Pronunciation:

DEN-gay tet-ra-VAY-lent vak-SEEN, lyve

Brand Names:

• Dengvaxia

Dosage Forms:

• Powder for Suspension

Classifications:

Therapeutic—

Vaccine, Live

Uses of This Medicine:

Dengue tetravalent vaccine, live is used to prevent dengue disease in children 9 to 16 years of age with a previous laboratory-confirmed dengue infection and who are living in endemic (where the disease is common) areas.

This vaccine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dengue tetravalent vaccine, live in children younger than 9 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of dengue tetravalent vaccine, live in the elderly 65 years of age and older. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

• Deflazacort
• Thiotepa

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adalimumab
• Alemtuzumab
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Bendamustine
• Betibeglogene Autotemcel
• Bortezomib
• Bosutinib
• Brexucabtagene Autoleucel
• Brodalumab
• Cabazitaxel
• Canakinumab
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Certolizumab Pegol
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cyclophosphamide
• Cyclosporine
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Deucravacitinib
• Docetaxel
• Doxorubicin
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Emapalumab-lzsg
• Epirubicin
• Etanercept
• Etoposide
• Everolimus
• Fingolimod
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Golimumab
• Guselkumab
• Hyaluronidase
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Ixekizumab
• Leflunomide
• Leniolisib
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mitomycin
• Mitoxantrone
• Mycophenolic Acid
• Nelarabine
• Nilotinib
• Ocrelizumab
• Ofatumumab
• Oxaliplatin
• Ozanimod
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Ponatinib
• Ponesimod
• Procarbazine
• Rilonacept
• Risankizumab-rzaa
• Ritlecitinib
• Rituximab
• Rozanolixizumab-noli
• Sarilumab
• Satralizumab-mwge
• Secukinumab
• Siponimod
• Sirolimus
• Spesolimab-sbzo
• Tacrolimus
• Temozolomide
• Teniposide
• Teplizumab-mzwv
• Teriflunomide
• Tildrakizumab-asmn
• Tocilizumab
• Tofacitinib
• Topotecan
• Tositumomab
• Trabectedin
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vinblastine
• Vinorelbine
• Voclosporin

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept
• Cytomegalovirus Immune Globulin, Human
• Hepatitis B Immune Globulin
• Rabies Immune Globulin
• Respiratory Syncytial Virus Immune Globulin, Human
• Tetanus Immune Globulin
• Vaccinia Immune Globulin, Human
• Varicella-Zoster Immune Globulin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Immune system problems (eg, immunodeficiency or immunosuppression caused by dengue disease or treatment), severe—Should not be used in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this vaccine. It is given as a shot under your skin.

This vaccine requires 3 doses that are given 6 months apart (at months 0, 6, and 12). If you miss the second or third shot, call your doctor to make another appointment as soon as possible.

Precautions While Using This Medicine:

It is very important that you receive the second and third dose of the vaccine series at the right times and that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Children without a previous laboratory-confirmed dengue infection should not receive the vaccine. Dengue tetravalent vaccine, live may increase your child's risk for severe dengue disease when vaccinated and later infected with the dengue virus. Your child's doctor should check for this information in your child's medical records.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

This vaccine may case syncope (fainting). Talk with your doctor if you have concerns.

Side effects from this vaccine could occur within 14 days after you receive a shot. Be sure to tell your doctor about any serious side effects that occur during that time.

This vaccine may not protect everyone completely. It is very important that you use precautions to reduce the risk of mosquito bites. Use insect repellents and mosquito nets, wear protective clothing, and stay indoors during twilight and after dark.

Make sure any doctor or dentist who treats you knows that you are receiving this medicine. This medicine may affect the results of certain medical tests, including tuberculin purified protein derivative (PPD) test sensitivity. Tuberculin testing should be done before or at least 1 month after receiving the vaccine.

Tell your doctor if you are using medicine that weakens the immune system, including cancer medicine, steroids, or radiation treatment.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Rare

Bleeding in the mouth

cough

high fever

noisy breathing

persistent vomiting

redness of the skin

restlessness

severe stomach pain or tenderness

sleepiness or drowsiness

swollen, painful, or tender lymph glands in the neck, armpit, or groin

tightness in the chest

trouble breathing

Incidence not known

Difficulty swallowing

dizziness

fast heartbeat

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

difficulty in moving

general feeling of discomfort or illness

headache

joint pain or swelling

lack or loss of strength

muscle pains, cramps, or stiffness

Rare

Collection of blood under the skin

deep, dark purple bruise

stomach pain

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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