Drugs Details

Drugs Info of Havrix, Vaqta
Drugs Details
  • Drugs Type  : FDA
  • Date : 31st Jan 2015 12:24 am
  • Brand Name : Havrix, Vaqta
  • Generic Name : hepatitis A adult vaccine (Pronunciation: HEP a TYE tis)
Descriptions

HAVRIX (Hepatitis A Vaccine) is a sterile suspension of inactivated virus for intramuscular administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. After removal of the cell culture medium, the cells are lysed to form a suspension. This suspension is purified through ultrafiltration and gel permeation chromatography procedures. Treatment of this lysate with formalin ensures viral inactivation. Viral antigen activity is referenced to a standard using an enzyme linked immunosorbent assay (ELISA), and is therefore expressed in terms of ELISA Units (EL.U.).

Each 1-mL adult dose of vaccine contains 1440 EL.U. of viral antigen, adsorbed on 0.5 mg of aluminum as aluminum hydroxide.

Each 0.5-mL pediatric dose of vaccine contains 720 EL.U. of viral antigen, adsorbed onto 0.25 mg of aluminum as aluminum hydroxide.

HAVRIX contains the following excipients: Amino acid supplement (0.3% w/v) in a phosphate-buffered saline solution and polysorbate 20 (0.05 mg/mL). From the manufacturing process, HAVRIX also contains residual MRC-5 cellular proteins (not more than 5 mcg/mL), formalin (not more than 0.1 mg/mL), and neomycin sulfate (not more than 40 ng/mL), an aminoglycoside antibiotic included in the cell growth media.

HAVRIX is formulated without preservatives.

HAVRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes may contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.

What are the possible side effects of hepatitis A vaccine (Havrix, Vaqta)?

You should not receive a booster vaccine if you have ever 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 hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Call your doctor at...

Read All Potential Side Effects and See Pictures of Havrix »

What are the precautions when taking hepatitis a vaccine, inactivated (Havrix)?

Before getting hepatitis A vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, formalin, latex in some vials/prefilled syringes), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If you have decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), your body may not make enough antibodies to protect you from hepatitis A...

Read All Potential Precautions of Havrix »


This monograph has been modified to include the generic and brand name in many instances.

Indications

HAVRIX® is indicated for active immunization against disease caused by hepatitis A virus (HAV). HAVRIX is approved for use in persons 12 months of age and older. Primary immunization should be administered at least 2 weeks prior to expected exposure to HAV.

Dosage Administration

Preparation For Administration

Shake well before use. With thorough agitation, HAVRIX is a homogeneous, turbid, white suspension. Do not administer if it appears otherwise. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the vaccine dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Administration

HAVRIX should be administered by intramuscular injection only. HAVRIX should not be administered in the gluteal region; such injections may result in suboptimal response.

Do not administer this product intravenously, intradermally, or subcutaneously.

Recommended Dose And Schedule

Children and Adolescents

Primary immunization for children and adolescents (12 months through 18 years of age) consists of a single 0.5-mL dose and a 0.5-mL booster dose administered anytime between 6 and 12 months later. The preferred sites for intramuscular injections are the anterolateral aspect of the thigh in young children or the deltoid muscle of the upper arm in older children.

Adults

Primary immunization for adults consists of a single 1-mL dose and a 1-mL booster dose administered anytime between 6 and 12 months later. In adults, the injection should be given in the deltoid region.

How Supplied

Dosage Forms And Strengths

Suspension for injection available in the following presentations:

  • 0.5-mL single-dose vials and prefilled TIP-LOK® syringes.
  • 1-mL single-dose vials and prefilled TIP-LOK syringes.

Storage And Handling

HAVRIX is available in single-dose vials and prefilled disposable TIP-LOK syringes (packaged without needles) (Preservative Free Formulation):

720 EL.U./0.5 mL

NDC 58160-825-01 Vial in Package of 10: NDC 58160-825-11
NDC 58160-825-43 Syringe in Package of 10: NDC 58160-825-52

1440 EL.U./mL

NDC 58160-826-01 Vial in Package of 10: NDC 58160-826-11
NDC
58160-826-05 Syringe in Package of 1: NDC 58160-826-34
NDC 58160-826-43 Syringe in Package of 10: NDC 58160-826-52

Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen. Do not dilute to administer.

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium, US License No. 1617. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice.

The safety of HAVRIX has been evaluated in 61 clinical trials involving more than 34,000 individuals receiving doses of 360 EL.U., 720 EL.U., or 1440 EL.U.

