Injection site reaction within 7 days post-dose (0.3%); placebo (0%)

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Warnings

Contraindications

History of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab or its excipients

Cautions

Hypersensitivity

  • Serious hypersensitivity reactions, including anaphylaxis, observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies
  • If signs and symptoms of clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy

Bleeding disorders

  • As with any other IM injections, use caution if administered to infants and children with thrombocytopenia, any coagulation disorder, or to individuals on anticoagulation therapy

RSV diagnostic assays

  • 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
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Pregnancy & Lactation

Pregnancy and Lactation

Not indicated for use in females of reproductive potential

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Recombinant human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that provides passive immunity by targeting the prefusion conformation of RSV F protein

It neutralizes RSV by inhibiting conformation changes in the F protein necessary for fusion of the viral and cellular membranes and viral entry

A triple amino acid substitution (YTE) in the Fc region increases binding to the neonatal Fc receptor and extends serum half-life

Absorption

Absolute bioavailability: 84%

Peak plasma concentration: 6 days

Distribution

Vd: 477 mL (infant weighing 5 kg)

Metabolism

Degraded into small peptides by catabolic pathways

Elimination

Half-life: ~71 days

Clearance: ~3.42 mL/day (infant weighing 5 kg)

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Administration

IM Preparation

Inspect visually for particulate matter and discoloration before administration; solution should appear clear to opalescent, and colorless to yellow

Discard if liquid is cloudy, discolored, or it contains large particles or foreign particulate matter

Do not use if syringe has been dropped or damaged, the security seal on carton has been broken, or expiration date has passed

Available as 50 mg and 100 mg prefilled syringes; to avoid errors, check labels on carton and prefilled syringe to ensure correct 50-mg or 100-mg product is being used; check dose and syringe; 50-mg prefilled syringe has purple plunger rod and 100-mg prefilled syringe has light blue plunger rod

IM Administration

Administer IM by healthcare provider

Instructions

  • Holding Luer lock in one hand (avoid holding plunger rod or syringe body), unscrew syringe cap by twisting it counter-clockwise with other hand
  • Attach a Luer lock needle to prefilled syringe by gently twisting needle clockwise onto the prefilled syringe until slight resistance is felt
  • Hold syringe body with one hand and carefully pull needle cover straight off with other hand; do not hold the plunger rod while removing the needle cover or the rubber stopper may move
  • Do not touch needle or let it touch any surface; do not recap needle or detach it from the syringe
  • Administer entire contents in prefilled syringe as an IM injection, preferably in anterolateral aspect of the thigh
  • Do not inject gluteal muscle because of risk of damage to the sciatic nerve in infants
  • Discard syringe into sharps container
  • If 2 injections are required, repeat above in a different injection site

Coadministration with childhood vaccines and immunoglobulin products

  • May be given concomitantly with childhood vaccines; administer with separate syringes and at different injection sites
  • Do not mix with any vaccines or medications in the same syringe or vial
  • No information available regarding coadministration of nirsevimab with other immunoglobulin products
  • Do not administer palivizumab to infants who have already received nirsevimab in the same season
  • There are no data regarding substitution for palivizumab once prophylaxis treatment is initiated with palivizumab for the RSV season
  • Initiate before or during the second RSV season to children up to 24 months of age who remain vulnerable to severe RSV disease, including those who received palivizumab in their first RSV season

Storage

Refrigerate 36-46ºF (2-8ºC)

May store at room temperature 68-77ºF (20-25ºC) for up to 8 hr

After removal from refrigerator, must use within 8 hr or discard

Store in original carton to protect from light until time of use

Do not freeze

Do not shake

Do not expose to heat

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.