Download Updated Synagis® Guidelines for RSV Prophylaxis

August 2014
Updated Synagis® Guidelines for RSV Prophylaxis
The American Academy of Pediatrics (AAP) has updated its guidelines for the
use of palivizumab (Synagis) for the prophylaxis of respiratory syncytial virus
(RSV) infection in infants and young children. Palivizumab is given
intramuscularly at a dosage of 15 mg/kg once a month for five doses for the
prevention of serious lower respiratory tract disease due to RSV in children at
high risk of RSV disease. The goal of this update is to provide more specific
guidance for identifying those infants and children who are at increased risk for
hospitalization due to RSV. The AAP found chronologic age to be the single most
important risk factor for RSV hospitalization, most of which occur during the
first 90 days after birth. Infants with certain comorbidities, such as prematurity,
chronic lung disease (CLD) or hemodynamically significant congenital heart
disease (CHD), may be at increased risk for RSV hospitalization. The AAP also
concluded that most host and environmental factors, such as variations in living
conditions and climate, do not significantly impact the risk of RSV
hospitalization.
Major points of revision from the guidance published in the 2012 Redbook
include:
• In the first year of life, palivizumab prophylaxis is recommended for infants
born before 29 weeks 0 days’ gestation. Consistent data demonstrate a two to
four times greater risk for hospitalization in this group than later preterm
infants. This is a change from gestational age before 35 weeks.
• Palivizumab prophylaxis is not recommended for otherwise healthy infants
born at or after 29 weeks 0 days’ gestation. Previous guidelines advised use in
infants younger than six months at the start of RSV if born at 29 to less than
32 weeks’ gestation or in infants three months of age at the start of RSV
season who were born at 32 to less than 35 weeks’ gestation who had
environmental risk factors for RSV infection.
• Palivizumab prophylaxis is recommended during the first year of life for
infants with chronic lung disease (CLD) of prematurity defined as gestational
age before 32 weeks 0 days’ and who required more than 21 percent oxygen
for at least 28 days after birth. Prophylaxis is no longer recommended in the
second year of life except for children with CLD who continue to require
medical intervention.
• Palivizumab prophylaxis may be considered in the first year of life for certain
infants with hemodynamically significant congenital heart disease (CHD).
• Children younger than 24 months who will be significantly
immunocompromised during the RSV season may be considered for prophylaxis.
• Discontinue monthly palivizumab if breakthrough RSV hospitalization occurs.
Drug Information Highlights
• The Drug Enforcement Administration (DEA) announced
that, effective August 18, 2014, tramadol will be assigned
a schedule IV controlled substances status. The centrallyacting opioid analgesic is used to manage moderate to
moderately-severe pain. The DEA concluded that
tramadol may lead to limited physical and psychological
dependence. Currently, approximately 10 states in the
U.S. classify tramadol as a controlled substance. Some
tramadol-containing products include the brands
Ultram®, Ultracet®, Ultram ER®, ConZip®, and also
generic formulations.
• The FDA has approved Flonase® Allergy Relief,
fluticasone propionate 50 mcg spray, by GlaxoSmithKline
for use without a prescription. The over-the-counter
(OTC) nasal steroid will have the same strength as
prescription Flonase® and will also be indicated in
children as young as four years of age for the
management of seasonal and perennial allergic and
nonallergic rhinitis as a once-daily dose. Launch of the
OTC product is expected in early 2015. Nasacort® Allergy
24 HR, triamcinolone nasal spray, is available as an OTC.
• On July 11th, the Senate Finance Committee requested
Gilead Sciences to provide information regarding the
determination of the price of the chronic hepatitis C
drug, sofosbuvir (Sovaldi®). In the U.S., the cost of
sofosbuvir is $1,000 per pill, translating to a cost of
$84,000 for a standard course of therapy. Gilead has 60
days from receipt of the Senate letter to provide the
requested information.
Pipeline News: Upcoming Prescription Drug
User Fee Acts (PDUFA) Dates
• Aug. 6: Orbactiv™; oritavancin; intravenous
oligoglycopetide antibiotic; acute bacteria skin and skin
structure infections (ABSSSI); The Medicines Co; the FDA
granted approval on August 6th.
• Aug. 9: Nepa; oral netupitant and palonosetron;
chemotherapy induced nausea and vomiting; Helsinn
Healthcare/Eisai.
• Aug. 10: Obi-1; injectable recombinant porcine sequence
factor VIII; hemophilia A; Baxter.
• Aug. 21: Pledgridy™; SC peginterferon beta 1a; relapsing
forms of multiple sclerosis; Biogen.
• Aug. 25: Eliquis®; oral apixaban for the pulmonary
embolism indication; Pfizer/BMS.
• 3rd Quarter: Hyqvia; combination of human
immunoglobulin/recombinant human hyaluronidase for
treatment of adult primary immunodeficiency;
subcutaneous (SC); Baxter/Halozyme.