Of solicited adverse events in clinical trials of adults, who received HAVRIX 1440 EL.U., and children (2 years of age and older), who received either HAVRIX 360 EL.U. or 720 EL.U., the most frequently reported was injection-site soreness (56% of adults and 21% of children); less than 0.5% of soreness was reported as severe. Headache was reported by 14% of adults and less than 9% of children. Other solicited and unsolicited events occurring during clinical trials are listed below.

Incidence 1% to 10% of Injections

Metabolism and Nutrition Disorders: Anorexia.

Gastrointestinal Disorders: Nausea.

General Disorders and Administration Site Conditions: Fatigue, fever > 99.5°F (37.5°C), induration, redness, and swelling of the injection site; malaise.

Incidence < 1% of Injections

Infections and Infestations: Pharyngitis, upper respiratory tract infections.

Blood and Lymphatic System Disorders: Lymphadenopathy.

Psychiatric Disorders: Insomnia.

Nervous System Disorders: Dysgeusia, hypertonia.

Eye Disorders: Photophobia.

Ear and Labyrinth Disorders: Vertigo.

Gastrointestinal Disorders: Abdominal pain, diarrhea, vomiting.

Skin and Subcutaneous Tissue Disorders: Pruritus, rash, urticaria.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia.

General Disorders and Administration Site Conditions: Injection site hematoma.

Investigations: Creatine phosphokinase increased.

Studies of HAVRIX 720 EL.U./0.5 mL in Children 11 to 25 Months of Age

In 4 studies, 3,152 children 11 to 25 months of age received at least one dose of HAVRIX 720 EL.U. administered alone or concomitantly with other routine childhood vaccinations [see Clinical Studies]. The studies included HAV 210 (N = 1,084), HAV 232 (N = 394), HAV 220 (N = 433), and HAV 231 (N = 1,241).

In the largest of these studies (HAV 231) conducted in the US, 1,241 children 15 months of age were randomized to receive: Group 1) HAVRIX alone; Group 2) HAVRIX concomitantly with measles, mumps, and rubella (MMR) vaccine (manufactured by Merck and Co.) and varicella vaccine (manufactured by Merck and Co.); or Group 3) MMR and varicella vaccines. Subjects in Group 3 who received MMR and varicella vaccines received the first dose of HAVRIX 42 days later. A second dose of HAVRIX was administered to all subjects 6 to 9 months after the first dose of HAVRIX. Solicited local adverse reactions and general events were recorded by parents/guardians on diary cards for 4 days (days 0 to 3) after vaccination. Unsolicited adverse events were recorded on the diary card for 31 days after vaccination. Telephone follow-up was conducted 6 months after the last vaccination to inquire about serious adverse events, new onset chronic illnesses and medically significant events. A total of 1,035 children completed the 6-month follow-up. Among subjects in all groups combined, 53% were male; 69% of subjects were white, 16% were Hispanic, 9% were black and 6% were other racial/ethnic groups.

Percentages of subjects with solicited local adverse reactions and general adverse events following HAVRIX administered alone (Group 1) or concomitantly with MMR and varicella vaccines (Group 2) are presented in Table 1. The solicited adverse events from the 3 additional coadministration studies conducted with HAVRIX were comparable to those from Study HAV 231.

Table 1: Solicited Local Adverse Reactions and General Adverse Events Occurring Within 4 Days of Vaccinationa in Children 15 to 24 Months of Age With HAVRIX Administered Alone or Concomitantly With MMR and Varicella Vaccines (TVC)

  Group 1 HAVRIX Dose 1 % Group 2 HAVRIX+ MMR+V Dose 1 % Group 1 HAVRIX Dose 2 % Group 2 HAVRIX Dose 2 %
Local (at injection site for HAVRIX)
N 298 411 272 373
Pain, any 23.8 23.6 24.3 30.3
Redness, any 20.1 20.0 22.8 23.9
Swelling, any 8.7 10.2 9.6 9.9
General
N 300 417 271 375
Irritability, any 33.3 43.9 31.0 27.2
Irritability, grade 3 0.3 1.9 1.5 0.3
Drowsiness, any 22.3 35.3 21.0 20.8
Drowsiness, grade 3 1.0 2.2 1.1 0.0
Loss of appetite, any 18.3 26.1 19.9 20.5
Loss of appetite, grade 3 1.0 1.4 0.4 0.3
Fever ≥ 100.6°F (38.1°C) 3.0 4.8 3.3 2.7
Fever ≥ 101.5°F (38.6°C) 2.0 2.6 1.8 1.6
Fever ≥ 102.4°F (39.1°C) 0.7 0.7 0.4 1.1
Total vaccinated cohort (TVC) = all subjects who received at least one dose of vaccine.
N = number of subjects who received at least one dose of vaccine and for whom diary card information was available.
Grade 3: drowsiness defined as prevented normal daily activities; irritability/fussiness defined as crying that could not be comforted/prevented normal daily activities; loss of appetite defined as no eating at all.
a Within 4 days of vaccination defined as day of vaccination and the next 3 days.
b MMR = measles, mumps, and rubella vaccine; V = varicella vaccine.

