DengVaxia - first vaccine against dengue

Dengvaxia is a vaccine used to help protect adult or children against dengue disease caused by dengue virus serotypes 1 , 2 , 3 and 4. Dengvaxia is given to adults , adolescents and children 9 through 45 years of age living in endemic areas.

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Full Prescribing Info - Dengvaxia

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Contents

Dengue tetravalent vaccine (live , attenuated).

Indications / Uses

Dosage / Direction for Use

The patient will receive 3 injections of 0.5 mL each at 6-month intervals.

The first injection will occur at the chosen or scheduled date; the second injection , 6 months after the first injection; and the third injection , 6 months after the second injection. Dengvaxia should be used according to the local vaccination schedule.

If the Patient Forgot an Injection of Dengvaxia: If the patient missed a scheduled injection , the physician will decide when to give the missed injection.

It is important that the patient follows the instructions of the physician , pharmacist or nurse regarding return visits for the follow-up injection. If the patient forgets or is not able to go back to the physician , pharmacist or nurse at the scheduled time , ask the physician , pharmacist or nurse for advice.

Administration: Dengvaxia is given by the physician or nurse as an injection underneath the skin (subcutaneous route) in the upper arm.

Contraindications

Do not use Dengvaxia if the patient is allergic (hypertensive) to the active substances or any of the other ingredients of Dengvaxia listed in Description (see Description); has developed an allergic reaction after prior administration of Dengvaxia. Signs of an allergic reaction may include an itchy rash , shortness of breath and swelling of the face and tongue; is suffering from a disease with mild to high fever or acute disease. In this case , the physician will postpone the administration of Dengvaxia until the patient has recovered; has a weakened immune system , for example due to a genetic defect , HIV infection or therapies that affect the immune system (for example , high-dose corticosteroids or chemotherapy); is pregnant; is breastfeeding.

Use in Pregnancy & Lactation: Dengvaxia must not be given to pregnant or breastfeeding women.

If the patient is of child-bearing stage , the patient should take the necessary precautions to avoid pregnancy for 1 month following administration of Dengvaxia; is pregnant or breastfeeding , the patient thinks may be pregnant or is planning to have a baby , ask the physician , pharmacist or nurse for advice before receiving Dengvaxia.

Special Precautions

Inform the physician , pharmacist or nurse before receiving Dengvaxia if the patient is taking an immunosuppressive treatment (prednisone or equivalent to 20 mg or 2 mg/kg for 2 weeks or more). The physician will postpone administration of Dengvaxia until 4 weeks after the treatment is discontinued; has experienced any health problems after prior administration of any vaccines. The physician will carefully consider the risks and benefits of vaccination.

As with all vaccines , Dengvaxia may not protect 100% of persons who have been vaccinated. Vaccination with Dengvaxia is not a substitute for protection against mosquito bites. The patient should take appropriate precautions to prevent mosquito bites , including the use of repellents , adequate clothing , and mosquito nets.

Fainting , sometimes accompanied by falling , can occur (mostly in adolescents) following , or even before , any injection with a needle. Therefore inform the physician , pharmacist or nurse if the patient fainted with a prior injection.

Adults Above 45 Years of Age: Adults above 45 years of age should not receive the vaccine.
Driving and Using Machines: No data are available on the effects of Dengvaxia on the ability to drive or use machines.
Use in Children: Children less than 9 years of age should not receive the vaccine.

Side Effects

Like all medicines , Dengvaxia can cause side effects , although not all patients get them.

Serious Allergic Reactions: If any of these symptoms occur after leaving the place where the patient received an injection , consult a physician immediately: Difficulty in breathing , blueness of the tongue or lips , a rash , swelling of the face or throat , low blood pressure causing dizziness or collapse.

When these signs and symptoms occur they usually develop quickly after the injection is given and while the patient is still in clinic or physician's surgery.

Serious allergic reactions are very rare (may affect up to 1 in 10 ,000 people) , after receiving any vaccine.

Other Side Effects: The following side effects were reported during clinical studies in children , adolescents and adults (from 9 to and including 60 years of age). Most of the reported side effects occurred within 3 days after the injection of the vaccine: Very Common (may affect more than 1 user in 10): Headache , muscle pain (myalgia) , generally feeling unwell (malaise) , feeling of weakness (asthenia) , injection site pain , fever.

Common (may affect up to 1 user in 10): Injection site reactions: redness (erythema) , bruising (hematoma) , swelling , and itching (pruritus).

Uncommon (may affect up to 1 user in 100): Infections of the upper respiratory tract , dizziness , sore throat (oropharyngeal pain) , cough , runny nose (rhinorrhea) , nausea , skin eruption (rash) , neck pain , hardening of skin at the injection site (injection site induration).

