Trumenba

Last updated on RxList: 2/26/2020
Trumenba Side Effects Center

What Is Trumenba?

Trumenba (Meningococcal Group B Vaccine) Suspension for intramuscular injection is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is approved for use in individuals 10 through 25 years of age.

What Are Side Effects of Trumenba?

Common side effects of Trumenba include:

Dosage for Trumenba

The dosing schedule of Trumenba is three doses (0.5 mL each) by intramuscular injection according to a 0- 2- and 6- month schedule.

What Drugs, Substances, or Supplements Interact with Trumenba?

Trumenba may interact with other drugs or vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Trumenba During Pregnancy and Breastfeeding

During pregnancy, Trumenba should be used only if prescribed. It is unknown if Trumenba passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Trumenba (Meningococcal Group B Vaccine) Suspension 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.

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Trumenba Consumer Information

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

Keep track of all side effects you have. If you need a booster dose, you will need to tell the vaccination provider if the previous shot caused any side effects.

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

Becoming infected with meningococcal disease and developing meningitis is much more dangerous to your health than receiving this vaccine. Any vaccine may cause side effects but the risk of serious side effects is low.

You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Common side effects may include:

  • headache;
  • feeling tired;
  • muscle or joint pain;
  • nausea, diarrhea; or
  • pain, redness, swelling, or a hard lump where the shot was given.

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 Trumenba (Meningococcal Group B Vaccine)

Trumenba Professional Information

SIDE EFFECTS

In clinical studies, the most common solicited adverse reactions in adolescents and young adults were pain at the injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%). Nausea was reported in up to 24% of adolescents in early phase studies.

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 to rates in the clinical trials of another vaccine and may not reflect the rates observed in clinical practice.

The safety of Trumenba was evaluated in 15,227 subjects 10 through 25 years of age in 11 clinical studies (8 randomized controlled and 3 supportive non-controlled studies) conducted in the U.S., Europe, Canada, Chile, and Australia. A total of 11,333 adolescents (10 through 18 years of age) and 3,894 adults (19 through 25 years of age) received at least one dose of Trumenba. A total of 5,501 subjects 10 through 25 years of age in the control groups received saline placebo and/or one of the following vaccine(s): Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV4) (Merck & Co., Inc.); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) (Sanofi Pasteur Ltd.); Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (MCV4) (Sanofi Pasteur Inc.); a non-U.S. licensed reduced diphtheria toxoid, tetanus toxoid, acellular pertussis and inactivated polio virus vaccine (dTaP-IPV) (Sanofi Pasteur, Inc.); Hepatitis A Vaccine, Inactivated (HAV) (GlaxoSmithKline Biologicals).

The safety evaluation in the clinical studies included an assessment of: (1) solicited local and systemic reactions, and use of antipyretic medication after each vaccination in an electronic diary maintained by the subject or the subject's parent/legal guardian and (2) spontaneous reports of adverse events (AEs), including serious adverse events (SAEs), throughout the study (day of vaccination through one month or 6 months after the last vaccination, depending on the study and safety parameter).

In controlled studies, demographic characteristics were generally similar with regard to gender, race, and ethnicity among subjects who received Trumenba and those who received control. Overall, across the 11 studies, among the subjects who received Trumenba, 50.5% were male and 49.5% were female, and the majority were White (86.3%) and non-Hispanic/non-Latino (87.3%).

Solicited Local And Systemic Adverse Reactions

Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter trial in the U.S., Canada, and Europe in which 2,693 subjects 10 to 18 years of age received at least 1 dose of Trumenba on a 0-, 2-, and 6- month schedule. A control group (n=897) received HAV at 0 and 6 months and saline at 2 months. 87.3% of subjects were White, 8.1% were Black or African-American, 0.4% were Asian, and 5.8% were Hispanic or Latino. Overall, 51.5% of subjects were male, 55.6% of participants were 10 to 14 years age, and 44.4% were 15 to 18 years of age.

Study 2 was a Phase 3, randomized, placebo-controlled, observer-blinded, multicenter trial in the U.S., Canada, and Europe in which 2,471 subjects 18 to 25 years of age received at least 1 dose of Trumenba and 822 subjects received saline on a 0-, 2,- and 6- month schedule. 76.1% of subjects were White, 20.8% were Black or African-American, 1.6% were Asian, and 17.1% were Hispanic or Latino. Overall, 41.3% of subjects were male.

Local adverse reactions at the Trumenba injection site and control (HAV/saline or saline) injection site were assessed in both studies.