Serious Adverse Events in Children 11 to 25 Months of Age: Among these 4 studies, 0.9% (29/3,152) of subjects reported a serious adverse event within the 31-day period following vaccination with HAVRIX. Among subjects administered HAVRIX alone 1.0% (13/1,332) reported a serious adverse event. Among subjects who received HAVRIX concomitantly with other childhood vaccines, 0.9% (8/909) reported a serious adverse event. In these 4 studies, there were 4 reports of seizure within 31 days post-vaccination: these occurred 2, 9, and 27 days following the first dose of HAVRIX administered alone and 12 days following the second dose of HAVRIX. In one subject who received INFANRIX and Hib conjugate vaccine followed by HAVRIX 6 weeks later, bronchial hyperreactivity and respiratory distress were reported on the day of administration of HAVRIX alone.

Postmarketing Experience

In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for HAVRIX since market introduction of this vaccine are listed below. This list includes serious adverse events or events which have a suspected causal connection to components of HAVRIX or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Infections and Infestations: Rhinitis.

Blood and Lymphatic System Disorders: Thrombocytopenia.

Immune System Disorders: Anaphylactic reaction, anaphylactoid reaction, serum sickness-like syndrome.

Nervous System Disorders: Convulsion, dizziness, encephalopathy, Guillain-Barre syndrome, hypoesthesia, multiple sclerosis, myelitis, neuropathy, paresthesia, somnolence, syncope.

Vascular Disorders: Vasculitis.

Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea.

Hepatobiliary Disorders: Hepatitis, jaundice.

Skin and Subcutaneous Tissue Disorders: Angioedema, erythema multiforme, hyperhidrosis.

Congenital, Familial, and Genetic Disorders: Congenital anomaly.

Musculoskeletal and Connective Tissue Disorders: Musculoskeletal stiffness.

General Disorders and Administration Site Conditions: Chills, influenza-like symptoms, injection site reaction, local swelling.

Read the Havrix (hepatitis a vaccine, inactivated) Side Effects Center for a complete guide to possible side effects

Interactions

Concomitant Administration With Vaccines And Immune Globulin

In clinical studies HAVRIX was administered concomitantly with the following vaccines [see ADVERSE REACTIONS and Clinical Studies]:

  • INFANRIX (DTaP);
  • Hib conjugate vaccine;
  • pneumococcal 7-valent conjugate vaccine;
  • MMR vaccine;
  • varicella vaccine.

HAVRIX may be administered concomitantly with immune globulin.

When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites. Do not mix HAVRIX with any other vaccine or product in the same syringe or vial.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to HAVRIX.

Read the Havrix Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Latex

The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex-sensitive individuals.

Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including HAVRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

Preventing And Managing Allergic Vaccine Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine [see CONTRAINDICATIONS].

Altered Immunocompetence

Immunocompromised persons may have a diminished immune response to HAVRIX, including individuals receiving immunosuppressant therapy.

Limitations Of Vaccine Effectiveness

Hepatitis A virus has a relatively long incubation period (15 to 50 days). HAVRIX may not prevent hepatitis A infection in individuals who have an unrecognized hepatitis A infection at the time of vaccination. Additionally, vaccination with HAVRIX may not protect all individuals.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

HAVRIX has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with HAVRIX. It is also not known whether HAVRIX can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HAVRIX should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether HAVRIX is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HAVRIX is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of HAVRIX, doses of 360 EL.U. or 720 EL.U., have been evaluated in more than 22,000 subjects 1 year to 18 years of age.

The safety and effectiveness of HAVRIX have not been established in subjects younger than 12 months of age.

Geriatric Use

Clinical studies of HAVRIX did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in overall safety between these subjects and younger adult subjects.

Hepatic Impairment

Subjects with chronic liver disease had a lower antibody response to HAVRIX than healthy subjects [see Clinical Studies].


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis Acontaining vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX [see DESCRIPTION].


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism Of Action

The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver.

The incubation period for hepatitis A averages 28 days (range: 15 to 50 days).1 The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death.

The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.

