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Optaflu suspension for injection in a pre-filled syringe

Last Updated on eMC 07-Nov-2013 View changes  | Novartis Vaccines Contact details

 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

1. Name of the medicinal product

Optaflu suspension for injection in pre-filled syringe

Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

(2013/2014 season)

2. Qualitative and quantitative composition

Influenza virus surface antigens (haemagglutinin and neuraminidase)*, inactivated, of the following strains:

A/California/7/2009 (H1N1)pdm09 - like strain used A/Brisbane/10/2010 wild type

15 micrograms HA**

A/Victoria/361/2011 (H3N2) - like strain used (NYMC X-223A) derived from A/Texas/50/2012

15 micrograms HA**

B/Massachusetts/2/2012

15 micrograms HA**

per 0.5 ml dose

……………………………………….

* propagated in Madin Darby Canine Kidney (MDCK) cells

** haemagglutinin

The vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2013/2014 season.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Suspension for injection in pre-filled syringe

Clear to slightly opalescent.

4. Clinical particulars
4.1 Therapeutic indications

Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications.

Optaflu should be used in accordance to Official guidance.

4.2 Posology and method of administration

Posology

Adults from the age of 18 years:

One dose of 0.5 ml

Paediatric population

The safety and efficacy of Optaflu in children and adolescents less than 18 years of age have not yet been established. Therefore, Optaflu is not recommended for use in children and adolescents (see section 5.1).

Method of administration

Immunisation should be carried out by intramuscular injection into the deltoid muscle.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Immunisation shall be postponed in patients with febrile illness or acute infection.

4.4 Special warnings and precautions for use

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.

Optaflu should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

4.5 Interaction with other medicinal products and other forms of interaction

Optaflu may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

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.

4.6 Fertility, pregnancy and lactation

The safety of Optaflu in pregnancy and breast-feeding has not been assessed in pre-clinical studies or in clinical trials.

In general data from influenza vaccinations in pregnant women do not indicate adverse foetal and maternal outcomes attributable to the vaccine. The use of Optaflu may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Optaflu may be used during lactation.

4.7 Effects on ability to drive and use machines

Optaflu has minor influence on the ability to drive and use machines.

4.8 Undesirable effects

a) Summary of safety profile

The safety of the Optaflu has been assessed in six randomized, active controlled clinical trials performed as part of the development program. Overall 3439 single doses of Optaflu were administered to 2366 adults aged 18 – 60 years of age and to 1073 elderly (aged 61 years or older). Safety and reactogenicity evaluations were performed for all subjects during the first 3 weeks following vaccination and SAEs have been collected for approximately 3100 vaccinees during six months of follow-up.

b) Summary of adverse reactions

Adverse reactions are listed according to the following frequency:

Very Common (≥1/10)

Common (≥1/100 -<1/10)

Uncommon (≥1/1,000 - <1/100)

Rare (≥1/10,000 - <1/1,000)

Very Rare (<1/10,000)

Not known (cannot be estimated from the available data)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The following adverse reactions have been observed:

Frequency in adults (18-60 years of age)

Organ class

Very common

≥ 1/10

Common

≥ 1/100 to < 1/10

Uncommon

≥ 1/1000 to < 1/100

Rare

≥ 1/10,000 to <1/1000

Very rare

<1/ 10,000

Not known (cannot be estimated from available data)

Nervous system disorders

Headache*

   

Neurological disorders, such as Guillain Barré syndrome, encephalomyelitis and neuritis

 

Vascular disorders

    

Vasculitis, possibly associated with transient renal involvement

 

Immune system disorders

    

Allergic reactions, in very rare cases leading to shock

Angioedema

Blood and lymphatic system disorders

    

Thrombocytopenia**

 

Musculoskeletal and connective tissue disorders

 

Myalgia*, arthralgia*

    

General disorders and administration site disorders

Erythema*, pain*

Malaise*, fatigue*

Swelling*, ecchymosis*, induration*

Fever*, shivering*

Gastrointestinal disorders such as abdominal pain, diarrhoea or dyspepsia*

 

Local lymphadeno-pathy

Fever greater than 39.0°C

  

Skin and subcutaneous tissue disorders

 

Sweating*

Generalised skin reactions including pruritus, urticaria or non-specific rash

   

* These reactions usually disappeared within 1-2 days without treatment.

** Thrombocytopenia (some very rare cases were severe with platelet counts less than 5000 per mm3)

In the elderly frequencies were similar, exept for headache and pain which were classified as 'common'. The incidence rates for moderate and severe pain after Optaflu vaccination are similar to those of egg-derived influenza vaccines; however a slightly increased risk for mild short-lasting injection site pain was observed with Optaflu in the subgroup of elderly vaccinees (8% compared to 6% with egg-derived influenza vaccine).

