Vx Labels

Vaccine Labels and Information

Vaccine Information: Flublok

FLUBLOK- influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen, influenza a virus a/texas/50/2012 (h3n2) recombinant hemagglutinin antigen and influenza b virus b/massachusetts/2/2012 recombinant hemagglutinin antigen injection, solution
Protein Sciences Corporation

1 INDICATIONS AND USAGE

Flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes A and type B contained in the vaccine. Flublok is approved for use in persons 18 years of age and older.

In persons 18 through 49 years of age, this indication is based on a controlled clinical study demonstrating a decrease in influenza disease after vaccination with Flublok. In persons 50 years of age and older, this indication is based on the immune response elicited by Flublok; data demonstrating a decrease in influenza disease in persons 50 years and older after vaccination with Flublok are not available. (see Clinical Studies [ 14 ])

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Dosage

Administer Flublok as a single 0.5-mL dose.

2.2 Administration

Shake the single-dose vial gently before withdrawing the vaccine dose.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permits. If either of these conditions exists, the vaccine should not be administered.

The preferred site for injection is the deltoid muscle. Administration is by sterile needle and syringe.

Flublok should not be mixed with any other vaccine in the same syringe or vial.

3 DOSAGE FORMS AND STRENGTHS

Flublok is a sterile solution supplied in single-dose vials, 0.5 mL.

4 CONTRAINDICATIONS

Flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see Description [11] and Postmarketing Experience [6.2]).

5 WARNINGS AND PRECAUTIONS

5.1 Managing Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

5.2 Guillain-Barré Syndrome

The 1976 swine influenza vaccine was associated with an increased frequency of Guillain-Barré Syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than one additional case per 1 million persons vaccinated. If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give Flublok should be based on careful consideration of the potential benefits and risks.

5.3 Altered Immunocompetence

If Flublok is administered to immunocompromised individuals, including persons receiving immunosuppressive therapy, the immune response may be diminished.

5.4 Limitations of Vaccine Effectiveness

Vaccination with Flublok may not protect all vaccine recipients.

6 ADVERSE REACTIONS

In adults 18 through 49 years of age, the most common (≥10%) injection-site reaction was pain (37%); the most common (≥10%) solicited systemic adverse reactions were headache (15%), fatigue (15%) and muscle pain (11%). (6.1)

In adults 50 through 64 years of age, the most common (≥10%) injection site reaction was pain (32%); the most common (≥10%) solicited systemic adverse reactions were headache (17%), fatigue (13%), and muscle pain (11%). (6.1)

In adults 65 years of age and older, the most common (≥10%) injection site reaction was pain (19%); the most common (≥10%) solicited systemic adverse reactions were fatigue (13%) and headache (10%). (6.1)

6.1 Clinical Trials Experience

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

Flublok has been administered to and safety data collected from 2497 adults 18 through 49 years of age, 972 adults 50 through 64 years of age, and 1078 adults aged 65 years and older enrolled in five randomized, placebo- or active-controlled clinical trials. Clinical safety data for Flublok are presented from four clinical trials (Studies 1, 2, 3, and 4). Data from a placebo-controlled trial in adults 18 through 49 years of age (Study 1) are presented, followed by data pooled according to age group from Studies 2 and 4 (adults 50 through 64 years of age) and Studies 3 and 4 (adults aged 65 years and older). Reactogenicity data from a small Phase 2 trial (Study 5) in adults 18 through 49 years of age, 153 of whom received Flublok 135mcg, are not presented. However, subjects from Study 5 are included in the description of deaths and serious adverse events (SAEs). In all studies local (injection site) and systemic adverse reactions were solicited with the use of a memory aid for 7 days following vaccination, and unsolicited adverse reactions were collected for 28-30 days post-vaccination. In Studies 1- 3 and 5, SAEs were collected for 6 months post-vaccination via clinic visit or telephone follow up on Day 28, telephone follow up on Day 180, or by spontaneous reporting. Study 4 collected SAEs through 30 days following receipt of vaccine. Study 4 also actively solicited pre-specified common hypersensitivity-type reactions through 30 days following receipt of vaccine as a primary endpoint.

Study 1 included 4648 subjects 18 through 49 years of age for safety analysis, randomized to receive Flublok (n=2344) or placebo (n=2304) (2) (see Clinical Studies [14]).

Study 2 included 602 subjects 50 through 64 years of age for safety analysis, randomized to receive Flublok (n=300) or another U.S.-licensed trivalent influenza vaccine (Fluzone, manufactured by Sanofi Pasteur, Inc.) as an active control (n=302) (3) (see Clinical Studies [14]).

