Dengue tetravalent vaccine, live (Subcutaneous)

Dengue tetravalent vaccine, live is used to prevent dengue disease in children aged 9 to 16 years who have had a previous lab-confirmed dengue infection and who live in areas where the disease is common.

This vaccine should only be given by your doctor or under their direct supervision.

It is very important that you get the second and third doses of the vaccine series on time and that your doctor checks your progress during regular visits to ensure that this medicine is working properly and to monitor for any unwanted effects.

Children who have not had a previous laboratory-confirmed dengue infection should not receive the vaccine. Dengue tetravalent vaccine, live may increase your child's risk of severe dengue disease if vaccinated and later infected with the dengue virus. Your child's doctor should verify 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 immediately if you experience 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 cause fainting (syncope). Discuss any concerns with your doctor.

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

This vaccine may not protect everyone completely. It is very important to take 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 the sensitivity of the tuberculin purified protein derivative (PPD) test. Tuberculin testing should be done before or at least 1 month after receiving the vaccine.

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

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine against the benefits it may provide. The following points should be taken into account for this vaccine:

Allergies

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

Pediatric

There have not been appropriate studies on how dengue tetravalent vaccine, live affects children younger than 9 years old. Safety and effectiveness have not been established for this age group.

Geriatric

There have not been appropriate studies on how dengue tetravalent vaccine, live affects elderly individuals aged 65 years and older. Safety and effectiveness have not been established for this age group.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose, or other precautions may be necessary. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this vaccine. The following interactions are based on their potential significance and may not include all possible interactions.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may choose not to use this vaccine or may 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both medicines.

• Adalimumab
• Alemtuzumab
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Bendamustine
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• 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
• Etrasimod
• 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
• Mirikizumab-mrkz
• 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
• Vamorolone
• Vinblastine
• Vinorelbine
• Voclosporin

Receiving this vaccine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Immune system problems (e.g., immunodeficiency or immunosuppression caused by dengue disease or treatment) – This vaccine should not be used in patients with this condition.

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

In the U.S.

• Dengvaxia

Available Dosage Forms:

• Powder for Suspension

Therapeutic Class: Vaccine, Live

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.

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