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SYNAGIS® Guidelines - Administration Manual


Education Objectives

Upon completion of this manual the reader will be able to:

  1. Explain what RSV is.
  2. Explain the importance of preventing RSV
  3. Be able to identify those infants at risk of RSV
  4. Explain the indications and risks associated with Synagis®
  5. Describe the dosing and time frame of receiving Synagis®

What is respiratory syncytial virus (RSV) and how does if affect babies?

Respiratory syncytial virus is the most common respiratory virus in infants and young

children, infecting virtually all infants by the age two. In most infants, the virus causes symptoms resembling those of the common cold. However, in infants born prematurely, children with chronic lung disease, or children with congenital heart disease, RSV can result in a severe or even life-threatening disease. Recent data reported by the CDC suggests that as many as 125,000 hospitalizations occur annually in children less than one year old due to lower respiratory infection or bronchiolitis. Additionally, investigators have found that RSV is the number one reason children require hospitalization during their first year of life, emphasizing the impact of RSV disease on children.

Respiratory syncytial virus (RSV) is ubiquitous and easily spread: approximately two thirds of all infants are infected with RSV during the first year of life and almost 100% are infected by the age of 2.1.2 Most of these RSV infections cause minor upper respiratory illness and cold-like symptoms. However, in certain high-risk pediatric patients, RSV infection may cause serious lower respiratory tract disease. It has been estimated in some U.S. communities that between 50% and 80% of bronchiolitis hospitalizations from November through April are due to RSV disease.

Is RSV contagious?

Yes, RSV is highly contagious. Up to two-thirds of infants are infected in the first year of life. The infection can sometimes be spread through the air, via coughing and sneezing. Transmission more commonly occurs by the sharing of respiratory secretions from infected persons, and then self-inoculation by rubbing the eyes, nose, or mouth. RSV can survive for up to 12 hours on nonporous surfaces such as cribs and countertops and can survive freezing and thawing. Transmission may be prevented by standard infection control practices, such as hand washing and proper cleaning.

What are the symptoms of RSV disease?

The symptoms of RSV are initially similar to a cold, and can include some or all of the following symptoms:

  • Fever
  • Runny nose
  • Other cold-like symptoms

More serious symptoms include:

  • Coughing
  • Difficult breathing
  • Rapid breathing
  • Wheezing
  • Hypoxia

How often do outbreaks or epidemics occur?

RSV outbreaks occur each year on a fairly predictable schedule that varies from one region to another. In the United States; the RSV epidemic “season” usually begins in the fall, and lasts through spring. However, in some parts of the United States, such as Southern Florida, year-round epidemic levels have been seen.

What factors increase risk of RSV disease?

Selected factors that increase the risk of acquiring RSV or having a severe RSV Infection:

  • Prematurity (born more than 4 weeks early)
  • Chronic lung disease or congenital hear disease
  • Low birth weight
  • Childcare or day care attendance
  • School-age siblings at home
  • Crowded living conditions
  • Multiple births
  • Family history of asthma
  • Exposure to tobacco smoke or other environmental air pollutants

Adverse Reactions and Side Effects

Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis®. Cases of anaphylaxis were reported following re-exposure to Synagis® and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis® should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on readministration Synagis®

In clinical trials, the most common adverse events occurring at least 1% more frequently in Synagis®-treated patients than controls were upper respiratory infection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seen in children with CHD.

Very rare cases (<100,000 patients) of severe allergic reactions such as anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported Synagis®. These rare reactions may occur when any dose of Synagis® is given, not just the first one. Also, rare but serious side effects can occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.

Other side effects with Synagis® may include upper respiratory tract infection, ear infection, fever, and runny nose. In children born with heart problems, Synagis® was associated with reports of low blood oxygen levels and abnormal heart rhythms. Synagis® should not be used in patients with a history of a severe prior reaction to Synagis® or its components. Side effects, such as skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort) can also occur.

DOSAGE AND ADMINISTRATION:

When: The first dose of Synagis® should be given before RSV season begins. Children who develop an RSV infection while receiving Synagis® should continue the monthly dosing schedule throughout the 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. Patients undergoing cardio-pulmonary bypass should receive a dose of Synagis® as soon as possible after-the cardio-pulmonary bypass procedure (even if sooner than a month from the previous dose).

To Whom: Synagis® (palivizumab) is indicated for the prevention of serious lung infections caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease: infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD).

Route: Synagis® is give as a shot, usually in the thigh muscle, each month during the RSV season. 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. Injection volumes over 1 mL should be given as a divided dose.

Dosage: The recommended dose of Synagis® is 15 mg/kg of body weight intramuscularly using aseptic technique. The client will need a current weight prior to the pharmacy filling the dose of Synagis® due to the fact that the dose is based on weight of the client. Injection volumes over 1 mL should be given as a divided dose.

Preparation:: DO NOT DILUTE THE PRODUCT
DO NOT SHAKE OR VIGOROUSLY AGITATE THE VIAL
  • 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 dose into the syringe.
  • 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. To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, sterile disposable syringes and needles should be used. DO NOT reuse syringes and needles.

Synagis® is currently supplied in single-dose containing 50 mg or 100 mg of product. Vials are used for single dose only and is currently available in a liquid solution.

Practice Example for Dosing

  1. Synagis® is supplied via 50 mg and 100 mg vials. The concentration is 100 mg/ml.
  2. The recommended dose is 15mg of Synagis/Kg of client's weight
  3. Injection volumes over 1ml should be given as a divided dose.
  4. The formula for dosing is: patient weight (kg) x 15 mg/kg ÷ 100 mg/mL of Synagis®.
  5. Infant must be weighed prior to each injection. Dosing is based on weight per kilogram. If obtaining a weight in pounds, you must convert to kilograms first.
  6. Conversion for pounds to kilograms: weight in pounds/2.2 lb/kg = X kg

Dose in lbs divided by 2.2. = weight in kilograms.

Kilograms x 15 = dose in mgs.

Dose in mgs divided by 100 = dose given in ml's.

Baby's weight is 7 lbs. 8 ounces (7.5) divided by 2.2 = 3.40. 3.40 x 15 = 51.1

51.1 divided by 100 = 0.51 or 0.51 ml

Dose give would be 0.51 ml, give IM in one shot on the outer thigh.




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