Sunday, April 09, 2017 by Gregory Van Dyke
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AFLURIA® QUADRIVALENT safely and effectively. See full prescribing information for AFLURIA QUADRIVALENT.
See full insert sheet at this link at the Natural News Reference website.
AFLURIA QUADRIVALENT, Influenza Vaccine
Suspension for Intramuscular Injection 2016-2017 Formula
Initial U.S. Approval (AFLURIA QUADRIVALENT): 2016
INGREDIENTS AND EXCIPIENTS
AFLURIA QUADRIVALENT, Influenza Vaccine for intramuscular injection, is a sterile, clear, colorless to slightly opalescent suspension with some sediment that resuspends upon shaking to form a homogeneous suspension. AFLURIA QUADRIVALENT is prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a “split virion”. The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.
AFLURIA QUADRIVALENT is standardized according to USPHS requirements for the 2016-2017 influenza season and is formulated to contain 60 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the four influenza strains recommended for the 2016-2017 Northern Hemisphere influenza season: A/California/7/2009 (H1N1), NYMC X-181, A/Hong Kong/4801/2014 (H3N2), NYMC X-263B, B/Phuket/3073/2013 and B/Brisbane/60/2008.
Thimerosal, a mercury derivative, is not used in the manufacturing process for the single dose presentation. This presentation does not contain preservative. The multi-dose presentation contains thimerosal added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.
A single 0.5 mL dose of AFLURIA QUADRIVALENT contains sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (0.5 mcg). From the manufacturing process, each 0.5 mL dose may also contain residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (< 1 mcg), sucrose (< 10 mcg), neomycin sulfate (≤ 81.8 nanograms [ng]), polymyxin B (≤ 14 ng), and beta-propiolactone (≤ 1.5 ng).
The rubber tip cap and plunger used for the preservative-free, single-dose syringes and the rubber stoppers used for the multi-dose vial were not made with natural rubber latex.
INDICATIONS AND USAGE
AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. (1)
FLURIA QUADRIVALENT is approved for use in persons 18 years of age and older. (1)
DOSAGE AND ADMINISTRATION
For intramuscular injection only, by needle and syringe (18 years of age and older) or by PharmaJet® Stratis® Needle-Free Injection System (18 through 64 years of age). Administer as a single 0.5 mL dose. (2)
DOSAGE FORMS AND STRENGTHS
AFLURIA QUADRIVALENT is a suspension for injection supplied in two presentations:
– 0.5 mL pre-filled syringe (single dose) (3, 11)
– 5 mL multi-dose vial (ten 0.5 mL doses) (3, 11)
Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine. (4, 11)
WARNINGS AND PRECAUTIONS
If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA QUADRIVALENT should be based on careful consideration of the potential benefits and risks. (5.1)
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. (5.2)
In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when AFLURIA QUADRIVALENT was administered by needle and syringe was pain (≥40%). The most common systemic adverse events were myalgia and headache (≥20%). (6.1)
In adults 65 years of age and older, the most commonly reported injection-site adverse reaction when AFLURIA QUADRIVALENT was administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%). (6.1)
In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions when AFLURIA® (trivalent formulation) was administered by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events were myalgia, malaise (≥30%), and headache (≥20%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus USA Inc. at 1-844-275-2461 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
USE IN SPECIFIC POPULATIONS
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There are no data for AFLURIA QUADRIVALENT administered to pregnant women to inform vaccine-associated risks in pregnancy. Available data on AFLURIA (trivalent formulation) administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.
There were no developmental toxicity studies of AFLURIA QUADRIVALENT performed in animals. The developmental effects of AFLURIA (trivalent formulation) are relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions. A developmental toxicity study of AFLURIA (trivalent formulation) has been performed in female rats administered 0.5 mL (divided) of AFLURIA (trivalent formulation) prior to mating and during gestation. This study revealed no evidence of harm to the fetus due to AFLURIA (trivalent formulation) (see 8.1 Data).
Disease-associated Maternal and/or Embryo-Fetal Risk
Pregnant women are at increased risk for severe illness due to influenza compared to non-pregnant women. Pregnant women with influenza may be at increased risk for adverse pregnancy outcomes, including preterm labor and delivery.
In a developmental toxicity study, female rats were administered 0.5 mL (divided) of AFLURIA (trivalent formulation) by intramuscular injection 21 days and 7 days prior to mating, and on gestation day 6. Some rats were administered an additional dose on gestation day 20. No vaccine-related fetal malformations or variations and no adverse effects on pre- weaning development were observed in the study.
It is not known whether AFLURIA QUADRIVALENT is excreted in human milk. Data are not available to assess the effects of AFLURIA QUADRIVALENT on the breastfed infant or on milk production/excretion.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AFLURIA QUADRIVALENT and any potential adverse effects on the breastfed child from AFLURIA QUADRIVALENT or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine or the effects on milk production.
The safety and efficacy of AFLURIA QUADRIVALENT in persons less than 18 years has not been established in clinical trials.
Administration of CSL’s 2010 Southern Hemisphere trivalent influenza vaccine was associated with increased rates of fever and febrile seizures, predominantly in children below the age of 5 years as compared to previous years, in postmarketing reports confirmed by postmarketing studies.
In clinical studies, AFLURIA QUADRIVALENT has been administered to, and safety information collected for, 867 subjects aged 65 years and older (see Adverse Reactions ). The 65 years and older age group included 539 subjects 65 through 74 years and 328 subjects 75 years and older. After administration of AFLURIA QUADRIVALENT, hemagglutination- inhibiting antibody responses were non-inferior to comparator trivalent influenza (TIV-1 and TIV-2) in persons 65 years of age and older, but were lower than younger adult subjects (see Clinical Studies ).
The PharmaJet Stratis Needle-Free Injection System is not approved as a method of administering AFLURIA QUADRIVALENT to adults 65 years of age and older due to lack of adequate data supporting safety and effectiveness in this population.