Becker's Hospital Review

BEYFORTUS™ Rx Only (nirsevimab-alip) injection, for intramuscular use Brief Summary of Prescribing Information 1 INDICATIONS AND USAGE 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. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage Neonates and Infants: First RSV Season For neonates and infants born during or entering the RSV season, administer BEYFORTUS starting from birth. For 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) in the full prescribing information]. 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 in Neonates and Infants Born During or Entering Their 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 Children Who Remain at Increased Risk for Severe RSV Disease: Second RSV Season For children up to 24 months of age who remain at increased risk for severe RSV disease in their second RSV season, the recommended dosage of BEYFORTUS is a single 200 mg dose administered as two IM injections (2 x 100 mg). Children Undergoing Cardiac Surgery with Cardiopulmonary Bypass 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. 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. 2.2 Administration Instructions BEYFORTUS must be administered by a healthcare provider. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. BEYFORTUS is a clear to opalescent, colorless to yellow solution. Do not inject BEYFORTUS if the liquid is cloudy, discolored, or it contains large particles or foreign particulate matter. Do not use if the BEYFORTUS pre-filled syringe has been dropped or damaged, the security seal on the carton has been broken, or the expiration date has passed. BEYFORTUS is available in a 50 mg and a 100 mg pre-filled syringe. Check the labels on the BEYFORTUS carton and pre-filled syringe to ensure the correct 50 mg or 100 mg product is being used. Co-administration with Childhood Vaccines and Immunoglobulin Products BEYFORTUS can be given concomitantly with childhood vaccines [see Clinical Pharmacology (12.3) in the full prescribing information]. When administered con- comitantly with injectable vaccines, they should be given with separate syringes and at different injection sites. Do not mix BEYFORTUS with any vaccines or medica- tions in the same syringe or vial. There is no information regarding co-administration of BEYFORTUS with other immunoglobulin products. Palivizumab should not be administered to infants who have already received BEYFORTUS in the same season. There are no data regarding substitution of BEYFORTUS for palivizumab once prophylaxis treatment is initiated with palivizumab for the RSV season. BEYFORTUS may be administered prior to or during the second RSV season to children up to 24 months of age who remain vulnerable to severe RSV disease, and who received palivizumab in their first RSV season [see Adverse Reactions (6.1) and Clinical Studies (14.3) in the full prescribing information]. Administration Instructions for Single-Dose Pre-filled Syringe BEYFORTUS 50 mg (50 mg/0.5 mL) pre-filled syringe with a purple plunger rod. BEYFORTUS 100 mg (100 mg/mL) pre-filled syringe with a light blue plunger rod. Refer to Figure 1 for pre-filled syringe components. Figure 1 Luer Lock Syringe Components Step 1: Holding the Luer lock in one hand (avoid holding the plunger rod or syringe body), unscrew the syringe cap by twisting it counter-clockwise with the other hand. Step 2: Attach a Luer lock needle to the pre-filled syringe by gently twisting the needle clockwise onto the pre-filled syringe until slight resistance is felt. Step 3: Hold the syringe body with one hand and carefully pull the needle cover straight off with the other hand. Do not hold the plunger rod while removing the needle cover or the rubber stopper may move. Do not touch the needle or let it touch any surface. Do not recap the needle or detach it from the syringe. Step 4: Administer the entire contents of the BEYFORTUS pre-filled syringe as an IM injection, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used as an injection site because of the risk of damage to the sciatic nerve. Step 5: Discard syringe into a sharps container. If two injections are required, repeat Steps 1-5 in a different injection site. 4 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 [see Warnings and Precautions (5.1) and Description (11) in the full prescribing information]. 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Including Anaphylaxis Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy. 5.2 Use in Individuals with Clinically Significant Bleeding Disorders As with any other IM injections, BEYFORTUS should be given with caution to infants and children with thrombocytopenia, any coagulation disorder, or to individuals on anticoagulation therapy. 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 3,224 pediatric subjects received the recommended dose of BEYFORTUS in Phase 2 and Phase 3 clinical trials (Trials 03, 04, and 05) including 2,119 infants who were born at 35 weeks gestational age (GA) or older, and 1,105 infants who were born at less than 35 weeks GA. A total of 247 infants of any GA with chronic lung disease (CLD) of prematurity or hemodynamically significant congenital heart disease (CHD) in Trial 05 received the recommended dose of BEYFORTUS. Neonates and Infants Entering Their First RSV Season (Trial 03 and Trial 04) Trial 03 was a randomized, double-blind placebo-controlled trial conducted in preterm infants born at a GA of greater than or equal to 29 weeks to less than 35 weeks. Subjects were randomized 2:1 to receive BEYFORTUS (N=968) or placebo (N=479) by IM injection. All subjects randomized to BEYFORTUS received a single 50 mg IM dose regardless of body weight. Safety data in Trial 03 are presented only for the infants in the BEYFORTUS arm who received the recommended dose [infants who weighed less than 5 kg and who received a single dose of 50 mg BEYFORTUS IM (N=572) or placebo (N=288)]. Trial 04 was a Phase 3, randomized, double-blind, placebo-controlled trial con- ducted in late preterm and term infants born at greater than or equal to 35 weeks

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