Source: European Medicines Agency (EU) Revision Year: 2015 Publisher: Novartis Vaccines and Diagnostics S.r.l. - Via Fiorentina, 1 – Siena, Italy
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)) of this vaccine.
See section 4.4 for special warnings and special precautions for use.
The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.
Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients and to residues (eggs and chicken protein, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)).
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Immunisation should be postponed in patients with severe febrile illness or acute infection.
Focetria should under no circumstances be administered intravascularly.
There are no data with Focetria using the subcutaneous route. Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.
Cases of convulsion with and without fever have been reported in subjects vaccinated with Focetria.
The majority of febrile convulsions occurred in paediatric subjects. Some cases were observed in subjects with a history of epilepsy. Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion. (See section 4.8).
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
A protective response may not be elicited in all vaccinees (see section 5.1).
In the event that a second dose is to be administered it should be noted that there are no safety, immunogenicity or efficacy data to support interchangeability of Focetria with other H1N1v vaccines.
Focetria H1N1v may be co-administered with a non adjuvanted seasonal influenza vaccine. Data on co-administration of Focetria H1N1v with a non-adjuvanted seasonal influenza subunit vaccine in healthy adults aged 18-60 years of age did not suggest any interference in the immune response to Focetria. The immune response to the seasonal antigens was satisfactory.
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Focetria alone.
The same study demonstrated that previous administration of adjuvanted or unadjuvanted seasonal influenza vaccines to adults and elderly does not interfere with the immune response to Focetria. Therefore the data indicate that Focetria may be co-administered with non adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).
There are no data on co-administration of Focetria with other vaccines. If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.
Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1. In such cases, the Western Blot method is negative. These transitory false positive results may be due to IgM production in response to the vaccine.
Safety data are available in pregnant women exposed to Focetria in particular during second and third trimesters. Postmarketing spontaneously reported adverse events, an interventional study and large observational studies do not suggest direct or indirect harmful effects of Focetria exposure on pregnancy. Further, data from vaccinations with seasonal interpandemic inactivated trivalent vaccines in pregnant women do not indicate that adverse foetal and maternal outcomes were attributable to the vaccine. Health care providers need to assess the benefits and potential risks of administering Focetria vaccine to pregnant women, taking into consideration official recommendations.
Focetria may be administered to lactating women.
An animal study with H5N1 mock-up vaccine did not indicate reproductive toxicity (see section 5.3).
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
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).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness:
In a clinical trial 131 adults and 123 elderly were exposed to two doses of the 7.5 µg Focetria. The safety profile of Focetria was similar to that of the H5N1 mock up vaccines. Most of the reactions were mild in nature and of short duration. The incidence of symptoms observed in subjects over 60 years of age was generally lower as compared to the 18-60 years old population.
Very common: pain, induration and erythema, myalgia, headache, sweating, malaise and fatigue
In clinical trials with different formulations (H5N3, H9N2 and H5N1) approximately 3400 subjects were exposed to the mock-up vaccines.
Most of the reactions were mild in nature, of short duration and qualitatively similar to those induced by conventional seasonal influenza vaccines. It is widely accepted that the adjuvant effect leading to increased immunogenicity is associated with a slightly higher frequency of local reactions (mostly mild pain) compared with conventional, nonadjuvanted influenza vaccines. There were fewer reactions after the second vaccination compared with the first.
Adverse reactions from clinical trials with the mock-up vaccine are listed below. The incidence of symptoms observed in subjects over 60 years of age was lower as compared to the 18-60 years old population.
Very common: headache
Rare: convulsions
Common: sweating
Uncommon: urticaria
Rare: eye swelling
Very common: myalgia
Common: arthralgia
Common: nausea
Very common: injection site swelling, injection site pain, injection site induration, injection site redness, fatigue, malaise and shivering
Common: injection site ecchymosis and fever
Uncommon: influenza like illness
Rare: anaphylaxis
The common reactions usually disappear within 1-2 days without treatment.
