Dose: 15 mg/kg/dose IM
Palivizumab (Human Respiratory Syncytial Virus Monoclonal Antibody)
| Dose: 15 mg/kg/dose IM |
| Frequency: Q 3 to 4 weeks |
| Comments: Palivizumab is a humanized monoclonal antibody to respiratory syncytial virus (RSV) produced by recombinant DNA technology. RSV is the leading cause of respiratory disease in infants and children. The AAP recommendations (Pediatr 1998; 102:1211-1215) for use of palivizumab are based on the studies outlined in the comments section. Palivizumab prophylaxis should be considered for infants and children younger than 2 years with chronic lung disease (CLD) who have required medical therapy for their CLD within 6 months before the anticipated start of the RSV season. Infants born at 32 weeks of gestation or earlier without CLD may also benefit from RSV prophylaxis. Infants born at 29 to 32 weeks of gestation may benefit most from prophylaxis up to 6 months of age by the start of the RSV season while those 28 weeks gestation or less may benefit from prophylaxis up to 12 months of age by the start of the RSV season. Though RSV prophylaxis was effective in infants with gestational ages of 33 to 35 weeks, given the cost of prophylaxis, the use of the drug in this age group should be reserved for infants with additional risk factors. Palivizumab has not been evaluated for infants with immune deficiency diseases. If these infants are receiving monthly infusions of IGIV, consideration should be given to substituting RSV-IGIV during the RSV season. RSV prophylaxis should be initiated at the onset of the RSV season and terminated at the end of the RSV season. Palivizumab is a monoclonal antibody and as such does not interfere with the response of other vaccines given during infancy. More comments on palivizumab. |
| Toxicity: Adverse effects at the site of injection are the most common reported side effects (2.7%) and include erythema, pain, induration, swelling, and bruising. These events were reported to be mild and of short duration (The IMpact-RSV Study Group. Pediatr 1998; 102:531). Other reported adverse effects judged to be drug related during the blinded study did not differ from the placebo group and included fever, nervousness, rash, altered liver enzymes, vomiting, cough, and rhinitis. Hypersensitivity reactions are theoretically possible but have not been reported. |
| Preparation: Palivizumab or Human Respiratory Syncytial Virus Monoclonal Antibody (Synagis) is available in a preservative-free 100 mg/ml concentration for IM administration. To reconstitute, slowly add 1 ml of sterile water for injection to the vial. Gently swirl (avoid producing foam) for 30 seconds; do not shake vial. Reconstituted polivizumab should stand at room temperature for at least 20 minutes until solution clarifies. Discard after 6 hours (Facts and Comparisons, Inc. Drug Facts and Comparisons. Olin, B.R. ed. St. Louis, MO:Facts and Comparisons, Inc; 1998, page 448j). How do you order the drug? Write physician’s orders to give the drug..."Give Synagis 30 mg IM today (15 mg/kg, 2 kg). Fill out a requisition for the number of vials needed...hopefully just one. Put the patients names on the requisition. Pharmacy will charge each patient for the dose that’s given. Be aware that you only get about 90 mg from each vial, since you waste a little filling the needle.
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