Vaccine Information: HAVRIX

HAVRIX- hepatitis a virus strain hm175 antigen (formaldehyde inactivated) injection, suspension
A-S Medication Solutions

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 Recommended Dose and Schedule

Children and Adolescents (aged 12 months through 18 years)

Primary immunization for children and adolescents 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 (aged 19 years and older)

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.

3 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. [See How Supplied/Storage and Handling (16).]

4 CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis A-containing vaccine, or to any component of HAVRIX, including neomycin, is a contraindication to administration of HAVRIX [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Latex

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

5.2 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.

5.3 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 (4)].

5.4 Altered Immunocompetence

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

5.5 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.

6 ADVERSE REACTIONS

6.1 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 with 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 approximately 37,000 individuals receiving doses of 360 EL.U. (n = 21,928 in 3- or 4-dose schedule), 720 EL.U. (n = 12,274 in 2- or 3-dose schedule), or 1440 EL.U. (n = 2,782 in 2- or 3-dose schedule).

Of solicited adverse reactions in clinical trials of adults, who received HAVRIX 1440 EL.U., and children (aged 2 years 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 reactions 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.

Coadministration Studies of HAVRIX in Children Aged 11 to 25 Months

In 4 studies, 3,152 children aged 11 to 25 months received at least 1 dose of HAVRIX 720 EL.U. administered alone or concomitantly with other routine childhood vaccinations [see Clinical Studies (14.2, 14.5)]. 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 U.S., 1,241 children aged 15 months 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 reactions following HAVRIX administered alone (Group 1) or concomitantly with MMR and varicella vaccines (Group 2) are presented in Table 1. The solicited adverse reactions 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 Reactions Occurring within 4 Days of Vaccinationa in Children Aged 15 to 24 Months with HAVRIX Administered Alone or Concomitantly with MMR and Varicella Vaccines (TVC)

Group 1

HAVRIX

Dose 1

%

Group 2

HAVRIX+

MMR+Vb

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

24

24

24

30

Redness, any

20

20

23

24

Swelling, any

9

10

10

10

General

n

300

417

271

375

Irritability, any

33

44

31

27

Irritability, Grade 3

0

2

2

0

Drowsiness, any

22

35

21

21

Drowsiness, Grade 3

1

2

1

0

Loss of appetite, any

18

26

20

21

Loss of appetite, Grade 3

1

1

0

0

Fever ≥100.6°F (38.1°C)

3

5

3

3

Fever ≥101.5°F (38.6°C)

2

3

2

2

Fever ≥102.4°F (39.1°C)

1

1

0

1

Total vaccinated cohort (TVC) = all subjects who received at least 1 dose of vaccine.

n = Number of subjects who received at least 1 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 Aged 11 to 25 Months: 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 1 subject who received INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) 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.

Page 1 of 3 1 2 3

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Vaccine Sections

Vaccine Information by RSS

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.