Beyfortus
(Nirsevimab)Dosage & Administration
Administer as an intramuscular injection. (
For neonates and infants born during the RSV season, administer BEYFORTUS starting from birth.
For neonates and infants born outside the RSV season, administer BEYFORTUS once prior to the start of the RSV season considering duration of protection provided by BEYFORTUS
The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season is based on body weight (see Table 1) and is administered as a single intramuscular (IM) injection.
| Body Weight at Time of Dosing | Recommended Dosage |
|---|---|
| Less than 5 kg | 50 mg by IM injection |
| 5 kg and greater | 100 mg by IM injection |
For children up to 24 months of age, regardless of body weight, who remain at increased risk for severe RSV disease in their second RSV season, refer to Table 2 below for recommended dosage.
| Child's Age at Time of Dosing | Recommended Dosage |
|---|---|
| Up to 24 months of ageRegardless of body weight | 200 mg administered as two IM injections of (2 × 100 mg) |
For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of BEYFORTUS is recommended as soon as the child is stable after surgery to ensure adequate nirsevimab-alip serum levels. The recommended dosage of BEYFORTUS is administered as an IM injection.
Recommended dosage:
Neonates and infants born during or entering their first RSV season:
Children who remain vulnerable through their second RSV season:
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Beyfortus Prescribing Information
BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (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.
Administer as an intramuscular injection. (
For neonates and infants born during the RSV season, administer BEYFORTUS starting from birth.
For neonates and infants born outside the RSV season, administer BEYFORTUS once prior to the start of the RSV season considering duration of protection provided by BEYFORTUS
The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season is based on body weight (see Table 1) and is administered as a single intramuscular (IM) injection.
| Body Weight at Time of Dosing | Recommended Dosage |
|---|---|
| Less than 5 kg | 50 mg by IM injection |
| 5 kg and greater | 100 mg by IM injection |
For children up to 24 months of age, regardless of body weight, who remain at increased risk for severe RSV disease in their second RSV season, refer to Table 2 below for recommended dosage.
| Child's Age at Time of Dosing | Recommended Dosage |
|---|---|
| Up to 24 months of ageRegardless of body weight | 200 mg administered as two IM injections of (2 × 100 mg) |
For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of BEYFORTUS is recommended as soon as the child is stable after surgery to ensure adequate nirsevimab-alip serum levels. The recommended dosage of BEYFORTUS is administered as an IM injection.
- If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be based on body weight at the time of the additional dose. Refer to Table 1 for weight-based dosing.
- If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 50 mg regardless of body weight.
- If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be 200 mg, regardless of body weight.
- If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 100 mg, regardless of body weight.
Recommended dosage:
Neonates and infants born during or entering their first RSV season:
- 50 mg if less than 5 kg in body weight. ()
2.1 Recommended DosageFirst RSV Season for Neonates and InfantsFor neonates and infants born during the RSV season, administer BEYFORTUS starting from birth.
For neonates and infants born outside the RSV season, administer BEYFORTUS once prior to the start of the RSV season considering duration of protection provided by BEYFORTUS[see Clinical Pharmacology (12.2)].The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season is based on body weight (see Table 1) and is administered as a single intramuscular (IM) injection.
Table 1 Recommended Dosage of BEYFORTUS for the First RSV Season Body Weight at Time of Dosing Recommended Dosage Less than 5 kg 50 mg by IM injection 5 kg and greater 100 mg by IM injection Second RSV Season for Children Who Remain at Increased Risk for Severe RSV DiseaseFor children up to 24 months of age, regardless of body weight, who remain at increased risk for severe RSV disease in their second RSV season, refer to Table 2 below for recommended dosage.
Table 2 Recommended Dosage of BEYFORTUS for the Second RSV Season for Children Who Remain at Increased Risk for Severe RSV Disease Child's Age at Time of Dosing Recommended Dosage Up to 24 months of ageRegardless of body weight 200 mg administered as two IM injections of (2 × 100 mg) First and Second RSV Season for Children Undergoing Cardiac Surgery with Cardiopulmonary BypassFor children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of BEYFORTUS is recommended as soon as the child is stable after surgery to ensure adequate nirsevimab-alip serum levels. The recommended dosage of BEYFORTUS is administered as an IM injection.
First RSV season:- If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be based on body weight at the time of the additional dose. Refer to Table 1 for weight-based dosing.
- If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 50 mg regardless of body weight.
Second RSV season:- If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be 200 mg, regardless of body weight.
- If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 100 mg, regardless of body weight.
- 100 mg if greater than or equal to 5 kg in body weight. ()
2.1 Recommended DosageFirst RSV Season for Neonates and InfantsFor neonates and infants born during the RSV season, administer BEYFORTUS starting from birth.
For neonates and infants born outside the RSV season, administer BEYFORTUS once prior to the start of the RSV season considering duration of protection provided by BEYFORTUS[see Clinical Pharmacology (12.2)].The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season is based on body weight (see Table 1) and is administered as a single intramuscular (IM) injection.
Table 1 Recommended Dosage of BEYFORTUS for the First RSV Season Body Weight at Time of Dosing Recommended Dosage Less than 5 kg 50 mg by IM injection 5 kg and greater 100 mg by IM injection Second RSV Season for Children Who Remain at Increased Risk for Severe RSV DiseaseFor children up to 24 months of age, regardless of body weight, who remain at increased risk for severe RSV disease in their second RSV season, refer to Table 2 below for recommended dosage.
