YF-Vax

Yellow fever is a serious disease caused by the yellow fever virus. It is found in certain parts of Africa and South America. Yellow fever is spread through the bite of an infected mosquito. It cannot be spread person to person by direct contact. People with yellow fever disease usually have to be hospitalized. Yellow fever can cause:

• fever and flu-like symptoms
• jaundice (yellow skin or eyes)
• bleeding from multiple body sites
• liver, kidney, respiratory and other organ failure
• death (20 to 50% of serious cases)

Yellow fever vaccine is a live, weakened virus. It is given as a single shot. For people who remain at risk, a booster dose is recommended every 10 years.

Yellow fever vaccine may be given at the same time as most other vaccines.

Yellow fever vaccine can prevent yellow fever. Yellow fever vaccine is given only at designated vaccination centers. After getting the vaccine, you should be given a stamped and signed ''International Certificate of Vaccination or Prophylaxis'' (yellow card). This certificate becomes valid 10 days after vaccination and is good for 10 years. You will need this card as proof of vaccination to enter certain countries. Travelers without proof of vaccination could be given the vaccine upon entry or detained for up to 6 days to make sure they are not infected. Discuss your itinerary with your doctor or nurse before you get your yellow fever vaccination. Consult your health department or visit CDC's travel information website at http://www.cdc.gov/travel to learn yellow fever vaccine requirements and recommendations for different countries.

Another way to prevent yellow fever is to avoid mosquito bites by:

• staying in well-screened or air-conditioned areas,
• wearing clothes that cover most of your body,
• using an effective insect repellent, such as those containing DEET.

• Persons 9 months through 59 years of age traveling to or living in an area where risk of yellow fever is known to exist, or traveling to a country with an entry requirement for the vaccination.
• Laboratory personnel who might be exposed to yellow fever virus or vaccine virus.

Information for travelers can be found online through CDC (http://www.cdc.gov/travel), the World Health Organization (http://www.who.int), and the Pan American Health Organization (http://www.paho.org).

You should not donate blood for 14 days following the vaccination, because there is a risk of transmitting the vaccine virus through blood products during that period.

• Ask your doctor. He or she can give you the vaccine package insert or suggest other sources of information.
• Call your local or state health department.
• Contact the Centers for Disease Control and Prevention (CDC) by calling 1-800-232-4636 (1-800-CDC-INFO), or by visiting CDC websites at http://www.cdc.gov/travel, http://www.cdc.gov/ncidod/dvbid/yellowfever, or http://www.cdc.gov/vaccines/vpd-vac/yf

Yellow Fever Vaccine Information Statement. U.S. Department of Health and Human Services/Centers for Disease Control and Prevention National Immunization Program. 3/30/2011.

Pregnancy Category: C

Lactation: There is a theoretical risk of transmission of vaccine components to the infants from breast-feeding mothers, lactation constitutes a contraindication, particularly when infants are <9 months of age because of the risk of encephalitis

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Yellow fever vaccine is for use in adults and children who are at least 9 months old. The vaccine is given every 10 years to people who are at risk of exposure to yellow fever. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department or the Centers for Disease Control and Prevention (CDC).

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with yellow fever is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

• Prior to administration of the vaccine dose, provide a copy of the appropriate CDC Vaccine Information Statement (VIS) to the patient or patient's legal representative (VISs are available at ).112

• Advise patient and/or patient's parent or guardian of the risks and benefits of vaccination with yellow fever vaccine.106

• Advise patient and/or patient's parent or guardian that yellow fever vaccine should not be used in individuals with life-threatening allergic reactions to eggs, egg products, or chicken protein, vaccine ingredients or packaging components (e.g., gelatin), or a previous dose of the vaccine.106 Importance of informing clinician of any history of sensitivity to egg or chicken protein since sensitivity testing may be necessary prior to vaccination.106 (See Sensitivity Reactions under Cautions.)

• Importance of informing clinicians if the patient has a weakened immune system (e.g., leukemia, lymphoma, HIV/AIDS, thymic disease) or is receiving treatment that may weaken the immune system (e.g., high-dose corticosteroids).

• Advise patient and/or patient's parent or guardian that yellow fever vaccine is given only at certain vaccination centers authorized to issue valid ICVPs and that the completed document will be needed as proof of vaccination before the individual is allowed to enter certain countries.100 106 115 Current information regarding which countries are in yellow fever endemic zones and/or have vaccination requirements for entry is available at CDC website ().115

• Advise patient and/or patient's parent or guardian that yellow fever vaccine may not provide protection in all vaccinees.106 In addition to being vaccinated, importance of avoiding exposure to mosquitoes while in yellow fever endemic areas (e.g., stay in air-conditioned or well-screened areas, wear long-sleeved shirts and long pants to cover the body, use appropriate insect repellents, use mosquito nets between dusk and dawn).115

• Advise patient and/or patient's guardian of the signs and symptoms of an allergic reaction (e.g., urticaria, angioedema, rash, dyspnea, bronchospasm, pharyngeal edema, wheezing, throat tightness) and importance of immediately contacting a clinician if any symptoms of an allergic reaction develop following vaccination.100

• Importance of informing clinicians if any adverse reactions (including allergic reactions) occur ≤30 days after vaccination with yellow fever vaccine.106 Clinicians or individuals can report any adverse reactions that occur following vaccination to VAERS at 800-822-7967 or .106

• Advise individuals ≥60 years of age that they may be at increased risk for adverse effects after receiving yellow fever vaccine compared with younger adults.106 115 (See Geriatric Use under Cautions.)

