Smallpox Vaccinia Monkeypox Vaccine Live Nonreplicati

What Is Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating and How Does It Work?

• Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating is indicated for the prevention of smallpox and monkeypox disease in adults who are at high risk for smallpox or monkeypox infection. 
• Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating is available under the following different brand names: Jynneos

Common side effects of Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating include:

• injection site reactions (pain, redness, swelling, a hard lump, and itching)
• muscle pain
• headache
• fatigue
• nausea
• chills

Serious side effects of Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• dizziness
• vision loss
• blurred vision
• tunnel vision
• eye pain or swelling
• seeing halos around lights
• fast, irregular, or pounding heartbeats
• fluttering in the chest
• shortness of breath
• sudden dizziness
• lightheadedness
• passing out
• severe headache
• confusion
• slurred speech
• arm or leg weakness
• trouble walking
• loss of coordination
• feeling unsteady
• very stiff muscles
• high fever
• profuse sweating
• tremors

Rare side effects of Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable, suspension

• 0.5 mL/single-dose vial

Prevention of Smallpox and Monkeypox Disease

Adult dosage

• 0.5 mL SC for 2 doses 4 weeks apart

Monkeypox EUA (intradermal administration)

• 0.1 mL ID x2 doses 4 weeks apart

Monkeypox EUA

Pediatric dosage

• 0.5 mL SC x2 doses 4 weeks apart

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating has no noted severe interactions with any other drugs
• Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating has no noted serious interactions with any other drugs
• Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating has no noted moderate interactions with any other drugs
• Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Smallpox (Vaccinia) Monkeypox Vaccine Live Nonreplicating?”

Cautions

• Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration; those who experienced a severe allergic reaction following a previous dose or following exposure to any vaccine component may be at increased risk for severe allergic reactions after administering
• Immunocompromised individuals, including those receiving immunosuppressive therapy, may have diminished response
• Vaccination may not protect all recipients

Pregnancy and Lactation

• Human data are insufficient to inform vaccine-associated risks in pregnancy
• Lactation
  • Unknown if excreted in human milk; data are not available to assess vaccine effects in breastfed infants or on milk production/excretion