Editorial Staff
Maryam Tabatabai, PharmD
Editor in Chief
1— August 2014
Contact
Carole Kerzic, RPh
Executive Editor
Leslie Pittman, PharmD
Deputy Editor
https://www.magellanmedicaid.com/news/clinicalalerts.asp
© 2014, Magellan Health, All Rights Reserved.
Barbara Dowd, RPh
Deputy Editor
Raquel Holmes, RPh
Deputy Editor
Dona Jones
Executive Assistant
[email protected]
The AAP does not support the use of more than five consecutive monthly doses of palivizumab given during the peak of RSV season,
which provides six months of coverage against RSV. For variations in the onset and offset of the RSV season in specific locations, such as
Alaska and Florida, local health departments or the Centers for Disease Control and Prevention (CDC) should be consulted.
International Antiviral Society-USA Updated HIV Clinical Practice Guidelines
The International Antiviral Society-USA (IAS-USA) published updated guidelines for the antiretroviral treatment (ART) of HIV infection in
adults. Since early initiation of ART reduces the likelihood of HIV transmission while providing clinical benefit, IAS-USA advises to start
ART as soon as possible after diagnosis, regardless of CD4 cell count. The decision of when to start ART in HIV positive persons with
cryptococcal meningitis should be directed by experts in the management of both cryptococcal and HIV infection, if available.
Strong recommendations for regimens that include the newer agents, dolutegravir (Ticvay®), and the co-formulated
elvitegravir/cobicistat/tenofovir/emtricitabine (Stribild®) and rilpivirine/tenofovir/emtricitabine (Complera®), have been added as
options for initial ART.
Genotype testing for resistance should be performed prior to starting therapy and upon confirmed virologic failure. HIV-1 RNA levels
should be monitored approximately four weeks after initiation of ART to confirm viral suppression and repeated every three months.
CD4 count is also monitored every three months as previously recommended. If HIV-1 RNA level increases above 200 copies/mL, causes
of virologic failure and need for a change of ART should be assessed. If multi-drug resistance is detected, therapy with a boosted
protease inhibitor and agents from newer drug classes should be considered.
IAS-USA also published new guidelines for the prevention of HIV infection in which they recommend HIV testing at least once for all
adults and adolescents, with repeated testing and risk reduction counseling for HIV negative individuals who are at increased risk of HIV
infection. The U.S. Preventive Task Force similarly recommends HIV screening for all persons aged 15 to 65 years. Self-testing and home
testing may be also an option for those with recurrent HIV risk or difficulties with testing in a clinical setting. In addition, IAS-USA
guidelines for ART prophylaxis are consistent with those published by the Centers for Disease Control and Prevention (CDC) and the U.S.
Public Health Service for pre- and post-exposure, respectively. Pre-exposure prophylaxis (PrEP) with daily doses of
emitricitabine/tenofovir (Truvada®) is recommended in individuals at high risk for HIV infection. Post-exposure prophylaxis (PEP) with
emitricitabine/tenofovir plus raltegravir (Insentress®), beginning within 72 hours after exposure, is recommended for persons who have
sustained a mucosal or parenteral exposure to HIV from a known infected source.
Recent FDA Approvals
Generic
Name
Trade
Name
valsartan
no trade name
2— August 2014
Description
Applicant
FDA Status*
First-time generic for Diovan®, valsartan, was approved
by the FDA. It is an angiotensin II receptor blocker (ARB)
indicated for the treatment of high blood pressure,
heart failure (NYHA class II-IV) and reduction of
cardiovascular mortality in clinically-stable patients
with left ventricular failure or left ventricular
dysfunction following myocardial infarction. It is
available in 40 mg, 80 mg, 160 mg, and 320 mg tablets.
It is dosed once to twice daily dependent on diagnosis
being treated.
OHM Labs
(subsidiary of
Ranbaxy with
180 days
exclusivity);
Sandoz
launched an
authorized
generic
FDA ANDA approval
06/26/2014
https://www.magellanmedicaid.com/news/clinicalalerts.asp
© 2014, Magellan Health, All Rights Reserved.
Recent FDA Approvals
Generic
Name
Trade
Name
belinostat
Description
Applicant
FDA Status*
Beleodaq®
Belinostat (Beleodaq), is a histone deacetylase (HDAC)
inhibitor, for the treatment of relapsed or refractory
peripheral T-cell lymphoma (PTCL). PTLC is a rare
disorder of a fast growing subtype of non-Hodgkin
lymphoma (NHL). Side effects include nausea, fatigue,
fever, anemia and vomiting. The recommended dose is
2
1,000 mg/m intravenously (IV) over 30 minutes daily
on days 1- 5 of a 21 day cycle. Cycles can be repeated
until disease progression or unacceptable toxicity. It is
expected to be available third quarter 2014.
Spectrum
FDA NDA approval
07/03/2014
tavaborole
Kerydin™
Tavaborole (Kerydin) is the first oxaborole antifungal
FDA approved for the topical treatment of
onychomycosis of the toenail due to Trichophyton
rubrum or Trichophyton mentagrophytes. The 5%
topical solution is applied to the affected toenail once
daily for 48 weeks. Common side effects occurring in at
least 1% of the patients treated include application site
exfoliation, ingrown toenail, application site erythema,
and application site dermatitis.
