Important Safety Information

IMVANEX® Abbreviated Prescribing Information

(See IMVANEX Summary of Product Characteristics for full Product Information)

Presentation:

Smallpox vaccine (Live Modified Vaccinia Ankara) suspension for subcutaneous injection supplied in single-dose glass vials. One dose (0.5 ml) contains: Modified Vaccinia Ankara – Bavarian Nordic Live virus1 no less than 5 x 107 TCID50 (50% tissue culture infectious dose, 1 Produced in chick embryo cells). This vaccine contains trace residues of gentamicin.

Indication:

Active immunization against smallpox in adults. The use of this vaccine should be in accordance with official recommendations.

Dosage:

Primary vaccination (individuals previously not vaccinated against smallpox): A first dose of 0.5 ml should be administered on an elected date. A second dose of 0.5 ml should be administered no less than 28 days after the first dose. Booster vaccination (individuals previously vaccinated against smallpox): There are inadequate data to determine the appropriate timing of booster doses. If a booster dose is considered necessary then a single dose of 0.5 ml should be administered. Special population: Immunocompromised patients (e.g., HIV infected, patients under immunosuppressive therapy) who have been previously vaccinated against smallpox should receive two booster doses. The second booster vaccination should be given no less than 28 days after the first dose.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients or trace residues (chicken protein, benzonase and gentamicin).

Warnings and Precautions:

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. Immunization should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination. The protective efficacy of IMVANEX against smallpox has not been studied. A protective immune response may not be elicited in all vaccinees. There are inadequate data to determine the appropriate timing of booster doses. Prior vaccination with IMVANEX may modify the cutaneous response (‘take’) to subsequently administered replication-competent smallpox vaccine resulting in a reduced or absent take. Individuals with atopic dermatitis developed more local and general symptoms after vaccination. Data have been generated in HIV infected individuals with CD4 counts ? 200 cells/µl and ? 750 cells/µl. Lower immune response data have been observed in HIV infected individuals compared to healthy individuals. There are no data on the immune response to IMVANEX in other immunosuppressed individuals. Two doses of IMVANEX given at a seven day interval showed lower immune responses and slightly more local reactogenicity than two doses given at a 28-day interval. Therefore, dose intervals of less than four weeks should be avoided.

Drug Interactions:

Concomitant administration of IMVANEX with other vaccines or any immunoglobulin including Vaccinia Immune Globulin (VIG) should be avoided.

Pregnancy and Lactation:

Not recommended in pregnancy and during breast feeding.

Driving and Operating Machinery:

Some of the undesirable effects may affect the ability to drive or operate machinery (e.g., dizziness).

Side Effects:

The most common adverse reactions observed in clinical trials were injection site reactions and common systemic reactions typical for vaccines which were mild to moderate in intensity and resolved without intervention within seven days following vaccination. Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar. Very commonly reported adverse reactions include headache, nausea, myalgia, injection site pain, injection site erythema, injection site induration, injection site swelling, injection site pruritus and fatigue. Commonly reported adverse reactions include appetite disorder, dizziness, pain in extremity, arthralgia, injection site discoloration, injection site nodule, injection site hematoma, injection site warmth, chills, underarm swelling, body temperature increased, troponin I increased and pyrexia. Uncommonly reported adverse reactions include nasopharyngitis, influenza, upper respiratory tract infection, lymphadenopathy, sleep disorder, paresthesia, vertigo, pharyngolaryngeal pain, rhinitis, cough, diarrhea, vomiting, dry mouth, abdominal pain, rash/pruritus/dermatitis and related symptoms (both generalized and at the injection sites), back pain, neck pain, musculoskeletal stiffness, muscle spasms, flushing, axillary pain, chest pain, asthenia, malaise, hepatic enzymes increased and white blood cell count increased, white blood cell count and mean platelet volume decreased and contusion. Rarely reported adverse reactions include sinusitis, conjunctivitis, peripheral sensory neuropathy, tachycardia, night sweats, angioedema, musculoskeletal pain, muscular weakness and oedema peripheral. The following general symptoms were reported more frequently in individuals with atopic dermatitis compared to healthy individuals: erythema and swelling at the injection site, headache, myalgia, chills, nausea and fatigue. For a complete list of observed adverse reactions, please see the full Summary of Product Characteristics (SmPC).

Overdose:

No case of overdose has been reported.

Legal Category:

POM

Marketing Authorization Holder:

Bavarian Nordic A/S, Hejreskovvej 10a, DK-3490 Kvistgaard, Denmark

Marketing Authorization Number:

EU/1/13/855/001

Price:

Country-specific

Note:

This medicinal product has been authorized under 'exceptional circumstances.' This means that due to the lack of smallpox disease in the world it has not been possible to obtain complete information on this medicinal product. The European Medicines Agency will review any new information which may become available every year.

Further Information Is Available on Request From:

Bavarian Nordic A/S, Hejreskovvej 10a, DK-3490 Kvistgaard, Denmark, Tel.:+45-33268383

Date of Preparation:

July 2014

Adverse events should be reported. Reporting forms and information: Country-specific.

Adverse events should also be reported to Bavarian Nordic A/S, Denmark.

Contact Us: drug.safety@bavarian-nordic.com

IMVANEX product site version 1. Last updated July 2014.