Study 3 included 869 subjects aged 65 years and older for safety analysis, randomized to receive Flublok (n=436) or another U.S.-licensed trivalent influenza vaccine (Fluzone) as an active control (n=433) (4) (see Clinical Studies [14]).

Study 4 included 2627 subjects aged 50 years and older for safety analysis, randomized to receive Flublok (n=1314) or another U.S.-licensed trivalent influenza vaccine (Afluria, manufactured by bioCSL Pty Ltd.) as an active control (n=1313). Among subjects 50 through 64 years of age, 672 received Flublok and 665 received Afluria. Among subjects aged 65 years and older, 642 received Flublok and 648 received Afluria (see Clinical Studies [14]).

In a clinical trial of adults 18-49 years of age (Study 1, Table 1) the mean age of participants was 32.5 years, 59% were female, and 67% were Caucasian (see Clinical Studies [14]).

Table 1: Frequency of Solicited Local Injection Site Reactions and Systemic Adverse Reactions within 7 Days of Administration of Flublok or Placebo in Adults 18-49 Years of Age, Study 1, Total Vaccinated Cohort1,2,3

Flublok N=2272

Placebo N=2231

Local

%

%

Any

Mod4

Sev4

Any

Mod4

Sev4

Pain

37

2

<1

8

<1

<1

Redness

4

<1

<1

2

<1

<1

Swelling

3

<1

<1

2

<1

<1

Bruising

3

<1

<1

3

<1

<1

Systemic

%

%

Headache

15

3

<1

16

3

<1

Fatigue

15

3

<1

14

3

<1

Muscle Pain

11

2

<1

7

<1

<1

Nausea

6

1

<1

5

1

<1

Joint pain

4

<1

<1

4

<1

<1

Chills

3

<1

<1

3

<1

<1

Fever

<1

<1

<1

<1

<1

<1

NOTE: Data based on the most severe response reported by subjects. Results ≥1% reported to nearest whole percent; results >0 but <1% reported as <1%.

Fever defined as ≥100.4°F (38°C). Mild (≥100.4º to <101.1ºF); Moderate (≥101.2ºF to <102.2ºF); Severe (≥102.2ºF)

1 Total Vaccinated Cohort is defined as all randomized subjects who received study vaccine according to the treatment actually received and who provided data.

2 Study 1 is registered as NCT00539981 under the National Clinical Trials registry.

3 Denominators for Study 1: The total number of enrolled, randomized, and vaccinated subjects was 2344 in the Flublok group and 2304 in the placebo group. For all categories except fever, the number of subjects with missing values was 72 in the Flublok group and 73 in the Placebo group so that these denominators are 2272 and 2231 respectively. For fever, 89 Flublok recipients and 104 Placebo recipients were missing data, making these denominators 2255 and 2200 respectively.

4 Moderate = had it, and it was bad enough to prevent a significant part of usual activities; Severe = had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine.

Across three clinical trials (Studies 2 – 4, Tables 2 and 3) a total of 2050 adults age 50 years and older received Flublok and 2048 received a U.S.-licensed IIV3 comparator. The mean age of these study participants was 65 years; 56% were female and 80% were Caucasian (see Clinical Studies [14]).

The incidence of solicited reactogenicity differed between adults 50 through 64 years of age and adults aged 65 years and older. Therefore, data from Studies 2, 3, and 4 were pooled according to age group and are presented separately (Tables 2 and 3).

Most events in both age groups were mild in severity.

Table 2: Frequency of Solicited Local Injection Site Reactions and Systemic Adverse Reactions within 7 Days of Administration of Flublok or Comparator in Adults 50-64 Years of Age, Studies 2 and 4, Total Vaccinated Cohort1,2

Flublok N=972

IIV32 N=967

Any

Mod3

Sev3

Any

Mod3

Sev3

Local

%

Pain

32

2

<1

37

<1

0

Firmness/Swelling

7

2

<1

6

1

<1

Redness

6

2

<1

5

1

<1

Systemic

%

Headache

17

4

<1

16

3

<1

Fatigue

13

3

<1

17

3

<1

Muscle Pain

11

2

<1

11

2

<1

Joint Pain

8

2

<1

8

2

<1

Nausea

6

1

0

5

<1

<1

Shivers/Chills

5

1

0

4

<1

<1

Fever

<1

<1

<1

<1

0

0

NOTE: Data based on the most severe response reported by subjects. Results ≥1% reported to nearest whole percent; results >0 but <1% reported as <1%.

‡ Fever defined as ≥100.4°F (38°C). Mild (≥100.4º to <101.1ºF); Moderate (≥101.2ºF to <102.2ºF); Severe (≥102.2ºF) For fever, 12 Flublok recipients and 5 IIV3 recipients were missing data, making these denominators 964 and 962, respectively.

