Applies to palivizumab: intramuscular solution.

Serious side effects of Palivizumab

Along with its needed effects, palivizumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking palivizumab:

More common

• Bluish color of the fingernails, lips, skin, palms, or nail beds
• blurred vision
• confusion
• cough
• difficulty with breathing
• difficulty with swallowing
• dizziness
• 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

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• pinpoint red spots on the skin
• unusual bleeding or bruising

Other side effects of Palivizumab

Some side effects of palivizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to palivizumab: intramuscular powder for injection, intramuscular solution.

Cardiovascular

Frequency not reported: Arrhythmia (during studies of congenital heart disease patients)^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, diarrhea^[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, anaphylactic shock (sometimes fatal)

Postmarketing reports: Angioedema^[Ref]

Local

Common (1% to 10%): Injection site reactions^[Ref]

Other

Very common (10% or more): Pyrexia^[Ref]

Dermatologic

Very common (10% or more): Rash

Uncommon (0.1% to 1%): Urticaria

Frequency not reported: Pruritus^[Ref]

General

The most serious adverse reactions are anaphylaxis and other acute hypersensitivity reactions.^[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia (mild), eosinophilia (mild)

Postmarketing reports: Severe thrombocytopenia (platelet count less than 50,000/microliter)^[Ref]

Nervous system

Uncommon (0.1% to 1%): Convulsions^[Ref]

Respiratory

Frequency not reported: Cyanosis during studies of congenital heart disease patients

Postmarketing reports: Dyspnea, asthma, bronchospasm^[Ref]