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Meningococcal Group B Vaccine

Medically reviewed by Drugs.com. Last updated on Jul 3, 2020.

Pronunciation

(me NIN joe kok al groop bee vak SEEN)

Index Terms

  • 4CMenB
  • MenB
  • MenB-4C
  • MenB-FHbp
  • rLP2086

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension Prefilled Syringe, Intramuscular:

Bexsero: (0.5 mL)

Suspension Prefilled Syringe, Intramuscular [preservative free]:

Trumenba: (0.5 mL) [contains polysorbate 80]

Brand Names: U.S.

  • Bexsero
  • Trumenba

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

Bexsero: Induces immunity against meningococcal disease caused by serogroup B Neisseria meningitidis (MenB) via the formation of antibodies directed toward the recombinant protein antigens combined together with outer membrane vesicles (OMV) from a group B strain.

Trumenba: Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis.

Efficacy:

Bexsero: Composite hSBA titer response one month after the second dose: 63% to 88%

Trumenba: 84% of adolescents had a ≥4-fold rise in hSBA titer and composite response after the third dose.

Use: Labeled Indications

Meningococcal group B disease prevention:

US labeling: Active immunization of children, adolescents, and adults aged 10 to 25 years against invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of persons ≥10 years of age with increased risk of meningococcal disease related to the following indications (ACIP [Folaranmi 2015; Patton 2017]):

- Persons with persistent complement component deficiencies (including patients receiving complement inhibitors [eg, eculizumab, ravulizumab])

- Persons with anatomic or functional asplenia (including sickle cell disease)

- Microbiologists routinely exposed to isolates of N. meningitidis

- Persons identified to be at increased risk due to a serogroup B meningococcal disease outbreak

The ACIP states that a meningococcal group B vaccination series may be administered to adolescents and young adults aged 16 to 23 years as determined by shared clinical decision-making to provide short-term protection against most strains of serogroup B meningococcal disease. The preferred age for vaccination is 16 to 18 years (ACIP [MacNeil 2015; Patton 2017; Freedman 2020; Robinson 2020]).

Canadian labeling: Active immunization against invasive meningococcal disease caused by N. meningitidis serogroup B (Bexsero: patients 2 months through 25 years of age; Trumenba: patients 10 through 25 years of age).

The Canadian National Advisory Committee on Immunization (NACI) recommends use of Bexsero (patients ≥2 months of age) or Trumenba (patients ≥10 years of age) in patients at high risk for serogroup B meningococcal disease (including disease outbreaks) and may be considered on an individual basis in healthy patients (Bexsero: 2 months to 25 years of age; Trumenba: 10 to 25 years of age) (NACI/CATMAT 2015; NACI 2019).

Contraindications

Severe hypersensitivity to the meningococcal group B vaccine or any component of the formulation.

Dosing: Adult

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should not be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, vaccination of patients with suspected or confirmed COVID-19 infection (regardless of symptoms) should be postponed to avoid exposure to health care personnel and other patients (CDC 2020). Additional information is available from the CDC, the American Academy of Pediatrics, and the Immunization Action Coalition.

Meningococcal group B disease prevention: Note: Products (Bexsero/Trumenba) are not interchangeable; the same product should be used for all doses in the series (ACIP [Patton 2017]).

ACIP recommendations (ACIP [Folaranmi 2015; MacNeil 2015; Patton 2017; Freedman 2020]): Note: Vaccines are approved in adults ≤25 years of age; however, ACIP only recommends routine vaccination of persons aged ≥10 years who are at increased risk for serogroup B meningococcal disease. In patients ≥16 years of age who are not at risk, use is per shared clinical decision-making. Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule.

Patients at increased risk for serogroup B meningococcal disease or during serogroup B meningococcal disease outbreak:

Bexsero: IM: 0.5 mL per dose given as 2 doses ≥1 month apart. Administer a booster dose 1 year after primary series and every 2 to 3 years thereafter if risk remains (ACIP [Freedman 2020]). A one-time booster dose is also recommended during an outbreak if it has been ≥1 year since completion of the primary series (ACIP 2020).

Trumenba: IM: 0.5 mL per dose given as 3-dose series at 0, 1 to 2 months, and 6 months. If the interval between the first and second dose is ≥6 months, then the third dose is not needed. Administer a booster dose 1 year after primary series and every 2 to 3 years thereafter if risk remains (ACIP [Freedman 2020]). A one-time booster dose is also recommended during an outbreak if it has been ≥1 year since completion of the primary series (ACIP 2020).