• Advise patients with young children that yellow fever vaccine should not be used in infants <9 months of age and of the importance of avoiding yellow fever endemic areas if traveling with children in this age group.106 (See Pediatric Use under Cautions.)

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.106

• Importance of women informing clinicians if they are or plan to become pregnant.106 Advise such women that the vaccine should be used during pregnancy only when clearly needed and that efforts should be made to postpone travel to yellow fever endemic areas until after delivery. 106 If travel to yellow fever endemic areas cannot be avoided during pregnancy, discuss the risks and benefits of vaccination. (See Pregnancy under Cautions.)

• Importance of women informing clinicians if they plan to breast-feed.106 Advise such women that the vaccine is not recommended for use in nursing women, particularly when breast-feeding infants are <9 months of age.106 (See Lactation under Cautions.)

• Importance of informing patients of other important precautionary information.106 (See Cautions.)

A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot under your skin.

A booster dose of the vaccine is recommended every 10 years for patients who are at continuous risk of exposure to the yellow fever virus, and is required by his or her doctor.

For all patients taking YF-VAX (yellow fever vaccine):

• If you have an allergy to this medicine or any part of YF-VAX.
• If you are allergic to eggs, talk with the doctor.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a weak immune system or a disease that may cause a weak immune system like HIV.
• If you are taking any drugs to suppress your immune system. This may be certain doses of steroids like prednisone. There are many drugs that can suppress your immune system. Ask your doctor or pharmacist if you are not sure.
• If you are getting radiation.
• If you are breast-feeding an infant younger than 9 months of age. Do not breast-feed an infant younger than 9 months of age if you get this drug.

Children:

• If your child is younger than 9 months of age. Do not give this vaccine to a child younger than 9 months of age.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take YF-VAX with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

NDC 49281-915-01

YF

Yellow Fever Vaccine
YF-Vax®

(live 17D virus, freeze-dried, avian
leukosis-free, sorbitol-gelatin stabilized)

5 VIALS
1 Dose
each

Rx only

sanofi pasteur

Applies to yellow fever vaccine: injectable powder for injection, subcutaneous powder for injection

Other

Minor side effects have included mild headache, myalgia, malaise, asthenia and low-grade fever for 5 to 10 days after vaccination in < 5% to 30% of vaccinees. The incidence of minor adverse events was lower in vaccinees > 60 years than in younger subjects.[Ref]

Local

Local side effects have included edema, erythema, hypersensitivity, pain, or mass at the injection site.[Ref]

Hypersensitivity

Hypersensitivity reactions have infrequently included immediate reactions characterized by rash, urticaria, and/or asthma. These mainly occur in vaccinees with histories of egg allergy.[Ref]

Nervous system

Nervous system side effects have very rarely included neurotropic disease (YEL-AND, post-vaccinal encephalitis) which has been fatal in rare instances. Symptoms have included diaphoresis, rigors, fever, malaise, headache, confusion, expressive aphasia, arm numbness, loss of fine motor control, severe dysarthria, loss of consciousness, elevated WBCs and protein in CSF, and/or leukocytosis. Immunosuppression and age < 9 months are known risk factors. The estimated incidence for all ages is 5.3 cases per million vaccinees.[Ref]

Fifteen cases of neurotropic disease were reported before 1960, 13 of these occurred in infants < 4 months and 2 in infants 6 and 7 months old. Six cases were reported worldwide between 1960 and 1996, 3 of these occurred in adults, and the other 3 in a 1-month-old infant, a 3-year-old, and a 13-year-old. A genetic variant of the vaccine virus was isolated from the brain of the 3-year-old, who died of encephalitis.

Four nonfatal cases of probable 17D vaccine-associated neurotropic disease were reported in the U.S. between 2001 and 2002. High levels of yellow fever-specific IgM antibody were observed in these patients' CSF; however viral isolation was negative or not performed.[Ref]

Other

Seven cases of YEL-AVD were reported between 1996 and 2001, 4 of them in U.S. residents. All patients (ages 5 to 79 years old) were considered healthy and did not have immunodeficiency. Six of these patients died 8 to 11 days after vaccination (1 had been vaccinated with the 17D-204 strain and 2 with the 17DD strain). A liver biopsy revealed rare yellow fever virus antigen within Kupffer cells. In 3 of the fatal cases, hepatic midzonal necrosis, microvesicular fatty change, and Councilman bodies were observed, which are characteristic of wild-type yellow fever. Vaccine-type yellow fever virus was isolated from blood and autopsy material.[Ref]

Vaccine-associated viscerotropic disease (YEL-AVD, multiple organ system failure), which may be fatal, has been reported rarely. It is characterized by initial symptoms of a nonspecific febrile syndrome with fatigue, myalgia, and headache. It quickly progresses to severe illness including respiratory failure, elevated hepatocellular enzymes, lymphocytopenia, thrombocytopenia, hyperbilirubinemia, hypotension with poor tissue perfusion, and/or renal failure requiring hemodialysis. Causality has not been clearly established. The syndrome may be related to unknown host factors rather than virulence of the 17D yellow fever strain. Recent reports suggest that a history of thymic dysfunction (e.g., myasthenia gravis, thymoma, thymectomy, DiGeorge syndrome) and age > 60 years may be risk factors for developing YEL-AVD. The estimated incidence is 1 per 400,000 doses.[Ref]

Health care providers should report any allergic or unusual adverse reactions to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 (USA) and the manufacturer.[Ref]

Some side effects of YF-Vax may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.