Palivizumab

Palivizumab is a prescription medication used for the  prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

• Palivizumab is available under the following different brand names: Synagis

Common side effects of Palivizumab include:

• Fever, and
• Rash

Serious side effects of Palivizumab include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Severe rash,
• Itching,
• Rapid or difficult breathing,
• Blue-colored lips, skin, or fingernails,
• Muscle weakness, and
• Being hard to wake up

Rare side effects of Palivizumab include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Pediatric dosage

• Powder for reconstitution (injection)
  • 100 mg/mL

RSV Prophylaxis

Pediatric dosage

• 15 mg/kg Intramuscular every 1 month during RSV season with the first dose before the season  

High risk for RSV

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

AAP guidelines

• Limit RSV prophylaxis to infants born before 29 weeks gestation and to infants with chronic illness (. g, 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 above 28 days after birth and who continue to need medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy)
• Clinicians may consider prophylaxis for children below 24 months if they will be profoundly immunocompromised during the RSV season
• Owing to the shift in RSV seasonality noted in spring 2021 and the surge of RSV cases in fall 2022, AAP supports providing above 5 consecutive doses to eligible children in regions with disease activity lasting more than the typical 6-month duration
• AAP Updated Guidance: Use of palivizumab prophylaxis to prevent hospitalization from severe RSV infection during the 2022-2023 RSV season

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Palivizumab has no noted severe interactions with any other drugs.
• Palivizumab has no noted serious interactions with any other drugs.
• Palivizumab has no noted moderate interactions with any other drugs.
• Palivizumab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Palivizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Palivizumab?”

Cautions

• Use caution in patients with thrombocytopenia, coagulation disorders
• For intramuscular use only, inject the in anterolateral thigh, the not gluteal muscle
• May interfere with immunological-based RSV diagnostic tests and viral culture assays
• Safety and efficacy not established for the treatment of RSV disease
• Hypersensitivity
  • Anaphylaxis and anaphylactic shock (including fatal cases), and other severe acute hypersensitivity reactions were reported; permanently discontinue therapy and administer appropriate medications if reactions occur
  • Signs and symptoms may include urticaria, pruritus, angioedema, dyspnea, respiratory failure, cyanosis, hypotonia, hypotension, and unresponsiveness
  • if anaphylaxis or other significant hypersensitivity reaction occurs, administer appropriate medications (. g, epinephrine) and provide supportive care as required; if a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious read ministration of this therapy

Pregnancy and Lactation

• Not indicated for use in females of reproductive potential
• Lactation
  • Not studied; not indicated for use in females of reproductive potential