Patients 16 to 23 years of age (preferred 16 to 18 years) who are not at increased risk for meningococcal disease (per shared clinical decision-making): Note: To provide short-term protection against most strains of serogroup B meningococcal disease:

Bexsero: IM: 0.5 mL per dose given as 2 doses ≥1 month apart.

Trumenba: IM: 0.5 mL per dose given as 2 doses 6 months apart. If the second dose is given earlier than 6 months, a third dose should be administered ≥4 months after the second dose.

NACI recommendations (NACI/CATMAT 2015; NACI 2019): Note: Vaccines are approved in adults ≤25 years of age; however, NACI recommends consideration for vaccination of any adults who are at high risk for serogroup B meningococcal disease. Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule.

Bexsero:

Patients at high risk for serogroup B meningococcal disease or healthy patients ≤24 years of age who are not at high risk for meningococcal disease (per clinical discretion): IM: 0.5 mL per dose given as a 2-dose series ≥4 weeks apart.

Close contacts and outbreak control of meningococcal serogroup B disease:

Unvaccinated: IM: 0.5 mL immediately after exposure; revaccinate with a single dose ≥4 weeks after first dose.

Previously vaccinated: IM: 0.5 mL immediately after exposure.

Booster dose (Canadian labeling): Consider a single booster dose for those individuals at continued risk of exposure to meningococcal disease as per current guideline recommendations.

Trumenba:

Patients with underlying medical conditions at higher risk for serogroup B meningococcal disease if exposed: IM: 0.5 mL per dose administered as a 3-dose series at 0, 1 to 2 months, and 6 months.

Patients at higher risk of exposure to serogroup B meningococcal disease or healthy patients ≤25 years of age who are not at high risk for meningococcal disease (per clinical discretion): IM: 0.5 mL per dose given as 2-dose series 6 months apart.

Dosing: Pediatric

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should not be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, vaccination of patients with suspected or confirmed COVID-19 infection (regardless of symptoms) should be postponed to avoid exposure to health care personnel and other patients (CDC 2020). Additional information is available from the CDC, the American Academy of Pediatrics, and the Immunization Action Coalition.

Meningococcal group B disease prevention: Note: Products (Bexsero/Trumenba) are not interchangeable; the same product should be used for all doses in the series. Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Ezeanolue 2020]).

ACIP Recommendations (ACIP [Folaranmi 2015; MacNeil 2015; Patton 2017; Robinson 2020]): Although FDA-approved in children and adolescents ≥10 years, use in patients 10 to 15 years of age who are not at risk for infection is not recommended. In patients ≥16 years of age who are not at risk, use is per shared clinical decision making. For children ≥10 years and adolescents, ACIP recommends routine vaccination in patients at increased risk for serogroup B meningococcal disease, including those with persistent complement component deficiencies (inherited or chronic), who are taking complement inhibitors (eg, eculizumab, ravulizumab), with anatomic or functional asplenia, or identified to be at increased risk due to an outbreak.

Patients at increased risk:

Children ≥10 years and Adolescents: Note: Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule; refer to ACIP recommendations for additional information.

Bexsero: IM: 0.5 mL per dose for a total of 2 doses administered at least 1 month apart.

Trumenba:

2-dose schedule: IM: 0.5 mL per dose for a total of 2 doses administered as follows: Initial dose followed by a second dose 6 months later; Note: If the interval between the first and second dose is inadvertently <6 months, administer a third dose ≥4 months after the second dose (manufacturer labeling).

3-dose schedule: IM: 0.5 mL per dose for a total of 3 doses administered as follows: Initial dose followed by a second and third dose 1 to 2 months and 6 months after the first dose, respectively. If the interval between the first and second dose is ≥6 months, then the third dose is not needed.

Booster: Administer a booster dose 1 year after primary series and every 2 to 3 years thereafter if risk remains. A one-time booster dose is also recommended during an outbreak if it has been ≥1 year since completion of the primary series (ACIP 2020).

Patients not at increased risk (per shared clinical decision-making): Note: To provide short-term protection against most strains of serogroup B meningococcal disease:

Adolescents ≥16 years: IM: 0.5 mL per dose. Administer 2-dose series of either Bexsero (separate doses by 1 month) or Trumenba (separate doses by 6 months; if the second dose is given earlier than 6 months, a third dose should be administered 4 months after the second dose). A one-time booster dose is also recommended during an outbreak if it has been ≥1 year since completion of the primary series (ACIP 2020).

