Beyfortus Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Nirsevimab

Indications/Uses

Prevention of resp syncytial virus (RSV) lower resp tract disease in neonates & infants during their 1st RSV season, & in childn up to 24 mth of age who remain vulnerable to severe RSV disease through their 2nd RSV season.

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Dosage/Direction for Use

IM Infant during 1st RSV season weighing ≥5 kg Single dose of 100 mg, <5 kg Single dose of 50 mg. Administer from birth for infants born during RSV season, & administer prior to RSV season for those born outside the season. Childn remaining vulnerable to severe RSV disease through 2nd RSV season Single dose of 200 mg (2 inj of 100 mg). Administer prior to start of 2nd RSV season. Individual undergoing cardiac surgery w/ cardiopulmonary bypass May administer additional dose as soon as individual is stable after surgery. W/in 90 days after receiving 1st dose: 50 mg or 100 mg according to body wt during 1st RSV season, or 200 mg during 2nd RSV season. >90 days since 1st dose: Single dose of 50 mg regardless of body wt during 1st RSV season, or 100 mg during 2nd RSV season.

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Overdosage

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Contraindications

Hypersensitivity.

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Special Precautions

Immediately discontinue administration if signs & symptoms of anaphylaxis or other clinically significant hypersensitivity reaction occur. Do not routinely use gluteal muscle as inj site due to risk of damage to sciatic nerve. Use different inj sites if 2 inj are required. Administer w/ caution to individuals w/ thrombocytopenia or any coagulation disorder. May not provide same level of protection in some immunocompromised childn w/ protein-losing conditions. Contains 0.1 mg of polysorbate 80 in each 50 mg (0.5 mL) dose & 0.2 mg in each 100 mg (1 mL) dose. No clinical data available for dosing in infants weighing 1 kg to <1.6 kg. Carefully consider benefits & risks of use in infants weighing <1 kg. Limited data available in extremely preterm infants (gestational age <29 wk) <8 wk of age. No clinical data available in infants w/ postmenstrual age <32 wk. Safety & efficacy in childn 2-18 yr have not been established.

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Use In Pregnancy & Lactation

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Adverse Reactions

Rash, pyrexia, inj site reactions.

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Drug Interactions

Do not mix w/ any vaccine in the same syringe or vial. Administer w/ separate syringes & at different inj sites when administered concomitantly w/ injectable vaccines.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Beyfortus detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Vaccines, Antisera & Immunologicals / Antivirals

ATC Classification

J06BD08 - nirsevimab ; Belongs to the class of antiviral monoclonal antibodies. Used in passive immunizations.

Regulatory Classification

P₁S₁S₃

Presentation/Packing

Form

Beyfortus soln for inj 100 mg/mL

Packing/Price

1's

Form

Beyfortus soln for inj 50 mg/0.5 mL

Packing/Price

1's

Beyfortus

Manufacturer:

Sanofi

Distributor:

Zuellig

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