ADMINISTRATION

HOW TO VACCINATE
WITH VIMKUNYA1

VIMKUNYA helps keep your patients protected from chikungunya
when they’re abroad, thanks to a single dose in a pre-filled syringe.

Pre-filled syringe1

VIMKUNYA is the only chikungunya vaccine administered as a single 0.8 mL intramuscular dose from a pre-filled syringe.

See the full administration instructions.

No need to reconstitute1

Just open, attach a needle,
shake, and inject.

See the full storage and
handling instructions
.

Preparation for Administration1

  • Immediately before use, shake the pre-filled syringe vigorously to form a homogeneous suspension.
  • After shaking, the suspension should be a white, cloudy liquid.
  • Inspect product visually for particulate matter or discoloration prior to administration, whenever solution and container permit. Discard if either condition is present.

ADMINISTRATION1

  • Blue circle with the number one inside

    Administer VIMKUNYA intramuscularly.

  • Blue circle with the number two inside

    VIMKUNYA may be held at room temperature (up to 25°C or 77°F) for up to 2 hours after removal from refrigerator.

  • Blue circle with the number three inside

    Discard the vaccine if not used within 2 hours after removal from refrigerator.

Syringe image

DOSAGE AND DESCRIPTION1

VIMKUNYA is a sterile suspension for IM injection, supplied in a single-dose pre-filled syringe. Each 0.8 mL dose contains 40 mcg of chikungunya virus virus-like particles adsorbed on aluminum hydroxide (approximately 300 mcg aluminum per 0.8 mL dose).

VIMKUNYA does not contain a preservative or antibiotics.

Storage and handling1

VIMKUNYA is supplied in a carton (NDC 50632-018-02) containing one single dose pre-filled syringe (NDC 50632-018-04), packaged without needles.

storage-and-handling-img
  • VIMKUNYA comes in a 52 mm x 28 mm x 143 mm package.
  • Store VIMKUNYA in a refrigerator at 2°C to 8°C (36°F to 46°F).
    DO NOT FREEZE.
  • Store in the original carton to protect from light.
  • VIMKUNYA may be held at room temperature (up to 25°C or 77°F) for up to 2 hours after removal from refrigerator.
  • Discard the vaccine if not used within 2 hours after removal from refrigerator.

COVERAGE

VIMKUNYA may be reimbursed through your patient’s business or organization if they are traveling for work or as a volunteer.

It can also be reimbursed or paid for through an FSA or HSA.

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Indications and Usage

VIMKUNYA is a vaccine indicated for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older. The indication is approved under accelerated approval based on anti-chikungunya virus neutralizing antibody levels. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

Important Safety Information

Contraindications

Do not administer VIMKUNYA to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

Warnings and Precautions


Adverse Reactions

In clinical studies, the most common solicited adverse reactions (>10%) in individuals 12 through 64 years of age were pain at the injection site (23.7%), fatigue (19.9%), headache (18%), and myalgia (17.6%). The most commonly reported solicited adverse reactions (>5%) in individuals 65 years of age and older were injection site pain (5.4%), myalgia (6.3%), and fatigue (6.3%).

Use in Specific Populations

There are no clinical studies of VIMKUNYA in pregnant individuals.

To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic Inc. at
1-833-365-9596 or drug.safety@bavarian-nordic.com or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see full Prescribing Information here.

Reference

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Indications and Usage

VIMKUNYA is a vaccine indicated for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older. The indication is approved under accelerated approval based on anti-chikungunya virus neutralizing antibody levels. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

Important Safety Information

Contraindications

Do not administer VIMKUNYA to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

Warnings and Precautions

  • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions.
  • Immunocompromised individuals, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VIMKUNYA.
  • Syncope (fainting) may occur in association with administration of injectable vaccines including VIMKUNYA. Procedures should be in place to avoid injury from fainting.

Adverse Reactions

In clinical studies, the most common solicited adverse reactions (>10%) in individuals 12 through 64 years of age were pain at the injection site (23.7%), fatigue (19.9%), headache (18%), and myalgia (17.6%). The most commonly reported solicited adverse reactions (>5%) in individuals 65 years of age and older were injection site pain (5.4%), myalgia (6.3%), and fatigue (6.3%).

Use in Specific Populations

There are no clinical studies of VIMKUNYA in pregnant individuals.

To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic Inc. at
1-833-365-9596 or drug.safety@bavarian-nordic.com or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see full Prescribing Information here.

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