"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(palivizumab) Injection for Intramuscular Use
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 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; or
- trouble breathing.
Less serious side effects...
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...
Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Synagis Information
Synagis - User Reviews
Synagis User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
Find out what women really need.