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Synagis
Overview
What is Synagis?
Palivizumab is a humanized monoclonal antibody (IgG1к) 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 V genes Cor and Cess. The human light chain sequence was derived from the constant domain of Cк and the variable framework regions of the V gene K104 with Jк -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 does Synagis look like?
What are the available doses of Synagis?
Single-dose liquid solution vials: 50 mg per 0.5 mL and 100 mg per 1 mL.
What should I talk to my health care provider before I take Synagis?
Safety and effectiveness in children older than 24 months of age at the start of dosing have not been established.
How should I use Synagis?
1 INDICATIONS AND USAGE
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:
Limitations of Use:
The safety and efficacy of Synagis have not been established for treatment of RSV disease .
The recommended dose of Synagis is 15 mg per kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season. In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities.
Synagis serum levels are decreased after cardio-pulmonary bypass . Children undergoing cardio-pulmonary bypass should receive an additional dose of Synagis as soon as possible after the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose). Thereafter, doses should be administered monthly as scheduled.
The efficacy of Synagis at doses less than 15 mg per kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.
What interacts with Synagis?
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What are the warnings of Synagis?
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What are the precautions of Synagis?
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What are the side effects of Synagis?
Sorry No records found
What should I look out for while using Synagis?
Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis .
What might happen if I take too much Synagis?
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.
How should I store and handle Synagis?
Store vials in a refrigerator at 2° to 8°C (36° to 46°F) until time of use. Keep the vial in the outer carton in order to protect from light. DO NOT FREEZE OR SHAKE the vial. Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.50 mg vial NDC 60574-4114-1The 50 mg vial contains 50 mg Synagis in 0.5 mL.100 mg vial NDC 60574-4113-1The 100 mg vial contains 100 mg Synagis in 1 mL.The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.StorageUpon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.50 mg vial NDC 60574-4114-1The 50 mg vial contains 50 mg Synagis in 0.5 mL.100 mg vial NDC 60574-4113-1The 100 mg vial contains 100 mg Synagis in 1 mL.The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.StorageUpon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.50 mg vial NDC 60574-4114-1The 50 mg vial contains 50 mg Synagis in 0.5 mL.100 mg vial NDC 60574-4113-1The 100 mg vial contains 100 mg Synagis in 1 mL.The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.StorageUpon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.50 mg vial NDC 60574-4114-1The 50 mg vial contains 50 mg Synagis in 0.5 mL.100 mg vial NDC 60574-4113-1The 100 mg vial contains 100 mg Synagis in 1 mL.The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.StorageUpon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.50 mg vial NDC 60574-4114-1The 50 mg vial contains 50 mg Synagis in 0.5 mL.100 mg vial NDC 60574-4113-1The 100 mg vial contains 100 mg Synagis in 1 mL.The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.StorageUpon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.50 mg vial NDC 60574-4114-1The 50 mg vial contains 50 mg Synagis in 0.5 mL.100 mg vial NDC 60574-4113-1The 100 mg vial contains 100 mg Synagis in 1 mL.The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.StorageUpon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.50 mg vial NDC 60574-4114-1The 50 mg vial contains 50 mg Synagis in 0.5 mL.100 mg vial NDC 60574-4113-1The 100 mg vial contains 100 mg Synagis in 1 mL.The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.StorageUpon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.Synagis is supplied in single-dose vials as a preservative-free, sterile liquid solution at 100 mg per mL for intramuscular injection.50 mg vial NDC 60574-4114-1The 50 mg vial contains 50 mg Synagis in 0.5 mL.100 mg vial NDC 60574-4113-1The 100 mg vial contains 100 mg Synagis in 1 mL.The rubber stopper used for sealing vials of Synagis is not made with natural rubber latex.StorageUpon receipt and until use, Synagis should be stored between 2°C and 8°C (36°F and 46°F) in its original container. DO NOT freeze. DO NOT use beyond the expiration date.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Palivizumab is a recombinant humanized monoclonal antibody with anti-RSV activity .
Non-Clinical Toxicology
Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis .In healthy volunteers, the pharmacokinetics of metformin and propranolol, and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies.
Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid, as compared to the sulfonylureas, which are extensively bound to serum proteins. —Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving metformin hydrochloride tablets or metformin hydrochloride extended-release tablets the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving metformin hydrochloride tablets or metformin hydrochloride extended-release tablets, the patient should be observed closely for hypoglycemia.
Carbonic anhydrase inhibitors
Alcohol
Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to Synagis. Other acute hypersensitivity reactions, which may be severe, have also been reported on initial exposure or re-exposure to Synagis. Signs and symptoms may include urticaria, pruritus, angioedema, dyspnea, respiratory failure, cyanosis, hypotonia, hypotension, and unresponsiveness. The relationship between these reactions and the development of antibodies to Synagis is unknown. If a significant hypersensitivity reaction occurs with Synagis, its use should be permanently discontinued. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of Synagis.
The most serious adverse reactions occurring with Synagis are anaphylaxis and other acute hypersensitivity reactions .
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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