Flublok Quadrivalent 2018-2019

Last updated on RxList: 10/17/2018
Flublok Quadrivalent 2018-2019 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/17/2018

Flublok Quadrivalent (Influenza Vaccine) is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older. Common side effects of Flublok Quadrivalent include:

  • injection site reactions (tenderness, pain, redness, swelling, a hard lump),
  • headache,
  • fatigue,
  • muscle pain,
  • joint pain,
  • fever, and
  • chills

Flublok Quadrivalent is administered as a single 0.5-mL dose. Flublok Quadrivalent may interact with other drugs. Tell your doctor all medications and supplements you use and all vaccines you recently received. Tell your doctor if you are pregnant or plan to become pregnant before using Flublok Quadrivalent; pregnancy outcomes in women exposed to Flublok Quadrivalent during pregnancy are being monitored. It is unknown if Flublok Quadrivalent passes into breast milk. Consult your doctor before breastfeeding.

Our Flublok Quadrivalent (Influenza Vaccine) Sterile Solution for Intramuscular Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Natural Remedies for Cold and Flu See Slideshow
Flublok Quadrivalent 2018-2019 Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. If you ever need to receive influenza virus vaccine in the future, you will need to tell your doctor if the previous shot caused any side effects.

Influenza virus injectable (killed virus) vaccine will not cause you to become ill with the flu virus that it contains. However, you may have flu-like symptoms at any time during flu season that may be caused by other strains of influenza virus.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever;
  • seizure (convulsions); or
  • unusual bleeding.

Common side effects may include:

  • low fever, chills;
  • mild fussiness or crying;
  • redness, bruising, pain, swelling, or a lump where the vaccine was injected;
  • headache, tired feeling; or
  • joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Flublok Quadrivalent 2018-2019 (Influenza Vaccine)

QUESTION

Which illness is known as a viral upper respiratory tract infection? See Answer
Flublok Quadrivalent 2018-2019 Professional Information

SIDE EFFECTS

In adults 18 through 49 years of age, the most common (≥10%) injection-site reactions were tenderness (48%) and pain (37%) ; the most common (≥10%) solicited systemic adverse reactions were headache (20%), fatigue (17%), myalgia (13%), and arthralgia (10%) (see Clinical Trials Experience).

In adults 50 years of age and older, the most common (≥10%) injection site reactions were tenderness (34%) and pain (19%); the most common (≥10%) solicited systemic adverse reactions were headache (13%) and fatigue (12%) (see Clinical Trials Experience).

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 Quadrivalent

Flublok Quadrivalent has been administered to and safety data collected from 998 adults 18-49 years of age (Study 1) and 4328 adults 50 years of age and older (Study 2).

In Studies 1 and 2, local (injection site) and systemic adverse reactions were solicited with the use of a memory aid for 7 days following vaccination, unsolicited adverse events were collected for ~28 days post-vaccination, and serious adverse events (SAEs) were collected for 6 months post-vaccination via clinic visit or remote contact.

Study 1 included 1330 subjects 18 through 49 years of age for safety analysis, randomized to receive Flublok Quadrivalent (n=998) or a comparator inactivated influenza vaccine (Fluarix Quadrivalent, manufactured by GlaxoSmithKline) (n=332) (see Clinical Studies). The mean age of participants was 33.5 years. Overall, 65% of subjects were female, 59% white/Caucasian, 37% black/African American, 1.0% Native Hawaiian/Pacific Islander, 0.8% American Indian/Alaskan Native, 0.5% Asian, 1.4% other racial groups, and 16% of Hispanic/Latino ethnicity. Table 1 summarizes the incidence of solicited local and systemic adverse reactions reported within seven days of vaccination with Flublok Quadrivalent or the comparator vaccine.

Table 1: Frequency of Solicited Local Injection Site Reactions and Systemic Adverse Reactions within 7 Days of Administration of Flublok Quadrivalent or Comparator1 in Adults 18-49 Years of Age, Study 1 (Reactogenicity Populations)1,2

