Pronunciation:

SMAWL-pox MUN-kee-pox vak-SEEN, lyve non - REP-li-kay-ting

Brand Names:

• Jynneos

Dosage Forms:

• Suspension

Uses of This Medicine:

Smallpox mpox vaccine, live non-replicating is used as an active immunization against smallpox and mpox infection in patients who may be at high risk to have this disease. It works by causing your immune system to produce its own protection (antibodies) against the virus.

This vaccine is to be given only by or under the supervision of your doctor or other authorized health care professional.

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 smallpox mpox vaccine, live non-replicating, in the pediatric population. Safety and efficacy have not been established. However, emergency use of this vaccine can be given in children who are at high risk for mpox infection.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of smallpox mpox vaccine, live non-replicating in the elderly 65 years of age and older. Safety and efficacy have not been established.

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 not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

• Deflazacort

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.

• Adalimumab
• Alemtuzumab
• Anifrolumab-fnia
• Bendamustine
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• Bortezomib
• Bosutinib
• Cabazitaxel
• Canakinumab
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Chlorambucil
• Cisplatin
• Cladribine
• Clofarabine
• Cyclophosphamide
• Cyclosporine
• Cytarabine
• Cytarabine Liposome
• Dacarbazine
• Dasatinib
• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Deucravacitinib
• Docetaxel
• Doxorubicin
• Dupilumab
• Efgartigimod Alfa-fcab
• Elivaldogene Autotemcel
• Epirubicin
• Etoposide
• Etrasimod
• Everolimus
• Fingolimod
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Hyaluronidase
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Infliximab
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Ixekizumab
• Leniolisib
• Lomustine
• Lovotibeglogene Autotemcel
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mirikizumab-mrkz
• Mitomycin
• Mitoxantrone
• Nelarabine
• Nilotinib
• Ofatumumab
• Oxaliplatin
• Ozanimod
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Ponatinib
• Ponesimod
• Procarbazine
• Ritlecitinib
• Rituximab
• Rozanolixizumab-noli
• Secukinumab
• Siponimod
• Spesolimab-sbzo
• Tacrolimus
• Temozolomide
• Teniposide
• Teplizumab-mzwv
• Tocilizumab
• Topotecan
• Tositumomab
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vamorolone
• Vinblastine
• Vinorelbine
• Voclosporin

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:

• Cancer or
• HIV infection or
• Weak immune system—Should not be given in patients with these conditions.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that you receive the second dose of the vaccine series at the right times and that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check 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 occur after you receive this vaccine. Your doctor may want to observe you after you get the injection to prevent or manage fainting.

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

This vaccine may not protect everyone who receives it.

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

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 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 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 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.