This vaccine is used to prevent dengue in people 6 through 16 years old who have had dengue in the past and live in areas with a risk of dengue.

Like any vaccine, the dengue vaccine may not provide protection from disease in every person.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Dengue vaccine is injected under the skin. You will receive this vaccine in a doctor's office, clinic setting, or pharmacy.

Dengue vaccine is administered in three doses 6 months apart. Talk with your doctor if you had a severe reaction after the first dose.

You may faint after receiving the dengue vaccine.

Dengue vaccine may affect the results of a tuberculosis test within one month after vaccination.

Usual Pediatric Dose for Infection Prophylaxis:

6 to 16 years: 0.5 mL subcutaneously at months 0, 6, and 12 (3 doses total)

Comments:
-Not approved for use in individuals not previously infected by any dengue serotype or for whom information is unknown.
-Limitation of use: The safety and effectiveness of this vaccine have not been established in individuals living in dengue nonendemic areas who travel to dengue endemic areas.

Use: Prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in patients with laboratory-confirmed previous dengue infection and living in endemic areas

You should not use dengue vaccine if you are allergic to it, or if you have a weak immune system (caused by disease or by using certain medicines).

Tell your doctor if:

• you have a weak immune system (caused by disease or by using certain medicines); or

• you have never been infected with dengue before.

Tell your doctor if you are pregnant or plan to become pregnant. Having dengue during pregnancy may increase the risk of premature birth. The benefit of receiving dengue vaccine may outweigh any risks to the baby.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dengue vaccine on the baby.

Ask a doctor if it is safe to breastfeed while using this vaccine.

Be sure you receive all recommended doses of this vaccine. You may not be fully protected against disease if you do not receive the full series.

Since this vaccine is given by a healthcare professional, an overdose of dengue vaccine is unlikely to occur.

Avoid mosquito bites. Talk with your doctor if you have any questions.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Dengue vaccine may cause serious side effects. Call your doctor at once if you have:

• signs and symptoms of dengue--high fever, severe stomach pain or tenderness, vomiting, bleeding gums, drowsiness, or hyperactivity.

Common side effects of dengue vaccine may include:

• pain, redness, swelling, or itching where the vaccine was injected;

• headache;

• not feeling well; or

• weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

• medicines to treat or prevent organ transplant rejection.

This list is not complete. Other drugs may interact with dengue vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.