Palivizumab

>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

Palivizumab is a humanized monoclonal antibody (IgG1κ) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of RSV. Palivizumab is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor and Cess. The human light chain sequence was derived from the constant domain of Cκ and the variable framework regions of the VL gene K104 with Jκ -4. The murine sequences were derived from a murine monoclonal antibody, Mab 1129, in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Palivizumab is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.

Synagis is supplied as a sterile, preservative-free liquid solution at 100 mg per mL to be administered by intramuscular injection. Thimerosal or other mercury-containing salts are not used in the production of Synagis. The solution has a pH of 6.0 and should appear clear or slightly opalescent.

Each 100 mg single-dose vial of Synagis liquid solution contains 100 mg of palivizumab and also contains chloride (0.5 mg), glycine (0.1 mg), and histidine (3.9 mg), in a volume of 1 mL. Each 50 mg single-dose vial of Synagis liquid solution contains 50 mg of palivizumab and also contains chloride (0.2 mg), glycine (0.06 mg), and histidine (1.9 mg), in a volume of 0.5 mL.

Overdoses with doses up to 85 mg per kg have been reported in clinical studies and post-marketing experience with Synagis, and in some cases, adverse reactions were reported. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

Palivizumab is a man-made antibody to respiratory syncytial (sin-SISH-ul) virus (RSV). RSV can cause serious illness in children. Palivizumab helps keep RSV cells from multiplying in the body.

Palivizumab is used to prevent serious lung disease caused by respiratory syncytial virus in premature infants, and infants born with certain lung disorders or heart disease.

Palivizumab will not treat a child who is already sick with RSV disease.

Palivizumab may also be used for other purposes not listed in this medication guide.

Palivizumab may cause serious side effects including:

• Severe allergic reactions (may occur after any dose of palivizumab). Such reactions may be life-threatening or cause death.
  • See “Drug Precautions” for a list of signs and symptoms.
• Unusual bruising or groups of tiny red spots on the skin.

Call your child’s healthcare provider or get medical help right away if your child has any of the serious side effects listed above after any dose of palivizumab.

Common side effects of palivizumab include:

• fever
• rash

Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort).

These are not all the possible side effects of palivizumab. Tell your child’s healthcare provider about any side effect that bothers your child or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your child’s healthcare provider if your child takes a blood thinner medicine.

The dose your doctor recommends may be based on your child's weight.

The recommended dose of palivizumab is 15 mg per kg of body weight given monthly by intramuscular injection.

Respiratory Syncytial Virus (RSV) Infections

Prevention of serious RSV lower respiratory tract infections in infants at high risk for RSV disease.1 6 7 8 50 51

Recommended for infants <24 months of age who have chronic lung disease (e.g., bronchopulmonary dysplasia [BPD]), history of premature birth (gestational age ≤35 weeks), or hemodynamically significant congenital heart disease (CHD).1 6 7 8 50 51 May reduce severity of RSV infection and reduce frequency and duration of RSV-related hospitalizations in these high-risk infants.1 6 7 8 37 39 40 41 42 50 51

Drug of choice when RSV prophylaxis is indicated.6 7 8 50

Need for and efficacy of palivizumab prophylaxis following institutional RSV outbreaks† (e.g., in neonatal intensive care units) not studied to date; the major means of preventing RSV illness in such situations is strict observance of infection control practices.3 8 9

Safety and efficacy for treatment of established RSV disease not established.1 37 Do not use for treatment of RSV infection.1 8 50

Significant prior hypersensitivity reaction to palivizumab or any component of the formulation

Canadian labeling: Additional contraindications (not in U.S. labeling): Known hypersensitivity to other humanized monoclonal antibodies.

Respiratory syncytial virus prophylaxis: IM: Infants and children <2 years: 15 mg/kg, monthly throughout RSV season (first dose administered prior to commencement of RSV season). Note: American Academy of Pediatrics (AAP) recommends a maximum of 5 doses per season; if hospitalization occurs for breakthrough RSV infection, monthly prophylaxis should be discontinued for the remainder of that season (AAP 2014).

Cardiopulmonary bypass patients: IM: Administer an additional 15 mg/kg dose as soon as possible after cardiopulmonary bypass procedure or at the conclusion of extracorporeal membrane oxygenation, even if <1 month from previous dose (AAP 2014).

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Anaphylaxis and anaphylactic shock, some fatal cases, have been reported following initial exposure or re-exposure to palivizumab; other acute hypersensitivity reactions (may be severe), have also been reported. If a significant hypersensitivity reaction occurs, permanently discontinue therapy. If anaphylaxis or other significant hypersensitivity reaction occurs, administer appropriate medications (eg, epinephrine) and provide supportive care as required. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration.

Drug-drug interactions:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Appropriate use: Palivizumab is not recommended for the prevention of health care-associated RSV disease (AAP 2014). Safety and efficacy have not been established for treatment of RSV disease.