SYNAGIS

Humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV).

Synagis 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 lightchain sequence was derived from the constant domain of Ck and the variable framework regions of the VL gene K104 withJk-4.

Palivizumab is expressed from a stable murine (mouse) myeloma cell line (NS0).

Palivizumab is composed of to heavy chains (50.6 kDa each) and two light chains (27.6 kDa each), contains 1-2% carbohydrate by weight and has a molecular weight of 147.7 kDa +/.

• 1 kDa (MALDI-TOF).

For prophylaxis of respiratory diseases casued by respiratory syncytial virus.

Synagis exhibits neutralizing and fusion-inhibitory activity against Respiratory syncytial virus (RSV).

These activities inhibit

RSV replication or spread.

Synagis is given to prevent the development of lower respiratory tract disease in pediatric patients.

Fusion glycoprotein

F0 (Human respiratory syncytial virus B (strain 18537)) Binder Low affinity immunoglobulin gamma Fc region receptor III-B Binder Low affinity immunoglobulin gamma Fc region receptor III-A Binder + 5 more targets.

Most likely removed by opsonization via the reticuloendothelial system.

18-20 days (in adults).

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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.

Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis.

Previous significant hypersensitivity reaction to

mg per kg of body weight, administered intramuscularly prior to commencement of the RSV season and remaining doses administered monthly throughout the RSV season.

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. 2.1 Dosing Information 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.

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. 2.2 Administration Instructions DO NOT DILUTE THE PRODUCT.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Do not use any vials exhibiting particulate matter or discoloration.

Using aseptic techniques, attach a sterile needle to a sterile syringe.

Remove the flip top from the

Synagis vial and wipe the rubber stopper with a disinfectant (e.g., 70% isopropyl alcohol).

Insert the needle into the vial and withdraw into the syringe an appropriate volume of solution.

Administer immediately after drawing the dose into the syringe.

Synagis should be administered in a dose of 15 mg per kg intramuscularly using aseptic technique, preferably in the anterolateral aspect of the thigh.

The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.

The dose (volume of injection in mL) per month = patient weight (kg) x 15 mg per kg ÷ 100 mg per mL of Synagis.

Injection volumes over 1 mL should be given as a divided dose.

Synagis is supplied as a single-dose vial and does not contain preservatives.

Do not re-enter the vial after withdrawal of drug; discard unused portion.

Only administer one dose per vial.

Use sterile disposable syringes and needles.

To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, DO NOT reuse syringes and needles.

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 66658-230-01 The 50 mg vial contains 50 mg Synagis in 0.5 mL. 100 mg vial NDC 66658-231-01 The 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.

Upon 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.

Upon 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 not indicated for use in females of reproductive potential.

The safety and effectiveness of

Synagis in children older than 24 months of age at the start of dosing have not been established.