Anacor
FDA NDA approval
07/07/2014
methotrexate
Rasuvo™
The FDA approved a subcutaneous, manually-triggered
auto-injector formulation of methotrexate (MTX) under
the trade name of Rasuvo for the management of
severe, active rheumatoid arthritis (RA), polyarticularcourse juvenile idiopathic arthritis (pJIA), and control of
severe, recalcitrant, disabling psoriasis. Rasuvo is not
indicated in neoplastic diseases. Rasuvo will be
available in 10 dosage strengths, ranging from 7.5 mg to
30 mg in 2.5 mg increments. It is administered
subcutaneously once weekly. This formulation is
expected to improve bioavailability since the oral form
is associated with inconsistent bioavailability.
Medac
FDA NDA approval
07/10/2014
recombinant
human C1
esterase
inhibitor
Ruconest®
Ruconest received FDA approval for the treatment of
acute attacks of hereditary angioedema (HAE) in adult
and adolescent patients. HAE is a rare genetic disorder
with unpredictable and recurrent attacks of
subcutaneous and submucosal angioedema in which
patients can develop swelling of the face, feet, hands,
or airways that can be life threatening. Ruconest is
administered IV over five minutes by a health care
professional, but can be self-administered by properly
trained patients. Dosage is body weight dependent, 50
IU/kg for patients weighing <84 kg and of 4,200 IU (two
vials) for patients weighing ≥84 kg. A second dose can
be administered if needed. No more than two doses
should be administered within 24 hours.
Pharming
Group IV
FDA BLA approval
07/16/2014
3— August 2014
https://www.magellanmedicaid.com/news/clinicalalerts.asp
© 2014, Magellan Health, All Rights Reserved.
Recent FDA Approvals
Generic
Name
Trade
Name
dantrolene
Description
Applicant
FDA Status
Ryanodex®
A skeletal muscle relaxant, dantrolene (Ryanodex), was
approved as an orphan-drug designation for the
treatment of malignant hyperthermia (MH) in
conjunction with supportive measures. It is also
indicated for the prevention of MH in patients at high
risk. MH is a life threatening emergency that can be
triggered by certain anesthesia agents in genetically
susceptible individuals. This single-vial formulation
allows for preparation and administration in less than
one minute compared to other multi-vial dantrolene
formulations that can take longer to reconstitute and
administer. Ryanodex is available in a single use vial
containing 250 mg of dantrolene. It is administered by
IV push at a minimum of 1 mg/kg with additional doses,
as needed, up to a maximum cumulative dose of 10
mg/kg. The recommended prophylactic dose is 2.5
mg/kg IV starting 75 minutes prior to surgery.
Eagle
FDA NDA approval
07/22/2014
idelalisib
Zydelig®
Idelalisib (Zydelig), a phosphoinositide 3-kinase (PI3K)
inhibitor, was granted accelerated FDA approval for the
treatment of relapsed chronic lymphocytic leukemia
(CLL), relapsed follicular B-cell non-Hodgkin lymphoma,
and relapsed small lymphocytic lymphoma. It carries a
black box warning for fatal and serious hepatic toxicities,
serious diarrhea, colitis, pneumonitis and intestinal
perforation. The recommended maximum starting dose is
150 mg twice daily with or without food. It is available in
100 mg and 150 mg tablets.
Gilead
Sciences
FDA NDA approval
07/23/2014
oxycodone/
naloxone
Targiniq™ ER
Targiniq ER is a combination of an opiate analgesic
(oxycodone) and an opioid antagonist (naloxone), in an
abuse-deterrent formulation. This long-acting
medication is indicated for the treatment of chronic
severe pain. When crushed, the naloxone blocks the
euphoric effect of the oxycodone which discourages the
abuse of the drug by snorting or injection. Targiniq ER
10 mg/5 mg, 20 mg/10 mg, and 40 mg/20 mg extendedrelease tablets are dosed every 12 hours.
Purdue
FDA NDA approval
07/23/2014
olodaterol
Striverdi®
Respimat®
Olodaterol (Striverdi Respimat) is a long-acting beta2adrenergic agonist (LABA) metered spray inhaler. It is
approved for long-term, once daily maintenance of
airflow obstruction in patients with chronic obstructive
pulmonary disease (COPD), including chronic bronchitis
and/or emphysema. Is not indicated to treat acute
deteriorations of COPD or asthma. The inhalation spray
is dosed as two inhalations (5 mcg) once daily.
Boehringer
Ingelheim
FDA NDA approval
07/31/2014
*ANDA (Abbreviated New Drug Application); NDA (New Drug Application); BLA (Biologics License Application)
4— August 2014
https://www.magellanmedicaid.com/news/clinicalalerts.asp
© 2014, Magellan Health, All Rights Reserved.
References
www.cdc.gov
www.dea.gov
www.fda.gov
www.medscape.com
http://pediatrics.org
www.pubmed.gov