NACI recommendations and Canadian labeling (NACI/CATMAT 2015; NACI 2019):

Patients at high risk for serogroup B meningococcal disease or healthy patients who are not at high risk for meningococcal disease (per clinical discretion): Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule.

Bexsero:

Infants 2 to 5 months: IM:

3-dose primary infant series: Total of 4 doses (0.5 mL each); a primary infant series is administered at 2, 4, and 6 months of age followed by a booster dose between 12 to 23 months of age; alternatively, may give first 3 doses at 2, 3, and 4 months of age; however, the immune response to 1 component (NHBA) of the vaccine is reduced with this regimen.

2-dose primary infant series: Total of 3 doses (0.5 mL each) with first and second dose administered at least 2 months apart; followed by a booster dose between 12 to 23 months of age.

Infants 6 months to <12 months (unvaccinated): IM: Total of 3 doses (0.5 mL each) with first and second dose administered at least 2 months apart; third dose is administered during second year of life at least 2 months after the second dose. The necessity of further booster doses has not yet been determined.

Children ≥1 year to <2 years of age (unvaccinated): IM: Total of 3 doses (0.5 mL each) with first and second dose administered at least 2 months apart; third dose is administered 12 to 23 months after the second dose. The necessity of further booster doses has not yet been determined.

Children ≥2 years and Adolescents: IM: Total of 2 doses (0.5 mL each) administered at least 1 month apart. Consider a single booster dose for those individuals at continued risk of exposure to meningococcal disease as per current guideline recommendations.

Trumenba: Children ≥10 years and Adolescents:

Patients at increased risk for meningococcal serogroup B disease: IM: 0.5 mL per dose as a 3-dose series with dose 1 and 2 separated by ≥1 month, followed by a third dose administered ≥4 months after the second dose.

Patients not at increased risk (ie, use per clinical discretion): IM: 0.5 mL per dose as a 2-dose series administered 6 months apart (eg, a 0- and 6-month schedule).

Close contacts and outbreak control of meningococcal serogroup B disease: Consider risk of exposure and patient's susceptibility to the disease when choosing a schedule.

Infants 2 months to <6 months: Bexsero:

Unvaccinated: IM: 0.5 mL immediately after exposure; revaccinate with 2 additional doses with ≥4 week interval between doses.

Previously vaccinated: IM: 0.5 mL immediately after exposure.

Infants 6 months to Children <10 years: Bexsero:

Unvaccinated: IM: 0.5 mL immediately after exposure; revaccinate with a single dose ≥8 weeks after first dose.

Previously vaccinated: IM: 0.5 mL immediately after exposure.

Children ≥10 years and Adolescents: Bexsero, Trumenba:

Unvaccinated: IM: 0.5 mL immediately after exposure; revaccinate with a single dose ≥4 weeks after first dose.

Previously vaccinated: IM: 0.5 mL immediately after exposure. Note: Product used for previous doses should be used.

Reconstitution

Shake vigorously to ensure that a homogenous white suspension is obtained. Do not use the vaccine if it cannot be resuspended.

Administration

IM: For IM administration only, preferably into the upper deltoid region. Do not administer via IV, SubQ, or intradermal route. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Ezeanolue 2020]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement edition date and date it was provided, and the administering person's name, title, and address be recorded.

For patients at risk of hemorrhage, the vaccine should be administered IM if, in the opinion of a health care provider familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient or family should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Ezeanolue 2020]).

Storage

Bexsero: Store between 2°C to 8°C (36°F to 46°F). Do not freeze; discard if frozen. Protect from light.

Trumenba: Store between 2°C to 8°C (36°F to 46°F). Do not freeze; discard if frozen. Store syringes in the refrigerator horizontally (lying flat on the shelf) to minimize the redispersion time.

Canadian labeling: Stable for 4 days at <25°C. Do not exceed 4 days (96 hours) cumulative multiple temperature excursions between 8°C and 25°C (46°F and 77°F).