Table 2 Recommended Dosage of BEYFORTUS for the Second RSV Season for Children Who Remain at Increased Risk for Severe RSV Disease Child's Age at Time of Dosing Recommended Dosage Up to 24 months of ageRegardless of body weight 200 mg administered as two IM injections of (2 × 100 mg) First and Second RSV Season for Children Undergoing Cardiac Surgery with Cardiopulmonary BypassFor children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of BEYFORTUS is recommended as soon as the child is stable after surgery to ensure adequate nirsevimab-alip serum levels. The recommended dosage of BEYFORTUS is administered as an IM injection.
First RSV season:- If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be based on body weight at the time of the additional dose. Refer to Table 1 for weight-based dosing.
- If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 50 mg regardless of body weight.
Second RSV season:- If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be 200 mg, regardless of body weight.
- If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 100 mg, regardless of body weight.
Children who remain vulnerable through their second RSV season:
- 200 mg (2 × 100 mg injections). ()
2.1 Recommended DosageFirst RSV Season for Neonates and InfantsFor neonates and infants born during the RSV season, administer BEYFORTUS starting from birth.
For neonates and infants born outside the RSV season, administer BEYFORTUS once prior to the start of the RSV season considering duration of protection provided by BEYFORTUS[see Clinical Pharmacology (12.2)].The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season is based on body weight (see Table 1) and is administered as a single intramuscular (IM) injection.
Table 1 Recommended Dosage of BEYFORTUS for the First RSV Season Body Weight at Time of Dosing Recommended Dosage Less than 5 kg 50 mg by IM injection 5 kg and greater 100 mg by IM injection Second RSV Season for Children Who Remain at Increased Risk for Severe RSV DiseaseFor children up to 24 months of age, regardless of body weight, who remain at increased risk for severe RSV disease in their second RSV season, refer to Table 2 below for recommended dosage.
Table 2 Recommended Dosage of BEYFORTUS for the Second RSV Season for Children Who Remain at Increased Risk for Severe RSV Disease Child's Age at Time of Dosing Recommended Dosage Up to 24 months of ageRegardless of body weight 200 mg administered as two IM injections of (2 × 100 mg) First and Second RSV Season for Children Undergoing Cardiac Surgery with Cardiopulmonary BypassFor children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of BEYFORTUS is recommended as soon as the child is stable after surgery to ensure adequate nirsevimab-alip serum levels. The recommended dosage of BEYFORTUS is administered as an IM injection.
First RSV season:- If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be based on body weight at the time of the additional dose. Refer to Table 1 for weight-based dosing.
- If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 50 mg regardless of body weight.
Second RSV season:- If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be 200 mg, regardless of body weight.
- If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 100 mg, regardless of body weight.
BEYFORTUS is a clear to opalescent, colorless to yellow solution available as follows:
- Injection: 50 mg/0.5 mL in a single-dose pre-filled syringe.
- Injection: 100 mg/mL in a single-dose pre-filled syringe.
The safety and effectiveness of BEYFORTUS in children older than 24 months of age have not been established. (
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
Use of BEYFORTUS in this population is supported by the following:
- Trial 03, a randomized, double-blind, placebo-controlled multicenter trial for the prevention of MA RSV LRTI conducted in preterm infants born at GA greater than or equal to 29 weeks and less than 35 weeks entering their first RSV season;- Trial 04, a double-blind, placebo-controlled multicenter trial, for the prevention of MA RSV LRTI in term and late preterm infants GA greater than or equal to 35 weeks entering their first RSV season;- Trial 05, a Phase 2/3 randomized, double-blind, palivizumab-controlled multicenter trial in pediatric subjects born less than 35 weeks GA and infants with CLD of prematurity or hemodynamically significant CHD entering their first or second RSV season.
In addition, BEYFORTUS was evaluated in an open-label, uncontrolled, single-dose trial (Trial 08) in 100 infants and children who were less than or equal to 24 months of age, who received BEYFORTUS in their first or second RSV season, and who had a wide variety of underlying diseases or treatments resulting in immune compromise. The safety profile of BEYFORTUS administered in Trial 08 was consistent with the safety profile of other trials of BEYFORTUS in infants and children
Trial 09 is a Phase 3b randomized, open-label trial of BEYFORTUS compared to no intervention for the prevention of hospitalization in term and preterm infants (GA greater than or equal to 29 weeks) born during or entering their first RSV season
The safety and effectiveness of BEYFORTUS have not been established in children older than 24 months of age.
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
Serious hypersensitivity reactions have been reported following BEYFORTUS administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.
Nirsevimab-alip, a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The molecular weight is approximately 146.3 kDa.
BEYFORTUS (nirsevimab-alip) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection. It is supplied in a single-dose siliconized Luer lock Type I glass pre-filled syringe with a FluroTec coated plunger stopper.
Each 0.5 mL contains 50 mg nirsevimab-alip, arginine hydrochloride (8 mg), histidine (1.1 mg), L-histidine hydrochloride monohydrate (1.6 mg), polysorbate 80 (0.1 mg), sucrose (21 mg), and water for injection (USP). The pH is 6.0.
Each 1 mL contains 100 mg nirsevimab-alip, arginine hydrochloride (17 mg), histidine (2.2 mg), L-histidine hydrochloride monohydrate (3.3 mg), polysorbate 80 (0.2 mg), sucrose (41 mg), and water for injection (USP). The pH is 6.0.
- Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions have been reported following BEYFORTUS administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment. ()
5.1 Hypersensitivity Reactions Including AnaphylaxisSerious hypersensitivity reactions have been reported following BEYFORTUS administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.