Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Synagis (Palivizumab). If you are concerned about side effects, discuss the risks and benefits of Synagis (Palivizumab) with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Constipation
• Fever
• gas
• redness, swelling, or pain at the injection site

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• changes in feeding habits
• changes in heart rate
• colds, sore throat, or runny nose
• cough
• Diarrhea
• nervousness or irritability
• rash
• signs of Anemia (e.g., pale skin, decreased energy, fatigue)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of lung infection (e.g., continuing cough, difficulty breathing, fever, irritability, headache, skin turning blue, weakness)
• swelling of arms or legs (edema)
• symptoms of an ear infection (e.g., pain in the ear, tugging on the ear, irritability, frequent crying, trouble sleeping, fluid draining from the ear)
• vomiting
• white patches in the mouth or throat

Stop taking the medication and seek immediate medical attention if any of the following occur:

• pauses in breathing or breathing difficulties
• seizures
• symptoms of a serious allergic reaction (e.g., Hives, swelling of the face or throat, difficulty breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Synagis (Palivizumab).

Lyophilized Powder

Solution for Injection

50 mg
Each 0.5 ml of solution for injection contains Synagis (Palivizumab) 50 mg. Nonmedicinal ingredients: chloride, glycine, histidine, and water for injection

100 mg
Each mL of solution for injection contains Synagis (Palivizumab) 100 mg. Nonmedicinal ingredients: chloride, glycine, histidine, and water for injection.

Do not take Synagis (Palivizumab) if you:

• are allergic to Synagis (Palivizumab) or any ingredients of the medication
• are allergic to medications that contain humanized monoclonal antibodies

Specific drug interaction studies have not been conducted with Synagis (Palivizumab). However, since Synagis (Palivizumab) is specific for RSV, it is not expected to interfere with the immune response to vaccines, including live viral vaccines.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications your child is taking. Also tell them about any supplements your child takes. Depending on your child's specific circumstances, your doctor may want your child to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies your child may have, any medications your child is taking, and any other significant facts about your child's health. These factors may affect how they should use Synagis (Palivizumab).

Acute infection or fever: A Synagis (Palivizumab) injection may be delayed if your child is feeling unwell or has a fever due to an infection.

Allergic reactions: Very rarely, Synagis (Palivizumab) may cause a serious allergic reaction. If your child develops hives, difficulty breathing, or swelling of the face or throat, seek medical attention immediately.

Bleeding disorders: Synagis (Palivizumab) is given by injection into the muscle. This can cause bleeding at the injection site when the child receiving the injection has a bleeding disorder. If your child has a bleeding disorder, discuss with their doctor how Synagis (Palivizumab) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Synagis (Palivizumab), and whether any special monitoring is needed.

The doctor should monitor your child if your child has a bleeding disorder and is receiving Synagis (Palivizumab).

Use by adults: Synagis (Palivizumab) is intended for use by infants and children. The safety and effectiveness of Synagis (Palivizumab) for use by adults have not been established.

Pregnancy: Synagis (Palivizumab) is not intended for adult use. Its safety and effectiveness when used by pregnant women are not known.

Breast-feeding: Synagis (Palivizumab) is not intended for adult use. Its safety and effectiveness when used by breast-feeding women are not known.