Important Safety Information
- Do not administer FLUCELVAX® (Influenza Vaccine) to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
Warnings & Precautions
- Guillain-Barré Syndrome (GBS): If GBS has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX® should be based on careful consideration of the potential benefits and risks.
- Latex: The tip caps of the pre-filled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.
- Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
- Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including Flucelvax. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.
- Altered Immunocompetence: After vaccination with FLUCELVAX®, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
- Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX® may not protect all vaccine recipients against influenza disease.
Most Common Adverse Reactions
- The most common (≥10%) solicited adverse reactions occurring in adults 18-64 years of age within 7 days of vaccination with FLUCELVAX® were pain at the injection site, erythema at the injection site, headache, fatigue, myalgia and malaise. The most common (≥10%) solicited adverse reactions occurring in adults ≥65 years of age within 7 days of vaccination were erythema at the injection site, fatigue, headache and malaise.