Medication Guide App

Palivizumab Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Respiratory Syncytial Virus

Hematopoietic stem cell transplant recipient: 15 mg/kg one time, infused intravenously over 30 minutes.

The use of palivizumab in adults is not approved by the FDA. This dosage is based on 2 small clinical trials which included 6 patients without active RSV infection, 3 patients with RSV upper respiratory tract infection (URTI), and 12 patients with RSV interstitial pneumonia (IP). The 15 patients with active RSV infection also received aerosolized ribavirin. The 3 patients with URTI recovered, 10 of the patients with IP survived for the 28-day study period, and 2 of the IP patients died. The virologic outcome of the 6 patients without active RSV was not stated.

Usual Pediatric Dose for Respiratory Syncytial Virus

Neonatal:
15 mg/kg IM once monthly during RSV season.

Note: For cardiopulmonary bypass patients, administer a dose as soon as possible after cardiopulmonary bypass procedure, even if less than 1 month from previous dose. American Academy of Pediatrics recommends a maximum of 3 doses for patients born gestational age 32 weeks 0 days through 34 weeks 6 days without significant congenital heart disease or chronic lung disease and maximum of 5 doses for all others.

Infants and Children:
IM: 15 mg/kg once monthly throughout RSV season.

IV: (IV route is investigational): 15 mg/kg has been administered to patients who could not receive IM injections. IV use has been investigated in hematopoietic stem cell transplant patients with active RSV upper respiratory tract infection.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Very rare cases of anaphylaxis have been reported following reexposure to palivizumab.

Rare severe acute hypersensitivity reactions have also been reported on initial exposure or reexposure to the drug. If a severe hypersensitivity reaction occurs, palivizumab should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on readministration of palivizumab therapy. If anaphylaxis or severe allergic reactions occur, appropriate medications (e.g., epinephrine) and provide supportive care should be administered as required.

Palivizumab is for intramuscular administration only. Caution should be used when palivizumab is administered in patients with bleeding diatheses, thrombocytopenia, or patients on anticoagulants.

The safety and efficacy of palivizumab for the treatment of respiratory syncytial virus disease have not been established.

The single-dose vial of palivizumab therapy does not contain a preservative. Palivizumab should be administered immediately after dose withdrawal from the vial. Vial should not be reentered. Discard any unused drug.

The preferred area for palivizumab injection is the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site to prevent the risk of damage to the sciatic nerve.

Injection volumes of over 1 mL should be given as divided doses.

Dialysis

Data not available

Other Comments

Palivizumab should be injected in the anterolateral aspect of the thigh; gluteal muscle should not be routinely used. Injection volumes over 1 mL should be given as divided doses.

The American Academy of Pediatrics recommends RSV prophylaxis with palivizumab during RSV season for:
Infants less than 3 months of age who were born between gestational age 32 weeks 0 days and 34 weeks 6 days and have one of the following:
1) Daycare attendance
2) Greater than or equal to 1 sibling who is less than 5 years of age living in the same household.
3) Infants less than 6 months of age who were born between gestational age 29 weeks to less than or equal to 31 weeks 6 days.
4) Infants less than 12 months of age who were born gestational age less than or equal to 28 weeks.
5) Infants less than 12 months of age with congenital airway abnormality or neuromuscular disorder that decreases the ability to manage airway secretions.
6) Infants and children less than 24 months of age with chronic lung disease (CLD) necessitating medical therapy within 6 months of age prior to the beginning of RSV season.
7) Infants and children less than 24 months with congenital heart disease and one of the following:
--Receiving medication to treat congestive heart failure
--Moderate to severe pulmonary hypertension
--Cyanotic heart disease

The American Academy of Pediatrics (AAP) recommends for cardiopulmonary bypass patients, administering a dose as soon as possible after cardiopulmonary bypass procedure, even if less than 1 month from the previous dose. AAP recommends a maximum of 3 doses for patients born gestational age 32 weeks 0 days through 34 weeks 6 days without significant congenital heart disease or chronic lung disease and a maximum of 5 doses for all others.

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