Dosing & Uses
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
- Owing to the shift in RSV seasonality noted in spring 2021 and the surge of RSV cases in fall 2022, AAP supports providing >5 consecutive doses to eligible children in regions with disease activity lasting more than the typical 6-month duration
- AAP Updated Guidance: Use of palivizumab prophylaxis to prevent hospitalization from severe RSV infection during the 2022-2023 RSV season
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
Warnings
Contraindications
Hypersensitivity
Cautions
Use caution in patients with thrombocytopenia, coagulation disorders
For intramuscular use only; inject in anterolateral thigh, not gluteal muscle
May interfere with immunological-based RSV diagnostic tests and viral culture assays
Safety and efficacy not established for treatment of RSV disease
Hypersensitivity
- Anaphylaxis and anaphylactic shock (including fatal cases), and other severe acute hypersensitivity reactions reported; permanently discontinue therapy and administer appropriate medications if reactions occur
- Signs and symptoms may include urticaria, pruritus, angioedema, dyspnea, respiratory failure, cyanosis, hypotonia, hypotension, and unresponsiveness
- if anaphylaxis or other significant hypersensitivity reaction occurs, administer appropriate medications (eg, epinephrine) and provide supportive care as required; if a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of this therapy
Pregnancy & Lactation
Pregnancy
Not indicated for use in females of reproductive potential
Lactation
Not studied; not indicated for use in females of reproductive potential
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.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)
Administration
IM Preparation
Do not dilute product
Do not shake vigorously
Inspect visually for particulate matter and discoloration before administration
Do not use any vials exhibiting particulate matter or discoloration
Dose (volume of injection in mL) per month = patient weight (kg) x 15 mg/kg ÷ 100 mg/mL of drug; injection volumes >1 mL should be given as a divided dose
Drug supplied as a single-dose vial and does not contain preservatives; do not re-enter the vial after withdrawal of drug; discard unused portion; only administer one dose per vial
Use sterile disposable syringes and needles; to prevent the transmission of hepatitis viruses or other infectious agents from one person to another, do not reuse syringes and needles
Using aseptic techniques, attach a sterile needle to a sterile syringe; remove flip top from vial and wipe rubber stopper with disinfectant (eg, 70% isopropyl alcohol)
Insert syringe needle into vial and withdraw appropriate volume of solution for dose
Administer immediately after drawing dose into syringe
IM Administration
Administer IM, preferably in anterolateral aspect of the thigh
Do not use gluteal muscle routinely as an injection site because of risk of damage to sciatic nerve
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Synagis intramuscular - | 50 mg/0.5 mL vial |  | |
| Synagis intramuscular - | 100 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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) 2023 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.
Formulary
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