Additional Side Effects in Adults (from 18 to and including 60 years of age): Uncommon (may affect up to 1 user in 100): Swollen glands (lymphadenopathy) , migraine , joint pain (arthralgia) , flu-like symptoms (influenza-like illness).
Additional Side Effects in Children and Adolescents (from 9 to and including 17 years of age):Uncommon (may affect up to 1 user in 100): Itchy rash (urticaria).
Reporting of Side Effects or Any Suspected Adverse Event: If the patient experiences any side effects after vaccination , advised to seek immediate medical attention.

By reporting side effects , it can help provide more information on the safety of the vaccine.

Click to View ADR Monitoring Form

Interactions

Using Other Medicines and Dengvaxia: Dengvaxia may not have an optimal effect if it used at the same time as medicines that suppress the immune system such as corticosteroids or chemotherapy.

Inform the physician , pharmacist or nurse if the patient is taking or has recently taken any other vaccines or any other medicines , including medicines obtained without a prescription.

Caution For Usage

Before administering any biological , the person responsible for administration must take all precautions to prevent allergic or other reactions. As with all injectable vaccines , appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of Dengvaxia.

Epinephrine (1:1000) and other appropriate agents used to control immediate allergic reactions must be available to treat unexpected events such as anaphylaxis.

Dengvaxia must not be mixed with other medicinal products in the same syringe.

Dengvaxia must not be administered by intravascular injection under any circumstances.

Syncope (fainting) can occur following , or even before , any vaccination as a psychogenic response to injection with a needle. Procedures should be in place to prevent injury from falling and to manage syncopal reactions.

Separate syringes and needles , separate injection sites and preferably separate limbs must be used if any other vaccine(s) or medicinal product(s) is/are concomitantly administered.

Dengvaxia is reconstituted by transferring all the solvent (0.4% sodium chloride solution) provided in the blue-labeled pre-filled syringe into the vial of freeze dried powder with a yellowish green flip off cap. The pre-filled syringe is fitted with a sterile needle for this transfer. The vial is then gently swirled. After complete dissolution , a 0.5 mL dose of reconstituted suspension is withdrawn into the same syringe. For injection , the syringe should be fitted with the new sterile needle.

The suspension should be visually inspected prior to administration. After reconstitution , Dengvaxia is clear , colorless liquid with the possible presence of white to translucent particles (of endogenous nature).

After reconstitution with the solvent provided , Dengvaxia must be used immediately.

Any unused Dengvaxia or waste material should be disposed of , preferably by heat inactivation or incineration , in accordance with local regulations.

Do not throw away any medicines via wastewater or household waste. Ask a pharmacist on how to throw away medicines that no longer use. These measures will help to protect the environment.

Storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the vaccine in the outer carton in order to protect it from light.

Description

After reconstitution , one dose (0.5 mL) contains 4.5-6.0 log10 CCID₅₀* of each serotype of the CYD dengue virus** (1 , 2 , 3 and 4).

* CCID₅₀: 50% Cell Culture Infectious Dose.

** Produced in serum-free Vero cells by recombinant DNA technology.

The powder is a white , homogenous , freeze-dried powder with possible retraction at the base , and may form a ring-shaped cake.

The solvent (0.4% sodium chloride solution) is a clear , colorless liquid.

After reconstitution with the solvent provided , Dengvaxia is a clear , colorless liquid with the possible presence of white to translucent particles.

Excipients/Inactive Ingredients: Essential amino acids including L-phenylalanine , non-essential amino acids , L-arginine hydrochloride , sucrose , D-trehalose dihydrate , D-sorbitol , trometamol , urea , sodium chloride , water for injections.

Mechanism of Action

Dengvaxia contains dengue virus serotypes 1 , 2 , 3 and 4 that have been weakened. Dengvaxia works by stimulating the body's natural defenses (immune system) , which produces its own protection (antibodies) against the viruses that cause dengue disease.

Dengue is a viral infection transmitted to humans through the bite of an infected Aedes mosquito. Dengue is not transmitted directly from person-to-person. Nevertheless the virus which replicates in an infected individual can be transmitted to other humans through mosquito bites for 4-5 days (maximum 12 days) after the first symptoms appear.

Dengue disease results in a wide range of symptoms including fever , headache , pain behind the eyes , muscle and joint pain , nausea , vomiting , swollen glands or skin rash. Symptoms usually last for 2-7 days. Dengue disease can also be asymptomatic.

However , occasionally dengue can be severe and potentially lead to hospitalization and in rare cases to death. Severe dengue is characterized by high fever and any of the following symptoms: Severe abdominal pain , persistent vomiting , rapid breathing , severe bleeding , bleeding in stomach , bleeding gums , fatigue , restlessness , coma , seizure and organ failure.

Source :- http://www.mims.com/philippines/drug/info/dengvaxia

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