Palivizumab

Trade Names:
Synagis
- Powder for injection, lyophilized 50 mg
- Powder for injection, lyophilized 100 mg

Pharmacology

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Neutralizing and fusion-inhibitory activity against respiratory syncytial virus (RSV), inhibiting RSV replication.

Pharmacokinetics

Elimination

The t _½ is 20 days in children younger than 24 mo of age.

Indications and Usage

Prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease.

Contraindications

Standard considerations.

Dosage and Administration

IM 15 mg/kg monthly through the RSV season. Preferably administer in anterolateral aspect of thigh. Avoid gluteal injections because of risk of damage to sciatic nerve. Give doses more than 1 mL in divided doses.

For IM administration only. Not for intra-arterial, intradermal, subcutaneous, or IV administration.

Storage/Stability

Store unopened vials in refrigerator (36° to 46°F). Do not freeze.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Dermatologic

Rash.

EENT

Otitis media, rhinitis (at least 1%).

GI

Diarrhea; vomiting; gastroenteritis.

Hepatic

Increased AST (at least 1%).

Respiratory

Upper respiratory tract infection (at least 1%); cough; wheezing.

Miscellaneous

Fever (at least 1%); hypersensitivity including dyspnea, cyanosis, respiratory failure, urticaria, pruritus, angioedema, hypotonia, and unresponsiveness (postmarketing).

Precautions

Pregnancy

Category C .

Hypersensitivity

Severe hypersensitivity reactions on initial exposure and re-exposure to palivizumab rarely have been reported. Monitor patient for signs and symptoms of allergic reaction. Immediately inform health care provider if anaphylaxis or any other severe reaction occurs. Be prepared to treat appropriately.

Administration

Administer with caution to patients with thrombocytopenia or any coagulation disorder caused by risk of bleeding at IM injection site.

Adults

Not indicated for adult use.

Cardiopulmonary bypass

Palivizumab serum levels are decreased after cardiopulmonary bypass. Administer a dose of palivizumab as soon as possible after the cardiopulmonary bypass procedure, even if sooner than a month from the previous dose. Thereafter, doses should be administered monthly.

Patient Information

• Advise family or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
• Educate family or caregiver of importance of monthly injection in helping to prevent RSV infection during the RSV season.
• Advise family or caregiver to report any of the following to health care provider: injection site reactions; fever or other signs of infection; sore throat; rash; itching or hives; swelling of the face, lips, eyes, or tongue; diarrhea; wheezing; shortness of breath; difficulty breathing.

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