Drug Interactions

Eculizumab: Meningococcal Group B Vaccine may diminish the therapeutic effect of Eculizumab. The meningococcal vaccine may result in increased complement activation, possibly worsening the symptoms of any underlying complement-mediated diseases, such as hemolysis and anemia. Eculizumab may diminish the therapeutic effect of Meningococcal Group B Vaccine. Management: Administer meningococcal vaccine at least 2 weeks prior to initiation of eculizumab in unvaccinated patients. If eculizumab is indicated urgently, administer meningococcal vaccine as soon as possible and administer 2 weeks of antibiotic prophylaxis. Consider therapy modification

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

Frequencies reported may include concomitant administration with routine pediatric vaccines or other vaccines.

>10%:

Central nervous system: Irritability (infants and children: 43% to 79%), drowsiness (infants and children: 53% to 72%; children: 30% to 51%), excessive crying (infants and children: 56% to 69%; children: 27% to 33%), fatigue (children, adolescents, and adults: 35% to 62%), headache (10% to 55%), malaise (children and adolescents: 50% to 56%; adults: 14%), chills (children and adolescents: 16% to 29%)

Gastrointestinal: Change in appetite (infants and children: 21% to 51%), diarrhea (children: 2% to 37%; infants and children: 18% to 24%; children and adolescents: years 9% to 15%), nausea (children, adolescents, and adults: 16% to 19%), vomiting (infants, children, and adolescents: ≤13%)

Local: Pain at injection site (children, adolescents, and adults: 82% to 98%), erythema at injection site (children: 60% to 98%; infants and children: 60% to 64%; children, adolescents, and adults: 45% to 54%), tenderness at injection site (children: 81% to 89%; infants and children: 65% to 66%), swelling at injection site (children: 26% to 63%; children and adolescents: 18% to 39%; infants and children: 26% to 31%), induration at injection site (infants and children: 33% to 56%; children, adolescents, and adults: 28% to 40%)

Neuromuscular & skeletal: Myalgia (children, adolescents, and adults: 31% to 57%), arthralgia (children, adolescents, and adults: 13% to 33%)

Miscellaneous: Fever (infants and children: 69% to 79%, ≥40°C [104°F] ≤1%; children: 10% to 28%, ≥40°C [104°F] ≤3%; children, adolescents, and adults: 1% to 8%)

1% to 10%:

Dermatologic: Skin rash (children: ≤9%), urticaria (infants and children: 5% to 6%)

Respiratory: Upper respiratory tract infection (infants: 10%; mostly considered unrelated to vaccination), nasopharyngitis (children, adolescents, and adults: ≥2%)

<1% (postmarketing, and/or case reports): Eczema, febrile seizures, hypersensitivity reaction (includes anaphylaxis), injection site blister formation, injection site nodule, Kawasaki syndrome, pallor, seizure, swelling of eye, syncope, vasodepressor syncope

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Ezeanolue 2020]).

• Apnea: Post immunization apnea may occur in premature infants, particularly if history of respiratory immaturity.

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinitis) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Ezeanolue 2020]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Ezeanolue 2020]).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Ezeanolue 2020]).

• Meningococcal infections: Not to be used to treat meningococcal infections or to provide immunity against N. meningitidis serogroups A, C, W-135, or Y. In addition, vaccine does not provide protection against all circulating meningococcal group B strains.

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration; ideally, vaccinations should be administered prior to initiation of anticoagulant therapy if possible (ACIP [Ezeanolue 2020]).

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. Because of differences in components and dosing regimen, meningococcal group B vaccines are not interchangeable (ACIP [Ezeanolue 2020]).

Special populations:

• Altered immunocompetence: Patients with certain complement deficiencies and patients receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at an increased risk for invasive meningococcal infection, including post-vaccination. Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Ezeanolue 2020]; IDSA [Rubin 2014]).

• Pediatric: Apnea has occurred following intramuscular vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (AAP [Saari 2003]; ACIP [Ezeanolue 2020]).

Dosage form specific issues:

• Kanamycin: May contain kanamycin.

• Latex: The packaging (needle cover of prefilled syringe) may contain latex.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Ezeanolue 2020]). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends on multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Ezeanolue 2020]).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Considerations

Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Ezeanolue 2020]). However, the Advisory Committee on Immunization Practices (ACIP) recommends deferring meningococcal group B vaccination in pregnant women unless the woman is at increased risk for meningococcal disease and vaccination benefits outweigh the potential risks (ACIP [Patton 2017]).

Patient Education

What is this drug used for?

• It is used to prevent meningococcal disease.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Injection site pain, redness, or swelling

• Loss of strength and energy

• Headache

• Muscle pain

• Joint pain

• Chills

• Diarrhea

• Nausea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe dizziness

• Passing out

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.