Varicella, live attenuated interacts in the following cases:
Maintenance chemotherapy should be withheld one week before and one week after immunisation of patients in the acute phase of leukaemia. Patients under radiotherapy should normally not be vaccinated during the treatment phase. Generally, patients are immunised when they are in complete haematological remission from their disease.
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.
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.
Vaccination should be carried out a few weeks before the administration of the immunosuppressive treatment for patients undergoing organ transplantation (e.g. kidney transplant).
Pregnant women should not be vaccinated with varicell vaccine. However, foetal damage has not been documented when varicella vaccines have been given to pregnant women.
There are no data regarding use in breast-feeding women. Due to the theoretical risk of transmission of the vaccine viral strain from mother to infant, varicella vaccine is generally not recommended for breast-feeding mothers. Vaccination of exposed women with negative history of varicella or known to be seronegative to varicella should be assessed on an individual basis.
Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.
No data available.
No studies on the effects of varicella vaccine on the ability to drive and use machines have been performed. It has no or negligible influence on the ability to drive and use machines. However, some of the undesirable effects may temporarily affect the ability to drive or use machines.
More than 7,900 individuals have participated in clinical trials evaluating the reactogenicity profile of the vaccine administered subcutaneously either alone or concomitantly with other vaccines.
The safety profile presented below is based on a total of 5,369 doses of varicella vaccine (live) administered alone to infants, children, adolescents and adults.
Adverse reactions reported are listed according to the following frequency: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000).
| System organ class∗ | Frequency | Adverse reactions |
|---|---|---|
| Infections and infestations | Uncommon | upper respiratory tract infection, pharyngitis |
| Blood and lymphatic system disorders | Uncommon | lymphadenopathy |
| Psychiatric disorders | Uncommon | irritability |
| Nervous system disorders | Uncommon | headache, somnolence |
| Eye disorders | Rare | conjunctivitis |
| Respiratory, thoracic and mediastinal disorders | Uncommon | cough, rhinitis |
| Gastrointestinal disorders | Uncommon | vomiting, nausea |
| Rare | diarrhoea, abdominal pain | |
| Skin and subcutaneous tissue disorders | Common | rash |
| Uncommon | viral rash, pruritus | |
| Rare | urticaria | |
| Musculoskeletal and connective tissue disorders | Uncommon | arthralgia, myalgia |
| General disorders and administration site conditions | Very common | pain, erythema |
| Common | pyrexia (oral/axillary temperature ≥37.5°C or rectal temperature ≥38.0°C)†, injection site swelling† | |
| Uncommon | pyrexia (oral/axillary temperature >39.0°C or rectal temperature >39.5°C), fatigue, malaise |
∗ According to MedDRA (Medical Dictionary for Regulatory Activities) terminology
† Injection site swelling and pyrexia were reported very commonly in studies conducted in adolescents and adults. Injection site swelling was also reported very commonly after the second dose in children under 13 years of age.
A trend for higher incidence of pain, erythema and injection site swelling after the second dose was observed as compared to the first dose.
No differences were seen in the reactogenicity profile between initially seropositive and initially seronegative subjects.
In a clinical trial, 328 children aged 11 to 21 months received combined measles, mumps, rubella and varicella vaccine either by subcutaneous or intramuscular route. A comparable safety profile was observed for both administration routes.
There are limited data from clinical trials available in subjects at high risk of severe varicella. However, vaccine-associated reactions (mainly papulo-vesicular eruptions and pyrexia) are usually mild. As in healthy subjects, erythema, swelling and pain at the site of injection are mild and transient.
The following additional adverse reactions have been identified in rare occasions during post-marketing surveillance. Because they are reported voluntarily from a population of unknown size, a true estimate of frequency cannot be provided.
| System organ class∗ | Adverse reactions |
|---|---|
| Infections and infestations | herpes zoster |
| Blood and lymphatic system disorders | thrombocytopenia |
| Immune system disorders | anaphylactic reaction, hypersensitivity |
| Nervous system disorders | encephalitis, cerebrovascular accident, seizure, cerebellitis, cerebellitis like symptoms (including transient gait disturbance and transient ataxia) |
| Vascular disorders | vasculitis (including Henoch Schonlein purpura and Kawasaki syndrome) |
| Skin and subcutaneous tissue disorders | erythema multiforme |
∗ According to MedDRA (Medical Dictionary for Regulatory Activities) terminology
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