ADACEL®
INDICATION FOR ADACEL® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed)
Adacel is a vaccine indicated for:
- Active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use in persons 10 through 64 years of age.
- Immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.
IMPORTANT SAFETY INFORMATION FOR ADACEL
Adacel is contraindicated in persons who have had a severe allergic reaction (e.g., anaphylaxis) to any other tetanus toxoid, diphtheria toxoid, or pertussis containing vaccine, or to any component of Adacel; or encephalopathy within 7 days of a previous dose of a pertussis containing vaccine with no other identifiable cause.
Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.
If Guillain‐Barré syndrome or brachial neuritis has occurred within 6 weeks following previous vaccination with a tetanus toxoid or if progressive or unstable neurologic disorders exist, the decision to give Adacel should be based on careful consideration of the potential benefits and risks.
Persons who experienced an Arthus‐type hypersensitivity reaction following a prior dose of tetanus toxoid‐containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of tetanus toxoid‐containing vaccine.
Some individuals with altered immunocompetence, including receiving immunosuppressant therapy, may have reduced immune responses to Adacel.
Syncope can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions.
After the first and second dose of Adacel, the most frequently reported solicited reactions were pain, swelling, and erythema at the injection site; headache, body ache or muscle weakness, tiredness, myalgia, and malaise.
Other adverse reactions may occur. Vaccination with Adacel may not protect all individuals.
Please see full Prescribing Information for Adacel.
BEYFORTUS®
INDICATION FOR BEYFORTUS® (Nirsevimab-alip) 50 mg/100 mg Injection
Beyfortus is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in:
- Neonates and infants born during or entering their first RSV season.
- Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
IMPORTANT SAFETY INFORMATION FOR BEYFORTUS
Contraindication
Beyfortus is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients.
Warnings and Precautions
- Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions have been reported following Beyfortus administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.
- Use in Individuals with Clinically Significant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.
Most common adverse reactions with Beyfortus were rash (0.9%) and injection site reactions (0.3%).
Please see full Prescribing Information for Beyfortus.
FLUZONE®
INDICATION FOR FLUZONE® (Influenza Vaccine)
Fluzone is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone is approved for use in persons 6 months of age and older.
IMPORTANT SAFETY INFORMATION FOR FLUZONE
Do not administer Fluzone to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine.
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of Fluzone.
If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone should be based on careful consideration of the potential benefits and risks.
If Fluzone is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.
Vaccination with Fluzone may not protect all recipients.
Syncope (fainting) has been reported following vaccination with Fluzone. Procedures should be in place to avoid injury from fainting.
In children 6 months through 8 years of age, the most common injection-site adverse reactions were pain or tenderness and redness; the most common solicited systemic adverse reactions were irritability, drowsiness (6 months through 35 months), and myalgia (3 years through 8 years). In adults 18 through 64 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache and myalgia. In adults over 65 years of age, the most common injection-site adverse reaction was pain; the most common solicited systemic adverse reactions were headache, myalgia, and malaise. Other reactions may occur.
Please see full Prescribing Information for Fluzone.
MENQUADFI®
INDICATION FOR MENQUADFI® (Meningococcal [Groups A, C, Y, W] Conjugate Vaccine)
MenQuadfi is a vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi is approved for use in individuals 2 years of age and older. MenQuadfi does not prevent N meningitidis serogroup B disease.
IMPORTANT SAFETY INFORMATION FOR MENQUADFI
MenQuadfi should not be administered to anyone who has had a severe allergic reaction to any component of the vaccine, or after a previous dose of MenQuadfi or any other tetanus toxoid-containing vaccine.
Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of MenQuadfi.
Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MenQuadfi. Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, W, and Y, even if they develop antibodies following vaccination with MenQuadfi.
Syncope (fainting) may occur in association with administration of injectable vaccines, including MenQuadfi. Procedures should be in place to avoid injury from fainting.
Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to give MenQuadfi to persons with a history of GBS should take into account the expected benefits and potential risks.
Immunization with MenQuadfi does not substitute for routine tetanus immunization.
Vaccination with MenQuadfi may not protect all vaccine recipients.
The most common adverse reactions following a primary dose of MenQuadfi in individuals 2 years of age and older include pain at the injection site; myalgia, headache, and malaise. Other common adverse reactions in children 2 through 9 years of age include erythema and swelling at the injection site. In adolescents and adults, rates of solicited adverse reactions following a booster dose were comparable to those observed following primary vaccination. Other adverse reactions may occur.
Please see full Prescribing Information for MenQuadfi.
PENTACEL®
INDICATION FOR PENTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine)
Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a 4-dose series in children 6 weeks through 4 years of age (prior to 5th birthday).