Reactogenicity Term Flublok Quadrivalent
N=996 %
Comparator
N=332 %
Any Grade 6 Grade 3 Grade 4 Any Grade6 Grade 3 Grade 4
Subjects with ≥1 injection site reaction3, 4 51 1 0 52 2 0
Local Tenderness 48 1 0 47 1 0
Local Pain 37 1 0 36 1 0
Firmness / Swelling 5 0 0 3 0 0
Redness 4 0 0 1 0 0
Subjects with ≥1 systemic reaction3,5 34 2 <1 36 3 <1
Headache 20 1 0 21 2 <1
Fatigue 17 1 0 17 1 0
Muscle Pain 13 1 0 12 1 0
Joint Pain 10 1 0 10 1 0
Nausea 9 1 <1 9 1 0
Shivering / Chills 7 1 0 6 1 0
Fever6, 7 2 <1 0 1 <1 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%.
1 Comparator = U.S.-licensed comparator quadrivalent inactivated influenza vaccine manufactured by GlaxoSmithKline.
2Study 1 is registered as NCT02290509 under the National Clinical Trials registry.
3 Reactogenicity Populations were defined as all randomized subjects who received study vaccine according to the treatment actually received and who had at least one non-missing data point for injection site, systemic or body temperature reactogenicity categories. For local pain, tenderness and systemic reactions: Grade 1 = No interference with activities. Grade 2 = Prevented some activities, and headache may have required non-narcotic pain reliever. Grade 3 = Prevented most or all normal activities or required prescription medications. Grade 4 = Required visit to ER or hospitalization. For injection site redness and firmness/swelling: Grade 1=25 to ≤50 mm (small). Grade 2=51 to ≤100 mm (medium). Grade 3=>100 mm (large). Grade 4=necrosis or exfoliative dermatitis.
4 Denominators for injection site reactions: Flublok Quadrivalent n = 996, Comparator n =332.
5 Denominators for systemic reactions: Flublok Quadrivalent n = 994, Comparator n = 332.
6 Denominators for fever: Flublok Quadrivalent n = 990, Comparator n = 327.
7 Fever defined as as ≥100.4°F (38°C). Grade 1 (≥100.4°F to ≤101.1°F); Grade 2 (101.2°F to ≤102.0°F); Grade 3 (102.1°F to ≤104°F). Grade 4 >104°F.

Study 2 included 8672 subjects 50 years of age and older for safety analysis, randomized to receive Flublok Quadrivalent (n=4328) or Comparator (Fluarix Quadrivalent, manufactured by GlaxoSmithKline) as an active control (n=4344) (see Clinical Studies). The mean age of participants was 62.7 years. Overall, 58% of subjects were female, 80% white/Caucasian, 18% black/African American, 0.9% American Indian/Alaskan Native, 0.4% Asian, 0.2% Native Hawaiian/Pacific Islander, 0.7% other racial groups, and 5% of Hispanic/Latino ethnicity. Table 2 summarizes the incidence of solicited local and systemic adverse reactions reported within seven days of vaccination with Flublok Quadrivalent or Comparator.

Table 2: Frequency of Solicited Local Injection Site Reactions and Systemic Adverse Reactions within 7 Days of Administration of Flublok Quadrivalent or Comparator1 in Adults 50 Years of Age and Older, Study 2 (Reactogenicity Populations)2,3

Reactogenicity Term Flublok Quadrivalent
N=4312 %
Comparator
N=4327 %
Any Grade Grade 3 Grade 4 Any Grade Grade 3 Grade 4
Subjects with ≥1 injection site reaction3,4 38 <1 <1 40 <1 <1
Local Tenderness 34 <1 <1 37 <1 <1
Local Pain 19 <1 0 22 <1 <1
Firmness / Swelling 3 <1 0 3 <1 0
Redness 3 <1 0 2 <1 0
Subjects with ≥1 systemic reactogenicity event3,5 25 1 <1 26 1 <1
Headache 13 <1 <1 14 1 <1
Fatigue 12 <1 0 12 <1 <1
Muscle Pain 9 <1 <1 9 <1 <1
Joint Pain 8 <1 0 8 <1 <1
Nausea 5 <1 0 5 <1 <1
Shivering / Chills 5 <1 0 4 <1 <1
Fever 6, 7 <1 <1 0 1 <1 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%.
1Comparator = U.S.-licensed comparator quadrivalent inactivated influenza vaccine, Fluarix Quadrivalent, manufactured by GlaxoSmithKline.
2 Study 2 is registered as NCT02285998 under the National Clinical Trials registry.
3 Reactogenicity Populations were defined as all randomized subjects who received study vaccine according to the treatment actually received and who had at least one non-missing data point for injection site, systemic or body temperature reactogenicity categories. For local pain, tenderness, and systemic reactions: Grade 1=No interference with activity. Grade 2=Some interference with activity. Grade 3=Prevents daily activity. Grade 4=Required ER visit or hospitalization. For injection site redness and firmness/swelling: Grade 1=25 to ≤50 mm (small). Grade 2=51 to ≤100 mm (medium). Grade 3=>100 mm (large). Grade 4=necrosis or exfoliative dermatitis.
4 Denominators for injection site reactions: Flublok Quadrivalent n = 4307, Comparator n = 4319.
5 Denominators for systemic reactions: Flublok Quadrivalent n = 4306, Comparator n = 4318.
6 Denominators for fever: Flublok Quadrivalent n = 4262, Comparator n = 4282.
7 Fever defined as ≥100.4°F (38°C). Grade 1 (≥100.4°F to ≤101.1°F); Grade 2 (101.2°F to ≤102.0°F); Grade 3 (102.1°F to ≤104°F). Grade 4 >104°F.