Clinical Studies

Pediatric Effectiveness Studies

Protective efficacy with HAVRIX has been demonstrated in a double-blind, randomized controlled study in school children (age 1 to 16 years) in Thailand who were at high risk of HAV infection. A total of 40,119 children were randomized to be vaccinated with either HAVRIX 360 EL.U. or ENGERIX-B 10 mcg at 0, 1, and 12 months. Of these, 19,037 children received 2 doses of HAVRIX (0 and 1 months) and 19,120 children received 2 doses of control vaccine, ENGERIX-B (0 and 1 months). A total of 38,157 children entered surveillance at day 138 and were observed for an additional 8 months. Using the protocol-defined endpoint ( ≥ 2 days absence from school, ALT level > 45 U/mL, and a positive result in the HAVAB-M test), 32 cases of clinical hepatitis A occurred in the control group. In the HAVRIX group, 2 cases were identified. These 2 cases were mild in terms of both biochemical and clinical indices of hepatitis A disease. Thus the calculated efficacy rate for prevention of clinical hepatitis A was 94% (95% Confidence Interval [CI]: 74, 98).

In outbreak investigations occurring in the trial, 26 clinical cases of hepatitis A (of a total of 34 occurring in the trial) occurred. No cases occurred in vaccinees who received HAVRIX.

Using additional virological and serological analyses post hoc, the efficacy of HAVRIX was confirmed. Up to 3 additional cases of mild clinical illness may have occurred in vaccinees. Using available testing, these illnesses could neither be proven nor disproven to have been caused by HAV. By including these as cases, the calculated efficacy rate for prevention of clinical hepatitis A would be 84% (95% CI: 60, 94).

Immunogenicity In Children And Adolescents

Immune Response to HAVRIX 720 EL.U./0.5 mL at 11 to 25 Months of Age (Study HAV 210)

In this prospective, open-label, multicenter study, 1,084 children were administered study vaccine in one of 5 groups:

  1. Children 11 to 13 months of age who received HAVRIX on a 0- and 6-month schedule;
  2. Children 15 to 18 months of age who received HAVRIX on a 0- and 6-month schedule;
  3. Children 15 to 18 months of age who received HAVRIX coadministered with INFANRIX and Haemophilus b (Hib) conjugate vaccine (no longer US-licensed) at month 0 and HAVRIX at month 6;
  4. Children 15 to 18 months of age who received INFANRIX coadministered with Hib conjugate vaccine at month 0 and HAVRIX at months 1 and 7;
  5. Children 23 to 25 months of age who received HAVRIX on a 0- and 6-month schedule.

Among subjects in all groups, 52% were male; 61% of subjects were white, 9% were black, 3% were Asian, and 27% were other racial/ethnic groups. The anti-hepatitis A antibody vaccine responses and GMTs, calculated on responders for groups 1, 2, and 5 are presented in Table 2. Vaccine response rates were similar among the 3 age groups that received HAVRIX. One month after the second dose of HAVRIX, the GMT in each of the younger age groups (11 to 13 and 15 to 18 months of age) was shown to be similar to that achieved in the 23 to 25 months of age group.

Table 2: Anti-Hepatitis A Immune Response Following 2 Doses of HAVRIX 720 EL.U./0.5 mL Administered 6 Months Apart in Children Given the First Dose of HAVRIX at 11 to 13 Months of Age, 15 to 18 Months of Age, or 23 to 25 Months of Age

Age group N Vaccine Response GMT (mIU/mL)
% 95% CI
11-13 months (Group 1) 218 99 97, 100 1,461a
15-18 months (Group 2) 200 100 98, 100 1,635a
23-25 months (Group 5) 211 100 98, 100 1,911
Vaccine response = Seroconversion (anti-HAV ≥ 15 mIU/mL [lower limit of antibody measurement by assay]) in children initially seronegative or at least the maintenance of the pre-vaccination anti-HAV concentration in initially seropositive children.
CI = Confidence Interval; GMT = Geometric mean antibody titer.
a Calculated on vaccine responders one month post-dose 2. GMTs in children 11 to 13 months of age and 15 to 18 months of age were non-inferior (similar) to the GMT in children 23 to 25 months of age (i.e., the lower limit of the two-sided 95% CI on the GMT ratio for Group 1/Group 5 and for Group 2/Group 5 were both ≥ 0.5).

