Prescribing Information

Qdenga ▼ (Dengue tetravalent vaccine - live, attenuated) powder and solvent for solution for injection in pre-filled syringe. PRESCRIBING INFORMATION FOR REPUBLIC OF IRELAND Refer to Summary of Product Characteristics (SmPC) before prescribing

Presentation: After reconstitution, 1 dose (0.5 mL) contains: live, attenuated dengue virus serotype 1: ≥ 3.3 log10 PFU [Plaque-Forming Units]/dose; live, attenuated dengue virus serotype 2: ≥ 2.7 log10 PFU/dose; live, attenuated dengue virus serotype 3: ≥ 4.0 log10 PFU/dose; and live, attenuated dengue virus serotype 4: ≥ 4.5 log10 PFU/dose. This product is produced in Vero cells and contains genetically modified organisms (GMOs).

Indication: Qdenga is indicated for the prevention of dengue disease in individuals from 4 years of age.

Dosage and administration: Qdenga should be administered as a 0.5 mL dose at a two-dose (0 and 3 months) schedule. The need for a booster dose has not been established. Method of administration: After complete reconstitution of the lyophilised vaccine with the solvent, Qdenga should be administered by subcutaneous injection preferably in the upper arm in the region of deltoid. Qdenga must not be injected intravascularly, intradermally or intramuscularly. The vaccine should not be mixed in the same syringe with any vaccines or other parenteral medicinal products.

Contraindications: Hypersensitivity to the active substances or to any of the excipients or hypersensitivity to a previous dose of Qdenga. Individuals with congenital or acquired immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g. 20 mg/day or 2 mg/kg body weight/day of prednisone for 2 weeks or more) within 4 weeks prior to vaccination, as with other live attenuated vaccines. Individuals with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function. Pregnant women. Breast-feeding women.

Warnings and precautions: Traceability: Name and batch number of the administered product should be clearly recorded. Anaphylaxis: Anaphylaxis has been reported in individuals who have received Qdenga. Appropriate medical treatment and supervision must be readily available in the event of a rare anaphylactic reaction. Review of medical history: vaccination should be preceded by a review of the individual’s medical history (especially with regard to previous vaccination and possible hypersensitivity reactions which occurred after vaccination). Concurrent illness: Vaccination with Qdenga should be postponed in subjects suffering from an acute severe febrile illness. Limitations of vaccine effectiveness: A protective immune response with Qdenga may not be elicited in all vaccinees against all serotypes of dengue virus and may decline over time. It is currently unknown whether a lack of protection could result in an increased severity of dengue. It is recommended to continue personal protection measures against mosquito bites after vaccination. There are no data on the use of Qdenga in subjects above 60 years of age and limited data in patients with chronic medical conditions. Anxiety-related reactions: Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. Women of childbearing potential: women of childbearing potential should avoid pregnancy for at least one month following vaccination.

Interactions: Avoid vaccination with Qdenga for at least 6 weeks, and preferably 3 months, following treatment with immunoglobulins or blood products containing immunoglobulins, such as blood or plasma. Qdenga should not be administered to subjects receiving immunosuppressive therapies within 4 weeks prior to vaccination. Use with other vaccines: Qdenga may be administered concomitantly with a hepatitis A vaccine. Co-administration has been studied in adults. Qdenga may be administered concomitantly with a yellow fever vaccine. In a clinical study involving approximately 300 adult subjects who received Qdenga concomitantly with yellow fever 17D vaccine, there was no effect on yellow fever seroprotection rate. Dengue antibody responses were decreased following concomitant administration of Qdenga and yellow fever 17D vaccine. The clinical significance of this finding is unknown. Qdenga may be administered concomitantly with a human papillomavirus (HPV) vaccine. Concomitant vaccines should be administered in separate syringes at different injection sites.

Fertility, pregnancy and lactation: Qdenga is a live attenuated vaccine, therefore Qdenga is contraindicated during pregnancy. Qdenga is contraindicated during breast-feeding. No specific studies have been performed on fertility in humans.

Effects on ability to drive and use machines: Qdenga has minor influence on the ability to drive and use machines.

Undesirable effects: Very common (³1/10): Upper respiratory tract infection, decreased appetite, irritability, headache, somnolence, myalgia, injection site pain, injection site erythema, malaise, asthenia, fever. Common (³1/100 to <1/10): Nasopharyngitis, pharyngotonsillitis, arthralgia, injection site swelling, injection site bruising, injection site pruritus, influenza like illness. Other serious undesirable effects: Angioedema (very rare), Anaphylactic reaction, including anaphylactic shock (frequency not known).

Refer to the SmPC for details on full side effect profile and interactions. Legal classification: POM. Marketing authorisation number(s): EU/1/22/1699/005.  Name and address of MA holder: Takeda GmbH, Byk-Gulden-Str.2, 78467 Konstanz, Germany.

PI approval code: pi- 03389. Date of preparation: November 2024.