Dengvaxia

Main information

  • Trade name:
  • Dengvaxia Powder for Suspension for Injection SC
  • Pharmaceutical form:
  • Powder for Suspension for Injection SC
  • Units in package:
  • Type I glass vial x 4mL + 2.5mL of 0.9% Sodium Chloride solvent in a vial (box of 5's and 10's) [Single Dose]
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Sanofi Pasteur

Documents

Localization

  • Available in:
  • Dengvaxia Powder for Suspension for Injection SC
    Philippines
  • Language:
  • English

Status

  • Source:
  • FDA - Food And Drug Administration - Philippines
  • Authorization number:
  • BR-1128
  • Authorization date:
  • 22-12-2020
  • Last update:
  • 26-01-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Sanofi Pasteur

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Package Leaflet: Information for the User

Dengvaxia, powder and solvent for suspension for injection

Dengue tetravalent vaccine (live, attenuated)

Read all of this leaflet carefully before you or your child is vaccinated because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This vaccine has been prescribed for you or your child only. Do not pass it on to others.

If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes

any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet

What Dengvaxia is and what it is used for

What you need to know before Dengvaxia is given to you or your child

How to use Dengvaxia

Possible side effects

How to store Dengvaxia

Contents of the pack and other information

1

What Dengvaxia is and what it is used for

Dengvaxia is a vaccine used to help protect you or your child 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.

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.

2

What you need to know before Dengvaxia is given to you or your child

To make sure that Dengvaxia is suitable for you or your child, it is important to tell your doctor,

pharmacist or nurse if any of the points below apply to you or your child. If there is anything you do

not understand, ask your doctor, pharmacist or nurse to explain.

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Do not use Dengvaxia if you or your child

are allergic (hypersensitive) to the active substances or any of the other ingredients of Dengvaxia

listed in Section 6,

have 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,

are suffering from a disease with mild to high fever or acute disease. In this case, your doctor will

postpone the administration of Dengvaxia until you or your child have recovered,

have 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),

are pregnant,

are breastfeeding.

Warnings and precautions

Tell your doctor, pharmacist or nurse before receiving Dengvaxia if you or your child:

are taking an immunosuppressive treatment (prednisone or equivalent 20 mg or 2 mg/kg body

weight for 2 weeks or more). Your doctor will postpone administration of Dengvaxia until 4

weeks after you stop taking the treatment.

have experienced any health problems after prior administration of any vaccines. Your doctor 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. You should take

appropriate precautions for you and your child 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 tell the doctor, pharmacist or nurse if you or your child

fainted with a prior injection.

Adults above 45 years of age

Adults above 45 years of age should not receive the vaccine.

Children

Children less than 9 years of age should not receive the vaccine.

Using other medicines and Dengvaxia

Dengvaxia may not have an optimal effect if it is used at the same time as medicines that suppress the

immune system such as corticosteroids or chemotherapy.

Please, tell your doctor, pharmacist or nurse if you or your child are taking or have recently taken any

other vaccines or any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

Dengvaxia must not be given to pregnant or breastfeeding women.

If you or your child:

are of child-bearing age, you should take the necessary precautions to avoid pregnancy for 1

month following administration of Dengvaxia.

are pregnant or breastfeeding, think you or your child may be pregnant or are planning to have a

baby, ask your doctor , pharmacist or nurse for advice before receiving Dengvaxia.

Driving and using machines

No data are available on the effects of Dengvaxia on the ability to drive or use machines.

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3

How to use Dengvaxia

Dengvaxia is given by your doctor or nurse as an injection underneath the skin (subcutaneous route) in

the upper arm.

You or your child 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.

Reconstitution instructions intended for medical and healthcare professionals are included at

the end of the leaflet.

If you or your child forget an injection of Dengvaxia

If you or your child miss a scheduled injection, your doctor will decide when to give the missed

injection.

It is important that you or your child follow the instructions of your doctor, pharmacist or nurse

regarding return visits for the follow-up injection. If you forget or are not able to go back to your

doctor, pharmacist or nurse at the scheduled time, ask him/her for advice.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4

Possible Side Effects

Like all medicines, Dengvaxia can cause side effects, although not everybody gets them.

Serious allergic reactions

If any of these symptoms occur after leaving the place where you or your child received an injection,

you must consult a doctor 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 or symptoms occur they usually develop quickly after the injection is given and

while you or your child are still in the clinic or doctor’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

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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 you or your child experience any side effects after vaccination, you are advised to seek immediate

medical attention. You are also encouraged to report any side effects to the Food and Drug

Administration via the ADR online reporting tool at www.fda.gov.ph/adr-report-new.

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

5

How to store Dengvaxia

Keep Dengvaxia out of the reach and sight of children.

Do not use Dengvaxia after the expiry date that is stated on the carton after EXP. The expiry date

refers to the last day of that month.

Store in a refrigerator (2

C - 8

Do not freeze.

Keep the vaccine in the outer carton in order to protect it from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help to protect the environment.

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6

Contents of the pack and other information

After reconstitution, one dose (0.5 mL) contains 4.5 - 6.0 log10 CCID

* of each serotype of the CYD

dengue virus** (1, 2, 3 and 4).

* CCID

: 50% Cell Culture Infectious Dose.

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

The other ingredients are: 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.

What Dengvaxia looks like and contents of the pack

Dengvaxia is a powder and solvent for suspension for injection. Dengvaxia is provided as a powder in

a single-dose vial and a solvent in single-dose pre-filled syringe (0.5 mL) with 2 separate needles. The

powder and the solvent must be mixed together before use.

Dengvaxia is available in packs of 1 or 10.

Not all pack sizes may be marketed.

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.

Name and Address of the Manufacturer

Manufactured by:

SANOFI PASTEUR SA

2, Avenue Pont Pasteur

69007 Lyon – FRANCE

This leaflet was last approved in 12/2015.

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The following information is intended for doctors, pharmacists or nurses only:

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 of 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

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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 the reconstituted suspension is withdrawn into

the same syringe. For injection, the syringe should be fitted with a new sterile needle.

The suspension should be visually inspected prior to administration. After reconstitution, Dengvaxia is

a 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 product or waste material should be disposed of, preferably by heat inactivation or

incineration, in accordance with local regulations.