In 3 additional clinical studies (HAV 232, HAV 220, and HAV 231), children received either 2 doses of HAVRIX alone or the first dose of HAVRIX concomitantly administered with other routinely recommended US-licensed vaccines followed by a second dose of HAVRIX. After the second dose of HAVRIX, there was no evidence for interference with the anti-HAV response in the children who received concomitantly administered vaccines compared to those who received HAVRIX alone. [See ADVERSE REACTIONS and Clinical Studies.]

Immune Response to HAVRIX 360 EL.U. Among Individuals 2 to 18 Years of Age

In 6 clinical studies, 762 subjects 2 to 18 years of age received 2 doses of HAVRIX (360 EL.U.) given 1 month apart (GMT ranged from 197 to 660 mIU/mL). Ninety-nine percent of subjects seroconverted following 2 doses. When a third dose of HAVRIX 360 EL.U. was administered 6 months following the initial dose, all subjects were seropositive (anti-HAV ≥ 20 mIU/mL) 1 month following the third dose, with GMTs rising to a range of 3,388 to 4,643 mIU/mL. In 1 study in which children were followed for an additional 6 months, all subjects remained seropositive.

Immune Response to HAVRIX 720 EL.U./0.5 mL Among Individuals 2 to 19 Years of Age

In 4 clinical studies, 314 children and adolescents ranging from 2 to 19 years of age were immunized with 2 doses of HAVRIX 720 EL.U./0.5 mL given 6 months apart. One month after the first dose, seroconversion (anti-HAV ≥ 20 mIU/mL [lower limit of antibody measurement by assay]) ranged from 96.8% to 100%, with GMTs of 194 mIU/mL to 305 mIU/mL. In studies in which sera were obtained 2 weeks following the initial dose, seroconversion ranged from 91.6% to 96.1%. One month following the booster dose at month 6, all subjects were seropositive, with GMTs ranging from 2,495 mIU/mL to 3,644 mIU/mL.

In an additional study in which the booster dose was delayed until 1 year following the initial dose, 95.2% of the subjects were seropositive just prior to administration of the booster dose. One month later, all subjects were seropositive, with a GMT of 2,657 mIU/mL.

Immunogenicity In Adults

More than 400 healthy adults 18 to 50 years of age in 3 clinical studies were given a single 1440 EL.U. dose of HAVRIX. All subjects were seronegative for hepatitis A antibodies at baseline. Specific humoral antibodies against HAV were elicited in more than 96% of subjects when measured 1 month after vaccination. By day 15, 80% to 98% of vaccinees had already seroconverted (anti-HAV ≥ 20 mIU/mL [lower limit of antibody measurement by assay]). GMTs of seroconverters ranged from 264 to 339 mIU/mL at day 15 and increased to a range of 335 to 637 mIU/mL by 1 month following vaccination.

The GMTs obtained following a single dose of HAVRIX are at least several times higher than that expected following receipt of immune globulin.

In a clinical study using 2.5 to 5 times the standard dose of immune globulin (standard dose = 0.02 to 0.06 mL/kg), the GMT in recipients was 146 mIU/mL at 5 days post-administration, 77 mIU/mL at month 1, and 63 mIU/mL at month 2.

In 2 clinical trials in which a booster dose of 1440 EL.U. was given 6 months following the initial dose, 100% of vaccinees (n = 269) were seropositive 1 month after the booster dose, with GMTs ranging from 3,318 mIU/mL to 5,925 mIU/mL. The titers obtained from this additional dose approximate those observed several years after natural infection.

In a subset of vaccinees (n = 89), a single dose of HAVRIX 1440 EL.U. elicited specific anti-HAV neutralizing antibodies in more than 94% of vaccinees when measured 1 month after vaccination. These neutralizing antibodies persisted until month 6. One hundred percent of vaccinees had neutralizing antibodies when measured 1 month after a booster dose given at month 6.

Immunogenicity of HAVRIX was studied in subjects with chronic liver disease of various etiologies. 189 healthy adults and 220 adults with either chronic hepatitis B (n = 46), chronic hepatitis C (n = 104), or moderate chronic liver disease of other etiology (n = 70) were vaccinated with HAVRIX 1440 EL.U. on a 0- and 6-month schedule. The last group consisted of alcoholic cirrhosis (n = 17), autoimmune hepatitis (n = 10), chronic hepatitis/cryptogenic cirrhosis (n = 9), hemochromatosis (n = 2), primary biliary cirrhosis (n = 15), primary sclerosing cholangitis (n = 4), and unspecified (n = 13). At each time point, geometric mean antibody titers (GMTs) were lower for subjects with chronic liver disease than for healthy subjects. At month 7, the GMTs ranged from 478 mIU/mL (chronic hepatitis C) to 1,245 mIU/mL (healthy). One month after the first dose, seroconversion rates in adults with chronic liver disease were lower than in healthy adults. However, 1 month after the booster dose at month 6, seroconversion rates were similar in all groups; rates ranged from 94.7% to 98.1%. The relevance of these data to the duration of protection afforded by HAVRIX is unknown.

