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palivizumab (Rx)Brand and Other Names:Synagis

 
 
 

Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

powder for reconstution (injection)

  • 100mg/mL
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RSV Prophylaxis

Indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease

15 mg/kg IM q1Month during RSV season with first dose administered prior to the season 

High risk for RSV

  • Children (≤2 yr) with bronchopulmonary dysplasia
  • Infants with a history of premature birth (≤35 weeks gestational age)
  • Children (≤2 yr) with hemodynamically significant congenital heart disease

AAP guidelines

  • Limit RSV prophylaxis to infants born before 29 weeks' gestation and to infants with chronic illness (eg, congenital heart disease, chronic lung disease)
  • Give infants who qualify for prophylaxis in the first year of life no more than 5 monthly doses of palivizumab (15 mg/kg per dose) during the RSV season
  • In the second year of life, palivizumab prophylaxis is recommended only for children who needed supplemental oxygen for ≥28 days after birth and who continue to need medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy)
  • Clinicians may consider prophylaxis for children <24 months if they will be profoundly immunocompromised during the RSV season
  • Pediatrics. 2014 Aug;134(2):415-20
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Adverse Effects

>10%

Fever (27%)

Rash (26%)

1-10%

Antibody formation (1-2%)

<1%

Pain

Hernia

SGOT increased

Cough

Bronchiolitis

Pneumonia

Dyspnea

Sinusitis

Apnea

Thrombocytopenia

Failure to thrive

Diarrhea

Vomiting

Conjunctivitis

Eczema

Anemia

Angioedema

Flu syndrome

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Warnings

Contraindications

Hypersensitivity

Cautions

Use caution in patients with thrombocytopenia, coagulation disorders

Inject in anterolateral thigh, not gluteal muscle

May interfere with immunological-based RSV diagnostic tests and viral culture assays

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: no studies done

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Monoclonal antibody binds to F protein on RSV; prevents virus from infecting cell

Pharmacokinetics

Half-Life: 20 days (<24 months old)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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