Drugs List

Therapeutic Indications

Uses

For active immunisation against varicella of healthy subjects (from 9 months of age). It is recommended to vaccinate susceptible, healthy, close contacts of subjects at risk of severe varicella, in order to reduce the risk of transmission of wild-type virus to these patients.
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/Greenbook/index.htm

Administration

For subcutaneous administration only. The deltoid region or the anterolateral area of the thigh is the preferred site of injection.

If it is considered necessary to administer another live vaccine at the same time, the vaccines must be given as separate injections and at different body sites.

Handling

Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they may inactivate the virus.

Any unused product or waste material should be disposed of in accordance with local requirements.

Reconstitution

Reconstitute with the water for injections from the vial solvent supplied with the product. After addition of the diluent, the mixture should be well shaken until the lyophilised pellet is completely dissolved in the diluent.

The colour of the reconstituted vaccine may vary from peach to pink due to minor variations in pH. Examine the diluent and the reconstituted vaccine visually for foreign particulate matter and/or variation in physical appearance before administration. In the event of either being observed, discard the diluent or the reconstituted vaccine.

The vaccine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 8 hours at 2-8 degrees C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Incompatibilities

Do not mix with any other medicinal product in the same syringe.

Contraindications

Children under 9 months of age.

Pregnancy - see Pregnancy section

Primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm cubed or presenting other evidence of lack of cellular immune competence, such as subjects with leukaemias, lymphomas, blood dyscrasias, clinically manifest HIV infection or receiving immunosuppressive therapy (including high dose corticosteroids).

Subjects who have received immune globulins or blood transfusion within the last 3 months should not be vaccinated because of the likelihood of vaccine failure from passively acquired antibody to the varicella virus.

Acute, severe febrile illness (postpone vaccination until recovery). However, the presence of a minor infection is not a contraindication.

In patients with phenylketonuria (PKU). Phenylalanine may be harmful for individuals with PKU.

Precautions and Warnings

Appropriate medical treatment and supervision should always be available in case of an anaphylactic reaction following administration of the vaccine.

Postpone immunisation if there is active or suspected infection.

Women of child bearing age must be advised to take adequate contraceptive precautions to prevent pregnancy occurring between the two doses and for 3 months after the second dose.

Serological studies indicate that the vaccine does not completely protect all individuals from naturally-acquired varicella and cannot be expected to provide maximal protection against infection with varicella zoster virus until about 6 weeks after the second dose.

Administration of the vaccine to subjects who are in the incubation period of varicella zoster infection cannot be expected to protect against clinically manifest disease or to modify the course of the disease.

The rash produced during naturally-acquired primary varicella zoster infection may be more severe in those with existing severe skin damage, including severe eczematous conditions. It is not known if there is an increased risk of vaccine-associated skin lesions in such subjects, but the possibility should be taken into consideration before vaccination.

Avoid salicylates (including aspirin) during the period between the two doses of vaccine and for 6 weeks afterwards as Reye's syndrome has been reported following the use of salicylates during natural varicella infection.

Transmission of vaccine virus
Transmission of the vaccine viral strain has been shown to occur from healthy vaccinees to healthy contacts, pregnant contacts and immunosuppressed contacts. Such transmission is rare and has not been confirmed to occur in the absence of vaccine-associated cutaneous lesions in the vaccinee.
In healthy contacts of vaccinees, seroconversion has sometimes occurred in the absence of any clinical manifestations of infection. Clinically apparent infections due to transmission of the vaccine have been associated with few skin lesions and minimal systemic upset.

If the vaccinee develops a cutaneous rash thought likely to be vaccine related (especially vesicular or papulovesicular) within 4 to 6 weeks of the first or second dose, contact with the following groups must be avoided until this rash has completely disappeared:
varicella-susceptible pregnant women
individuals at high risk of severe varicella, such as those with primary and acquired immunodeficiency states (including those with leukaemias, lymphomas, blood dyscrasias, clinically manifest HIV infection and patients receiving immunosuppressive therapy, including high dose corticosteroids).

In the absence of a rash in the vaccinee, the risk of transmission of the vaccine viral strain to contacts in the above groups appears to be extremely small. Nevertheless, vaccinees (e.g. healthcare workers) who are very likely to come into contact with persons in the above groups should preferable avoid any such contact during the period between vaccinations and for 4 to 6 weeks after the second dose. If this is not feasible, then vaccinees should be vigilant regarding the reporting of any skin rash during this period, and should take steps as above if a rash is discovered.

In healthy, seronegative children vaccinated as close contacts of persons at high risk of severe varicella infection continued contact between the vaccinee and the person at risk may be unavoidable. The risk of transmission of the attenuated viral strain from the vaccinee should be weighed against the potential for acquisition of wild-type varicella zoster by the at-risk person.

The Oka vaccine viral strain has been shown to be sensitive to aciclovir.

