Pronunciation:

tik-BORN en-sef-a-LYTE-is VAX-een

Brand Names:

• Ticovac

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Tick-borne encephalitis vaccine is used to prevent infection caused by the tick-borne encephalitis virus. It works by causing your body to produce its own protection (antibodies) against the virus.

This vaccine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of Ticovac™ in children younger than 1 year of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ticovac™ in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Immune system problems—This vaccine may not work as well in patients with a weak immune system.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this vaccine. It is given as a shot into one of your muscles.

This vaccine is usually given in 3 doses. After the first dose, 2 more doses are given within 1 to 12 months. It is very important that you receive all 3 doses of the vaccine at least 1 week before possible exposure.

You might need a booster dose (fourth dose) in the future if you will be exposed to tick-borne encephalitis again. A booster dose may be given at least 3 years after you completed the first 3 doses.

Precautions While Using This Medicine:

Be sure to notify your doctor of any side effects that occur after you receive this vaccine.

This vaccine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the vaccine.

This vaccine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jakob Disease) to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

This vaccine may not protect everyone who receives it. It will also not treat an active infection.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Trouble sleeping

Incidence not known

Back pain, sudden and severe

blindness

blue-yellow color blindness

blurred vision

chest tightness

confusion

cough

decreased vision

difficulty seeing at night

difficulty swallowing

dizziness

eye pain

fast, pounding, or irregular heartbeat or pulse

fever

headache

hives, itching, skin rash

hoarseness

inability to move the arms and legs

increased sensitivity of the eyes to sunlight

irritability

joint pain, stiffness, or swelling

muscle weakness, sudden and progressing

nausea

nerve pain

numbness, tingling, pain, or weakness in the hands or feet

pain in the arms or legs

painful blisters on the trunk of the body

paralysis of one side of the body

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

seizures

stiff neck or back

sudden numbness and weakness in the arms and legs

trouble breathing

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Muscle pain

pain or tenderness at the injection site

Less common

Loss of appetite

redness, swelling, or lumps at the injection site

Rare

Bruising or itching at the injection site

swollen lymph glands in the neck, armpit, or groin

Incidence not known

Blistering, crusting, irritation, itching, or reddening of the skin

continuing ringing or buzzing or other unexplained noise in the ears

cracked, dry, or scaly skin

hearing loss

increased sweating

lack or loss of strength

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.