Dengue Tetravalent Vaccine, Live (DEN-gay tet-ra-VAY-lent vak-SEEN, lyve)

Prevents dengue disease in children who have had the disease and living in endemic areas.

Brand Name(s):

Dengvaxia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• This vaccine requires 3 doses that are given 6 months apart.
• A nurse or other health provider will give you this medicine.
• Missed dose: If you miss your appointment for the second or third shot, call your doctor to make another appointment as soon as possible.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how dengue tetravalent vaccine, live works. Tell your doctor if you are using medicine that weakens the immune system, including cancer medicine, steroids, or radiation treatment.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• This medicine may increase the risk of severe dengue disease in children not previously infected with the dengue virus when they are later infected with the virus.
• This vaccine may not protect everyone who receives it. Dengue disease is spread by mosquitoes. Prevent mosquito bites by using insect repellent and mosquito nets and wearing protective clothing when you are outside.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results. Tuberculin testing should be done before or at least 1 month after receiving the vaccine.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fainting, lightheadedness, dizziness
• High fever, severe stomach pain or tenderness, vomiting, bleeding in the mouth, drowsiness, restlessness

If you notice these less serious side effects, talk with your doctor:

• Headache
• Joint or muscle pain
• Lack or loss of strength
• Pain, redness, or tenderness where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088