Practice Guidelines
AAP Issues Updated Guidance on Palivizumab
Prophylaxis for RSV Infection
Key Points for Practice
• Palivizumab may be administered to infants born before 29 weeks’
gestation who are younger than 12 months at the beginning of RSV
season.
•Palivizumab prophylaxis may be given during RSV season during the first
year of life in preterm infants with chronic lung disease of prematurity
who are born before 32 weeks’ gestation.
•Infants 12 months or younger who have hemodynamically significant
CHD may benefit from palivizumab prophylaxis, especially those with
acyanotic heart disease.
From the AFP Editors
Coverage of guidelines
from other organizations
does not imply endorsement by AFP or the AAFP.
This series is coordinated
by Sumi Sexton, MD,
Associate Medical Editor.
A collection of Practice
Guidelines published in
AFP is available at http://
www.aafp.org/afp/
practguide.
The American Academy of Pediatrics (AAP)
Committee on Infectious Diseases has updated
its guidance on the use of palivizumab (Synagis) prophylaxis in infants and children at
increased risk of respiratory syncytial virus
(RSV) infection. Because the palivizumab
package labeling does not include a definition of high-risk children, the AAP aims to
provide health care professionals with specific
guidance on who should receive prophylaxis.
Use of palivizumab should be restricted to the
populations addressed in this guideline.
Preterm Infants Without Chronic Lung
Disease of Prematurity or CHD
In preterm infants without chronic lung disease of prematurity or congenital heart disease
(CHD), palivizumab may be administered to
those born before 29 weeks’ gestation who
are younger than 12 months at the beginning of RSV season. In infants born in the
midst of RSV season, fewer than five doses of
palivizumab are needed. Data are unclear on
the benefits of prophylaxis in infants born at
29 weeks’ gestation or later; these infants may
receive prophylaxis if they have CHD, chronic
lung disease, or another condition. Once
infants reach the second year of life, palivizumab is not recommended solely on the
basis of prematurity. Despite this guidance,
some experts have stated that prophylaxis is
not warranted even in infants born before 29
weeks’ gestation because of data showing only
a small increase in the risk of hospitalization.
Preterm Infants with Chronic Lung
Disease
In preterm infants with chronic lung disease
of prematurity (those born before 32 weeks’
gestation who require greater than 21% oxygen for at least the first 28 days after birth),
palivizumab prophylaxis may be considered
during RSV season during the first year of
life. If the infant continues to require medical
support (maintenance corticosteroid therapy, diuretic therapy, or supplemental oxygen) during the six months before the start
of his or her second RSV season, prophylaxis
may be considered. Otherwise, prophylaxis is
not recommended in the second year of life.
Infants with Hemodynamically
Significant CHD
Infants 12 months or younger who have
hemodynamically significant CHD may benefit from palivizumab prophylaxis. Those
most likely to benefit include infants with
acyanotic heart disease who are receiving
medication to control congestive heart failure and who will require cardiac surgery, and
infants with moderate to severe pulmonary
hypertension. These recommendations apply
to infants in the first year of life who are
born within 12 months of the beginning of
RSV season. Those who are not at increased
risk of RSV infection and therefore should
not receive prophylaxis include: infants and
children with hemodynamically insignificant
heart disease, infants with lesions corrected
by surgery (unless continued medication for
heart failure is needed), infants with mild
cardiomyopathy not receiving medical therapy, and children in the second year of life.
◆ Volume 90, Number 12
December
2014
www.aafp.org/afp
American
Family
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American Academy of Family
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Practice Guidelines
Other Recommendations
Infants with neuromuscular disease or congenital anomaly
that impairs ability to clear secretions from the upper airway because of ineffective cough are at risk of prolonged
hospitalization from lower respiratory tract infection;
therefore, prophylaxis may be considered in the first year
of life. Prophylaxis may also be considered in children
younger than 24 months who are profoundly immunocompromised during RSV season. There are insufficient
data to recommend routine palivizumab prophylaxis in
children with Down syndrome or cystic fibrosis. In Alaska
Native and American Indian populations, infants may be
eligible for prophylaxis depending on the burden of RSV
disease.
Monthly prophylaxis should be discontinued in
infants who have a breakthrough RSV hospitalization.
The likelihood of a second RSV hospitalization in the
same season is extremely low.
Palivizumab prophylaxis is not recommended for
the prevention of health care–associated RSV disease.
Infants in a neonatal unit who qualify for prophylaxis
because of prematurity, chronic lung disease, or CHD
may receive a first dose of palivizumab 48 to 72 hours
before discharge or promptly following discharge.
Dosing
A maximum of five monthly doses of palivizumab
(15 mg per kg per dose) may be administered during the
RSV season to qualifying infants. Administering more
than this is not recommended within the continental
United States. Five monthly doses will provide more than
six months of serum palivizumab concentrations above
the desired level for most children. A dose beginning in
November and continuing for a total of five doses provides protection through April. Infants born during RSV
season may require fewer doses.
Guideline source: American Academy of Pediatrics
Evidence rating system used? No
Literature search described? No
Guideline developed by participants without relevant financial
ties to industry? No
Published source: Pediatrics, August 2014
Available at: http://pediatrics.aappublications.org/content/134/2/415.
full.html
MARA LAMBERT, AFP Senior Associate Editor ■
Code Confidently in ICD-10
Be properly compensated for the services you provide. Help your practice
through the ICD-10 transition with the AAFP Coding Toolkit.*
ICD-10 Educational Series
ICD-10 Flashcards
• Developed by coding experts, this 11-module voice-guided
PowerPoint series offers a comprehensive map to a
smooth ICD-10 conversion.
• Created to help physicians, practice managers,
coders, and those who work on office dictation easily
transition from ICD-9 to ICD-10.
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8Phys
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