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Stamaril (live-attenuated yellow fever vaccine)

Stamaril is the brand name of a yellow fever vaccine. It contains a live-attenuated (weakened) version of the yellow fever virus.

stamaril

Uses

What is Stamaril used for?

Stamaril is a live-attenuated (weakened) vaccine that provides immunization against yellow fever in patients who are:

  • Traveling to or living in an endemic area.
  • Handling potentially infectious materials (e.g. laboratory personnel).
  • Traveling to any country that requires an International Certificate of Vaccination for entry (which may or may not depend on the previous itinerary).

How should I take Stamaril?

All vaccines should be administered by a licensed health professional. For this vaccine, the subcutaneous route is preferred.

Intramuscular injection may be performed if this is in accordance with applicable official recommendations.

For intramuscular use, the recommended injection sites are the anterolateral aspect of the thigh in children less than 12 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 12 months through 35 months of age or the deltoid muscle in children from 36 months of age onwards and adults.

How do I store Stamaril?

This drug should be stored in a refrigerator (2-8°C) and be protected from light and moisture. Do not freeze this product. Always check the label before using this product. For safety, keep out of the reach of children and pets.

Do not use if the printed expiration date has passed, the product seal has been broken, or the product has changed in color, odor, or consistency.

The Vaccine Vial Monitors (VVMs) are on the cap of Stamaril supplied through Sanofi Pasteur. The colored dot which appears on the cap of the vial is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end-user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.

Do not dispose of this product by pouring it down the drain, toilet, or into the environment. Ask your pharmacist regarding the proper way and location of disposal.

Precautions & warnings

What should I know before using Stamaril?

Before using this drug, tell your doctor if you are/have:

  • Pregnant or breastfeeding.
  • Taking any other medicines. This includes any prescription, OTC, and herbal remedies.
  • An allergy to any of the ingredients of this product, especially:
  • Any other illnesses, disorders, or medical conditions, especially:
    • Compromised immunity (e.g. HIV/AIDS, cancer)
    • Taking immunosuppression drugs
    • Thymus dysfunction (e.g. myasthenia gravis, thymoma)

Is it safe during pregnancy or breastfeeding?

This medication is pregnancy risk category D, according to the US Food and Drug Administration (FDA). Do not administer this vaccine or any live vaccine to pregnant women as there is an increased risk of fetal harm. Only administer this vaccine if the potential benefits outweigh the potential risks, as determined by your physician.

FDA pregnancy risk category reference below:

  • A=No risk
  • B=No risk in some studies
  • C=There may be some risk
  • D=Positive evidence of risk
  • X=Contraindicated
  • N=Unknown

Side effects

What side effects can occur when using Stamaril?

Like all drugs, Stamaril may have side effects. If they occur, side effects are generally mild and resolve once treatment is finished or the dose is lowered. Some reported side effects include:

  • Injection site reactions
    • Pain
    • Bruising
    • Swelling
    • Inflammation
  • Headache
  • Malaise
  • Diarrhea
  • Muscle pain
  • Weakness

Rare, serious adverse reactions:

  • Anaphylaxis
    • Rash or hives
    • Swelling of the lips, tongue, throat
    • Difficulty breathing or swallowing
    • Dizziness or loss of consciousness
  • CNS disturbances (within 1 month after injection)
    • High fever with a headache
    • Confusion
    • Lethargy
    • Stiff neck
    • Meningitis
    • Convulsions
    • Loss or difficulty of movement or feeling
  • Yellow Fever-like symptoms (within 10 days after injection)
    • Fatigue
    • Fever
    • Headache
    • Muscle pain
    • Low blood pressure

However, not everyone experiences these side effects. In addition, some people may experience other side effects. So, if you have any concerns about a side effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Stamaril?

This vaccine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects.

To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist.

Drugs with known interactions:

  • Other live vaccines (e.g. flu vaccine, MMR)

If you experience an adverse drug interaction, inform your doctor right away.

Does food or alcohol interact with Stamaril?

This drug may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Stamaril?

This drug may interact with underlying conditions. This interaction may worsen your health condition or alter the way the drug works. Therefore, it is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. Therefore, you should always consult with your doctor or pharmacist before using any medication.

What is the dose for an adult?

Primary vaccination

The vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed.

For adults, the recommended dose is a single dose of 0.5 ml of the reconstituted vaccine.

For older people, the dose is the same as for adults. However due to a potentially higher risk of yellow fever vaccine-associated severe and potentially fatal disease in persons from 60 years of age, the vaccine should only be given when it is considered that there is a significant and unavoidable risk of acquiring yellow fever infection.

Re-vaccination

Typically, revaccination is not necessary because the vaccine offers long-term or lifetime protection.

For patients with insufficient response to the first dose of vaccine, another 0.5 mL dose is used. Some countries require revaccination for entry and travel.

What is the dose for a child?

Primary vaccination

Administer the vaccine at least 10 days before travel or exposure to give enough time for the vaccine to be fully effective.

9 months and older, the recommended dose is a single dose of 0.5 ml of the reconstituted vaccine.

6 to 9 months of age, vaccination is not recommended, except in specific circumstances and in accordance with available official recommendations, in which case the dose is the same as in children aged 9 months and older.

Under 6 months of age, vaccination is contraindicated in this case.

Re-vaccination

Typically, revaccination is not necessary because the vaccine offers long-term or lifetime protection.

For patients with insufficient response to the first dose of vaccine, another 0.5 mL dose is used. Some countries require revaccination for entry and travel.

How is Stamaril available?

Stamaril is available in the following dosage forms and strengths:

  • 10 vials 10 doses + 10 vials 5 ml (diluent)
  • 1 dose (0.5 ml) contains: Yellow fever virus 1 17D-204 strain (live, attenuated), not less than 1000 IU

What should I do in case of an emergency or overdose?

Overdose is not likely to occur with vaccines. In case of a severe reaction or emergency, call your local emergency services or go to the nearest emergency room.

What should I do if I miss a dose?

Stamaril is a single-dose injection that offers lifelong protection, therefore multiple doses are not necessary.

Hello Health Group does not provide medical advice, diagnosis or treatment.

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Written by Stephanie Nicole Nera, RPh, PharmD Updated Jun 13
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