Dryvax (Injection)

Smallpox vaccine is an active immunizing agent used to prevent smallpox infection. It helps your immune system create its own protection (antibodies) against the virus.

This vaccine should only be given by or under the supervision of your doctor or another health care professional.

This medicine is available only with a doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this vaccine is working properly and to check for unwanted effects.

This vaccine may cause serious heart problems in some patients. Contact your doctor right away if you experience chest pain or discomfort; dizziness; a fast or irregular heartbeat; fever and chills; shortness of breath; sweating; weakness; or trouble breathing.

Inform your doctor if you smoke cigarettes or other tobacco products. The risk of heart problems is higher in people who smoke.

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

You should not become pregnant for at least 3 months after receiving this vaccine without first consulting your doctor. There is a possibility that this vaccine may cause problems during pregnancy. If you believe you have become pregnant, inform your doctor immediately.

This vaccine contains neomycin and polymyxin B. Make sure your doctor is aware if you have had an allergic reaction to these medicines.

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 others. 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 provide instructions on 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 2 to 4 weeks after vaccination). Discuss any concerns with your doctor.

You must wait at least 30 days 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, inform the medical doctor in charge that you have received this vaccine. The results of these tests may be affected by this vaccine.

In deciding to use a vaccine, you and your doctor need to think about the risks of taking the vaccine compared to the benefits it offers. For this vaccine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There are no appropriate studies on how the smallpox vaccine affects children under 16 years old. Its safety and effectiveness have not been established for this age group.

Geriatric

There is no information on how the smallpox vaccine affects older adults.

Breast Feeding

There are no sufficient studies in women regarding the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may adjust the dose or take other precautions. When receiving this vaccine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and may not include all possibilities.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may choose not to use this vaccine or alter some of the other medicines you are taking.

• Deflazacort
• Thiotepa

Receiving this vaccine with any of the following medicines is usually not recommended, but may be necessary in some instances. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Adalimumab
• Alemtuzumab
• Anifrolumab-fnia
• Ansuvimab-zykl
• Antithymocyte Globulin Rabbit
• Atoltivimab
• Axicabtagene Ciloleucel
• Azathioprine
• Baricitinib
• Belatacept
• Bendamustine
• Betibeglogene Autotemcel
• Bimekizumab-bkzx
• Bortezomib
• Bosutinib
• Brexucabtagene Autoleucel
• Brodalumab
• Cabazitaxel
• Canakinumab
• Capecitabine
• Carboplatin
• Carfilzomib
• Carmustine
• Certolizumab Pegol
• 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
• Emapalumab-lzsg
• Epirubicin
• Etanercept
• Etoposide
• Etrasimod
• Everolimus
• Fingolimod
• Fludarabine
• Fluorouracil
• Gemcitabine
• Gemtuzumab Ozogamicin
• Golimumab
• Guselkumab
• Hyaluronidase
• Hydroxyurea
• Idarubicin
• Ifosfamide
• Imatinib
• Immune Globulin
• Inebilizumab-cdon
• Infliximab
• Interferon Alfa
• Irinotecan
• Irinotecan Liposome
• Ixekizumab
• Leflunomide
• Leniolisib
• Lomustine
• Mechlorethamine
• Melphalan
• Mercaptopurine
• Methotrexate
• Mirikizumab-mrkz
• Mitomycin
• Mitoxantrone
• Mycophenolic Acid
• Nelarabine
• Nilotinib
• Ocrelizumab
• Ofatumumab
• Oxaliplatin
• Ozanimod
• Paclitaxel
• Paclitaxel Protein-Bound
• Pemetrexed
• Pentostatin
• Ponatinib
• Ponesimod
• Procarbazine
• Rilonacept
• Risankizumab-rzaa
• Ritlecitinib
• Rituximab
• Rozanolixizumab-noli
• Sarilumab
• Satralizumab-mwge
• Secukinumab
• Siponimod
• Sirolimus
• Spesolimab-sbzo
• Tacrolimus
• Temozolomide
• Teniposide
• Teplizumab-mzwv
• Teriflunomide
• Tildrakizumab-asmn
• Tocilizumab
• Tofacitinib
• Topotecan
• Tositumomab
• Trabectedin
• Tralokinumab-ldrm
• Ublituximab-xiiy
• Upadacitinib
• Ustekinumab
• Valoctocogene Roxaparvovec-rvox
• Vamorolone
• Vinblastine
• Vinorelbine
• Voclosporin

Receiving this vaccine with any of the following medicines may increase the risk of certain side effects, but using both medications may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you take 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Be sure to inform your doctor about any other medical problems, especially:

• Bone marrow transplant or
• Cancer or
• HIV or AIDS or
• Immune deficiency conditions or
• Leukemia (blood cancer) or
• Lymphoma (cancer of lymph nodes)
• Organ transplant—Should not use in patients with these conditions.

• Severe burns
• Chest pain
• Chickenpox
• Congestive heart failure
• Dermatitis
• Diabetes
• Eczema
• Eye disease
• History of heart attack
• Heart disease (or family history of)
• High blood pressure
• High cholesterol
• Impetigo
• Psoriasis
• Shingles
• Stroke—May increase the chance and severity of side effects.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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 skin
• blue or pale skin
• blurred vision
• changes in vision
• chest discomfort
• chest pain, possibly moving to the left arm, neck, or shoulder
• confusion
• convulsions (seizures)
• 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
• shortness of breath
• skin rash that is encrusted, scaly, and oozing
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stiff neck
• tightness in the chest
• trouble breathing
• unusual tiredness or weakness
• vomiting
• wheezing

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 or cramping
• muscle 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.

In the U.S.

• Dryvax

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Vaccine, Live

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.