Dengvaxia

This vaccine is used to prevent dengue in people 6 through 16 years old who have had dengue before and live in areas where dengue is a risk.

Like any vaccine, Dengvaxia may not protect every person from the disease.

Use only as directed. Inform your doctor if you are taking other medicines, have other medical conditions, or have allergies.

You should not use Dengvaxia if you are allergic to it, or if you have a weak immune system (from a disease or from taking certain medicines).

Tell your doctor if:

• you have a weak immune system (from a disease or from taking certain medicines); or
• you have never been infected with dengue before.

Tell your doctor if you are pregnant or planning to become pregnant. Having dengue during pregnancy may increase the risk of premature birth. The benefits of getting Dengvaxia may be greater than any risks to the baby.

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

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

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

Dengvaxia may cause serious side effects. Call your doctor right away 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 Dengvaxia may include:

• pain, redness, swelling, or itching where the vaccine was injected;
• headache;
• feeling unwell; 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.

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

Dengvaxia 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 Dengvaxia.

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

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

Since this vaccine is given by a healthcare professional, it is unlikely for someone to receive too much Dengvaxia.

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

Before getting this vaccine, inform the doctor about all other vaccines you have had recently.

Also let the doctor know if you have recently taken any drugs or treatments that can weaken your immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine;
• medications for psoriasis, rheumatoid arthritis, or other autoimmune disorders; or
• medicines to prevent or treat 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 mentioned in this medication guide.

• Why can't the dengue vaccine Dengvaxia be used in people who haven't already had dengue?