Shingrix Prefilled Syringe (recombinant)

Herpes zoster is caused by the same virus (varicella) that causes chickenpox in children. When this virus becomes active again, it can lead to herpes zoster, or shingles. Recombinant Shingrix Prefilled Syringe helps prevent shingles.

This vaccine does not contain live virus. It helps your body build immunity to shingles. This vaccine will not treat an active infection that has already developed in the body.

Recombinant Shingrix Prefilled Syringe is used to prevent herpes zoster virus (shingles):

• in people age 50 and older, including those who have previously received a live Shingrix Prefilled Syringe (Zostavax); and
• in people 18 years and older who are or will be at increased risk of herpes zoster virus (shingles) because of a weak immune system caused by disease or treatment.

Recombinant Shingrix Prefilled Syringe will not prevent or treat chickenpox.

Like any vaccine, recombinant Shingrix Prefilled Syringe may not provide protection from disease in every person.

You should not receive this vaccine if you have ever had a severe allergic reaction to a previous Shingrix Prefilled Syringe.

You should not receive this vaccine if you have ever had a severe allergic reaction to any ingredient in this vaccine or after a previous dose of this vaccine.

Tell your vaccination provider if you:

• have ever had an allergic reaction to any vaccine;
• have ever fainted after receiving an injection; or
• currently have shingles.

Tell your doctor if you are pregnant or plan to become pregnant. You may need to wait until after pregnancy to receive this vaccine.

Ask a doctor if it is safe to breastfeed after receiving this vaccine.

Get emergency medical help if you notice signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You should not get the second shot if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you experience after receiving recombinant Shingrix Prefilled Syringe. When you get the second shot, inform the doctor if the first shot caused any side effects.

Getting infected with shingles may be more harmful to your health than getting the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the chance of serious side effects is very low.

Some people who received this vaccine experienced nervous system problems within 42 days after vaccination, but the risk of this side effect is very low. Seek medical attention immediately if you have:

• weakness or tingling;
• trouble speaking or swallowing;
• issues with balance or eye movement; or
• loss of bladder or bowel control.

Call your doctor right away if you have a high fever.

Common side effects include:

• headache, muscle pain;
• feeling tired;
• stomach pain, nausea, vomiting, diarrhea;
• fever, shivering; or
• pain, redness, or swelling at the injection site.

This is not a complete list of side effects, and others may occur. Contact your doctor for medical advice about side effects. You can report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Recombinant Shingrix Prefilled Syringe is given as an injection (shot) into a muscle. A healthcare provider will give you this injection.

This vaccine is usually given in a series of 2 shots:

• The second shot may be given any time within 2 to 6 months after the first shot.
• For people who have a weak immune system, the second shot may be given any time within 1 to 2 months after the first shot.

You may receive this vaccine at the same time that you get a flu shot.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Call your doctor if you miss the second dose or if you fall behind schedule. You must receive all recommended doses of this vaccine to be fully protected against disease.

An overdose of this vaccine is not likely to happen.

Follow your doctor's guidance on any limits regarding food, drinks, or activities.

Other drugs may affect Shingrix Prefilled Syringe (recombinant), including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.