Synagis^® (Solution, Lyophilisate) Instructions for Use

Instructions
Dosage forms

ATC Code

J06BD01 (Palivizumab)

Active Substance

Palivizumab (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Humanized monoclonal antibodies with antiviral activity

Pharmacotherapeutic Group

Monoclonal antibodies

Pharmacological Action

Humanized monoclonal antibodies IgG_1k, interacting with epitope A of the fusion protein (F protein) of the respiratory syncytial virus (RSV). The palivizumab molecule consists of human (95%) and murine (5%) sequences.

Palivizumab exhibits pronounced neutralizing and inhibitory activity against the fusion proteins of RSV strains of subtypes A and B.

At a plasma concentration of about 30 µg/ml in cotton rats, palivizumab reduces RSV replication by 99%.

Pharmacokinetics

In clinical studies in adult volunteers, palivizumab administered intramuscularly once a month had a pharmacokinetic profile similar to that of human IgG₁ antibodies in terms of V_d (mean value 57 ml/kg) and T_1/2 (mean value 18 days).

In a study in children, the mean T_1/2 after a single dose of 15 mg/kg was 20 days.

After 30 days, the minimum serum concentration of the active substance was about 40 µg/ml after the first injection, about 60 µg/ml after the second injection, and about 70 µg/ml after the third and fourth injections.

Indications

Prevention of severe lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at high risk of RSV infection, which include: children under 6 months of age born at 35 weeks of gestation or earlier; children under 2 years of age who required treatment for bronchopulmonary dysplasia within the last 6 months; children under 2 years of age with hemodynamically significant congenital heart defects.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
J12.1	Pneumonia due to respiratory syncytial virus
Z29.8	Other specified prophylactic measures

ICD-11 code	Indication
CA40.11	Pneumonia due to respiratory syncytial virus
QC05.Z	Prophylactic measures, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution, Lyophilisate

Administered intramuscularly, preferably into the anterolateral aspect of the thigh.

The single dose is 15 mg/kg. The regimen consists of 5 injections given at monthly intervals during the seasonal rise in RSV incidence.

Children who become infected with RSV during palivizumab administration should continue to receive it monthly throughout the season to reduce the risk of reinfection.

Adverse Reactions

Respiratory system: Uncommon – upper respiratory tract infections, rhinitis, cough, sneezing; Rare – apnea.

Hematopoietic system: Uncommon – leukopenia.

Skin and subcutaneous tissue: Uncommon – rash.

Digestive system: Uncommon – diarrhea, vomiting, abnormal liver function tests (including increased AST, ALT).

Allergic reactions: Very rare – anaphylaxis and urticaria.

General disorders and administration site conditions: Common – fever, injection site reactions, nervousness; Uncommon – viral infection, pain.

Immunological reactions: 1% – formation of antibodies specific to palivizumab, characterized by low titer (transient and of no clinical significance).

Contraindications

Hypersensitivity to palivizumab or to other human monoclonal antibodies.

Special Precautions

Administration of palivizumab may be accompanied by immediate-type allergic reactions, including anaphylactic reactions. Therefore, patients should be under medical supervision for at least 30 minutes, and the room where the administration takes place should be equipped with anti-shock therapy means.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Synagis^® [AstraZeneca AB (Sweden)]
Solution for intramuscular injection 100 mg/1 ml: 0.5 ml or 1 ml vial 1 pc.

Marketing Authorization Holder

AstraZeneca AB (Sweden)

Manufactured By

Boehringer Ingelheim Pharma, GmbH & Co. KG (Germany)

Packaging and Quality Control Release

AbbVie, S.r.L. (Italy)

PHARMSTANDARD-UfaVITA, JSC (Russia)

Dosage Form

Synagis^®

Solution for intramuscular injection 100 mg/1 ml: 0.5 ml or 1 ml vial 1 pc.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection clear or slightly opalescent, colorless or slightly yellowish, the presence of small translucent particles is acceptable.

	1 ml
Palivizumab*	100 mg

Excipients: glycine – 0.12 g, histidine – 3.9 mg, water for injections – q.s. to 1 ml.

0.5 ml (nominal volume) – 2R vials made of colorless glass (1) – plastic containers (1) – cardboard packs with first-opening control.
1 ml (nominal volume) – 2R vials made of colorless glass (1) – plastic containers (1) – cardboard packs with first-opening control.

* The vial contains an overfill of the drug to ensure the withdrawal of a dose of 50 mg or 100 mg, respectively. The volume of the finished product is about 0.7 ml ± 0.1 ml (nominal volume 0.5 ml) or 1.2 ml ± 0.1 ml (nominal volume 1 ml) of a solution with a concentration of 100 mg/ml.

Synagis^® [AbbVie, LLC (Russia)]
Lyophilizate for preparation of solution for intramuscular injection 50 mg: fl. 4 ml 1 pc.