Post-marketing surveillance:

So far there is limited post-marketing experience with Optaflu.

The following additional adverse reactions were reported from post-marketing surveillance with egg-based seasonal trivalent vaccines:

Nervous system disorders:

Neuralgia, paraesthesia, convulsion, febrile convulsion,.

4.9 Overdose

No case of overdose has been reported for Optaflu.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Influenza vaccine, ATC-Code: J07BB02

Seroprotection is generally obtained within 3 weeks, as shown by the pivotal phase III clinical study V58P4 for the adult and elderly population.

In this comparative trial against an egg-derived influenza vaccine the seroprotection* rate, seroconversion or significant increase rate** and the geometric mean ratio (GMR) for anti-HA antibody (measured by HI) were assessed according to predefined criteria.

Data for adults were as follows (values in brackets show the 95% confidence intervals):

Strain specific anti-HA antibody

A/H1N1

N=650

A/H3N2

N=650

B

N=650

Seroprotection rate

86%

(83, 88)

98%

(97, 99)

83%

(80, 86)

Seroconversion/ Significant increase rate

63%

(59, 67)

58%

(54, 62)

78%

(75, 81)

GMR

7.62

(6.86, 8.46)

4.86

(4.43, 5.33)

9.97

(9.12, 11)

* Seroprotection = HI titers ≥ 40

** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥40; significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer

Data for elderly were as follows (values in brackets show the 95% confidence intervals):

Strain specific anti-HA antibody

A/H1N1

N=672

A/H3N2

N= 672

B

N=672

Seroprotection rate

76%

(72, 79)

97%

(96, 98)

84%

(81, 87)

Seroconversion/ Significant increase rate

48%

(44, 52)

65%

(61, 68)

76%

(72, 79)

GMR

4.62

(4.2, 5.08)

5.91

(5.35, 6.53)

9.63

(8.77, 11)

* Seroprotection = HI titers ≥ 40

** Seroconversion = negative pre-vaccination HI titer and post-vaccination HI titer ≥40; significant increase = positive pre-vaccination HI titer and at least a 4-fold increase in post-vaccination HI titer.

No differences were observed between the cell-culture and the comparator egg-derived vaccine. Across all three influenza strains, for the egg-derived vaccine seroprotection rates ranged between 85% and 98%, seroconversion or significant increase rates ranged between 62% and 73% and GMRs ranged between 5.52- and 8.76-fold over baseline HI titers.

The persistence of postvaccination antibodies to strains included in the vaccine is usually 6-12 months, as shown by studies performed during the clinical development of this vaccine.

Paediatric population

Optaflu has not been studied in the paediatric population and therefore, data on immune response are not available for this age group.

The European Medicines Agency has deferred the obligation to submit the results of studies withOptaflu in one or more subsets of the paediatric population in the prevention of influenza (see section 4.2 for information on paediatric use).

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional repeat dose toxicity studies. Optaflu was well tolerated and immunogenic in mice and ferrets. In a repeated-dose toxicity study in rabbits there was no evidence of systemic toxicity and the vaccine was locally well tolerated

6. Pharmaceutical particulars
6.1 List of excipients

Sodium chloride,

Potassium chloride,

Magnesium chloride hexahydrate,

Disodium phosphate dihydrate,

Potassium dihydrogen phosphate,

Water for injections.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

1 year

6.4 Special precautions for storage

Store in a refrigerator (2 °C – 8 °C).

Do not freeze.

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

6.5 Nature and contents of container

0.5 ml suspension in pre-filled syringes (type I glass), with a plunger stopper (bromobutyl rubber). Pack sizes of 1, 10 or 20 (2 × 10), each with or without needle.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The vaccine should be allowed to reach room temperature before use.

Shake before use.

Visually inspect the contents of each Optaflu syringe for particulate matter and/or change in colour prior to administration. If either condition exists, do not administer the vaccine.

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

7. Marketing authorisation holder

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Strasse 76

D-35041 Marburg

Germany

8. Marketing authorisation number(s)

EU/1/07/394/001 – EU/1/07/394/011

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 01 June 2007

Date of latest renewal: 01 June 2012

10. Date of revision of the text

10/13

Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.

UK/OPT/13-0001 October 2013

Company contact details

Novartis Vaccines

Company image
Address

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

Fax

+44 (0)1276 698 460

Medical Information e-mail
Telephone

+44 (0)1276 694 490

Medical Information Direct Line

+44 (0)8457 451 500

Medical Information Fax

+44 (0)1517 055 669

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Active ingredients

influenza vaccine (surface antigen, inactivated)

Legal categories

POM - Prescription Only Medicine

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