Tables 1 and 2 present the percentage and severity of reported local adverse reactions within 7 days following each dose of Trumenba or control (HAV/saline or saline) for Study 1 and Study 2, respectively.

Local adverse reactions were reported more frequently following Trumenba compared to control (see Tables 1 and 2).

Table 1: Percentages of Subjects 10 to 18 Years of Age (Study 1*) Reporting Local Adverse Reactions Within 7 Days After Each Vaccination

  Dose 1 Dose 2 Dose 3
Trumenba HAV/Saline Trumenba HAV/Saline Trumenba HAV/Saline
Local Reaction N=2681 N=890 N=2545 N=843 N=2421 N=821
Pain
  Any§ 86.7 47.0 77.7 15.2 76.0 34.0
  Mild 41.1 36.5 39.4 12.3 34.1 23.8
  Moderate 40.7 9.9 33.2 2.7 36.5 9.9
  Severe 5.0 0.6 5.1 0.1 5.4 0.4
Redness¶
  Any§ 16.2 1.3 12.5 0.6 13.9 1.1
  Mild 5.6 1.2 5.2 0.6 4.9 1.0
  Moderate 8.8 0.1 6.1 0.0 6.8 0.1
  Severe 1.9 0.0 1.1 0.0 2.2 0.0
Swelling
  Any§ 18.0 2.2 13.9 0.6 15.4 0.9
  Mild 8.5 1.8 6.3 0.5 7.9 0.7
  Moderate 8.8 0.4 7.3 0.1 6.8 0.1
  Severe 0.7 0.0 0.2 0.0 0.7 0.0
*Study 1: National Clinical Trial (NCT) number NCT01830855.
Trumenba was administered at 0, 2, and 6 months. HAV was administered at 0 and 6 months and saline was administered at 2 months.
Mild (does not interfere with activity); moderate (interferes with activity); severe (prevents daily activity).
§"Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
Mild (2.5–5.0 cm); moderate (>5.0–10.0 cm); severe (>10.0 cm).

Table 2: Percentages of Subjects 18 to 25 Years of Age (Study 2*) Reporting Local Adverse Reactions Within 7 Days After Each Vaccination

  Dose 1 Dose 2 Dose 3
Trumenba Saline Trumenba Saline Trumenba Saline
Local Reaction N=2425 N=798 N=2076 N=706 N=1823 N=624
Pain
  Any§ 84.2 11.8 79.3 7.8 80.4 6.7
  Mild 42.3 10.7 42.2 6.8 36.1 6.4
  Moderate 37.1 1.1 32.7 1.0 38.9 0.3
  Severe 4.8 0.0 4.4 0.0 5.3 0.0
Redness
  Any§ 13.8 0.6 11.8 0.3 17.1 0.2
  Mild 5.8 0.5 4.6 0.1 6.2 0.2
  Moderate 7.1 0.0 6.3 0.0 8.6 0.0
  Severe 0.9 0.1 0.9 0.1 2.3 0.0
Swelling
  Any§ 15.5 0.6 14.0 0.4 16.6 0.3
  Mild 8.5 0.3 7.7 0.3 8.8 0.0
  Moderate 6.8 0.3 6.0 0.1 7.2 0.3
  Severe 0.2 0.1 0.3 0.0 0.5 0.0
*Study 2: National Clinical Trial (NCT) number NCT01352845.
Trumenba was administered at 0, 2, and 6 months. Saline was administered at 0, 2, and 6 months.
Mild (does not interfere with activity); moderate (interferes with activity); severe (prevents daily activity).
§"Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
Mild (2.5–5.0 cm); moderate (>5.0–10.0 cm); severe (>10.0 cm).

In Study 1, mean duration of pain was 2.4 to 2.6 days (range 1–17 days), for redness 2.0 to 2.2 days (range 1– 12 days) and for swelling 2.0 to 2.1 days (range 1–21 days) in the combined Trumenba group. In Study 2, mean duration of pain was 2.6 to 2.8 days (range 1–67 days), for redness 2.2 to 2.5 days (range 1–13 days) and for swelling 2.1 to 2.6 days (range 1–70 days) in the Trumenba group.

Tables 3 and 4 present the percentage and severity of reported solicited systemic adverse reactions within 7 days of each dose of Trumenba or control (HAV/saline or saline) for Study 1 and Study 2, respectively.

