palivizumab (Rx)

Brand and Other Names:Synagis
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Dosing & Uses

AdultPediatric

Not indicated

Dosage Forms & Strengths

powder for reconstution (injection)

  • 100mg/mL

RSV Prophylaxis

Indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease

15 mg/kg IM q1Month during RSV season with first dose administered prior to the season  

High risk for RSV

  • Children (≤2 yr) with bronchopulmonary dysplasia
  • Infants with a history of premature birth (≤35 weeks gestational age)
  • Children (≤2 yr) with hemodynamically significant congenital heart disease

AAP guidelines

  • Limit RSV prophylaxis to infants born before 29 weeks' gestation and to infants with chronic illness (eg, congenital heart disease, chronic lung disease)
  • Give infants who qualify for prophylaxis in the first year of life no more than 5 monthly doses of palivizumab (15 mg/kg per dose) during the RSV season
  • In the second year of life, palivizumab prophylaxis is recommended only for children who needed supplemental oxygen for ≥28 days after birth and who continue to need medical intervention (supplemental oxygen, chronic corticosteroid, or diuretic therapy)
  • Clinicians may consider prophylaxis for children <24 months if they will be profoundly immunocompromised during the RSV season
  • Pediatrics. 2014 Aug;134(2):415-20
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Adverse Effects

>10%

Fever (27%)

Rash (26%)

1-10%

Antibody formation (1-2%)

<1%

Pain

Hernia

SGOT increased

Cough

Bronchiolitis

Pneumonia

Dyspnea

Sinusitis

Apnea

Thrombocytopenia

Failure to thrive

Diarrhea

Vomiting

Conjunctivitis

Eczema

Anemia

Angioedema

Flu syndrome

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Warnings

Contraindications

Hypersensitivity

Cautions

Anaphylaxis and anaphylactic shock (including fatal cases), and other severe acute hypersensitivity reactions reported; permanently discontinue therapy and administer appropriate medications if reactions occur

Use caution in patients with thrombocytopenia, coagulation disorders

Inject in anterolateral thigh, not gluteal muscle

May interfere with immunological-based RSV diagnostic tests and viral culture assays

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Pregnancy & Lactation

Pregnancy

Not indicated for use in females of reproductive potential

Lactation

Not indicated for use in females of reproductive potential

Lactation: no studies done

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Monoclonal antibody binds to F protein on RSV; prevents virus from infecting cell

Pharmacokinetics

Half-Life: 20 days (<24 months old)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Synagis intramuscular
-
100 mg/mL vial
Synagis intramuscular
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50 mg/0.5 mL vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
palivizumab intramuscular

PALIVIZUMAB - INJECTION

(PAL-i-VIZ-ue-mab)

COMMON BRAND NAME(S): Synagis

USES: Palivizumab is used in certain infants and young children to prevent serious lung infections (such as pneumonia) that are caused by a certain virus (respiratory syncytial virus-RSV). Palivizumab works by preventing the growth of the virus. This medication is not used to treat RSV infection, but should be continued even if your child gets the RSV infection to prevent a more serious infection.

HOW TO USE: Read the Patient Information Leaflet if available from your health care professional before your child starts receiving palivizumab and before each injection. If you have any questions, ask your doctor or pharmacist.This medication is given into a muscle (usually the thigh) by a health care professional as directed by your child's doctor, usually once a month during RSV season. RSV season in the northern hemisphere usually starts in November and runs through April. The dosage is based on your child's weight.Your child should receive this medication regularly to get the most benefit from it. To help you remember, mark the days on a calendar when your child should receive the medication.

SIDE EFFECTS: Fever or pain/redness/swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using palivizumab, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: bleeding/blood clotting problems (such as thrombocytopenia, coagulation disorder).Before having surgery (especially certain heart procedures), tell the doctor or dentist about this medication and all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).This medication is not usually used by adults. It is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may interfere with certain laboratory tests (including RSV diagnostic tests, virus culture tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Keep all regular medical and lab appointments.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If your child misses a dose, ask the doctor or pharmacist right away for a new dosing schedule.

STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

Information last revised July 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.