FLUAD® (Influenza Vaccines, Adjuvanted) Important Safety Information
INDICATIONS AND USAGE
FLUAD® (Influenza Vaccine, Adjuvanted) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older.
Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.
WARNINGS AND PRECAUTIONS
• If Guillain-Barré syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.
• The most common (≥10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%).
• The most common (≥10%) systemic adverse reactions observed in clinical studies were myalgia (15%), headache (13%), and fatigue (13%).
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1- 855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.
For more information, please see accompanying US full Prescribing Information for FLUAD.
FLUAD® is a registered trademark of Seqirus UK Limited or its affiliates.
AFLURIA® QUADRIVALENT (Influenza Vaccine) Important Safety Information
AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older.
- Severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.
Warnings and precautions
- If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
- Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
- Immunocompromised persons may have a diminished immune response to AFLURIA QUADRIVALENT.
- In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when administered by needle and syringe was pain (≥40%). The most common systemic adverse events were myalgia and headache (≥20%).
- In adults 65 years of age and older, the most commonly reported injection-site adverse reaction when administered by needle and syringe was pain (≥20%). The most common systemic adverse event was myalgia (≥10%).
- In children 5 through 8 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse event was headache (≥10%).
- In children 9 through 17 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), redness and swelling (≥10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥10%).
- The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions:
- In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions with AFLURIA (trivalent formulation) when administered by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). The most common systemic adverse events were myalgia, malaise (≥30%), and headache (≥20%).
Please see the accompanying important safety information and the full prescribing information for AFLURIA QUADRIVALENT.
AFLURIA is a registered trademark of Seqirus UK Limited or its affiliates.
RAPIVAB® (Peramivir Injection) Important Safety Information
RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than 2 days.
Limitations of Use
- Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled.
- Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB.
- The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization.
RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product. Severe allergic reactions have included anaphylaxis, erythema multiforme and Stevens-Johnson Syndrome.
Warnings and Precautions
- Rare cases of serious skin reactions, including erythema multiforme, have been reported with RAPIVAB in clinical studies and in postmarketing experience. Cases of anaphylaxis and Stevens-Johnson Syndrome have been reported in postmarketing experience with RAPIVAB. Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis or a serious skin reaction occurs or is suspected. The use of RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to RAPIVAB.
- Influenza can be associated with a variety of neurologic and behavioral symptoms that can include events such as hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. There have been postmarketing reports of delirium and abnormal behavior leading to injury in patients with influenza who were receiving neuraminidase inhibitors, including RAPIVAB. Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made, but they appear to be uncommon. These events were reported primarily among pediatric patients. The contribution of RAPIVAB to these events has not been established. Patients with influenza should be closely monitored for signs of abnormal behavior.
- Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. RAPIVAB has not been shown to prevent such complications.
The most common adverse reaction in adults (18 years of age and older) was diarrhea (8% RAPIVAB vs 7% placebo). Lab abnormalities (incidence ≥2%) occurring more commonly with RAPIVAB than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), elevated serum glucose >160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%), and neutrophils <1.0 x 109/L (8% vs 6%). In a subset of subjects with serious influenza requiring hospitalization treated with RAPIVAB 600 mg as monotherapy (N=101), the following adverse reactions were also reported more frequently with RAPIVAB as compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased (3% versus 2%), and hypertension (2% versus 0%).
The safety profile of RAPIVAB in subjects 2 to 17 years of age was generally similar to that observed in adults. Specific adverse reactions reported in pediatric subjects treated with RAPIVAB (occurring in ≥2% of subjects) and not reported in adults included vomiting (3% versus 9% for oseltamivir), fever and tympanic membrane erythema (2% versus 0%, respectively, for each of these events). The only clinically significant laboratory abnormality (DAIDS Grade 2) occurring in ≥2% of pediatric subjects treated with RAPIVAB was proteinuria by dipstick analysis (3% versus 0% for oseltamivir).
Concurrent Use With Live Attenuated Influenza Vaccine
Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and thus may reduce vaccine efficacy). The concurrent use of RAPIVAB with LAIV intranasal has not been evaluated. Because of the potential for interference between these two products, avoid use of RAPIVAB within 2 weeks after or 48 hours before administration of LAIV unless medically indicated.
Please see the accompanying important safety information and the full prescribing information for RAPIVAB.
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2. FLUAD [package insert]. (2018) Summit, NJ. Seqirus USA Inc.
3. CDC. “Flu Vaccine with Adjuvant.” Retrieved from: https://www.cdc.gov/flu/prevent/adjuvant.htm?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fflu%2Fprotect%2Fvaccine%2Fadjuvant.htm. Accessed July 2019.
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5. FLUCELVAX QUADRIVALENT [package insert]. (2018) Holly Springs, NC. Seqirus USA Inc.
6. WHO. (2019). Addendum to the recommended composition of influenza virus vaccines for use in the 2019–2020 northern hemisphere influenza season. Retrieved from: https://www.who.int/influenza/vaccines/virus/recommendations/201902_recommendation_addendum.pdf?ua=1. Accessed March 2019.
7. Data on file. (2019). Seqirus USA Inc.
8. This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I.
9. AFLURIA QUADRIVALENT [prescribing information]. Parkville, AU: Seqirus, Inc. 2018.
10. RAPIVAB (Peramivir Injection) [prescribing information]. Durham, NC: BioCryst Pharmaceuticals, Inc. 2018.
11. Kohno S, Kida H, Mizuguchi M, Shimada J; S-021812 Clinical Study Group. Efficacy and safety of intravenous peramivir for treatment of seasonal influenza virus infection. Antimicrob Agents Chemother. 2010;54(11):4568-4574.
12. CDC. “What You Should Know About Flu Antiviral Drugs.” Retrieved from: https://www.cdc.gov/flu/antivirals/whatyoushould.htm. Accessed July 2019.