adenovirus vaccine, live (Oral route)

AD-e-noe-vye-rus VAX-een type 4, lyve, AD-e-noe-vye-rus VAX-een type 7, lyve

Uses For adenovirus vaccine, live

Adenovirus type 4 and type 7 live vaccine is used to prevent febrile (with fever) acute respiratory disease (ARD) caused by adenovirus type 4 and type 7. It works by causing your body to produce its own protection (antibodies) against the virus.

This vaccine is given to military personnels 17 to 50 years of age.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using adenovirus vaccine, live

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to adenovirus vaccine, live or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of adenovirus type 4 and type 7 live vaccine in children up to 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of adenovirus type 4 and type 7 live vaccine in the geriatric population. Safety and efficacy have not been established.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

  • Aclarubicin
  • Adalimumab
  • Aldesleukin
  • Altretamine
  • Amonafide
  • Amsacrine
  • Asparaginase
  • Azacitidine
  • Azathioprine
  • Bleomycin
  • Broxuridine
  • Busulfan
  • Capecitabine
  • Carboplatin
  • Carmustine
  • Certolizumab Pegol
  • Chlorambucil
  • Cisplatin
  • Cladribine
  • Cyclophosphamide
  • Cytarabine
  • Cytarabine Liposome
  • Dacarbazine
  • Dactinomycin
  • Daunorubicin
  • Daunorubicin Citrate Liposome
  • Decitabine
  • Docetaxel
  • Doxifluridine
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Edatrexate
  • Eflornithine
  • Epirubicin
  • Estramustine
  • Etanercept
  • Etoposide
  • Everolimus
  • Fingolimod
  • Floxuridine
  • Fludarabine
  • Fluorouracil
  • Fotemustine
  • Gallium Nitrate
  • Gemcitabine
  • Golimumab
  • Hydroxyurea
  • Idarubicin
  • Ifosfamide
  • Infliximab
  • Irinotecan
  • Lomustine
  • Mechlorethamine
  • Melphalan
  • Mercaptopurine
  • Methotrexate
  • Mitolactol
  • Mitomycin
  • Mitotane
  • Mitoxantrone
  • Mycophenolic Acid
  • Oxaliplatin
  • Paclitaxel
  • Pegaspargase
  • Pentostatin
  • Pipobroman
  • Pirarubicin
  • Plicamycin
  • Procarbazine
  • Raltitrexed
  • Rilonacept
  • Rituximab
  • Siltuximab
  • Sirolimus
  • Streptozocin
  • Teceleukin
  • Tegafur
  • Temsirolimus
  • Teniposide
  • Thioguanine
  • Thiotepa
  • Topotecan
  • Trabectedin
  • Treosulfan
  • Trimetrexate
  • Trofosfamide
  • Uracil Mustard
  • Ustekinumab
  • Vinblastine
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vindesine
  • Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Leflunomide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergic reactions (e.g., anaphylaxis), severe to this vaccine or
  • Difficulty with swallowing a whole tablet, without chewing—Should not be used in patients with these conditions.
  • Diarrhea or
  • Vomiting—Use with caution. You may need to wait until you feel better before receiving the vaccine.
  • Weakened immune system (e.g., HIV, cancer, or receiving steroid or cancer medicines)—May not work as well in patients with this condition.

Proper Use of adenovirus vaccine, live

A nurse or other trained health professional will give you this vaccine. It is given by mouth.

Swallow each tablet whole. Do not break, crush, or chew them.

Dosing

The dose of adenovirus vaccine, live will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of adenovirus vaccine, live. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (enteric coated tablets):
    • To prevent febrile acute respiratory disease:
      • Adults and teenagers 17 to 50 years of age—Two tablets taken as a single dose.
      • Children younger than 17 years of age—Use and dose must be determined by your doctor.

Missed Dose

adenovirus vaccine, live needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using adenovirus vaccine, live

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

Do not take this vaccine if you are pregnant and do not plan to become pregnant for 6 weeks after receiving this vaccine without first checking with your doctor. There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.

This vaccine contains live viruses that are shed in the stool for up to 28 days after receiving the vaccine and can cause disease to other people if transmitted. Your doctor may recommend ways (e.g., proper and frequent hand washing, especially right after bowel movements) to help prevent the spread of virus to other people.

You should avoid close contact with people at high risk for catching the adenovirus for 28 days after receiving this vaccine. People who are at risk for catching the virus are pregnant women, children younger than 7 years of age, and anyone who has a weak immune system that keeps them from fighting infections.

This vaccine contains albumin, which comes from human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

adenovirus vaccine, live Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • fever greater than or equal to 100.5 degrees F
  • headache
  • loss of voice
  • runny nose
  • sneezing
  • sore throat
  • stuffy nose
  • unusual tiredness or weakness

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
  • Diarrhea
  • difficulty with moving
  • muscle pain or stiffness
  • nausea
  • pain in the joints
  • upper abdominal or stomach pain
  • vomiting
Less common
  • Pain in the arms or legs

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.

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