Avaxim

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes Avaxim (Hepatitis-a-Avaxime). If you are concerned about side effects, discuss the risks and benefits of Avaxim (Hepatitis-a-Avaxime) with your doctor.

The following side effects have been reported by at least 1% of people taking Avaxim (Hepatitis-a-Avaxime). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Diarrhea
• drowsiness
• fatigue
• fever
• generally feeling unwell
• headache
• irritability
• loss of appetite
• muscle or joint achiness
• nausea or vomiting
• pain and redness at the injection site
• swelling or hard lump at the injection site
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Seek immediate medical attention if any of the following side effects occur:

• symptoms of a serious allergic reaction (e.g., Hives, difficulty breathing, or swelling of the face or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Avaxim (Hepatitis-a-Avaxime).

Pediatric/Adolescent Avaxime

Each 0.5 mL dose of sterile, whitish, cloudy suspension, contains 80 antigen units of inactivated hepatitis A virus. Nonmedicinal ingredients: aluminum hydroxide (expressed as aluminum): 0.15 mg; 2-phenoxyethanol: 2.5 µL; formaldehyde: 12.5 µg; polysorbate 80 in less than 750 µg; medium 199, water for injection up to: 0.5 mL; neomycin: trace amounts.

Adult Avaxime

Each 0.5 mL dose of sterile, whitish, cloudy suspension, contains 160 antigen units of inactivated hepatitis A virus. Nonmedicinal ingredients: aluminum hydroxide (expressed as aluminum): 0.3 mg; 2-phenoxyethanol: 2.5 µL; formaldehyde: 12.5 µg; polysorbate 80 in less than 750 µg; medium 199, water for injection up to 0.5 mL; neomycin: trace amounts.

Do not use hepatitis A Avaxime if you:

• are allergic to any ingredient of the Avaxime
• have an acute, severe illness with Fever

There may be an interaction between the hepatitis A Avaxime and any of the following:

• Acetaminophen
• Belimumab
• Fingolimod
• immunosuppressive therapy (e.g., some medications used for the treatment of cancer, or for transplant recipients, or immune conditions)
• Azathioprine
• corticosteroids (e.g., budesonide, Dexamethasone, Hydrocortisone, fluticasone, Prednisone)
• Cyclosporine
• Hydroxyurea
• Infliximab
• medications to treat cancer (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• mycophenolate
• Rituximab
• Tacrolimus
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Avaxim (Hepatitis-a-Avaxime). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Avaxim (Hepatitis-a-Avaxime).

Bleeding disorders: If you have any bleeding problems (such as Hemophilia) or are taking blood thinners such as Warfarin, tell your doctor before receiving Avaxim (Hepatitis-a-Avaxime).

Cancer and immunosuppression: Hepatitis A Avaxime may not be as effective if you have cancer, if you are receiving immunosuppressive therapy (e.g., some medications used to treat cancer or for transplant recipients), or if you are immunocompromised (i.e., your immune system does not work properly).

Immunization record: Make sure any new doctors know that you have had this Avaximation so that they can put this information in your immunization record.

Infection and fever: If you have an infection or fever, your doctor may recommend that you wait until you are better before receiving the hepatitis A Avaxime.

Neomycin allergy: The Avaxime may contain trace amounts of neomycin and thus may cause an allergic reaction in people who are allergic to neomycin.

Avaxime protection: As with any Avaxime, this Avaxime may not result in total protection from hepatitis A and may not prevent hepatitis A for people who are infected with the virus at the time of Avaximation.

Pregnancy: This Avaxime should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Avaxim (Hepatitis-a-Avaxime), contact your doctor immediately.

Breast-feeding: It is not known if the Avaxime passes into breast milk. If you are a breast-feeding mother and are plan to receive this Avaxime, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Avaxim (Hepatitis-a-Avaxime) have not been established for children below the minimum age stated above.