Pronunciation:

ZOS-ter VAX-een ree-KOM-bi-nant, AD-joo-van-ted

Brand Names:

• Shingrix

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Zoster vaccine recombinant, adjuvanted is used to prevent herpes zoster (shingles) in adults.

This vaccine is to be given 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 zoster 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 zoster 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. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

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:

• Weak immune system—May decrease the effect of the vaccine and the body's response to it.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given as a shot into one of your muscles, usually in the deltoid (upper arm).

This medicine is given as two doses. The second dose is given 2 to 6 months after the first dose. To get the best possible protection against herpes zoster infection, you should complete your vaccine dosing schedule.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

It is important that your doctor check your progress to make sure this medicine is working properly and to check for unwanted effects.

This vaccine may increase the risk for nervous system problems, including Guillain-Barré syndrome. Check with your doctor right away if you have sudden numbness and weakness in the arms and legs or inability to move the arms and legs.

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. Tell your doctor if you are receiving inactivated influenza vaccine.

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 immediately if any of the following side effects occur:

Rare

Ankle, knee, or great toe joint pain

blindness

blurred vision

decreased vision

eye pain

fever greater than 39 degree Celsius

joint stiffness or swelling

lower back or side pain

swollen, painful, or tender lymph glands in the neck, armpit, or groin

Incidence not known

Hives, welts, or itching

inability to move the arms and legs

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

redness of the skin

sudden numbness and weakness in the arms and legs

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

Diarrhea

difficulty in moving

fever

headache

muscle aches, cramps, pains, or stiffness

nausea

pain, redness, and swelling at the injection site

shivering

stomach pain

unusual tiredness or weakness

vomiting

Less common

Chills

dizziness

general feeling of discomfort or illness

itching at the injection site

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.