Bexsero: Package Insert and Label Information

BEXSERO- neisseria meningitidis group b nhba fusion protein antigen, neisseria meningitidis group b fhbp fusion protein antigen, neisseria meningitidis group b nada protein antigen and neisseria meningitidis group b strain nz98/254 outer membrane vesicle antigen injection, suspension
GlaxoSmithKline Biologicals SA

1 INDICATIONS AND USAGE

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dose and Schedule

Administer 2 doses (0.5-mL each) of BEXSERO at least 1 month apart.

2.2 Administration

Shake the syringe immediately before use to form a homogeneous suspension. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulate matter or discoloration is found.

Administer BEXSERO as a 0.5-mL intramuscular injection into the deltoid muscle of the upper arm.

2.3 Use of BEXSERO with Other Meningococcal Group B Vaccines

Sufficient data are not available on the safety and effectiveness of using BEXSERO and other meningococcal group B vaccines interchangeably to complete the vaccination series.

3 DOSAGE FORMS AND STRENGTHS

BEXSERO is a suspension for intramuscular injection in 0.5-mL single-dose prefilled syringes.

4 CONTRAINDICATIONS

Hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Preventing and Managing Allergic Reactions

Appropriate observation and medical treatment should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.

5.2 Syncope

Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope.

5.3 Latex

The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

5.4 Limitation of Vaccine Effectiveness

BEXSERO may not protect all vaccine recipients. BEXSERO may not provide protection against all meningococcal serogroup B strains [see Clinical Pharmacology (12.1)].

5.5 Altered Immunocompetence

Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO.

Complement Deficiency

Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis serogroup B even if they develop antibodies following vaccination with BEXSERO. [See Clinical Pharmacology (12.1).]

6 ADVERSE REACTIONS

The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%).

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

In 4 clinical trials, 3,058 individuals aged 10 through 25 years received at least one dose of BEXSERO, 1,436 participants received only BEXSERO, 2,089 received only placebo or a control vaccine, and 1,622 participants received a mixed regimen (placebo or control vaccine and BEXSERO).

In a randomized controlled study1 conducted in U.S. and Poland, 120 participants aged 10 through 25 years received at least 1 dose of BEXSERO, including 112 participants who received 2 doses of BEXSERO 2 months apart; 97 participants received saline placebo followed by MENVEO [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine]. Across groups, median age was 13 years, males comprised 49%, and 60% were white, 34% were Hispanic, 4% were black, <1% were Asian, and 2% were other.

In a second randomized controlled study2 conducted in Chile, all subjects (N = 1,622) aged 11 through 17 years received at least 1 dose of BEXSERO. This study included a subset of 810 subjects who received 2 doses of BEXSERO 1 or 2 months apart. A control group of 128 subjects received at least 1 dose of placebo containing aluminum hydroxide. A subgroup of 128 subjects received 2 doses of BEXSERO 6 months apart. In this study, median age was 14 years, males comprised 44%, and 99% were Hispanic.

In a third randomized controlled study3 conducted in the United Kingdom (U.K.), 974 university students aged 18 through 24 years received at least 1 dose of BEXSERO, including 932 subjects who received 2 doses of BEXSERO 1 month apart. Comparator groups received 1 dose of MENVEO followed by 1 dose of placebo containing aluminum hydroxide (n = 956) or 2 doses of IXIARO (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) (n = 947). Across groups, median age was 20 years, males comprised 46%, and 88% were white, 5% were Asian, 2% were black, <1% were Hispanic, and 4% were other.

In an uncontrolled study4 conducted in Canada and Australia, 342 participants aged 11 through 17 years received at least 1 dose of BEXSERO, including 338 participants who received 2 doses of BEXSERO 1 month apart. The median age was 13 years, males comprised 55%, and 80% were white, 10% were Asian, 4% were Native American/Alaskan, and 4% were other.

Local and systemic reactogenicity data were solicited from all participants in the studies conducted in Chile, U.S./Poland, Canada/Australia, and in a subset of participants in the U.K. study. Reports of unsolicited adverse events occurring within the first 7 days after each vaccination were collected in all studies. In the U.S./Poland study, reports of unsolicited adverse events were collected up to 1 month after the second vaccination.

Reports of all serious adverse events, medically attended adverse events, and adverse events leading to premature withdrawal were collected throughout the study period for the studies conducted in Chile (12 months), U.K. (12 months), U.S./Poland (8 months), and Canada/Australia (2 months).

Solicited Adverse Reactions

The reported rates of local and systemic reactions among participants aged 10 through 25 years following each dose of BEXSERO administered 2 months apart or control in the U.S./Polish study1 are presented in Table 1.

Table 1. Percentage of U.S. and Polish Participants Aged 10 through 25 Years Reporting Solicited Local and Systemic Adverse Reactions within 7 Days after BEXSERO or Control, by Dose
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 activity).
b Administered 2 months after Dose 1.

Solicited Reactiona

Dose 1

Dose 2b

BEXSERO

Placebo

(Saline)

BEXSERO

MENVEO

n = 110-114

n = 94-96

n = 107-109

n = 90-92

Local Adverse Reactions

Pain

Any

90

27

83

43

Mild

27

20

18

26

Moderate

44

5

37

9

Severe

20

2

29

8

Erythema

Any

50

13

45

26

1-25 mm

41

11

36

13

>25-50 mm

6

1

5

6

>50-100 mm

3

0

5

4

>100 mm

0

0

0

2

Induration

Any

32

10

28

23

1-25 mm

24

9

22

16

>25-50 mm

7

0

4

0

>50-100 mm

1

1

2

4

>100 mm

0

0

0

2

Systemic Adverse Reactions

Fatigue

Any

37

22

35

20

Mild

19

17

18

11

Moderate

14

5

10

7

Severe

4

0

6

2

Nausea

Any

19

4

18

4

Mild

12

3

10

3

Moderate

4

1

5

1

Severe

4

0

4

0

Myalgia

Any

49

26

48

25

Mild

21

20

16

14

Moderate

16

5

19

7

Severe

12

1

13

4

Arthralgia

Any

13

4

16

4

Mild

9

3

8

2

Moderate

3

1

6

2

Severe

2

0

2

0

Headache

Any

33

20

34

23

Mild

19

15

21

8

Moderate

9

4

6

12

Severe

4

1

6

3

Fever

≥38°C

1

1

5

0

38.0-38.9°C

1

1

4

0

39.0-39.9°C

0

0

1

0

≥40°C

0

0

0

0

Solicited adverse reaction rates were similar among participants aged 11 through 24 years who received BEXSERO in the other 3 clinical studies,2,3,4 except for severe myalgia which was reported by 3% to 7% of subjects. Severe pain was reported by 8% of university students in the U.K.3

Non-serious Adverse Reactions

In the 3 controlled studies1,2,3 (BEXSERO n = 2,221, control n = 2,204), non-serious unsolicited adverse events that occurred within 7 days of any dose were reported by 439 (20%) participants receiving BEXSERO and 197 (9%) control recipients. Unsolicited adverse reactions that were reported among at least 2% of participants and were more frequently reported in participants receiving BEXSERO than in control recipients were injection site pain, headache, injection site induration unresolved within 7 days, and nasopharyngitis.

Serious Adverse Events

Overall, in clinical studies, among 3,058 participants aged 10 through 25 years 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 = 2,716, control n = 2,078), serious adverse events within 30 days after any dose were reported in 23 (0.8%) participants receiving BEXSERO and 10 (0.5%) control recipients.

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