Description
Smallpox and mpox vaccine, live 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
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of smallpox and mpox vaccine, live 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.
Geriatric
Appropriate studies have not been performed on the relationship of age to the effects of smallpox and mpox vaccine, live in the elderly 65 years of age and older. Safety and efficacy have not been established.
Breastfeeding
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.
Drug Interactions
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
- Thiotepa
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
- Anifrolumab-fnia
- Ansuvimab-zykl
- Antithymocyte Globulin Rabbit
- Atidarsagene Autotemcel
- Atoltivimab
- Axicabtagene Ciloleucel
- Azathioprine
- Baricitinib
- Belatacept
- Betibeglogene Autotemcel
- Bimekizumab-bkzx
- Brexucabtagene Autoleucel
- Brodalumab
- Canakinumab
- Certolizumab Pegol
- Cyclosporine
- Deucravacitinib
- Deuruxolitinib
- Dupilumab
- Efgartigimod Alfa-fcab
- Elivaldogene Autotemcel
- Emapalumab-lzsg
- Etanercept
- Etrasimod
- Everolimus
- Fidanacogene Elaparvovec-dzkt
- Fingolimod
- Golimumab
- Guselkumab
- Hyaluronidase
- Immune Globulin
- Inebilizumab-cdon
- Infliximab
- Ixekizumab
- Lebrikizumab-lbkz
- Leflunomide
- Leniolisib
- Lovotibeglogene Autotemcel
- Methotrexate
Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abatacept
- Cytomegalovirus Immune Globulin, Human
- Hepatitis B Immune Globulin
- Rabies Immune Globulin
- Respiratory Syncytial Virus Immune Globulin, Human
- Tetanus Immune Globulin
- Vaccinia Immune Globulin, Human
- Varicella-Zoster Immune Globulin
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:
- Angina, history of or
- Congestive heart failure, history of or
- Diabetes or
- Eye disease or
- Heart attack, history of or
- Heart or blood vessel disease, or family history of or
- High blood pressure or
- High cholesterol in the blood or
- Skin problems (eg, eczema, dermatitis, burns, impetigo, chickenpox, shingles, psoriasis, or uncontrolled acne) or
- Smoke cigarettes or other tobacco products or
- Stroke, history of��Use with caution. May increase the chance of serious side effects.
- Weak immune system (eg, bone marrow transplant, cancer, HIV infection)—Should not use in patients with these conditions.
Proper Use
A nurse or other trained health professional will give you this vaccine. This vaccine is given by using a needle to poke or jab the skin on your upper arm.
You may need a booster dose of this vaccine every three years to maintain protection against smallpox. Ask your doctor if you will need another dose of this vaccine.
This vaccine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Do not use creams, ointments, or other skin care products on the vaccination site.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this vaccine is working properly and to check for unwanted effects.
You should not become pregnant for 6 weeks after receiving this vaccine without first checking with your doctor. This vaccine may transmit virus from pregnant women to their babies. If you think you have become pregnant, tell your doctor right away.
This vaccine may cause serious heart problems (eg, myocarditis, pericarditis). Check with your doctor right away if you have anxiety, blue or pale skin, chest pain or discomfort, possibly moving to the left arm, neck, or shoulder, fast heartbeat, fever and chills, trouble breathing, or unusual tiredness or weakness.
Check with your doctor right away if you have agitation, back pain, blurred vision, coma, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, seizures, stiff neck, unusual tiredness or weakness, or vomiting. These may be symptoms of swelling of the brain or spinal cord.
This medicine may cause serious skin reactions (eg, eczema vaccinatum, Stevens-Johnson syndrome). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
This medicine may cause eye or vision problems. Check with your doctor right away if you have blindness, blurred vision, eye redness, irritation, or pain. Tell your doctor if you are using a steroid eye drop or ointment.
This vaccine may not protect everyone who receives it.
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.
This vaccine contains a live virus. The virus can cause an infection in other parts of your body or in other people if you touch the vaccination site and then touch your body or other people. Always cover the vaccination site with a bandage. Wash your hands thoroughly after changing the bandage or after touching the vaccination site. Your doctor will tell you how to care for the vaccination site. Make sure you understand the directions and follow them carefully. Avoid contact with people who are sick or have infections until the scab falls off (usually 3 to 6 weeks after vaccination). Talk to your doctor about this if you have concerns.
You must wait at least 6 weeks before you can donate blood, use a hot tub or swim, handle a baby, or breastfeed.
Before you have any medical tests for syphilis or a tuberculin (TB) skin test, tell the medical doctor in charge that you have received this vaccine. The results of these tests may be affected by this vaccine.
Side Effects
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:
More common
- Feeling unusually cold
- shivering
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
Less common
- Agitation
- anxiety
- back pain
- blindness
- blistering, peeling, or loosening of the skin
- blue or pale skin
- blurred vision
- changes in vision
- chest discomfort or tightness
- chest pain, possibly moving to the left arm, neck, or shoulder
- confusion
- cough
- diarrhea
- difficult or labored breathing
- dizziness
- drowsiness
- fast heartbeat
- fever and chills
- hallucinations
- headache
- irritability
- itching
- joint or muscle pain
- loss of consciousness
- mood or mental changes
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- skin rash that is encrusted, scaly, and oozing
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stiff neck
- trouble breathing
- unusual tiredness or weakness
- vomiting
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
- Decreased ability to exercise
- difficulty having a bowel movement (stool)
- difficulty with moving
- flushing or redness of the skin
- general feeling of discomfort or illness
- itching, pain, redness, or swelling at the vaccine site
- muscle aching, cramping, or stiffness
- nausea
- rash
- swollen joints
- unusually warm skin
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.
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