Dengvaxia Special Precautions

As with any vaccine, vaccination with Dengvaxia may not protect 100% of vaccinated individuals. It is recommended to continue personal protection measures against mosquito bites after vaccination.
As a precaution, healthcare professionals should follow-up and appropriately manage any vaccines with signs and symptoms of dengue fever, with particular attention to dengue warning signs (e.g., high fever, severe abdominal pain or tenderness, persistent vomiting, mucosal bleeding, somnolence and hyperactivity according to WHO guidelines 2009).
In individuals who have not been previously infected by the dengue virus, an increased risk of hospitalization for dengue and clinically severe dengue (predominantly grade 1 or 2 Dengue Hemorrhagic Fever [WHO 1997]) has been observed in the long-term follow up of clinical trials (see Adverse Reactions).
Vaccination should only be recommended when the potential benefits outweigh the potential risks (for those living in areas with a high dengue seroprevalence or where epidemiological data indicate a high burden of dengue disease). Healthcare professionals would need to assess the likelihood of prior dengue infection in these individuals before vaccinating. For individuals who have not been previously infected by dengue virus, vaccination should not be recommended. Previous infection by dengue virus can be substantiated through serotesting where available.
For patients receiving treatment with high doses of systemic corticosteroids given for 2 weeks or more (daily receipt of prednisone or equivalent 20 mg or 2 mg/kg body weight is considered as a substantially immunosuppressive dose), it is advisable to wait until immune function has recovered, i.e., for at least 4 weeks after stopping treatment, before administering Dengvaxia.
Vaccination is not recommended for individuals without prior dengue infection, living in non-endemic areas, who travel to endemic areas.
Dengvaxia must not be administered by intravascular injection under any circumstances.
In individuals who have a history of serious or severe reactions within 48 hours after a prior administration of Dengvaxia or of a vaccine containing similar components, the risks and benefits of administering Dengvaxia must be carefully considered.
Before administering any biological, the person responsible for administration must take all precautions to prevent allergic or other reactions. As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following administration of the vaccine. Epinephrine (1:1000) and other appropriate agents used to control immediate allergic reactions must be available to treat unexpected events such as anaphylaxis.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to injection with a needle. Procedures should be in place to prevent injury from falling and to manage syncopal reactions.
No studies have been performed on the interference of Dengvaxia with laboratory and/or diagnostic tests.
The tip caps of the pre-filled syringes contain a natural rubber latex derivative, which may cause allergic reactions in latex sensitive individuals.
Dengvaxia contains phenylalanine, sodium and sorbitol: Dengvaxia contains 41 micrograms of phenylalanine in each 0.5 ml dose of single dose presentation. Phenylalanine may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up becuase the body cannot remove it properly.
Dengvaxia contains less than 1mmol of sodium (23 mg) per 0.5 ml dose, that is to say essentially "sodium-free".
Dengvaxia contains 9.38 milligrams of sorbitol in each 0.5 ml dose of single dose presentation.
Effects on ability to drive and use machines: No studies have been performed on the effects of the vaccine on the ability to drive or to use machines.