palivizumab

Therapeutic Classification: antivirals

Pharmacologic Classification: monoclonal antibodies

Indications ⬆ ⬇

REMS

Prevention of serious respiratory tract disease due to respiratory syncytial virus (RSV) in children ≤ 24 mo of ageat high risk (infants with bronchopulmonary dysplasia, history of prematurity, or hemodynamically significant congenital heart disease).

Action ⬆ ⬇

Neutralizes and inhibits fusion of RSV virus; subsequently inhibits viral replication.

Therapeutic effects:

Prevents serious sequelae of RSV disease in susceptible children.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed after IM administration.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 20 days.

Time/Action Profile ⬆ ⬇

(antibody levels)

ROUTE	ONSET	PEAK	DURATION
IM	rapid	48 hr	30 days

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

History of thrombocytopenia or bleeding disorders.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash

Hemat: thrombocytopenia

Local: erythema, induration

Neuro: fever

Misc: ANAPHYLACTOID REACTIONS AND ANAPHYLAXISHYPERSENSITIVITY REACTIONS INCLUDING

Interactions ⬆ ⬇

Drug-drug:

None known.

Route/Dosage ⬆ ⬇

IM (Children ): 15 mg/kg/month during RSV season (first dose should be administered prior to the RSV season; RSV season is November through April in most northern hemisphere countries). AAP recommends a maximum of 3 doses for patients born at a gestational age of 32–34 wk without congenital heart or chronic lung disease and a maximum of 5 doses for all others.

Availability ⬆ ⬇

Solution for injection: 50 mg/0.5 mL vial; 100 mg/1 mL vial

Assessment ⬆ ⬇

Assess patient for signs of lower respiratory tract disease periodically during therapy.
Assess patient for signs of anaphylactic reaction (rash, pruritus, laryngeal edema, wheezing) after injection. Epinephrine, antihistamine, and equipment for resuscitation should be readily available.

Lab Test Considerations:

May cause thrombocytopenia. Monitor platelet count periodically during therapy.

Implementation ⬆ ⬇

First dose should be administered before RSV season, then monthly thereafter during RSV season.
IM: Contains no preservatives; administer within 6 hr.
- Administer IM injection into the lateral aspect of the thigh. Avoid gluteal muscle to prevent damage to the sciatic nerve.
- Give injections >1 mL as a divided dose.

Patient/Family Teaching ⬆ ⬇

Explain to parents/caregivers importance of monthly palivizumab to prevent RSV infection. Injection is administered even if infection is present. Advise parents to read the Information for Patients and Their Caregivers prior to first dose and with each Rx refill; information may have changed.
Instruct parent to notify health care professional immediately if signs of anaphylactic reaction (severe rash, hives, or itching skin; difficulty breathing; closing of throat; difficulty swallowing; swelling of the lips, tongue, or face; bluish color of skin, lips, or under fingernails; muscle weakness or floppiness; unresponsiveness) or if unusual bleeding or bruising occurs.
Advise parents to consult health care professional before administering other Rx, OTC, or herbal products to their child.

Evaluation/Desired Outcomes ⬆ ⬇

Prevention of the serious sequelae of RSV disease in susceptible children.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

60574- MedImmune, LLC
- 60574-4113- Synagis
  - 60574-4113-1- 1 mL in 1 VIAL, SINGLE-DOSE (60574-4113-1)

60574- MedImmune, LLC
- 60574-4114- Synagis
  - 60574-4114-1- .5 mL in 1 VIAL, SINGLE-DOSE (60574-4114-1)

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Pronunciation ⬇

Classifications ⬆ ⬇