Drugs List

Therapeutic Indications

Uses

Active immunisation against varicella zoster (chickenpox)

Active immunisation for the primary prevention of varicella in individuals aged 12 months of age and older.

Can be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations.

May be administered to susceptible individuals within 3 days of exposure to the varicella virus to prevent a clinically apparent infection or modify the course of the infection. There is limited data to suggest that vaccination within 5 days of exposure may modify the course of the disease.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book

Administration

Administer by intramuscular or subcutaneous injection in the deltoid region in older children, adolescents and adults, or the higher anterolateral region of the thigh in younger children.

The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.

Contraindications

Children under 9 months
Family history of congenital hereditary immunodeficiency
Immunosuppression
Severe febrile conditions
Acute untreated tuberculosis
Haematological disorder
Immunodeficiency syndromes
Leukaemia
Lymphoma
Malignant neoplasm
Pregnancy

Precautions and Warnings

Children aged 9 to 12 months
Females of childbearing potential
Breastfeeding
Thrombocytopenia

Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Postpone immunisation if there is active or suspected infection
Vaccine may not be effective in 100% of patients
May contain trace amounts of neomycin
Do not give within 5 months of blood/plasma transfusions or immunoglobulins
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Exclude pregnancy prior to initiation of treatment
Follow national immunisation guidelines
Advise patients to avoid aspirin/salicylates until 6wks after 2nd dose
Female: Contraception required during and for 1 month after treatment
Avoid contact with susceptible individuals for 6 weeks after vaccination

The vaccine does not completely protect all individuals from naturally-acquired varicella. Efficacy has only been assessed in clinical trials from 6 weeks after the single dose in children aged 12 and under, and 6 weeks after the second dose in adults and adolescents.

Hypersensitivity reactions may occur. These may be due to the active ingredient or to excipients and trace residues in the vaccine including gelatin, neomycin, components of MRC-5 cells such as DNA and proteins, and bovine calf serum from the culture medium.

Pregnancy and Lactation

Pregnancy

Varicella vaccine is contraindicated in pregnancy.

However foetal damage as not been reported when varicella vaccines have been given to pregnant women and Schaefer (2007) notes that inadvertent vaccination of a pregnant woman does not require any intervention.

Before vaccinating women of child-bearing potential pregnancy must be excluded.

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 to 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 ).

Lactation

Varicella vaccine is not generally recommended in breastfeeding due to the theoretical risk of vaccine virus transmission to the infant. Vaccination of exposed women with a negative history of varicella or known to be seronegative should be assessed on an individual basis. However, 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

Acne
Agitation
Anaphylaxis
Anorexia
Apathy
Aplastic anaemia
Arthritis
Aseptic meningitis
Ataxia
Bell's palsy
Bronchitis
Candidiasis
Cellulitis
Cerebrovascular accident
Conjunctivitis
Contusion
Convulsions
Cough
Crying
Dermatitis
Dizziness
Dream abnormalities
Ear pain
Eczema
Emotional upsets
Encephalitis
Epistaxis
Erythema
Erythema multiforme
Exanthema
Extravasation
Eye irritation
Eyelid oedema
Fatigue
Fever
Fixed drug eruption
Flushing
Gait abnormality
Gastro-intestinal disturbances
Guillain-Barre syndrome
Haematochezia
Haematoma
Headache
Henoch-Schonlein purpura
Herpes simplex
Herpes zoster
Hyperpigmentation
Hypersomnia
Idiopathic thrombocytopenic purpura (ITP)
Impetigo
Induration
Infections
Influenza
Influenza-like syndrome
Injection site reactions
Irritability
Lymphadenitis
Lymphadenopathy
Malaise
Miliaria
Mouth ulcers
Musculoskeletal pain
Myalgia
Myelitis
Nasal congestion
Nausea
Nervousness
Numbness
Oedema
Otitis media
Paraesthesia
Pharyngitis
Pneumonia
Pneumonitis
Pruritus
Pulmonary congestion
Rash
Respiratory tract infection
Rhinitis
Rhinorrhoea
Sensation of heaviness
Sensation of warmth
Sinusitis
Sleep disturbances
Sneezing
Somnolence
Stevens-Johnson syndrome
Stiffness
Sunburn
Tearing
Thrombocytopenia
Trauma
Tremor
Urticaria
Varicella
Vertigo
Vesicles
Viral infection
Vomiting
Wheezing

Presentation

Vaccine containing live attenuated varicella zoster (Oka/Merck strain) virus

Drugs List

Therapeutic Indications

Uses

Active immunisation against varicella zoster (chickenpox)

Active immunisation for the primary prevention of varicella in individuals aged 12 months of age and older.

Can be administered to infants from 9 months of age under special circumstances, such as to conform with national vaccination schedules or in outbreak situations.

