Varilrix

/ GSK

Healthy subjects Children from 12 months up to and including 12 years of age: It is recommended to administer 2 doses of Varilrix to children from 12 months to 12 years of age in order to ensure optimal protection against varicella.
It is preferable to administer the second dose at least 6 weeks, but under no circumstances less than 4 weeks, after the first dose.
Adolescents 13 years of age and above and adults: Two doses are required for subjects 13 years of age and above. An interval of at least 6 weeks, but under no circumstances less than 4 weeks, should be maintained between the 2 doses.
High-risk patients- The vaccination schedule described for healthy subjects is also applicable to high-risk patients, but additional doses may be necessary
Interchangeability– A single dose may be administered to subjects who have already received a single dose of another varicella-containing vaccine. A single dose may be administered followed by a single dose of another varicella-containing vaccine.
Method of administration- Subcutaneous injection in the deltoid region of the arm or in the anterolateral part of the thigh.

Intended for the active immunization against varicella where there is no history of varicella:
– Healthy subjects, from the age of 12 months.
– Patients at high risk of severe varicella, such as patients with acute leukemia or a chronic condition, those on immunosuppressive therapy or those for whom an organ transplant is being considered.
– Healthy persons living in close contact with patients with varicella and high-risk patients.

* Individuals with severe humoral or cellular (primary or acquired)
Immunodeficiency (See prescribing information for full details).
* Hypersensitivity to the active substance or to any of the excipients or to neomycin. However, a history of contact dermatitis to neomycin, is not a contraindication.
* Subjects having shown signs of hypersensitivity after previous administration of varicella vaccine.

* Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination.

* As with other vaccines, the administration should be postponed in subjects suffering from acute severe febrile illness. In healthy subjects the presence of a minor infection, however, is not a contra-indication for vaccination.
* Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
* As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
* Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine.
* Limited protection against varicella may be obtained by vaccination up to 72 hours after exposure to natural disease.
* As with any vaccine, a protective immune response may not be elicited in all vaccinees. As for other varicella vaccines, cases of varicella disease have been shown to occur in persons who have previously received this medical product. These breakthrough cases are usually mild, with a fewer number of lesions and less fever as compared to cases in unvaccinated individuals.
Transmission
Transmission of the Oka varicella vaccine virus has been shown to occur at a very low rate in seronegative contacts of vaccinees with rash. Transmission of the Oka varicella vaccine virus from a vaccinee who does not develop a rash to seronegative contacts cannot be excluded. Compared to healthy vaccinees, leukaemia patients are more likely to develop a papulovesicular rash. In these cases too, the course of the disease in the contacts was mild. Vaccine recipients, even those who do not develop a varicella-like rash, should attempt to avoid contact, whenever possible, with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination. In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus. High-risk individuals susceptible to varicella include:
– Immunocompromised individuals
– Pregnant women without documented positive history of varicella (chickenpox) or laboratory evidence of prior infection;
– Newborns of mothers without documented positive history of chickenpox or laboratory evidence of prior infection.
The mild nature of the rash in the healthy contacts indicates that the virus remains attenuated after passage through human hosts.
Individuals at high risk of severe varicella
There is only limited data from clinical trials available for this medical product (+4°C formulation) in individuals at high risk of severe varicella.
Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (e.g. asymptomatic HIV subjects, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases). Immunocompromised patients who have no contraindication for this vaccination may not respond as well as immunocompetent subjects, therefore some of these patients may acquire varicella in case of contact, despite appropriate vaccine administration. These patients should be monitored carefully for signs of varicella.
Due to the potential risk of decreased vaccine response and/or disseminated disease, consideration should be given to the time interval between vaccination and immunosuppressive therapy.
Encephalitis:
Encephalitis has been reported during post-marketing use of live attenuated varicella vaccines. In a few cases fatal outcomes have been observed, especially in patients who were immunocompromised. Vaccinees/parents should be instructed to seek prompt medical attention if they/their child experience, after vaccination, symptoms suggestive of encephalitis such as loss or reduced levels of consciousness, convulsions or ataxia accompanied by fever and headache.
See prescribing information for full details.

Very common: pain, erythema
Common: rash, pyrexia (oral/axillary temperature ³ 37.5°C or rectal temperature ³ 38.0°C), injection site swelling
See preascribing information for full details.

If tuberculin testing has to be done it should be carried out before or simultaneously with vaccination since it has been reported that live viral vaccines may cause a temporary depression of tuberculin skin sensitivity. As this anergy may last up to a maximum of 6 weeks, tuberculin testing should not be performed within that period after vaccination to avoid false negative results.

In individuals who have received immunoglobulins or a blood transfusion, vaccination should be delayed for at least three months because of the likelihood of vaccine failure due to passively acquired varicella antibodies.
Salicylates should be avoided for 6 weeks after varicella vaccination as Reye’s Syndrome has been reported
following the use of salicylates during natural varicella infection.
Healthy subjects: This product can be administered at the same time as any other vaccine. Different injectable vaccines should always be administered at different injection sites. Should a measles containing vaccine not be given at the same time, it is recommended that an interval of at least one month should be respected since it is recognized that measles vaccination may lead to short lived suppression of the cell mediated immune response.
High-risk patients: This product should not be administered at the same time as other live attenuated vaccines. Inactivated vaccines may be administered in any temporal relationship to this product, given that no specific contra-indication has been established. However, different injectable vaccines should always be administered at different injection sites.

Pregnancy: It is contra-indicated to administer VARILRIX to pregnant women, because the possible effects on foetal development are unknown. Furthermore, pregnancy should be avoided for three months after vaccination.
Lactation: There are no data regarding use in breastfeeding women.

Cases of accidental administration of more than the recommended dose of Varilrix have been reported. Amongst these cases, the following adverse events were reported: lethargy and convulsions. In the other cases reported as overdose there were no associated adverse events.