1 Total Vaccinated Cohort is defined as all randomized subjects who received study vaccine according to the treatment actually received and who provided data.

2 Pooled Data from Studies 2 and 4. For Studies 2 and 4, the U.S.-licensed IIV3 comparators were Fluzone and Afluria, respectively. Studies 2 and 4 are registered as NCT00539864 and NCT01825200, respectively, under the National Clinical Trials registry.

3 Moderate = had it, and it was bad enough to prevent a significant part of usual activities; Severe = had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine.

Table 3: Frequency of Solicited Local Injection Site Reactions and Systemic Adverse Reactions within 7 Days of Administration of Flublok or Comparator in Adults ≥65 Years of Age, Studies 3 and 4, Total Vaccinated Cohort1,2

Flublok N=1078

IIV32 N=1081

Any

Mod3

Sev3

Any

Mod3

Sev3

Local

%

Pain

19

<1

<1

20

<1

<1

Redness

7

1

<1

7

1

1

Firmness/Swelling

7

2

<1

7

<1

<1

Systemic

%

Fatigue

13

3

<1

15

2

<1

Headache

10

<1

<1

9

1

<1

Muscle Pain

8

2

<1

8

1

<1

Joint Pain

6

1

<1

6

1

<1

Shivers/Chills

5

<1

<1

5

<1

<1

Nausea

4

<1

<1

3

<1

<1

Fever

3

<1

<1

2

0

0

NOTE: Data based on the most severe response reported by subjects. Results ≥1% reported to nearest whole percent; results >0 but <1% reported as <1%.

‡ Fever defined as ≥100.4°F (38°C). Mild (≥100.4º to <101.1ºF); Moderate (≥101.2ºF to <102.2ºF); Severe (≥102.2ºF)

1 Total Vaccinated Cohort is defined as all randomized subjects who received study vaccine according to the treatment actually received and who provided data.

2 Pooled Data from Studies 3 and 4. For Studies 3 and 4, the U.S.-licensed IIV3 comparators were Fluzone and Afluria, respectively. Studies 3 and 4 are registered as NCT00395174 and NCT01825200, respectively, under the National Clinical Trials registry.

3 Moderate = had it, and it was bad enough to prevent a significant part of usual activities; Severe = had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine.

Among adults 18-49 years of age (Studies 1 and 5 pooled), through 6 months post-vaccination, two deaths were reported, one in a Flublok recipient and one in a placebo recipient. Both deaths occurred more than 28 days following vaccination and neither was considered vaccine-related. SAEs were reported by 32 Flublok recipients and 35 placebo recipients. One SAE in a Flublok recipient was assessed as possibly related to the vaccine: pleuropericarditis with effusions requiring hospitalization and drainage. No specific cause was identified. The patient recovered.

Among adults 50-64 years of age (Studies 2 and 4 pooled), through up to 6 months post-vaccination, there were no deaths; SAEs were reported by 10 subjects, 6 Flublok recipients and 4 IIV3 recipients. One of the SAEs, vasovagal syncope following injection of Flublok, was considered related to study vaccine. Among adults 65 years of age and older (Studies 3 and 4 pooled), through up to 6 months post-vaccination, there were 4 deaths, 2 in Flublok recipients and 2 in IIV3 recipients. None were considered related to the study vaccines. SAEs were reported from 80 subjects, 37 Flublok recipients, 43 in IIV3 recipients. None were considered related to the study vaccines.

In Study 1(adults 18-49 years of age), the most frequent unsolicited adverse events, occurring in 1%-2% of subjects, were nasopharyngitis, upper respiratory infection, headache, cough, nasal congestion, pharyngolaryngeal pain, and rhinorrhea.

Among adults 50-64 years of age (Studies 2 and 4 pooled), the most frequent unsolicited adverse events, occurring in 1% of subjects, were diarrhea and cough. Among adults ≥65 years of age (Studies 3 and 4 pooled), the most frequent unsolicited adverse events, occurring in 1% of subjects, were nasopharyngitis and cough.

Among adults 50 years of age and older (Study 4) for whom the incidence of rash, urticaria, swelling, non-pitting edema, or other potential hypersensitivity reactions were actively solicited for 30 days following vaccination, a total of 2.4% of Flublok recipients and 1.6% of IIV3 recipients reported such events over the 30 day follow-up period. A total of 1.9% and 0.9% of Flublok and IIV3 recipients, respectively, reported these events in the 7 days following vaccination. Of these solicited events, rash was most frequently reported (Flublok 1.3%, IIV3 0.8%) over the 30 day follow-up period.

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