In subjects with chronic liver disease, local injection site reactions with HAVRIX were similar among all 4 groups, and no serious adverse events attributed to the vaccine were reported in subjects with chronic liver disease.

Duration Of Immunity

The duration of immunity following a complete schedule of immunization with HAVRIX has not been established.

Immune Response To Concomitantly Administered Vaccines

In 3 clinical studies HAVRIX was administered concomitantly with other routinely recommended US-licensed vaccines: Study HAV 232: Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (INFANRIX, DTaP) and Haemophilus b (Hib) conjugate vaccine (tetanus toxoid conjugate) (manufactured by sanofi pasteur SA); Study HAV 220: Pneumococcal 7-valent conjugate vaccine (PCV-7) (manufactured by Pfizer), and Study HAV 231: MMR and varicella vaccines. [See ADVERSE REACTIONS]

Concomitant Administration With DTaP and Hib Conjugate Vaccine (Study HAV 232)

In this US multicenter study, 468 subjects, children 15 months of age were randomized to receive: Group 1) HAVRIX coadministered with INFANRIX and Hib conjugate vaccine (n = 127); Group 2) INFANRIX and Hib conjugate vaccine alone followed by a first dose of HAVRIX one month later (n = 132); or Group 3) HAVRIX alone (n = 135). All subjects received a second dose of HAVRIX alone 6 to 9 months following the first dose. Among subjects in all groups combined, 53% were male; 64% of subjects were white, 12% were black, 6% were Hispanic, and 18% were other racial/ethnic groups.

There was no evidence for reduced antibody response to diphtheria and tetanus toxoids (percentage of subjects with antibody levels ≥ 0.1 mIU/mL to each antigen), pertussis antigens (percentage of subjects with seroresponse, antibody concentrations ≥ 5 EL.U./mL in seronegative subjects or post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration in seropositive subjects, and GMTs), or Hib (percentage of subjects with antibody levels ≥ 1 mcg/mL to polyribosyl-ribitol phosphate, PRP) when HAVRIX was administered concomitantly with INFANRIX and Hib conjugate vaccine (Group 1) relative to INFANRIX and Hib conjugate vaccine administered together (Group 2).

Concomitant Administration With Pneumococcal 7-Valent Conjugate Vaccine (Study HAV 220)

In this US multicenter study, 433 children 15 months of age were randomized to receive: Group 1) HAVRIX coadministered with PCV-7 vaccine (n = 137); Group 2) HAVRIX administered alone (n = 147); or Group 3) PCV-7 vaccine administered alone (n = 149) followed by a first dose of HAVRIX one month later. All subjects received a second dose of HAVRIX 6 to 9 months after the first dose. Among subjects in all groups combined, 53% were female; 61% of subjects were white, 16% were Hispanic, 15% were black, and 8% were other racial/ethnic groups.

There was no evidence for reduced antibody response to PCV-7 (GMC to each serotype) when HAVRIX was administered concomitantly with PCV-7 vaccine (Group 1) relative to PCV- 7 administered alone (Group 3).

Concomitant Administration With MMR and Varicella Vaccines (Study HAV 231)

In a US multicenter study, there was no evidence for interference in the immune response to MMR and varicella vaccines (the percentage of subjects with pre-specified seroconversion/seroresponse levels) administered at 15 months of age concomitantly with HAVRIX relative to the response when MMR and varicella vaccines are administered without HAVRIX. [See ADVERSE REACTIONS]

REFERENCES

1. Centers for Disease Control and Prevention. Prevention of hepatitis A through active or passive immunization: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 2006;55(RR-7):1-23.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

  • Inform vaccine recipients and parents or guardians of the potential benefits and risks of immunization with HAVRIX.
  • Emphasize, when educating vaccine recipients and parents or guardians regarding potential side effects, that HAVRIX contains non-infectious killed viruses and cannot cause hepatitis A infection.
  • Instruct vaccine recipients and parents or guardians to report any adverse events to their healthcare provider.
  • Give vaccine recipients and parents or guardians the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

HEPATITIS A VACCINE - INJECTION

 

(hep-uh-TIE-tuss A)

 

COMMON BRAND NAME(S): Havrix, Vaqta

 

USES: This medication is used to help prevent infection from the hepatitis A virus. Hepatitis A infection can be mild with no symptoms or a severe illness that can rarely cause liver failure and death. Preventing infection can prevent these problems.

