Allopathy
Prescription Required
DCGI (Drugs Controller General of India)
Schedule H
Palivizumab belongs to the Monoclonal IgG1 Antibodies Pharmacological class.
Palivizumab is approved for the treatment of Respiratory Syncytial Virus.
The volume of distribution of Palivizumab was found to be 57 ml/kg. No clinical data on the excretion and the total body clearance was noted.
The common side effects associated with Palivizumab are headache, dizziness, nausea, pain, itching, swelling at the site of Injection, ear pain, etc.
Palivizumab is available in the form of Intramuscular injections for pediatric patients.
Palivizumab is available in India, U.K., U.S., Canada, India, E.U., China, Japan, and Australia.
Palivizumab has neutralizing and fusion inhibiting activity against the Respiratory Syncytial Virus. Palivizumab serum concentrations of approximately 30 mcg/mL have shown to produce a mean 99% reduction in pulmonary Respiratory Syncytial Virus replication in the cotton rat model.
Palivizumab hence leads to relief from the Respiratory Syncytial Virus.
Palivizumab onset of action is found to be 90 minutes, and the mean half-life was found to be 20 days.
Palivizumab is available in Intramuscular Injection.
- Palivizumab should be administered once in a monthly dose of 15 mg/kg intramuscularly using an aseptic technique and preferably in the anterolateral aspect of the thigh.
- 0.5 mL and 1 mL vials containing an overfill of Palivizumab to allow the withdrawal of 50 mg or 100 mg, respectively.
- It is advised not to dilute the Vial.
- It is advised not to shake the vial.
- To administer, the tab portion of the vial cap is removed and the stopper is cleaned with 70% ethanol or equivalent.
- The needle is inserted into the vial and an appropriate volume of solution is withdrawn into the syringe.
- Palivizumab does not contain a preservative and hence should be administered immediately after drawing the dose into the syringe.
Palivizumab can be used in the treatment of:
- Respiratory Syncytial Virus
Palivizumab can help to relieve symptoms of Respiratory Syncytial Virus.
Palivizumab is approved for use in the following clinical indications:
- Respiratory Syncytial Virus
The recommended dose of Palivizumab has been found to be 15 mg/kg of body weight, Intramuscular only, given every 28 to 30 days during anticipated periods of Respiratory Syncytial Virus risk in the community.
Intramuscular: 50 mg/0.5 mL, 100 mg/1 mL
Intramuscular
Palivizumab may be contraindicated in pediatric patients having a previous history condition of Hypersensitivity to Palivizumab or to the ingredients of the medication.
The Treating physician should closely monitor the patient and keep pharmacovigilance as follows:
If the patient experiences anaphylaxis, anaphylactic shock, or severe allergic reaction, administer epinephrine in appropriate pediatric dosage and provide supportive care as required.
Breast Feeding Warning
It is not known whether Palivizumab is excreted in human milk as it is not indicated in adults.
Pregnancy Warning
Pregnancy Category C: Palivizumab has not been indicated for adult usage and also no animal reproduction studies have been conducted. It is not known whether Palivizumab can lead to fetal harm when administered to a pregnant woman or could affect reproductive capacity.
Food Warning
No sufficient scientific evidence is traceable regarding the use and safety of Palivizumab in concurrent use with any particular food.
The adverse reactions related to Palivizumab can be categorized as:
Common
- Hives
- Confusion
- Fever
- Irregular heartbeat
- Vomiting
- Headache
- Blurred vision
- Dizziness
Rare
- Black or Tarry stools
- Pinpoint red spots on the skin
- Bleeding gums
- Unusual Bleeding or Bruising
No drug interaction studies were conducted; hence no data is available.
The common side of Palivizumab includes the following:
- Runny or stuffy nose
- Sneezing
- Rash
- Injection site reactions ex: pain, redness, or swelling
- Diarrhea
- Vomiting
- Fever
- Cough
- Earache
Pregnancy
Pregnancy Category C: Palivizumab has not been indicated in adult usage and also no animal reproduction studies have been conducted. It is not known whether Palivizumab can cause fetal harm when administered to a pregnant woman or could affect reproductive capacity.
Labor and Delivery
There is no well-documented experience of clinical studies in women undergoing labor and delivery. Palivizumab should only be used during pregnancy if the potential benefits outweigh the risks associated with the fetus’s growth.
Nursing Mothers
It is not known whether Palivizumab is excreted in human milk as it is not indicated in adults.
Geriatric Use
Palivizumab is not indicated in adults.
The physician should be vigilant about the knowledge and treatment pertaining to the identification and treatment of overdosage of Palivizumab.
No data from clinical studies were found or available on overdosage. No toxicity data were observed in rabbits administered a single intramuscular or subcutaneous injection of Pavlivizumab at a dose of 50 mg/kg,
Pharmacodynamics
Palivizumab exhibits neutralizing and fusion-inhibitory activity against the Respiratory Syncytial Virus (RSV). These activities inhibit Respiratory Syncytial Virus replication or spread. Palivizumab is given to prevent the development of lower respiratory tract disease in pediatric patients.
Pharmacokinetics
In studies consisting of adult volunteers, Palivizumab had a pharmacokinetic profile that is similar to a human IgG1 antibody in regard to the volume of distribution and the half-life which is means of 18 days. In pediatric patients aged less than 24 months, the mean half-life of Palivizumab was found to be 20 days and monthly intramuscular doses of 15 mg/kg achieved a mean ±Standard Deviation of 30 days through serum drug concentrations of 37 ±21 µg/mL after the first injection. After the second injection, it was found to be 57 ±41 µg/mL. After the third injection, the mean ±SD 30-day trough serum drug concentrations was 68 ±51 µg/mL and 72 ±50 µg/mL after the fourth injection. In pediatric patients after giving Palivizumab for a second season, the mean ±SD serum concentrations following the first injection were 61 ±17 µg/mL and the fourth injection was found to be 86 ±31µg/mL.
- Volume of Distribution
The mean volume of distribution was found to be 57 ml/kg
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- Navas L, et.al. Improved outcome of respiratory syncytial virus infection in a high-risk hospitalized population of Canadian children.
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- Simoes EA, et al. Respiratory syncytial virus immune globulin for prophylaxis against respiratory syncytial virus disease in infants and children with congenital heart disease. J Pediatr 1998; 133:492-9.
- Johnson S, et al. Development of a humanized monoclonal antibody with potent in vitro and in vivo activity against respiratory syncytial virus.
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