Palivizumab
Indications
Registered South African indications:
- Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus
Cautions
Contraindications
- Hypersensitivity to the active ingredient or any of its excipients
- Hypersensitivity to to other humanised monoclonal antibodies
Cautions
- Moderate to severe acute infection or febrile illness
- Thrombocytopaenia or any coagulation disorder
Adult dosage
Not established for use in adults
Paediatric dosage
Paed. forms avail. in SA and covered in this monograph: inj
Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in paediatric patients at high risk for RSV disease
- Infants with bronchopulmonary dysplasia (BPD)
- Infants with a history of prematurity (<35 weeks gestational age)
- Children < 2 years with haemodynamically significant congenital heart disease (CHD)
- IM: 15mg/kg, monthly during periods of increased RSV risk
The first dose should be administered prior to commencement of the RSV season and subsequent doses should be administered monthly throughout the RSV season
In the southern hemisphere the RSV season typically commences in March and lasts until August but RSV activity may begin earlier or persist later
To avoid risk of reinfection, it is recommended that children receiving palivizumab who become infected with RSV continue to receive monthly doses for the duration of the RSV season
Preferably administer into the anterolateral aspect of the thigh, gluteal muscle should not be used
Injection volumes over 1ml should be given as a divided dose
Special populations
Pregnancy
- Not indicated for use in adults
- Palivizumab is not indicated for use in adults. Data on pregnancy are not available
Breastfeeding
- Not indicated for use in adults
- Palivizumab is not indicated for use in adults. Data on breastfeeding women are not available
Renal Impairment
Hepatic Impairment
Elderly
Porphyria Information
Drugs in Sport
- Permitted - No warnings
Adverse reactions
Central Nervous System Disorders
- Seizures
Respiratory Disorders
- Apnoea
Skin and Subcutaneous Tissue Disorders
- Rash
- Urticaria
- Injection site reaction
Immune, Blood and Lymphatic System Disorders
- Thrombocytopenia
- Anaphylaxis
- Anaphylactic shock
- Pyrexia
Interactions
No information available
Monitoring
- Reporting of suspected adverse reactions
Mechanism of action
Palivizumab is a humanised IgG1K monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV). Palivizumab exhibits neutralising and fusion-inhibitory activity against RSV.
Dosage forms
- Injection
Formulation
Injection (per 0.5ml) 50mg
- Synagis (AbbVie) originator
Injection (per ml) 100mg
- Synagis (AstraZeneca Pharmaceuticals) originator
References
1. SAMF_12th Edition_Page 351 2. SmPC: Synagis 100 mg/ml solution for injection, AbbVie Ltd: Last updated on eMC: 23 May 2018; Downl;oaded onlie 22 Feb 2019 [https://www.medicines.org.uk/emc/product/6963] 3. https://drive.google.com/drive/folders/1fOXwLsWjP9v-i3Do2u_4e1gE8v4OLID2 (22/06/2015_Abbvie_Synagis_50mg, 100mg_inj) 4. https://www.drugs.com/pregnancy/palivizumab.html 5. U2D: Palivizumab: Drug information; Uptodate; Downloaded online 22 Feb 2019 [https://www.uptodate.com/contents/palivizumab-drug-information?source=search_result&search=Palivizumab&selectedTitle=1~32] 6. https://trello.com/c/HC9W6XWF/5-palivizumab 7. NAPOS The Drug Database for Acute Porphyria: J06BB16 Palivizumab; Accessed online 22 Feb 2019 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=J06BB16] 8. South African Institute for Drug-Free Sport: Synagis; Accessed online 22 Feb 2019 [http://www.drugfreesport.org.za/online-medication-check/] 9. NAPOS The Drug Database for Acute Porphyria: J06BB16 Palivizumab; Accessed online 8 April 2020 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?l=gbr&atc_code=J06BB16] 10. SmPC: Synagis solution for injection, AbbVie Ltd: Last updated 20 Dec 2019; updated 8 April 2020, [https://www.medicines.org.uk/emc/product/6963] 11. Dr Irhuma. Updates for Palivizumab [https://trello.com/c/rMS5bjHg/321-list-of-hot-monographs-1]. Dated 13 November 2019. Updated 8 April 2020. 12. Porphyria information: Palivizumab, Updated 15 April 2020 [http://porphyriadrugs.com/search/?q=Palivizumab]
Brands & products
3 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days oldinjectionGeneric· 3 products
from R8966.87/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Synagis 50 Mg | 50 mg | 1 | S4 | R8966.87 | R8966.87 | R703.27 | 883856005 |
| Synagis | 100 mg/ml | 0 | S4 | R9388.19 | R9388.19 | R726.18 | 3000492001 |
| Synagis | 100 mg/ml | 1 | S4 | R18548.27 | R18548.27 | R1224.25 | 3000493001 |
- Synagis
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.