Children and adolescents 6 months to 17 years of age
Safety data after the first and second dose in children and adolescents suggest a comparable safety profile with that reported for the H5N1 mock-up vaccine formulation.
Adverse reactions in the week following vaccination from 87 children 3-8 years old and 95 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows:
| Injection 1 | Injection 2 | |
|---|---|---|
| Children (3 to 8 years of age) | N=87 | N=85 |
| Any adverse reaction | 67% | 61% |
| Local | 56% | 49% |
| Systemic | 32% | 31% |
| Fever ≥38°C to 38.9°C | 3% | 1% |
| Fever 39°C to 39.9°C | 0% | 1% |
| Fever ≥40° | 0% | 0% |
| Any other AE | 13% | 15% |
| Adolescents (9 to 17 years of age) | N=95 | N=94 |
| Any adverse reaction | 67% | 55% |
| Local | 60% | 49% |
| Systemic | 38% | 26% |
| Fever ≥38°C to 38.9°C | 2% | 1% |
| Fever 39°C to 39.9°C | 0% | 0% |
| Fever ≥40°C | 0% | 0% |
| Any other AE | 11% | 9% |
Data in children and adolescents 3-17 years suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Very common reactions reported in children and adolescents 3 to 17 years of age: Pain, induration and erythema, malaise, myalgia, headache and fatigue.
Adverse reactions in the week following vaccination from 80 infants 6-11 months old and 82 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows:
| Injection 1 | Injection 2 | |
|---|---|---|
| Infants (6 to 11 months of age) | N=80 | N=75 |
| Any adverse reaction | 79% | 65% |
| Local | 44% | 29% |
| Systemic | 69% | 55% |
| Fever ≥38°C to 38.9°C | 9% | 6% |
| Fever 39°C to 39.9°C | 2% | 4% |
| Fever ≥40°C | 0% | 0% |
| Any other AE | 29% | 28% |
| Toddlers (12 to 35 months of age) | N=82 | N=81 |
| Any adverse reaction | 70% | 70% |
| Local | 50% | 48% |
| Systemic | 55% | 44% |
| Fever ≥38°C to 38.9°C | 10% | 11% |
| Fever 39°C to 39.9°C | 4% | 1% |
| Fever ≥40°C | 1% | 0% |
| Any other AE | 21% | 22% |
Data in infants and toddlers 6-35 months of age suggest a slight decrease in reactogenicity after the second dose, with no increase in rates of fever.
Very common reactions reported in 233 infants and toddlers 6 to 35 months of age: Tenderness, erythema, irritability, unusual crying, sleepiness, diarrhoea and change in eating habits. Induration was a common reaction in toddlers but was less common in infants.
In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Focetria H1N1v:
Blood and lymphatic system disorders: Lymphadenopathy.
Cardiac disorders: Palpitation, tachycardia.
General disorders and administration site conditions: Asthenia.
Muscoskeletal, connective tissue and bone disorders: Muscular weakness, pain in extremities.
Respiratory disorders: Cough.
Skin and subcutaneous tissue disorders: Generalised skin reactions including pruritus, urticaria or non-specific rash; angioedema.
Gastrointestinal disorders: Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Nervous system disorders: Headache, dizziness, somnolence, syncope. Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis.
Immune system disorders: Allergic reactions, anaphylaxis including dyspnoea, bronchospasm, laryngeal oedema, in rare cases leading to shock.
In addition, from Post-marketing surveillance with seasonal trivalent vaccines in all age groups and with the MF59 adjuvanted seasonal trivalent vaccine with the similar composition of Focetria (surface antigen, inactivated, adjuvanted with MF59C.1), licensed for use in elderly subjects above 65 years of age, the following adverse events have been reported:
Rare: Transient thrombocytopenia.
Very rare: Vasculitis with transient renal involvement and exudative erythema multiforme. Neurological disorders, such as encephalomyelitis and Guillain Barré syndrome.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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