Among adults 18-49 years of age (Study 1), through 6 months post-vaccination, no deaths were reported. SAEs were reported by 12 subjects, 10 (1%) Flublok Quadrivalent recipients and 2 (0.6%) Comparator recipients. No SAEs were considered related to study vaccine.

Among adults 50 years of age and older (Study 2), 20 deaths occurred in the 6 months post-vaccination, including 8 Flublok Quadrivalent and 12 Comparator recipients. No deaths were considered related to study vaccine. SAEs were reported by 145 (3.4%) Flublok Quadrivalent recipients and 132 (3%) Comparator recipients. No SAEs were considered related to study vaccine.

In the 28 days following vaccination, one or more unsolicited treatment emergent adverse events occurred in 10.3% of Flublok Quadrivalent and 10.5% of Comparator recipients in Study 1 (adults 18-49 years of age) and in 13.9% of Flublok Quadrivalent and 14.1% of Comparator recipients in Study 2 (adults ≥50 years of age). In both studies, rates of individual events were similar between treatment groups, and most events were mild to moderate in severity.

Flublok (Trivalent Formulation)

The safety experience with Flublok is relevant to Flublok Quadrivalent because both vaccines are manufactured using the same process and have overlapping compositions (see DESCRIPTION).

Flublok (trivalent formulation) has been administered to and safety data collected from a total of 4547 subjects in five clinical trials (Studies 3-7): 2497 adults 18 through 49 years, 972 adults 50 through 64 years, and 1078 adults 65 years and older. In Studies 3 - 5 and 7, SAEs were collected for 6 months post-vaccination. Study 6 collected SAEs through 30 days following receipt of vaccine. Study 6 also actively solicited pre-specified common hypersensitivity-type reactions through 30 days following receipt of vaccine as a primary endpoint.

Study 3 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).

Study 4 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).

Study 5 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).

Study 6 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 Seqirus 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.

Study 7 was a Phase 2 dose-finding trial conducted in adults 18 through 49 years of age, 153 of whom received Flublok 135mcg, the licensed trivalent formulation.

Serious Adverse Events

Among 2497 adults 18-49 years of age (Studies 3 and 7 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 (pleuropericarditis) in a Flublok recipient was assessed as possibly related to the vaccine.

Among 972 adults 50-64 years of age (Studies 4 and 6 pooled), through up to 6 months post-vaccination, no deaths occurred, and SAEs were reported by 10 subjects, 6 Flublok recipients and 4 Comparator recipients. One of the SAEs, vasovagal syncope following injection of Flublok, was considered related to administration of study vaccine.

Among 1078 adults 65 years of age and older (Studies 5 and 6 pooled), through up to 6 months post-vaccination, 4 deaths occurred, 2 in Flublok recipients and 2 in Comparator recipients. None were considered related to the study vaccines. SAEs were reported by 80 subjects (37 Flublok recipients, 43 Comparator recipients). None were considered related to the study vaccines.

Among 1314 adults 50 years of age and older (Study 7) 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 Comparator recipients reported such events over the 30 day follow-up period. A total of 1.9% and 0.9% of Flublok and Comparator recipients, respectively, reported these events in the 7 days following vaccination. Of these solicited events, rash was most frequently reported (Flublok 1.3%, Comparator 0.8%) over the 30 day follow-up period.

Post-marketing Experience

There is no post-marketing experience with Flublok Quadrivalent.

The following events have been spontaneously reported during post-approval use of Flublok (trivalent formulation). They are described because of the temporal relationship, the biologic plausibility of a causal relationship to Flublok (trivalent formulation), and their potential seriousness. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Immune system disorders: anaphylaxis, anaphylactoid reactions, allergic reactions, and other forms of hypersensitivity.

Read the entire FDA prescribing information for Flublok Quadrivalent 2018-2019 (Influenza Vaccine)

© Flublok Quadrivalent 2018-2019 Patient Information is supplied by Cerner Multum, Inc. and Flublok Quadrivalent 2018-2019 Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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