If a measles containing vaccine is not given at the same time as a varicella-containing vaccine, it is recommended that an interval of at least one month between vaccinations is respected, since it is recognised that measles vaccination may cause short-term suppression of the cell-mediated response.

Syncope can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements. It is important that procedures are in place to avoid injury.

Breastfeeding - see Lactation section

This product contains phenylalanine.

Pregnancy and Lactation

Pregnancy

The vaccine is contraindicated in pregnancy.

Varicella zoster virus may cause severe clinical disease in pregnant individuals and may adversely affect the foetus and/or result in perinatal varicella, depending on the gestational stage when the infection occurs. As the possible effects of infection with the vaccine viral strain on the mother and the foetus are unknown, the vaccine must not be administered to pregnant women.

Women of child-bearing potential must be advised to take adequate precautions to avoid pregnancy occurring between the two vaccine doses and for 3 months following the second dose.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Licensed in pregnancy? - No, contraindicated

Lactation

This vaccine is not generally recommended for breastfeeding due to the theoretical risk of vaccine virus transmission to the infant.

Studies have shown that the vaccine virus is not transferred to the infant through breast milk and therefore breastfeeding women can be vaccinated if indicated.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Swelling (injection site)
Erythema at injection site
Local pain (injection site)
Fatigue
Fever
Malaise
Headache
Dizziness
Nausea
Arthralgia
Myalgia
Somnolence
Cough
Pharyngitis
Rhinitis
Pruritus
Lymphadenopathy
Urticaria
Thrombocytopenia
Conjunctivitis
Vomiting
Abdominal pain
Diarrhoea
Rash
Upper respiratory tract infection
Facial oedema
Irritability
Convulsions
Herpes zoster
Hypersensitivity reactions
Anaphylactic reaction
Decreased appetite
Influenza-like symptoms
Paraesthesia
Bronchospasm
Angioedema

Presentation

Powder and solvent to produce a solution for injection of live attenuated varicella zoster (Oka strain) virus propagated in MRC5 human diploid cells and containing 10 to the power of 3.3 plaque forming units per 0.5ml dose.

Drugs List

Therapeutic Indications

Uses

For active immunisation against varicella of healthy subjects (from 9 months of age). It is recommended to vaccinate susceptible, healthy, close contacts of subjects at risk of severe varicella, in order to reduce the risk of transmission of wild-type virus to these patients.
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/Greenbook/index.htm

Dosage

Adults

Elderly

Children

Additional Dosage Information

Administration

For subcutaneous administration only. The deltoid region or the anterolateral area of the thigh is the preferred site of injection.

If it is considered necessary to administer another live vaccine at the same time, the vaccines must be given as separate injections and at different body sites.

Handling

Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they may inactivate the virus.

Any unused product or waste material should be disposed of in accordance with local requirements.

Reconstitution

Reconstitute with the water for injections from the vial solvent supplied with the product. After addition of the diluent, the mixture should be well shaken until the lyophilised pellet is completely dissolved in the diluent.

The colour of the reconstituted vaccine may vary from peach to pink due to minor variations in pH. Examine the diluent and the reconstituted vaccine visually for foreign particulate matter and/or variation in physical appearance before administration. In the event of either being observed, discard the diluent or the reconstituted vaccine.

The vaccine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 8 hours at 2-8 degrees C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Incompatibilities

Do not mix with any other medicinal product in the same syringe.

Contraindications

Children under 9 months of age.

Pregnancy - see Pregnancy section

Primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm cubed or presenting other evidence of lack of cellular immune competence, such as subjects with leukaemias, lymphomas, blood dyscrasias, clinically manifest HIV infection or receiving immunosuppressive therapy (including high dose corticosteroids).

Subjects who have received immune globulins or blood transfusion within the last 3 months should not be vaccinated because of the likelihood of vaccine failure from passively acquired antibody to the varicella virus.

Acute, severe febrile illness (postpone vaccination until recovery). However, the presence of a minor infection is not a contraindication.

In patients with phenylketonuria (PKU). Phenylalanine may be harmful for individuals with PKU.

Precautions and Warnings

Appropriate medical treatment and supervision should always be available in case of an anaphylactic reaction following administration of the vaccine.

Postpone immunisation if there is active or suspected infection.

Women of child bearing age must be advised to take adequate contraceptive precautions to prevent pregnancy occurring between the two doses and for 3 months after the second dose.

Serological studies indicate that the vaccine does not completely protect all individuals from naturally-acquired varicella and cannot be expected to provide maximal protection against infection with varicella zoster virus until about 6 weeks after the second dose.

Administration of the vaccine to subjects who are in the incubation period of varicella zoster infection cannot be expected to protect against clinically manifest disease or to modify the course of the disease.

The rash produced during naturally-acquired primary varicella zoster infection may be more severe in those with existing severe skin damage, including severe eczematous conditions. It is not known if there is an increased risk of vaccine-associated skin lesions in such subjects, but the possibility should be taken into consideration before vaccination.