IMPORTANT SAFETY INFORMATION FOR PENTACEL
Contraindications to vaccination with Pentacel include: a severe allergic reaction (e.g., anaphylaxis) after a previous dose of Pentacel, or any other diphtheria toxoid-, tetanus toxoid-, pertussis antigen-containing vaccine, inactivated poliovirus vaccine, or Haemophilus influenzae type b vaccine, any ingredient of Pentacel; encephalopathy within 7 days after a previous dose of a pertussis antigen-containing vaccine with no other identifiable cause; or a progressive neurologic disorder.
Carefully consider benefits and risks before administering Pentacel to persons with a history of: fever ≥105°F not attributable to another identifiable cause, hypotonic-hyporesponsive episode within 48 hours, or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis antigen-containing vaccine; seizures with or without fever within 3 days after a previous pertussis antigen-containing vaccine; or adverse events after a previous dose of Pentacel or receipt of any other tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine.
If Guillain-Barré syndrome has occurred within 6 weeks following receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following Pentacel.
For infants and children with a history of previous seizures, an antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing acellular pertussis antigens (including Pentacel) and for the next 24 hours.
Individuals with altered immunocompetence, including individuals receiving immunosuppressive therapy, may have reduced immune responses to Pentacel.
Apnea following intramuscular vaccination has been observed in some infants born prematurely.
Syncope (fainting) may occur in association with administration of injectable vaccines including Pentacel. Procedures should be in place to avoid injury from fainting.
Vaccination with Pentacel may not protect all individuals.
The most frequent (>50% of participants) systemic reactions following any dose were fussiness/irritability and inconsolable crying. The most frequent (>30% of participants) injection site reactions following any dose were tenderness and increased circumference of the injected arm. Other adverse reactions may occur.
Please see full Prescribing Information for Pentacel.
QUADRACEL®
INDICATION FOR QUADRACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)
Quadracel® is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis. A single dose of Quadracel® is approved as a fifth dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and as a fourth or fifth dose in the inactivated poliovirus (IPV) vaccination series, in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Pentacel® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate [Tetanus Toxoid Conjugate] Vaccine) and/or DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or VAXELIS® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine).
IMPORTANT SAFETY INFORMATION FOR QUADRACEL®
Contraindications to vaccination with Quadracel® include: a severe allergic reaction (e.g., anaphylaxis) to any ingredient of Quadracel® or following any other diphtheria toxoid-, tetanus toxoid-, or pertussis antigen-containing vaccine, or inactivated poliovirus vaccine; encephalopathy within 7 days of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause; or a progressive neurologic disorder.
Carefully consider benefits and risks before administering Quadracel® to persons with a history of: fever ≥105°F, hypotonic-hyporesponsive episode, or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis antigen-containing vaccine; seizures within 3 days after a previous pertussis antigen-containing vaccine; Guillain-Barré syndrome occurring within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or adverse events after a previous dose of Quadracel® or receipt of any other tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine.
Vaccination with Quadracel® may not protect all individuals.
If Quadracel® is administered to immunocompromised persons, including persons receiving immuno-suppressive therapy, the expected immune response may not be obtained.
Syncope (fainting) may occur in association with administration of injectable vaccines including Quadracel®. Procedures should be in place to avoid injury from fainting.
The most common local and systemic adverse reactions to Quadracel® include pain, erythema, and edema at the injection site; myalgia, malaise, and headache. Other adverse reactions may occur.
Please see full Prescribing Information for Quadracel (49281-564-10/15 and 49281-562-10).
VAXELIS®
INDICATION FOR VAXELIS® (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)
VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Hib). VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).
IMPORTANT SAFETY INFORMATION FOR VAXELIS
Do not administer VAXELIS to anyone with a history of severe allergic reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.
Do not administer VAXELIS to anyone with a history of encephalopathy within 7 days of a pertussis-containing vaccine with no other identifiable cause.
Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized.
Carefully consider benefits and risks before administering VAXELIS to persons with a history of: fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours after a previous pertussis-containing vaccine; and/or seizures within 3 days after a previous pertussis-containing vaccine.
If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS.
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Consider the individual infant’s medical status and potential benefits and possible risks of intramuscular vaccination in deciding when to administer VAXELIS to an infant born prematurely.
Vaccination with VAXELIS may not protect all individuals.
The solicited adverse reactions 0-5 days following any dose were irritability (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).
The 3-dose immunization series consists of a 0.5 mL intramuscular injection, administered at 2, 4, and 6 months of age.
A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.
Before administering VAXELIS, please read the accompanying Prescribing Information. The Patient Product Information also is available.