May be administered to susceptible individuals within 3 days of exposure to the varicella virus to prevent a clinically apparent infection or modify the course of the infection. There is limited data to suggest that vaccination within 5 days of exposure may modify the course of the disease.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.

https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book

Dosage

Adults

Elderly

Children

Adolescents

Additional Dosage Information

Administration

Administer by intramuscular or subcutaneous injection in the deltoid region in older children, adolescents and adults, or the higher anterolateral region of the thigh in younger children.

The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.

Contraindications

Children under 9 months
Family history of congenital hereditary immunodeficiency
Immunosuppression
Severe febrile conditions
Acute untreated tuberculosis
Haematological disorder
Immunodeficiency syndromes
Leukaemia
Lymphoma
Malignant neoplasm
Pregnancy

Precautions and Warnings

Children aged 9 to 12 months
Females of childbearing potential
Breastfeeding
Thrombocytopenia

Live vaccine must not be given during/within 6 months of chemotherapy
Live vaccine must not be given during/within 6 months of radiotherapy
Postpone immunisation if there is active or suspected infection
Vaccine may not be effective in 100% of patients
May contain trace amounts of neomycin
Do not give within 5 months of blood/plasma transfusions or immunoglobulins
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Exclude pregnancy prior to initiation of treatment
Follow national immunisation guidelines
Advise patients to avoid aspirin/salicylates until 6wks after 2nd dose
Female: Contraception required during and for 1 month after treatment
Avoid contact with susceptible individuals for 6 weeks after vaccination

The vaccine does not completely protect all individuals from naturally-acquired varicella. Efficacy has only been assessed in clinical trials from 6 weeks after the single dose in children aged 12 and under, and 6 weeks after the second dose in adults and adolescents.

Hypersensitivity reactions may occur. These may be due to the active ingredient or to excipients and trace residues in the vaccine including gelatin, neomycin, components of MRC-5 cells such as DNA and proteins, and bovine calf serum from the culture medium.

Pregnancy and Lactation

Pregnancy

Varicella vaccine is contraindicated in pregnancy.

However foetal damage as not been reported when varicella vaccines have been given to pregnant women and Schaefer (2007) notes that inadvertent vaccination of a pregnant woman does not require any intervention.

Before vaccinating women of child-bearing potential pregnancy must be excluded.

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 to 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 ).

Lactation

Varicella vaccine is not generally recommended in breastfeeding due to the theoretical risk of vaccine virus transmission to the infant. Vaccination of exposed women with a negative history of varicella or known to be seronegative should be assessed on an individual basis. However, 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

Acne
Agitation
Anaphylaxis
Anorexia
Apathy
Aplastic anaemia
Arthritis
Aseptic meningitis
Ataxia
Bell's palsy
Bronchitis
Candidiasis
Cellulitis
Cerebrovascular accident
Conjunctivitis
Contusion
Convulsions
Cough
Crying
Dermatitis
Dizziness
Dream abnormalities
Ear pain
Eczema
Emotional upsets
Encephalitis
Epistaxis
Erythema
Erythema multiforme
Exanthema
Extravasation
Eye irritation
Eyelid oedema
Fatigue
Fever
Fixed drug eruption
Flushing
Gait abnormality
Gastro-intestinal disturbances
Guillain-Barre syndrome
Haematochezia
Haematoma
Headache
Henoch-Schonlein purpura
Herpes simplex
Herpes zoster
Hyperpigmentation
Hypersomnia
Idiopathic thrombocytopenic purpura (ITP)
Impetigo
Induration
Infections
Influenza
Influenza-like syndrome
Injection site reactions
Irritability
Lymphadenitis
Lymphadenopathy
Malaise
Miliaria
Mouth ulcers
Musculoskeletal pain
Myalgia
Myelitis
Nasal congestion
Nausea
Nervousness
Numbness
Oedema
Otitis media
Paraesthesia
Pharyngitis
Pneumonia
Pneumonitis
Pruritus
Pulmonary congestion
Rash
Respiratory tract infection
Rhinitis
Rhinorrhoea
Sensation of heaviness
Sensation of warmth
Sinusitis
Sleep disturbances
Sneezing
Somnolence
Stevens-Johnson syndrome
Stiffness
Sunburn
Tearing
Thrombocytopenia
Trauma
Tremor
Urticaria
Varicella
Vertigo
Vesicles
Viral infection
Vomiting
Wheezing

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 ).

Further Information

Last Full Review Date: August 2013

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

BNF for Children (2013-2014) Pharmaceutical Press, London.

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

Immunisation against infectious disease (The Green Book).
Available at https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Last accessed: August 20, 2013.

Summary of Product Characteristics: Varivax. Sanofi Pasteur MSD Limited. Revised April 2013.

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: April 3, 2012.
Last accessed: August 20, 2013.