Synagis

Synagis injection is a humanized monoclonal antibody used for the prevention of serious lung infection in children and babies caused by a respiratory syncytial virus.

This drug works by giving your body antibodies to protect it against RSV infection. Pneumonia and bronchitis and even death can be caused by RSV infection.

These problems are more likely to occur in infants and children younger than 6 months of age with chronic lung disease and breathing problems.

Babies who were born premature or babies who were born with heart disease may also have problems with RSV. The onset of RSV activity usually occurs in November and continues through April, but it may begin earlier or continue later in certain communities.

It is recommended to receive palivizumab before the start of the RSV season in order to prevent RSV infection. This drug is to be given only by or under the direct supervision of your healthcare professional.

Before using Synagis, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children older than 24 months of age at the start of dosing regarding the correlation of age to the effects of palivizumab injection have not been performed while safety and efficacy have not been established.

Data regarding the relationship of age to the effects of palivizumab injection in geriatric patients are still unavailable. Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other prescription or nonprescription drugs. Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco. Inform your healthcare provider for any other medical problems such as bleeding problems, or thrombocytopenia.

Proper usage of Synagis requires strict adherence to your doctor’s orders. A trained healthcare professional will be only to give your child this drug in a hospital.

This drug is administered intramuscularly as a shot into one of your child's muscles. This drug is usually given once a month during the RSV season, which is the time of year that RSV is most common in your community.

Your child should receive the first shot of this drug before the season starts to help prevent serious infections from the RSV virus. Consult with your healthcare professional for any concerns.

Before using Synagis, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Seek immediate medical attention if you have symptoms of anaphylaxis such as:

• Rash
• Itching
• Hoarseness
• Lightheadedness
• Dizziness, or fainting
• Trouble breathing
• Trouble swallowing
• Any swelling of the hands, face, or mouth after receiving the drug

Your child may be given an additional shot of this drug soon after surgery if your child has certain types of heart disease and needs to have a corrective surgery.

Inform any healthcare professional who treats your child that he or she is using this drug since this drug may affect the results of certain medical tests.

As with many medications, there are several potential side effects associated with Synagis. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

• Bluish color of the fingernails, lips, skin, palms, or nail beds
• Blurred vision
• Confusion
• Cough
• Difficulty with breathing
• Difficulty with swallowing
• Dizziness
• Faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Fast heartbeat
• Fever
• Hives or welts
• Irregular, fast or slow, or shallow breathing
• Itching
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Loss of strength or energy
• Muscle pain or weakness
• Redness of the skin
• Shortness of breath
• Skin rash
• Sweating
• Tightness in the chest
• Unresponsiveness, unusual tiredness or weakness
• Wheezing
• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Pinpoint red spots on the skin
• Unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.