Engerix-B Pediatric

Contact your doctor if you miss a booster 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 your child receives all recommended doses of this vaccine. Your child may not be fully protected if he or she does not receive the full series.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

In the U.S.

• Engerix-B
• Engerix-B Pediatric
• Recombivax HB
• Recombivax HB Pediatric/Adolescent

Available Dosage Forms:

• Suspension

Therapeutic Class: Vaccine

It is very important that you or your child return to your doctor’s office at the right time for the second and third 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 B infection if you are already infected with the virus at the time you receive the shot.

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:

• Fever of 37.7 degrees C (100 degrees F) or higher

• Aches or pain in the joints, fever, or skin rash or welts (may occur days or weeks after receiving the vaccine)
• blurred vision or other vision changes
• confusion
• difficulty with breathing or swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• hives
• itching, especially of the feet or hands
• muscle weakness
• numbness or tingling of the arms and legs
• reddening of the skin, especially around the ears
• sweating
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness (sudden and severe)

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:

• Dizziness
• headache
• soreness at the injection site

• Hard lump, redness, swelling, pain, itching, purple spot, tenderness, or warmth at the injection site
• unusual tiredness or weakness

• Aches or pain in the muscles
• agitation
• back pain or stiffness or pain in neck or shoulder
• chills
• constipation
• diarrhea
• difficulty with moving
• feeling of warmth
• general feeling of discomfort or illness
• headache (mild), sore throat, runny nose, or fever (mild)
• increased sweating
• itching
• lack of appetite or decreased appetite
• nausea or vomiting
• redness of the face, neck, arms, and occasionally, upper chest
• sleepiness or unusual drowsiness
• sleeplessness
• stomach cramps or pain
• sudden redness of skin
• swelling of glands in the armpit or neck
• trouble with sleeping
• unable to sleep
• welts
• weight loss

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.

Applies to hepatitis b pediatric vaccine: intramuscular suspension

Get emergency medical help if your child has signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with hepatitis B is much more dangerous to your child's health than receiving this vaccine. However, 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 your child has:

• high fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• fussiness, irritability, crying for an hour or longer;

• unusual muscle weakness;

• changes in behavior; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects include:

• diarrhea, loss of appetite;

• feeling weak or tired;

• mild fussiness or crying;

• low fever; or

• runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Applies to hepatitis b pediatric vaccine: intramuscular suspension

General

The most common adverse events were injection site reactions, headache, and fatigue.[Ref]

Local

Very common (10% or more): Injection site pain (33.8%), injection site soreness (22%), injection site redness (15.6%), injection site swelling (11.7%)
Common (1% to 10%): Injection site induration
Uncommon (0.1% to 1%): Injection site ecchymosis, injection site pruritus
Postmarketing reports: Injection site reaction[Ref]

Nervous system

Very common (10% or more): Headache (23.4%)
Common (1% to 10%): Dizziness, drowsiness
Uncommon (0.1% to 1%): Somnolence, tingling, paresthesia
Postmarketing reports: Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy including hypoesthesia, Guillain-Barre syndrome and Bell's palsy, optic neuritis, paralysis, paresis, seizures, syncope, transverse myelitis, vertigo, demyelinating disease of the central nervous system, exacerbation of multiple sclerosis[Ref]

Other

Very common (10% or more): Fatigue (33.8%)
Common (1% to 10%): Fever, malaise
Uncommon (0.1% to 1%): Chills, influenza-like symptoms, sweating, achiness, sensation of warmth, lightheadedness, flushing, earache
Postmarketing reports: Tinnitus[Ref]

Hypersensitivity

Apparent hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as urticaria, erythema multiforme, ecchymosis, and erythema nodosum.[Ref]

Postmarketing reports: Allergic reaction, anaphylactoid reaction, anaphylaxis, apparent hypersensitivity syndrome[Ref]

Metabolic

Common (1% to 10%): Appetite lost
Uncommon (0.1% to 1%): Anorexia[Ref]

Psychiatric

Very common (10% or more): Irritability
Uncommon (0.1% to 1%): Agitation, insomnia[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, upper respiratory infection
Uncommon (0.1% to 1%): Upper respiratory tract illnesses, rhinitis, cough, influenza
Frequency not reported: Pharyngitis
Postmarketing reports: Apnea, bronchospasm including asthma-like symptoms[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck
Postmarketing reports: Arthritis, muscular weakness[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal symptoms
Uncommon (0.1% to 1%): Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting
Postmarketing reports: Dyspepsia[Ref]

Hematologic

Uncommon (0.1% to 1%): Lymphadenopathy
Postmarketing reports: Thrombocytopenia, increased erythrocyte sedimentation rate[Ref]

Dermatologic

Uncommon (0.1% to 1%): Erythema, petechiae, pruritus, rash, sweating, urticaria
Postmarketing reports: Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Flushing, hypotension
Postmarketing reports: Palpitations, tachycardia, vasculitis, syncope[Ref]

Ocular

Very rare (less than 0.01%): Uveitis
Postmarketing reports: Conjunctivitis, keratitis, visual disturbances, optic neuritis[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysuria[Ref]

Hepatic

Postmarketing reports: Abnormal liver function tests[Ref]

Immunologic

Postmarketing reports: Herpes zoster, meningitis[Ref]

Some side effects of Engerix-B Pediatric may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Primary Vaccination:
Engerix-B(R): Three doses (10 mcg each), IM, on a 0, 1, and 6 month schedule

Recombivax HB(R): Three doses (5 mcg each), IM, on a 0, 1, and 6 month schedule

Known or Presumed Hepatitis B Exposure:
Use recommended doses (above) on a 0, 1, and 6 month schedule OR a 0, 1, 2, and 12 month schedule.
Comments:
-Administer hepatitis B immune globulin if appropriate.
-Start hepatitis B vaccine as soon as possible after exposure.

Data not available