Avoid salicylates (including aspirin) during the period between the two doses of vaccine and for 6 weeks afterwards as Reye's syndrome has been reported following the use of salicylates during natural varicella infection.

Transmission of vaccine virus
Transmission of the vaccine viral strain has been shown to occur from healthy vaccinees to healthy contacts, pregnant contacts and immunosuppressed contacts. Such transmission is rare and has not been confirmed to occur in the absence of vaccine-associated cutaneous lesions in the vaccinee.
In healthy contacts of vaccinees, seroconversion has sometimes occurred in the absence of any clinical manifestations of infection. Clinically apparent infections due to transmission of the vaccine have been associated with few skin lesions and minimal systemic upset.

If the vaccinee develops a cutaneous rash thought likely to be vaccine related (especially vesicular or papulovesicular) within 4 to 6 weeks of the first or second dose, contact with the following groups must be avoided until this rash has completely disappeared:
varicella-susceptible pregnant women
individuals at high risk of severe varicella, such as those with primary and acquired immunodeficiency states (including those with leukaemias, lymphomas, blood dyscrasias, clinically manifest HIV infection and patients receiving immunosuppressive therapy, including high dose corticosteroids).

In the absence of a rash in the vaccinee, the risk of transmission of the vaccine viral strain to contacts in the above groups appears to be extremely small. Nevertheless, vaccinees (e.g. healthcare workers) who are very likely to come into contact with persons in the above groups should preferable avoid any such contact during the period between vaccinations and for 4 to 6 weeks after the second dose. If this is not feasible, then vaccinees should be vigilant regarding the reporting of any skin rash during this period, and should take steps as above if a rash is discovered.

In healthy, seronegative children vaccinated as close contacts of persons at high risk of severe varicella infection continued contact between the vaccinee and the person at risk may be unavoidable. The risk of transmission of the attenuated viral strain from the vaccinee should be weighed against the potential for acquisition of wild-type varicella zoster by the at-risk person.

The Oka vaccine viral strain has been shown to be sensitive to aciclovir.

If a measles containing vaccine is not given at the same time as a varicella-containing vaccine, it is recommended that an interval of at least one month between vaccinations is respected, since it is recognised that measles vaccination may cause short-term suppression of the cell-mediated response.

Syncope can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements. It is important that procedures are in place to avoid injury.

Breastfeeding - see Lactation section

This product contains phenylalanine.

Pregnancy and Lactation

Pregnancy

The vaccine is contraindicated in pregnancy.

Varicella zoster virus may cause severe clinical disease in pregnant individuals and may adversely affect the foetus and/or result in perinatal varicella, depending on the gestational stage when the infection occurs. As the possible effects of infection with the vaccine viral strain on the mother and the foetus are unknown, the vaccine must not be administered to pregnant women.

Women of child-bearing potential must be advised to take adequate precautions to avoid pregnancy occurring between the two vaccine doses and for 3 months following the second dose.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Licensed in pregnancy? - No, contraindicated

Lactation

This vaccine is not generally recommended for breastfeeding due to the theoretical risk of vaccine virus transmission to the infant.

Studies have shown that the vaccine virus is not transferred to the infant through breast milk and therefore breastfeeding women can be vaccinated if indicated.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

It would not be expected that vaccination would affect the ability to drive or operate machinery.

Counselling

Advise women of child-bearing age to take adequate contraceptive precautions between the two doses of vaccine and for three months after the second dose.

Advise vaccinees that if they develop a rash they should avoid contact with varicella-susceptible pregnant women and individuals at high risk of severe varicella infection.

Advise patients to avoid salicylates, including aspirin, during the period between the two doses of vaccine and for 6 weeks afterwards.

Side Effects

Swelling (injection site)
Erythema at injection site
Local pain (injection site)
Fatigue
Fever
Malaise
Headache
Dizziness
Nausea
Arthralgia
Myalgia
Somnolence
Cough
Pharyngitis
Rhinitis
Pruritus
Lymphadenopathy
Urticaria
Thrombocytopenia
Conjunctivitis
Vomiting
Abdominal pain
Diarrhoea
Rash
Upper respiratory tract infection
Facial oedema
Irritability
Convulsions
Herpes zoster
Hypersensitivity reactions
Anaphylactic reaction
Decreased appetite
Influenza-like symptoms
Paraesthesia
Bronchospasm
Angioedema

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Store at 2 to 8 degrees C (in a refrigerator).

Store in the original package in order to protect from light.

The lyophilised vaccine is not affected by freezing.

Further Information

Last Full Review Date: July 2012

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Varilrix 10 3.3 PFU/0.5ml, powder and solvent for solution for injection. GlaxoSmithKline UK. Revised October 2021.

Immunisation against infectious disease (The Green Book), November 2006.
Available at: https://www.dh.gov.uk/en/Publichealth/Healthprotection/Immunisation/Greenbook/index.htm
Last accessed July 11, 2012.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 September 2017
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Varicella Vaccine. Last revised: April 3, 2012.
Last accessed: July 11, 2012.