Vaqta

Generic Name: hepatitis a vaccine (Intramuscular route)

hep-a-TYE-tis A VAX-een, in-AK-ti-vay-ted

Commonly used brand name(s)

In the U.S.

• Havrix


• Havrix Pediatric


• Vaqta


• Vaqta Pediatric

Available Dosage Forms:

• Suspension


• Solution


• Injectable

Therapeutic Class: Vaccine

Uses For Vaqta

Hepatitis A vaccine is used to prevent infection caused by the hepatitis A virus (HAV). The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Hepatitis A is a serious disease of the liver that can cause death. It is caused by the hepatitis A virus (HAV), and is spread most often through infected food or water. Hepatitis A may also be spread by close person-to-person contact with infected persons (such as between persons living in the same household). Although some infected persons do not appear to be sick, they are still able to spread the virus to others.

Hepatitis A is less common in the U.S. and other areas of the world that have a higher level of sanitation and good water and sewage (waste) systems. However, it is a significant health problem in parts of the world that do not have such systems. If you are traveling to certain countries or remote (out-of-the-way) areas, hepatitis A vaccine will help protect you from hepatitis A disease.

It is recommended that adults and children 12 months of age and older to be vaccinated with hepatitis A vaccine when traveling to the following parts of the world:

• Africa.


• Asia (except Japan).


• Parts of the Caribbean.


• Central and South America.


• Eastern Europe.


• The Mediterranean basin.


• The Middle East.


• Mexico.

Immunization against hepatitis A disease is also recommended for adults and children 12 months of age and older who live in areas that have a high rate of hepatitis A disease or who may be at increased risk of infection from hepatitis A virus. These persons include:

• Military personnel.


• Persons living in or moving to areas that have a high rate of HAV infection.


• Persons who may be exposed to the hepatitis A virus repeatedly due to a high rate of hepatitis A disease, such as Alaskan Eskimos and Native Americans.


• Persons engaging in high-risk sexual activity, such as homosexual and bisexual males.


• Persons who use illegal injection drugs.


• Persons living in a community experiencing an outbreak of hepatitis A.


• Persons working in facilities for the mentally retarded.


• Employees of child day-care centers.


• Persons who work with hepatitis A virus in the laboratory.


• Persons who handle primate animals.


• Persons with hemophilia.


• Food handlers.


• Persons with chronic liver disease.

This vaccine is to be given only by or under the supervision of a doctor.

Before Using Vaqta

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 this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hepatitis A vaccine in children. However, safety and efficacy have not been established in infants younger than 12 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hepatitis A vaccine in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Allergy to neomycin—Should not be used in patients with this condition.

• Bleeding problems (e.g., hemophilia)—Use with caution. May have an increased risk of bleeding at the injection site.

• Liver disease or


• Weak immune system from a disease or medicine—May not work as well in patients with these conditions.

• Severe illness with fever—Your dose may need to be given at a later time.

Proper Use of hepatitis a vaccine, inactivated

This section provides information on the proper use of a number of products that contain hepatitis a vaccine, inactivated. It may not be specific to Vaqta. Please read with care.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles.

This vaccine is usually given as 2 doses. After the first dose, the Havrix® booster dose is given anytime between 6 to 12 months later, while the Vaqta® booster dose is given anytime between 6 to 18 months later, unless your doctor tells you otherwise.

Precautions While Using Vaqta

It is very important that you or your child return to your doctor’s office at the right time for the second dose. Be sure to notify your doctor of any unwanted effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

Tell your doctor if you or your child are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe contain dry natural latex rubber, which may cause an allergic reaction in people with a latex allergy.

This vaccine may not protect you against hepatitis A infection if you are already infected with the virus at the time you receive the shot.

Vaqta 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

• Fever more than 99.5 degrees F


• general feeling of discomfort or illness


• unusual tiredness or weakness

Rare

• Body aches or pain


• chills


• congestion


• cough


• difficulty with breathing or swallowing


• dryness or soreness of the throat


• ear congestion


• headache


• hives


• hoarseness


• itching, especially of the feet or hands


• loss of voice


• nasal congestion


• reddening of the skin, especially around the ears


• runny nose


• shortness of breath


• sneezing


• sore throat


• swelling of the eyes, face, or inside of the nose


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• tender, swollen glands in the neck


• tightness in the chest


• unusual tiredness or weakness (sudden and severe)


• voice changes


• wheezing

Incidence not known

• Abdominal or stomach pain


• agitation


• back pain


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• blood in the urine or stools


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs


• clay-colored stools


• coma


• confusion


• dark urine


• diarrhea


• difficulty controlling your bladder or bowels


• difficulty with walking


• dizziness


• drowsiness


• fainting


• fast heartbeat


• feeling of discomfort


• feeling sad or depressed


• flu-like symptoms


• forgetful


• hallucinations


• inability to move the arms and legs


• increased sweating


• inflammation of the joints


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of appetite


• muscle aches or cramps


• nausea


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rash


• red, irritated eyes


• seizures


• sensation of pins and needles


• shakiness and unsteady walk


• slurred speech


• sores, ulcers, or white spots in the mouth or on the lips


• stabbing pain


• stiff neck


• sudden numbness and weakness in the arms and legs


• swollen lymph glands


• unpleasant breath odor


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• vomiting of blood


• yellow eyes or skin

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

• Pain, redness, swelling, or lumps at the injection site


• weight loss

Less common

• Arm pain


• bleeding between periods


• change in the amount of bleeding during periods


• change in the pattern of monthly periods


• lack or loss of strength


• tenderness or warmth at the injection site


• unusual stopping of menstrual bleeding

Rare

• Change in color vision


• change in taste


• collection of blood under the skin


• deep, dark purple bruise


• difficulty seeing at night


• difficulty with moving


• dizziness or lightheadedness


• excessive muscle tone


• feeling of constant movement of self or surroundings


• increased sensitivity of the eyes to sunlight


• loss of taste


• muscle tension or tightness


• sensation of spinning


• sleeplessness


• trouble with sleeping


• unable to sleep


• welts

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site


• sleepiness or unusual drowsiness

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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