Table 3: Percentages of Subjects 10 to 18 Years of Age (Study 1*) Reporting Systemic Adverse Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination

  Dose 1 Dose 2 Dose 3
Trumenba HAV/Saline Trumenba HAV/Saline Trumenba HAV/Saline
Systemic Reaction N=2681 N=890 N=2545 N=843 N=2421 N=821
Fever (≥38°C)
  ≥38.0°C 6.4 1.9 2.0 1.5 2.7 2.3
3  8.0°C to <38.5°C 4.0 1.3 1.2 0.7 1.8 1.3
  38.5°C to <39.0°C 1.9 0.3 0.7 0.7 0.6 0.4
  39.0°C to ≤40.0°C 0.5 0.2 0.1 0.1 0.3 0.5
  >40.0°C 0.0 0.0 0.0 0.0 0.0 0.0
Vomiting§
  Any 3.7 1.9 2.2 1.4 1.7 2.2
  Mild 2.8 1.7 1.7 1.1 1.4 1.7
  Moderate 0.9 0.2 0.4 0.4 0.3 0.5
  Severe 0.0 0.0 0.0 0.0 0.0 0.0
Diarrhea#
  Any 10.6 12.1 7.6 9.1 7.7 7.6
  Mild 9.1 10.9 6.2 7.6 6.4 6.2
  Moderate 1.3 1.1 1.3 1.2 1.0 1.1
  Severe 0.3 0.1 0.1 0.4 0.3 0.2
Headacheþ
  Any 51.8 37.2 37.8 28.1 35.4 24.8
  Mild 28.7 24.0 20.2 15.7 18.9 13.5
  Moderate 21.0 12.5 16.0 10.9 15.2 10.4
  Severe 2.2 0.7 1.7 1.5 1.3 1.0
Fatigue            
  Any 54.0 40.3 38.3 26.3 35.9 24.4
  Mild 27.8 23.5 20.6 13.2 18.4 13.5
  Moderate 23.2 15.2 15.8 11.7 15.2 10.0
  Severe 3.0 1.7 1.9 1.4 2.3 0.9
Chillsþ
  Any 25.3 17.2 16.0 10.3 13.1 8.3
  Mild 16.2 13.3 10.6 8.1 8.7 6.5
  Moderate 8.0 3.5 4.8 1.8 3.8 1.7
  Severe 1.2 0.4 0.6 0.5 0.5 0.1
Muscle pain (other than muscle pain at the injection site)þ
  Any 24.4 19.2 17.8 10.3 17.6 11.1
  Mild 13.2 13.5 8.7 5.2 9.5 6.6
  Moderate 10.1 5.4 7.9 4.5 7.2 4.3
  Severe 1.2 0.3 1.2 0.6 0.8 0.2
Joint painþ
  Any 21.9 13.6 16.7 9.1 16.0 8.9
  Mild 11.8 8.3 8.4 5.0 8.9 5.5
  Moderate 8.7 4.6 7.5 3.4 5.9 3.0
  Severe 1.4 0.7 0.8 0.7 1.2 0.4
Use of antipyretic medication 20.7 10.4 13.6 8.9 12.7 6.8
*Study 1: National Clinical Trial (NCT) number NCT01830855.
Trumenba was administered at 0, 2, and 6 months. HAV was administered at 0 and 6 months and saline was administered at 2 months.
Study 1: Fever (≥38°C): N=2679, 2540, and 2414 for Trumenba at Dose 1, Dose 2, and Dose 3, respectively; N=890, 840, and 819 for HAV/saline at Dose 1, Dose 2, and Dose 3, respectively.
§Mild (1–2 times in 24 hours); moderate (>2 times in 24 hours); severe (requires intravenous hydration).
"Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
#Mild (2–3 loose stools in 24 hours); moderate (4–5 loose stools in 24 hours); severe (6 or more loose stools in 24 hours).
þMild (does not interfere with activity); moderate (interferes with activity); severe (prevents daily activity).

Table 4: Percentages of Subjects 18 to 25 Years of Age (Study 2*) Reporting Systemic Adverse Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination

