Smallpox and Mpox Vaccine Injection, Live

What is this medication?

SMALLPOX and MPOX VACCINE (smol poks and EM poks vak SEEN) reduces the risk of smallpox and monkeypox (mpox). It does not treat smallpox or mpox. It is still possible to get smallpox or mpox after receiving this vaccine, but the symptoms may be less severe or not last as long. It works by helping your immune system learn how to fight off a future infection.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): JYNNEOS

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• An unusual or allergic reaction to smallpox and monkeypox vaccine, other medicines, foods, dyes, or preservatives
• Immune system problems
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This vaccine is injected under the skin. It is given by your care team.

This vaccine requires 2 doses to get the full benefit. Set a reminder for when your next dose is due.

A copy of Vaccine Information Statements will be given before each vaccination. Be sure to read this information carefully each time. This sheet may change often.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team regularly.

Cases of inflammation of the heart have been reported after receiving the smallpox vaccine. It is not known whether the smallpox and monkeypox vaccine causes the heart inflammation. Talk to your care team right away if you are unusually weak or tired, have trouble breathing, chest pain, dizziness, fast or irregular heartbeat, fever, joint pain, swelling of the ankles, feet, hands or other unusual swelling. Adolescents or young adult males at an increased risk of inflammation of the heart may consider waiting 4 weeks after smallpox and monkeypox vaccination before getting an mRNA COVID-19 vaccine.

This vaccine, like all vaccines, may not fully protect everyone. Continue to follow all guidelines to prevent exposure.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in skin color
• Fatigue
• Hardening or thickening of tissue at injection site
• Headache
• Muscle pain
• Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This vaccine is only given by your care team. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.