Nirsevimab-alip: Difference between revisions
Alen Antony (talk | contribs) (Created page with "{{DrugProjectFormSinglePage |authorTag={{AAP}} |genericName=Nirsevimab-alip |aOrAn=a |drugClass=human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody |indicationType=prevention |indication=Respiratory Syncytial Virus (RSV) lower respiratory tract disease for neonates and infants born during or entering their first RSV season and children up to 24 years of age who are vulnerable to severe RSV disease in their second RSV season. |adverseReactions=rashes and injection...") |
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2. Usage in children with bleeding and coagulation disorder. | 2. Usage in children with bleeding and coagulation disorder. | ||
Since BEYFORTUS is administered intramuscularly, it should given with caution in the children with thrombocytopenia and other bleeding disorder. | Since BEYFORTUS is administered intramuscularly, it should given with caution in the children with thrombocytopenia and other bleeding disorder. | ||
|clinicalTrials=The adverse effects reported from a clinical trial consisting of 3,224 pediatric subjects, in which 2,570 received BEYFORTUS and 0.9% experienced rashes and 0.3% experienced injection site reactions (pain, induration, edema, swelling) and 1,284 received Placebo had experienced 0.6% experienced rashes. | |||
|useInPregnancyFDA=BEYFORTUS is not indicated for use in females of reproductive potential. | |||
|useInLaborDelivery=BEYFORTUS is not indicated for use in females of reproductive potential. | |||
|useInNursing=BEYFORTUS is not indicated for use in females of reproductive potential. | |||
|useInReproPotential=BEYFORTUS is not indicated for use in females of reproductive potential. | |||
|administration=BEYFORTUS is administered intramuscularly | |||
The recommended dosage for neonates and infants born during or entering their first RSV season depends upon the body weight: | |||
Less than 5 kg: 50 mg of IM injection | |||
5 kg or greater: 100 mg of IM injection | |||
The recommended dosage for children up to age of 24 months who remain at increased risk for severe RSV disease in their second RSV season, 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 bypass surgery, they may receive additional dosage of BEYFORTUS after the child is stable post-surgery. | |||
For the first RSV season, if the surgery was in 90 days of receiving BEYFORTUS additional dose is given as per body weight and if after 90 days the additional dose is 50 mg regardless of body weight. | |||
For the second RSV season, if surgery is within 90 days of receiving BEYFORTUS additional dose is 200mg and if after 90 days additional dose is 100mg. | |||
|monitoring=BEYFORTUS can be given co-adminstered with other childhood vaccines, but should not be given with 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 | |||
|mechAction=BEYFORTUS is a monoclonal antibody with anti-RSV activity. | |||
This provides passive immunity by targeting the prefusion conformation of the RSV F protein which then neutralizes RSV by inhibiting conformation changes in the F protein necessary for fusion of the viral and cellular membranes and viral entry. | |||
|structure=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. | |||
|PK=The estimated nirsevimab-alip absolute bioavailability is 84% and the median time to maximum concentration is 6 days. | |||
The estimated nirsevimab-alip total volume of distribution is 477 mL, for an infant weighing 5 kg. | |||
The nirsevimab-alip terminal half-life is approximately 71 days and the estimated clearance is 3.42 mL/day for an infant weighing 5 kg. | |||
Nirsevimab-alip is degraded into small peptides by catabolic pathway. | |||
|howSupplied=BEYFORTUS injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution supplied as, | |||
*One 50 mg/0.5 mL single-dose pre-filled syringe in a carton | |||
*Five 50 mg/0.5 mL single-dose pre-filled syringes in a carton | |||
*One 100 mg/mL single-dose pre-filled syringe in a carton | |||
*Five 100 mg/mL single-dose pre-filled syringes in a carton | |||
|storage=Store refrigerated between 36°F to 46°F (2°C to 8°C). | |||
BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 8 hours. | |||
After removal from the refrigerator, BEYFORTUS must be used within 8 hours or | |||
discarded. | |||
Store BEYFORTUS in original carton to protect from light until time of use. | |||
Do not freeze. Do not shake. Do not expose to heat. | |||
|brandNames=BEYFORTUS | |brandNames=BEYFORTUS | ||
}} | }} | ||
Latest revision as of 23:46, 13 May 2024
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]
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Overview
Nirsevimab-alip is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is FDA approved for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease for neonates and infants born during or entering their first RSV season and children up to 24 years of age who are vulnerable to severe RSV disease in their second RSV season.. Common adverse reactions include rashes and injection site reactions..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
BEYFORTUS is a respiratory syncytial virus (RSV) F protein‑directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and children up to age 24 years during the RSV season.
The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season, which is given intramuscularly: Less than 5 kg: 50 mg of IM injection 5 kg or greater: 100 mg of IM injection
The recommended dosage for children up to 24 months of age who remain at increased risk for severe RSV disease in their second RSV season is 200 mg administered as two doses (100 mg each).