Hepatitis A vaccine is made from whole, killed hepatitis A virus. It does not contain live virus, so you cannot get hepatitis from the vaccine. This vaccine works by helping the body produce immunity (through antibody production) that will prevent you from getting infection from hepatitis A virus. Hepatitis A vaccine does not protect you from other virus infections (such as HIV virus, which causes AIDS; hepatitis B, hepatitis C or hepatitis E; HPV virus, which causes genital warts and other problems).

The vaccine is recommended for people aged 12 months and older, especially those at an increased risk of getting the infection. Those at an increased risk include people who live with or spend much time with people with hepatitis A infections, institutional or daycare workers, lab workers, people with multiple sex partners, men who have sex with men, sex workers, injecting and non-injecting drug abusers, and people traveling to high-risk areas.

 

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

Depending on your age, this vaccine is usually given by injection into a shoulder or thigh muscle by a health care professional.

A series of 2 injections is usually given over a 6- to 18-month period. Your doctor will give you a vaccination schedule, which must be followed closely for best effectiveness. If you have an illness with fever at the time a vaccination is scheduled, your doctor may choose to delay the injection until you are better.

The dosage is based on your age. Different brands of hepatitis A vaccine are available and may be given differently. Make sure that you receive the same brand for each injection.

If you are receiving the first hepatitis A vaccine injection at a time when your doctor feels you may have been exposed to hepatitis A, you will also receive an injection of immune globulin (IG). IG contains antibodies against the hepatitis A virus and will immediately help protect you from developing an infection. These antibodies only last a few months. For long-term protection, it is important to follow your vaccination schedule for the hepatitis A vaccine exactly.

Consumer Overview Side Effect

SIDE EFFECTS: Pain/redness/swelling at the injection site, fever, tiredness, headache, nausea, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Report all side effects to your doctor before you receive the next injection.

Tell your doctor immediately if this rare but serious side effect occurs: seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

 

Read the Havrix (hepatitis a vaccine, inactivated) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before getting hepatitis A vaccine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as neomycin, formalin, latex in some vials/prefilled syringes), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems (such as hemophilia, low platelets, anticoagulant treatment), current illness with fever.

If you have decreased immune function from other medications (see also Drug Interactions) or other illness (such as HIV, leukemia, lymphoma, other cancer), your body may not make enough antibodies to protect you from hepatitis A infection. Antibody levels should be checked after the vaccine series.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some of the products that may interact with this drug include: chemotherapy, corticosteroids (such as prednisone, dexamethasone), drugs that weaken the immune system (such as cyclosporine, efalizumab, tacrolimus, mycophenolate).

Other vaccines may be given at the same time as hepatitis A vaccine, but should be given with separate syringes and at different injection sites.

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: As with any vaccine, this vaccine may not fully protect everyone who receives it.

Hepatitis A spreads very easily, often through contaminated food or water, infected food handlers, sexual contact with an infected individual, eating raw shellfish from contaminated water, poor sanitary conditions, and rarely by blood transfusions or sharing needles with actively infected people.

Keep vaccine records for yourself and all of your children, and after your children are grown provide their records to them and their doctors. This will prevent unnecessary re-vaccinations.

 

MISSED DOSE: It is important to receive each vaccination as scheduled. Be sure to ask when each dose should be received and make a note on a calendar to help you remember.

 

STORAGE: Not applicable. This vaccine is given in a doctor's office and will not be stored at home.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Havrix, Vaqta

Generic Name: hepatitis A adult vaccine (Pronunciation: HEP a TYE tis)

  • What is hepatitis A vaccine (Havrix)?
  • What are the possible side effects of hepatitis A vaccine (Havrix)?
  • What is the most important information I should know about hepatitis A vaccine (Havrix)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Havrix)?
  • How is this vaccine given (Havrix)?
  • What happens if I miss a dose (Havrix)?
  • What happens if I overdose (Havrix)?
  • What should I avoid before or after getting this vaccine (Havrix)?
  • What other drugs will affect hepatitis A vaccine (Havrix)?
  • Where can I get more information?

What is hepatitis A vaccine (Havrix)?

Hepatitis is a serious disease caused by a virus. Hepatitis A is spread through contact with the stool (bowel movements) of a person infected with the hepatitis A virus. This usually occurs by eating food or drinking water that has become contaminated as a result of handling by an infected person.

Hepatitis causes inflammation of the liver, vomiting, and jaundice (yellowing of the skin or eyes). Hepatitis can lead to liver cancer, cirrhosis, or death.

