AAP News TODAY 2016 - Sunday, October 23, 2016 - 19
Table 1: Percentage of US and Polish Participants 10 through 25 Years of
Age Reporting Solicited Local and Systemic Adverse Reactions
within 7 Days after BEXSERO or Control, by Dose
N=110-114 N= 94-96 N=107-109 N=90-92
Systemic Adverse Reactions
Clinicaltrials.gov Identifier NCT01272180.
a Erythema, and induration: Any (≥ 1 mm). Pain and systemic reactions:
mild (transient with no limitation in normal daily activity); moderate (some
limitation in normal daily activity); severe (unable to perform normal daily
b Administered 2 months after Dose 1
Solicited adverse reaction rates were similar among participants 11
through 24 years of age who received BEXSERO in the other three clinical studies,2,3,4 except for severe myalgia which was reported by 3-7%
of subjects. Severe pain was reported by 8% of university students in
7 DRUG INTERACTIONS
Sufficient data are not available to establish the safety and immunogenicity of concomitant administration of BEXSERO with recommended
8 USE IN SPECIFIC POPULATIONS
Pregnancy Category B:
Reproduction studies have been performed in rabbits at doses up to
15 times the human dose on a body weight basis and have revealed no
evidence of impaired fertility in females or harm to the fetus due to
BEXSERO. There are, however, no adequate and well controlled studies
in pregnant women. Because animal reproduction studies are not always
predictive of human response, BEXSERO should be used during pregnancy only if clearly needed.
Pregnancy Registry for BEXSERO
Novartis Vaccines and Diagnostics Inc. maintains a pregnancy registry
to monitor the fetal outcomes of pregnant women exposed to BEXSERO.
Health care providers are encouraged to register women who receive
BEXSERO during pregnancy by calling 1-877-683-4732.
8.3 Nursing Mothers
It is not known whether BEXSERO is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised
when BEXSERO is administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness of BEXSERO have not been established in children younger than 10 years of age.
8.5 Geriatric Use
Safety and effectiveness of BEXSERO have not been established in adults
older than 65 years of age.
Novartis Vaccines and Diagnostics S.r.l.,
Bellaria-Rosia 53018, Sovicille (SI), Italy.
An affiliate of:
Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue,
Cambridge, MA 02139-4182, USA
BEXSERO is a registered trademark of Novartis AG.
©2015 GSK group of companies.
All rights reserved. Printed in USA. 465406R0 August 2015
6.2 Additional Pre-licensure Safety Experience
In response to outbreaks of serogroup B meningococcal disease at two
universities in the US, BEXSERO was administered as a 2 dose series at
least 1 month apart. Information on serious adverse events was collected
for a period of 30 days after each dose from 15,351 individuals 16
through 65 years of age who received at least 1 dose. Overall 50 individuals (0.3%) reported serious adverse events, including one event considered related to vaccination, a case of anaphylaxis within 30 minutes
Nervous System Disorders:
Blisters at or around the
Allergic reactions (including
anaphylactic reactions), rash,
Syncope, vasovagal responses
Serious Adverse Events
Overall, in clinical studies, among 3,058 participants 10 through 25 years
of age who received at least 1 dose of BEXSERO, 66 (2.1%) participants
reported serious adverse events at any time during the study. In the
3 controlled studies1,2,3 (BEXSERO N=2716, Control N=2078), serious
adverse events within 30 days after any dose were reported in 23 (0.8%)
BEXSERO recipients and 10 (0.5%) control recipients.
General disorders and
administration site conditions:
Immune System Disorders:
Non-serious Adverse Events
In the 3 controlled studies1,2,3 (BEXSERO N=2221, control N=2204), nonserious unsolicited adverse events that occurred within 7 days of any
dose were reported by 439 (20%) BEXSERO and 197 (9%) control recipients. Unsolicited adverse events that were reported among at least 2%
of participants and were more frequently reported in BEXSERO recipients
than in control recipients were injection site pain, headache, and injection site induration unresolved within 7 days, and nasopharyngitis.
6.3 Postmarketing Experience
Adverse event reports received for BEXSERO marketed outside the US
are listed below. Because these events are reported voluntarily from a
population of uncertain size, it is not always possible to estimate reliably
their frequency, or to establish a causal relationship to vaccination. This
list includes serious events or events which have suspected causal association to BEXSERO.