Pronunciation:

chik-en-GUN-ye VAX-een, lyve

Brand Names:

• Ixchiq

Uses of This Medicine:

Chikungunya vaccine, live injection is used to prevent infection caused by chikungunya virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

This vaccine is to be given only by or under the 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 Ixchiq® vaccine in the pediatric population. 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 Ixchiq® vaccine 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:

• Bleeding problems or
• Immune system problem—Use with caution. These conditions may decrease the useful effects of the vaccine.

• Weak immune system (eg, cancer, HIV infection)—Should not be used in patients with this condition.

Proper Use of This Medicine:

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

This vaccine comes with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 may cause severe or prolonged chikungunya-like reactions. Check with your doctor right away if you have blurred vision, confusion, decreased urine output, difficulty moving, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast or irregular heartbeat, headache, increased thirst, joint pain, muscle aches, cramps, pains, stiffness, nausea, seizures, sweating, swollen joints, trouble breathing, unusual tiredness or weakness, or vomiting.

Tell your doctor if you are pregnant or planning to become pregnant. This vaccine may transmit chikungunya virus from pregnant women to their babies. Talk to your doctor if you have concerns.

Fainting may occur after you receive this vaccine. Your doctor may want you to be observed after you get the injection to prevent or manage fainting.

This vaccine may not protect everyone who receives it. It will not treat symptoms of chikungunya virus if you already have the disease.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

More common

Difficulty in moving

fever

joint pain

muscle pain or stiffness

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

burning, numbness, tingling, or painful sensations

rapid weight gain

tingling of the hands or feet

unsteadiness or awkwardness

unusual weight gain or loss

weakness in the arms, hands, legs, or feet

Incidence not known

Blurred vision

coma

confusion

decreased urine output

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast or irregular heartbeat

headache

increased thirst

muscle cramps

seizures

sweating

swelling of the face, ankles, or hands

swollen joints

trouble breathing

unusual tiredness or weakness

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

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

nausea

Less common

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.