Synagis (Palivizumab) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 21, 2012

Synagis

Respiratory Syncytial Virus »

Respiratory syncytial virus (RSV) facts

RSV is a highly contagious virus infection that most commonly causes illness during the winter season.
Most children who develop an RSV infection have mild symptoms of fever, nasal congestion, and nasal discharge.
High-risk groups are more likely to have a more severe disease process, including wheezing (bronchiolitis in infants) and/or pneumonia. Such high-risk groups include premature infants, those children with a compromised immune system, or those with chronic pulmonary disease or congenital/acquired cardiac disease.
Supportive care is the mainstay of therapy. For high-risk patients, palivizumab (Synagis) preventative therapy is available.

What is the respiratory syncytial virus (RSV)?

The respiratory syncytial virus (RSV), discovered in 1956, is capable of causing a broad spectrum of illnesses. Older children and adults will commonly e...

Read the Respiratory Syncytial Virus article »

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Synagis

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Synagis®
(palivizumab)

DRUG DESCRIPTION

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.

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

high fever, ear pain or drainage, tugging at the ear;
warmth or swelling of the ear;
crying or fussiness, especially while lying down;
change in sleeping patterns;
poor feeding or loss of appetite;
easy bruising or bleeding;...

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What are the precautions when taking palivizumab (Synagis)?

Before using palivizumab, tell your child's doctor or pharmacist if your child is allergic to it; or to mouse proteins; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell the doctor your child's medical history, especially of: bleeding/blood clotting problems (e.g., thrombocytopenia, coagulation disorder), recent heart bypass...

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Last reviewed on RxList: 4/17/2012
This monograph has been modified to include the generic and brand name in many instances.