Nirsevimab

Registered South African indications:

• Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

South African recommendations

Caution in the following patient groups

• Renal impairment
• Hepatic impairment

Traceability

• In order to improve the traceability of biological medicines, the name and the batch number of the administered product should be clearly recorded

Hypersensitivity including anaphylaxis

• Serious hypersensitivity reactions, including anaphylaxis, have been observed with monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medicines and/or supportive therapy

Clinically significant bleeding disorders

• As with any other intramuscular injections, nirsevimab should be given with caution to infants with thrombocytopenia or any coagulation disorder

Infants at higher risk for severe RSV disease

• There was no significant influence of chronic lung disease or congenital heart disease on the pharmacokinetics of nirsevimab

Effects on ability to drive and use machines

• Not applicable

Not established for use in adults

Paed. forms avail. in SA and covered in this monograph: inj

South African registered indications and dosages

Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season

Infants with body weight < 5kg

• IM: 50mg, admin. as a single dose prior to commencement of the RSV season, or from birth for infants born during the RSV season

Infants with body weight ≥ 5kg

• IM: 100mg, admin. as a single dose prior to commencement of the RSV season, or from birth for infants born during the RSV season

Children 2-18 years

• Not established for use

Nirsevimab should be used in accordance with official recommendations

Dosing in infants with a body weight from 1.0kg to < 1.6kg is based on extrapolation, no clinical data are available. Exposure in infants < 1kg is anticipated to yield higher exposures than in those weighing more. The benefits and risks of nirsevimab use in infants < 1kg should be carefully considered

There are limited data available in extremely preterm infants (gestational age [GA] < 29 weeks) less than 8 weeks of age. No clinical data available in infants with a postmenstrual age (gestational age at birth plus chronological age) of less than 32 weeks

For infants undergoing cardiac surgery with cardiopulmonary bypass, an additional dose may be administered as soon as the infant is stable after surgery to ensure adequate nirsevimab serum levels. If within 90 days after receiving the first dose of nirsevimab, the additional dose should be 50mg or 100mg according to body weight. If more than 90 days have elapsed since the first dose, the additional dose could be a single dose of 50mg regardless of body weight, to cover the remainder of the RSV season

There are no safety and efficacy data available on repeat dosing

Method of administration

Nirsevimab is for intramuscular injection only. It is administered intramuscularly, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. See additional prescribing points for instructions

Pregnancy

South African recommendations

• No applicable

Breastfeeding

South African recommendations

• No applicable

Fertility

South African recommendations

• No applicable

South African recommendations

• Caution; no information available
  No clinical studies have been conducted to investigate the effect of renal impairment. As a typical IgG monoclonal antibody, nirsevimab is not cleared renally due to its large molecular weight, change in renal function is not expected to influence nirsevimab clearance

South African recommendations

• Caution; no information available
  No clinical studies have been conducted to investigate the effect of hepatic impairment. As IgG monoclonal antibodies are not primarily cleared via the hepatic pathway, change in hepatic function is not expected to influence nirsevimab clearance

South African recommendations

• Not indicated for use in geriatric patients

Skin and Subcutaneous Tissue Disorders

Uncommon

• Rash
  • Maculo-papular rash
  • Macular rash

General Disorders and Administration Site Conditions

Uncommon

• Injection site reaction
  • Injection site pain
  • Injection site induration
  • Injection site oedema
  • Injection site swelling

None known

None routine

Instructions for administration

• Nirsevimab is available in a 50mg and a 100mg pre-filled syringe. Check the labels on the carton and pre-filled syringe to make sure you have selected the correct 50mg or 100mg presentation as required
• There is no standard protocol on needle size across countries. Healthcare professionals should use a needle long enough to reach deep into the muscle to ensure that the product is deposited within the proper tissue layer, an appropriate length and gauge of needle must be selected. Healthcare professionals should review their local requirements for needle usage
• Refer to product packaging for strength identification and steps

Nirsevimab is a recombinant neutralising human IgG1ĸ long-acting monoclonal antibody to the prefusion conformation of the RSV F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half-life. Nirsevimab binds to a highly conserved epitope in antigenic site Ø (zero) on the prefusion protein with dissociation constants KD = 0.12 nM and KD = 1.22 nM for RSV subtype A and B strains, respectively. Nirsevimab inhibits the essential membrane fusion step in the viral entry process, neutralising the virus and blocking cell to-cell fusion.