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Generic Name: palivizumab (PAL-i-VIZ-ue-mab)
Brand Name: Synagis

Synagis is used for:

Preventing serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

Synagis is a monoclonal antibody. It works by preventing RSV from reproducing.

Do NOT use Synagis if:

  • the patient is allergic to any ingredient in Synagis

Contact the patient's doctor or health care provider right away if any of these apply to the patient.

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Before using Synagis:

Some medical conditions may interact with Synagis. Tell the patient's doctor or pharmacist if the patient has any medical conditions, especially if any of the following apply to the patient:

  • if the patient is taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if the patient has allergies to medicines, foods, or other substances
  • if the patient has a bleeding or blood clotting problem or low blood platelet levels
  • if the patient is having heart surgery (cardiopulmonary bypass)
  • if the patient is taking a blood thinner (eg, warfarin)

Some MEDICINES MAY INTERACT with Synagis. However, no specific interactions with Synagis are known at this time.

Ask the patient's health care provider if Synagis may interact with other medicines that the patient takes. Check with the patient's health care provider before starting, stopping, or changing the dose of any medicine.

How to use Synagis:

Use Synagis as directed by the patient's doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Synagis. Talk to the patient's pharmacist if you have questions about this information.
  • Synagis is usually given as an injection at the patient's doctor's office, hospital, or clinic. If you will be using Synagis at home, a health care provider will teach you how to use it. Be sure you understand how to use Synagis. Follow the procedures you are taught when the patient uses a dose. Contact the patient's health care provider if you have any questions.
  • Do not use Synagis if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask the patient's health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • It is important to continue using Synagis, even if the patient feels well or if the patient has an RSV infection. Do not miss any doses. Be sure to keep all doctor appointments.
  • If the patient misses a dose of Synagis, contact the patient's doctor right away.

Ask the patient's health care provider any questions you may have about how to use Synagis.

Important safety information:

  • Children, including those who develop RSV, should continue to receive monthly doses of Synagis throughout the RSV season (generally November through April in most parts of the United States). The first dose should be given before the RSV season begins.
  • The patient may still get severe RSV disease after receiving Synagis. Talk to the patient's health care provider about what symptoms to look for.
  • Synagis may interfere with certain lab tests, including certain RSV diagnostic tests. Be sure the patient's doctor and lab personnel know the patient is using Synagis.
  • Synagis is not for use in adults or children older than 24 months of age at the start of using Synagis. Discuss any questions or concerns with your doctor.
  • PREGNANCY and BREAST-FEEDING: It is not known if Synagis can cause harm to the fetus. It is not known if Synagis is found in breast milk. Synagis is not for use in adults.

Possible side effects of Synagis:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild fever.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness; muscle weakness or limpness; difficult, fast, or irregular breathing; unresponsiveness); blue lips or skin (including under the fingernails); fainting; redness, swelling, warmth, or discomfort around the injection site; severe dizziness or light-headedness; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact the patient's health care provider. Call the patient's doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Synagis:

Synagis is usually handled and stored by a health care provider. If you are using Synagis at home, store Synagis as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Synagis out of the reach of children and away from pets.

General information:

  • If you have any questions about Synagis, please talk with the patient's doctor, pharmacist, or other health care provider.
  • Synagis is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If the patient's symptoms do not improve or if they become worse, check with your doctor.
  • Check with the patient's pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Synagis or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Synagis. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Synagis. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Synagis.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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