Dosing & Uses
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
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%)
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
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.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)
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
Images
Formulary
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