  Dose 1 Dose 2 Dose 3
Trumenba Saline Trumenba Saline Trumenba Saline
Systemic Reaction N=2425 N=798 N=2076 N=706 N=1823 N=624
Fever (≥38°C)
  ≥38.0°C 2.4 0.6 1.2 1.0 2.0 0.6
3  8.0°C to <38.5°C 1.6 0.4 0.7 0.6 1.4 0.5
  38.5°C to <39.0°C 0.7 0.0 0.4 0.3 0.4 0.2
  39.0°C to ≤40.0°C 0.0 0.3 0.1 0.1 0.1 0.0
  >40.0°C 0.0 0.0 0.0 0.0 0.1 0.0
Vomiting§
  Any 2.6 2.1 2.1 1.6 2.0 1.4
  Mild 2.2 2.1 1.6 1.3 1.8 1.1
  Moderate 0.4 0.0 0.5 0.3 0.2 0.3
  Severe 0.0 0.0 0.0 0.0 0.0 0.0
Diarrhea#
  Any 12.7 11.8 8.6 8.1 7.5 6.9
  Mild 10.2 9.8 6.4 4.7 6.1 5.3
  Moderate 2.4 1.9 1.7 2.8 1.2 1.3
  Severe 0.2 0.1 0.5 0.6 0.2 0.3
Headacheþ
  Any 43.9 36.2 33.1 24.9 32.5 21.6
  Mild 24.3 22.1 18.4 13.6 17.6 12.5
  Moderate 17.9 13.5 13.3 10.1 13.3 8.3
  Severe 1.6 0.6 1.4 1.3 1.6 0.8
Fatigue
  Any 50.9 39.8 39.2 27.3 39.3 24.5
  Mild 25.4 23.2 20.6 13.9 18.9 13.1
  Moderate 22.1 15.8 16.4 11.5 18.8 9.6
  Severe 3.4 0.9 2.2 2.0 1.6 1.8
Chillsþ
  Any 18.1 9.8 12.4 8.5 12.6 6.4
  Mild 12.0 8.1 8.1 6.9 7.7 4.3
  Moderate 4.9 1.6 3.5 1.6 4.2 2.1
  Severe 1.1 0.0 0.8 0.0 0.8 0.0
Muscle pain (other than muscle pain at the injection site)þ
  Any 25.9 14.5 15.6 8.5 16.9 7.5
  Mild 13.0 9.6 7.6 5.8 8.9 4.5
  Moderate 11.3 4.4 7.1 2.3 6.8 2.9
  Severe 1.6 0.5 0.8 0.4 1.2 0.2
Joint painþ
  Any 19.6 10.9 15.1 6.5 12.6 5.3
  Mild 10.3 6.9 8.1 3.7 6.6 2.9
  Moderate 7.9 3.5 6.2 2.5 5.4 2.4
  Severe 1.4 0.5 0.9 0.3 0.6 0.0
Use of antipyretic medication 13.4 8.9 12.3 7.6 12.8 6.6
*Study 2: National Clinical Trial (NCT) number NCT01352845.
Trumenba was administered at 0, 2, and 6 months. Saline was administered at 0, 2, and 6 months.
Study 2: Fever (≥38°C): N=2415, 2067, and 1814 for Trumenba at Dose 1, Dose 2, and Dose 3, respectively; N=796, 705, and 621 for saline at Dose 1, Dose 2, and Dose 3, respectively.
§Mild (1–2 times in 24 hours); moderate (>2 times in 24 hours); severe (requires intravenous hydration).
"Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
#Mild (2–3 loose stools in 24 hours); moderate (4–5 loose stools in 24 hours); severe (6 or more loose stools in 24 hours).
þMild (does not interfere with activity); moderate (interferes with activity); severe (prevents daily activity).

The frequencies of adverse reactions were highest after the first dose regardless of the schedule. After subsequent doses, the frequencies of adverse reactions were similar regardless of dose number and schedule.

Serious Adverse Events

Overall in clinical studies in which 15,227 subjects 10 through 25 years of age received at least one dose of Trumenba, serious adverse events (SAEs) were reported by 269 (1.8%) subjects.

Among the 8 controlled studies (Trumenba N=13,275, control N=5,501), SAEs were reported by 213 (1.6%) subjects and by 106 (1.9%) subjects who received at least one dose of Trumenba or control, respectively.

Non-Serious Adverse Events

Overall in clinical studies in which 15,227 subjects 10 through 25 years of age received Trumenba, non-serious AEs within 30 days after any dose were reported in 4,463 (29.3%) subjects. Among the 8 controlled studies (Trumenba N=13,275, control N=5,501), AEs that occurred within 30 days of vaccination were reported in 4,056 (30.6%) subjects who received Trumenba and 1,539 (28.0%) subjects in the control group, for individuals who received at least one dose. AEs that occurred at a frequency of at least 2% and were more frequently observed in subjects who received Trumenba than subjects in the control group were injection site pain, fever, and headache.

Postmarketing Experience

The following is considered an adverse reaction for Trumenba and was reported in the postmarketing experience. Because this reaction was derived from spontaneous reports, the frequency could not be determined.

Immune System Disorders: Hypersensitivity reactions, including anaphylactic reactions.

Read the entire FDA prescribing information for Trumenba (Meningococcal Group B Vaccine)

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

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