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Nirsevimab-alip FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
BEYFORTUS is contraindicated in children who have any history of hypersensitivity reaction to nirsevimab-alip or to any of the excipients.
Warnings
1. Hypersensitivity Reactions Including Anaphylaxis some children may develop severe hypersensitivity reactions like urtricaria, dyspnea, cyanosis, or hypotonia following the administration. Since BEYFORTUS is a human immunoglobulin G1 (IgG1) monoclonal antibodies, it may even cause anaphylatic reaction. Appropriate treatment should be immediately given if the child develops any of the reaction.
2. Usage in children with bleeding and coagulation disorder. Since BEYFORTUS is administered intramuscularly, it should given with caution in the children with thrombocytopenia and other bleeding disorder.
Adverse Reactions
Clinical Trials Experience
The adverse effects reported from a clinical trial consisting of 3,224 pediatric subjects, in which 2,570 received BEYFORTUS and 0.9% experienced rashes and 0.3% experienced injection site reactions (pain, induration, edema, swelling) and 1,284 received Placebo had experienced 0.6% experienced rashes.
Postmarketing Experience
There is limited information regarding Nirsevimab-alip Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Nirsevimab-alip Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
BEYFORTUS is not indicated for use in females of reproductive potential.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nirsevimab-alip in women who are pregnant.
Labor and Delivery
BEYFORTUS is not indicated for use in females of reproductive potential.
Nursing Mothers
BEYFORTUS is not indicated for use in females of reproductive potential.
Pediatric Use
There is no FDA guidance on the use of Nirsevimab-alip in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Nirsevimab-alip in geriatric settings.
Gender
There is no FDA guidance on the use of Nirsevimab-alip with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nirsevimab-alip with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Nirsevimab-alip in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Nirsevimab-alip in patients with hepatic impairment.
Females of Reproductive Potential and Males
BEYFORTUS is not indicated for use in females of reproductive potential.
Immunocompromised Patients
There is no FDA guidance one the use of Nirsevimab-alip in patients who are immunocompromised.
Administration and Monitoring
Administration
BEYFORTUS is administered intramuscularly
The recommended dosage for neonates and infants born during or entering their first RSV season depends upon the body weight: Less than 5 kg: 50 mg of IM injection 5 kg or greater: 100 mg of IM injection
The recommended dosage for children up to age of 24 months who remain at increased risk for severe RSV disease in their second RSV season, 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 bypass surgery, they may receive additional dosage of BEYFORTUS after the child is stable post-surgery. For the first RSV season, if the surgery was in 90 days of receiving BEYFORTUS additional dose is given as per body weight and if after 90 days the additional dose is 50 mg regardless of body weight. For the second RSV season, if surgery is within 90 days of receiving BEYFORTUS additional dose is 200mg and if after 90 days additional dose is 100mg.
Monitoring
BEYFORTUS can be given co-adminstered with other childhood vaccines, but should not be given with 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
IV Compatibility
There is limited information regarding the compatibility of Nirsevimab-alip and IV administrations.
Overdosage
There is limited information regarding Nirsevimab-alip overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Nirsevimab-alip Pharmacology in the drug label.
Mechanism of Action
BEYFORTUS is a monoclonal antibody with anti-RSV activity. This provides passive immunity by targeting the prefusion conformation of the RSV F protein which then neutralizes RSV by inhibiting conformation changes in the F protein necessary for fusion of the viral and cellular membranes and viral entry.
Structure
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.
Pharmacodynamics
There is limited information regarding Nirsevimab-alip Pharmacodynamics in the drug label.
Pharmacokinetics
The estimated nirsevimab-alip absolute bioavailability is 84% and the median time to maximum concentration is 6 days.
The estimated nirsevimab-alip total volume of distribution is 477 mL, for an infant weighing 5 kg.
The nirsevimab-alip terminal half-life is approximately 71 days and the estimated clearance is 3.42 mL/day for an infant weighing 5 kg.
Nirsevimab-alip is degraded into small peptides by catabolic pathway.
Nonclinical Toxicology
There is limited information regarding Nirsevimab-alip Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Nirsevimab-alip Clinical Studies in the drug label.
How Supplied
BEYFORTUS injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution supplied as,
- One 50 mg/0.5 mL single-dose pre-filled syringe in a carton
- Five 50 mg/0.5 mL single-dose pre-filled syringes in a carton
- One 100 mg/mL single-dose pre-filled syringe in a carton
- Five 100 mg/mL single-dose pre-filled syringes in a carton
Storage
Store refrigerated between 36°F to 46°F (2°C to 8°C). BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 8 hours. After removal from the refrigerator, BEYFORTUS must be used within 8 hours or discarded. Store BEYFORTUS in original carton to protect from light until time of use. Do not freeze. Do not shake. Do not expose to heat.
Images
Drug Images
{{#ask: Page Name::Nirsevimab-alip |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Nirsevimab-alip |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Nirsevimab-alip Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Nirsevimab-alip interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
BEYFORTUS
Look-Alike Drug Names
There is limited information regarding Nirsevimab-alip Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.