Synagis

palivizumab

Synagis

Pharmacologic class: Monoclonal antibody

Therapeutic class: Immunologic agent

Pregnancy risk category C

Action

Neutralizes and suppresses activity of syncytial virus in respiratory tract, inhibiting respiratory syncytial virus (RSV) replication

Availability

Injection: 50 mg, 100-mg vial

Indications and dosages

➣ To prevent serious lower respiratory disease caused by RSV in high-risk children

Children: 15 mg/kg I.M. q month throughout RSV season

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:

• thrombocytopenia, coagulation disorders, established RSV infection.

Administration

See Keep epinephrine 1:1,000 available in case anaphylaxis occurs. (However, drug isn't known to cause anaphylaxis.)

• Dilute in sterile water for injection. Gently swirl for 30 seconds to avoid foaming.

• Keep reconstituted solution at room temperature for at least 20 minutes before administering. Give within 6 hours of reconstitution.

• Inject I.M. into anterolateral thigh. Avoid gluteal injection, which may damage sciatic nerve.

Adverse reactions

CNS: nervousness, pain

EENT: conjunctivitis, otitis media, rhinitis, pharyngitis, sinusitis

GI: vomiting, diarrhea, gastroenteritis, oral moniliasis

Hematologic: anemia

Respiratory: upper respiratory tract infection, cough, wheezing, dyspnea, bronchiolitis, bronchitis, pneumonia, croup, asthma, apnea

Skin: rash, fungal dermatitis, eczema

Other: hernia, pain, fever, injection site reaction, viral infection, flulike symptoms, failure to thrive

Interactions

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase: increased levels

Hemoglobin: decreased level Immunological-based RSV diagnostic tests: interference, possibly leading to false-negative test results

Patient monitoring

See Watch closely for signs and symptoms of anaphylaxis immediately after dosing.

• Assess for signs and symptoms of infection, particularly EENT and respiratory infection.

• Monitor liver function tests and CBC.

• Assess patient's weight and hydration status.

Patient teaching

• Tell parent that monthly injections are necessary during RSV season (November through April).

• Inform parent that drug may cause GI symptoms and failure to thrive. Provide dietary consultation as needed.

See Caution parent that EENT and respiratory infections may follow administration. Advise parent to contact pre-scriber immediately if child has fever or other signs or symptoms of infection.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

palivizumab

(pal-i-vi-zoo-mab) palivizumab,

Synagis

(trade name)

Classification

Therapeutic: antivirals
Pharmacologic: monoclonal antibodies
Pregnancy Category: C

Indications

Prevention of serious respiratory tract disease due to respiratory syncytial virus (RSV) in children ≤ 24 months 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 and Excretion: Unknown.Half-life: 20 days.

Time/action profile (antibody levels)

ROUTEONSETPEAKDURATION
IMrapid48 hr30 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity.Use Cautiously in: History of thrombocytopenia or bleeding disorders.

Adverse Reactions/Side Effects

Central nervous system

  • fever

Dermatologic

  • rash

Hematologic

  • thrombocytopenia

Local

  • erythema
  • induration

Miscellaneous

  • hypersensitivity reactions including anaphylactoid reactions and anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

None known.

Route/Dosage

Intramuscular (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 weeks 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

Nursing implications

Nursing 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.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • First dose should be administered before RSV season, then monthly thereafter during RSV season.
  • Intramuscular: 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.

Synagis™

Immunology A humanized monoclonal antibody for preventing winter RSV in children. See RSV.