Smallpox monkeypox vaccine, live non-replicating (Intradermal, Subcutaneous)

Smallpox monkeypox vaccine, live non-replicating is used to help protect against smallpox and monkeypox infections in people who might be at high risk for these diseases. It helps your immune system create its own defense (antibodies) against the virus.

This vaccine should only be given by your doctor or another authorized health care professional.

It is very important that you get the second dose of the vaccine series at the correct times and that your doctor checks your progress during regular visits to ensure that this medicine is working properly and to monitor for unwanted effects.

This vaccine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive the vaccine.

Fainting may happen after you receive this vaccine. Your doctor may want to watch you after you get the injection to prevent or manage fainting.

You should not receive this vaccine if you are taking medicines that weaken your immune system, including steroids, radiation, or cancer medicines.

This vaccine may not protect everyone who receives it.

In deciding to use a vaccine, you and your doctor will need to consider the risks of the vaccine compared to its benefits. For this vaccine, keep in mind the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. If you are using non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the use of smallpox monkeypox vaccine, live non-replicating, in children. Its safety and effectiveness have not been confirmed. However, this vaccine can be used in children who are at high risk for monkeypox infection in emergencies.

Geriatric

Studies have not been conducted to understand how age affects the use of smallpox monkeypox vaccine, live non-replicating in older adults aged 65 years and above. Its safety and effectiveness have not been confirmed.

Breast Feeding

There are not enough studies to determine the risks to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. If you are receiving this vaccine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen for their potential importance and are not a complete list.

It is not recommended to receive this vaccine with any of the following medicines. Your doctor may choose not to use this vaccine or may adjust some of your other medications.

• Deflazacort

It is usually not recommended to receive this vaccine with any of the following medicines, but it may be necessary in certain situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

• Adalimumab
• Anifrolumab-fnia
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• Canakinumab
• Deucravacitinib
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Etrasimod
• Everolimus
• Fingolimod
• Hyaluronidase
• Infliximab
• Ixekizumab
• Leniolisib
• Methotrexate
• Mirikizumab-mrkz
• Ozanimod
• Ponesimod
• Ritlecitinib
• Rozanolixizumab-noli
• Secukinumab
• Siponimod
• Spesolimab-sbzo
• Tacrolimus
• Teplizumab-mzwv
• Tocilizumab
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vamorolone
• Voclosporin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as certain foods or types of foods, as interactions may occur. Using alcohol or tobacco with some medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this vaccine. Be sure to tell your doctor if you have any other medical issues, especially:

• Cancer or
• HIV infection or
• Weak immune system—This vaccine should not be given to patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

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

More common

• Chills

Less common

• Fever

Incidence not known

• Chest tightness
• cough
• difficulty with swallowing
• dizziness
• fainting
• fast heartbeat
• hives, itching, rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing
• unusual tiredness or weakness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you about ways to prevent or lessen 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 the 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
• headache
• muscle pain
• nausea

Other side effects not listed may also happen 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.

In the U.S.

• Jynneos

Available Dosage Forms:

• Suspension

A nurse or other trained health professional will give you this vaccine. It is given as a shot under your skin, usually in the outer thigh (for children younger than 1 year of age), upper arm (for children 1 to 17 years of age), or inner side of the arm (for adults).

This vaccine is given in 2 doses at least 4 weeks apart. If you miss the second shot, call your doctor to make another appointment as soon as possible.