The hepatitis A adult vaccine is used to help prevent this disease in adults. The vaccine works by exposing you to a small amount of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Vaccination with hepatitis A adult vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.

Like any vaccine, the hepatitis A vaccine may not provide protection from disease in every person.

What are the possible side effects of hepatitis A vaccine (Havrix)?

You should not receive a booster vaccine if you have ever 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 hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Call your doctor at once if you have any of these serious side effects:

  • high fever;
  • fast or uneven heartbeats; or
  • behavior changes.

Less serious side effects include:

  • low fever;
  • headache;
  • dizziness, tired feeling;
  • nausea, vomiting, stomach pain, diarrhea, loss of appetite;
  • joint pain;
  • sore throat; or
  • swelling, redness, or a hard lump where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the Havrix (hepatitis a vaccine, inactivated) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about hepatitis A vaccine (Havrix)?

Hepatitis A vaccine will not protect you against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect you from hepatitis A if you are already infected with the virus, even if you do not yet show symptoms.

You will most likely receive 2 separate injections of the hepatitis A vaccine at 6 months apart, depending on your exposure or risk of infection. Children should receive their first hepatitis A vaccine between 12 months and 23 months of age.

Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Vaccination with hepatitis A adult vaccine is recommended for all adults who travel in certain areas of the world where hepatitis A is a common disease.

Other risk factors for hepatitis include: being a homosexual male; having chronic liver disease; using intravenous (IV) drugs; receiving treatment for hemophilia or other bleeding disorders; working in a research laboratory or around animals (especially monkeys) where you may be exposed to the hepatitis A virus; or being in an area where there has been an outbreak of hepatitis A.

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

You can still receive a vaccine if you have a cold or fever. 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 hepatitis A is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers
  • Havrix
  • Vaqta

Patient Detailed How Take

What should I discuss with my healthcare provider before receiving this vaccine (Havrix)?

Hepatitis A vaccine will not protect you against infection with hepatitis B, C, and E, or other viruses that affect the liver. It may also not protect you from hepatitis A if you are already infected with the virus, even if you do not yet show symptoms.

You should not receive this vaccine if you have ever had a life-threatening allergic reaction to any vaccine containing hepatitis A, or if you have received cancer chemotherapy or radiation treatment in the past 3 months.

Before receiving this vaccine, tell your doctor if you have:

  • a bleeding or blood clotting disorder such as hemophilia or easy bruising;
  • a history of seizures;
  • a neurologic disorder or disease affecting the brain;
  • an allergy to latex rubber;
  • a weak immune system caused by disease, bone marrow transplant, or by using certain medicines or receiving cancer treatments; or
  • if you are taking a blood thinner such as warfarin (Coumadin).

You can still receive a vaccine if you have a cold or fever. 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.

Before receiving the hepatitis A vaccine, tell your doctor if you are pregnant.

It is not known if hepatitis A vaccine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is this vaccine given (Havrix)?

This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or other clinic setting.

You will most likely receive 2 separate injections of the hepatitis A vaccine at 6 months apart, depending on your exposure or risk of infection.

To prevent hepatitis A while traveling, you should receive this vaccine at least 2 weeks before your trip. Your healthcare provider will determine the best dosing schedule for your situation.

Your doctor may recommend treating fever and pain with an aspirin-free pain reliever such as acetaminophen (Tylenol) or ibuprofen (Motrin, Advil, and others) when the shot is given and for the next 24 hours. Follow the label directions or your doctor's instructions about how much of this medicine to take.

It is especially important to prevent fever from occurring if you have a seizure disorder such as epilepsy.

Side Effects Centers
  • Havrix
  • Vaqta

Patient Detailed Avoid Taking

What happens if I miss a dose (Havrix)?

Contact your doctor if you will miss a hepatitis A vaccine dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure to receive all recommended doses of this vaccine. If you do not receive the full series of vaccines, you may not be fully protected against the disease.

What happens if I overdose (Havrix)?

An overdose of hepatitis A vaccine is unlikely to occur.

What should I avoid before or after getting this vaccine (Havrix)?

There are no restrictions on food, beverages, or activity before or after receiving this vaccine, unless your doctor has told you otherwise.

What other drugs will affect hepatitis A vaccine (Havrix)?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

Also tell the doctor if you have recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

If you are using any of these medications, you may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

There may be other drugs that can affect this vaccine. Tell your doctor about all the prescription and over-the-counter medications you have received. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Side Effects Centers
  • Havrix
  • Vaqta

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