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HibTITER

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HibTITER

HibTITER Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

HibTITER (diphtheria crm197 protein conjugate) Haemophilus b Conjugate Vaccine is an immunization indicated for children 2 months to 71 months of age used to prevent infection caused by haemophilus B bacteria. The vaccine will not protect against other types of influenza. Common side effects include pain, swelling, and redness at the injection site. Drowsiness, irritability/crying, loss of appetite, diarrhea, fever, or vomiting may also occur.

For infants 2 to 6 months of age, the immunizing dose of HibTITER is three separate injections of 0.5 mL given at approximately 2-month intervals. Previously unvaccinated infants from 7 through 11 months of age should receive two separate injections approximately 2 months apart. Children from 12 through 14 months of age who have not been vaccinated previously receive one injection. HibTITER may interact with other vaccines, steroids, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you use and all vaccines your child recently received. HibTITER vaccine is not recommended for use during pregnancy and is not usually used in adults. It is unknown if this drug passes into breast milk. This vaccine is not usually used in adults and is unlikely to be used while breastfeeding. Consult your doctor.

Our HibTITER (diphtheria crm197 protein conjugate) Haemophilus b Conjugate Vaccine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

HibTITER Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain, swelling, and redness at the injection site may occur. Drowsiness, irritability/crying, loss of appetite, diarrhea, fever, or vomiting may also occur. If any of these effects persist or worsen, notify the 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 your child has 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 your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, unresponsiveness.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 entire patient information overview for HibTITER (Diphtheria CRM197 Protein Conjugate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

HibTITER FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse reactions associated with HibTITER (diphtheria crm197 protein conjugate) have been evaluated in 401 infants who were vaccinated initially at 1 to 6 months of age and were given 1,118 doses independent of DTP vaccine. Observations were made during the day of vaccination and days 1 and 2 postvaccination. A temperature > 38.3°C was recorded at least once during the observation period following 2% of the vaccinations. Local erythema, warmth, or swelling ( ≥ 2 cm) was observed following 3.3% of vaccinations. The incidence of temperature > 38.3°C was greater during the first postvaccination day than during the day of vaccination or the second postvaccination day. The incidence of local erythema, warmth, or swelling was similar during the day of vaccination and the first postvaccination day; it was lower during the second postvaccination day. All side effects have been infrequent, mild, and transient with no serious sequelae (Table 1). No difference in the rates of these complaints was reported after dose 1, 2, or 3.

TABLE 1: Number of Subjects (Percent) Manifesting Side Effects Associated with HibTITER (diphtheria crm197 protein conjugate) Administered Independently from DTP* (Infants Vaccinated Initially at 1-6 Months of Age)

  Dose 1
n = 401
Dose 2
n = 383
Dose 3
n = 334
Symptoms Same Day As Vacc. +1 Day +2 Days Same Day As Vacc. +1 Day +2 Days Same Day As Vacc. +1 Day +2 Days
Temp > 38.3°C 0 2 2 2 3 2 2 6 5
- < 1% < 1% < 1% < 1% < 1% < 1% 1.8% 1.5%
Redness > 2 cm 1 0 0 1 6 0 5 4 0
< 1% - - < 1% 1.6% - 1.5% 1.2% -
Warmth ≥ 2 cm 1 1 0 2 1 0 1 6 0
< 1% < 1% - < 1% < 1% - < 1% 1.8% -
Swelling ≥ 2 cm 5 1 0 2 2 0 1 0 0
1.2% < 1% - < 1% < 1% - < 1% - -
*DTP and HibTITER given 2 weeks apart with DTP having been given first.

The following complaints were also observed after 1,118 vaccinations with HibTITER (diphtheria crm197 protein conjugate) : irritability (133), sleepiness (91), prolonged crying [ ≥ 4 hours] (38), appetite loss (23), vomiting (9), diarrhea (2), and rash (1).

Additional safety data with HibTITER (diphtheria crm197 protein conjugate) are available from the efficacy studies conducted in young infants.30 There were 79,483 doses given to 30,844 infants at approximately 2, 4, and 6 months of age in California, usually at the same time as DTP (but at a separate injection site) and OPV; approximately 100,000 doses have been given to 53,000 infants at 4 and 6 months in Finland at the same time as a combined DTP and inactivated polio (IPV) vaccine (but at a separate injection site). The rate and type of reactions associated with the vaccinations were no different from those seen when DTP or DTP-IPV was administered alone. These included fever, local reactions, rash, and one hyporesponsive episode with a single seizure. The safety of HibTITER (diphtheria crm197 protein conjugate) was also evaluated in the California study by direct phone questioning of the parents or guardians of 6,887 vaccine recipients. The incidence and type of side effects reported within 24 hours of vaccination were similar to those cited in Table 1. In addition, analysis of emergency room (ER) visits within 30 days and hospitalization within 60 days after receipt of 23,800 doses of HibTITER (diphtheria crm197 protein conjugate) showed no increase in the rates of any type of ER visit or hospitalization.

Table 2 details the side effects associated with a single vaccination of HibTITER (diphtheria crm197 protein conjugate) given (without DTP) to infants of 15 to 23 months of age.

TABLE 2: Selected Adverse Reactions* in Children of 15-23 Months of Age Following Vaccination with HibTITER (diphtheria crm197 protein conjugate)

Adverse Reaction No. of Subjects Reaction Within 24 h % Postvaccination At 48 h
Fever > 38.3°C 354 1.4 0.6
Erythema 354 2.0 -
Swelling 354 1.7 -
Tenderness 354 3.7 0.3
* The following complaints were reported after vaccination of these 354 children in the indicated number of children: diarrhea (9), vomiting (5), prolonged crying [ > 4 hours] (4), and rashes (2).

Similar results have been observed in the analysis of 2,285 subjects of 18 to 60 months of age, vaccinated as part of a postmarketing safety study of HibTITER (diphtheria crm197 protein conjugate) .20 These data were collected by telephone survey 24 to 48 hours postvaccination. Additional observations included irritability, restless sleep, and Gl symptoms (diarrhea, vomiting, and loss of appetite) in the group that received HibTITER (diphtheria crm197 protein conjugate) alone. A cause and effect relationship between these observations and the vaccinations has not been established.

Post Approval Experience

The following adverse reactions have been identified during post approval use of HibTITER (diphtheria crm197 protein conjugate) . Because these reactions 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 drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to the vaccine for post marketing surveillance information.

Injection Site Reactions

Injection site reactions including hypersensitivity (including urticaria), induration, inflammation, mass, and skin discoloration.

Systemic Events

Anaphylactoid/anaphylactic reactions (including shock), angioneurotic edema, convulsions,53 erythema multiforme, facial edema, febrile seizures, Guillain-Barré syndrome,54headache, hives (urticaria), hypersensitivity reaction, lethargy, and malaise. Also reported, hypotonia or hyporesponsive-hypotonic-episodes (in many instances pertussis-containing vaccine was coadministered).

There have been spontaneous reports of apnea in temporal association with the administration of HibTITER (diphtheria crm197 protein conjugate) . In most cases HibTITER (diphtheria crm197 protein conjugate) was administered concomitantly with other vaccines including DTP, DTaP, hepatitis B vaccine, IPV, OPV, pneumococcal 7-valent conjugate vaccine, MMR, and/or meningococcal group C conjugate vaccine (not licensed in the US). In addition, in some of the reports existing medical conditions such as prematurity and/or history of apnea were present.

Reporting of Adverse Reactions

Any suspected adverse events following immunization should be reported by the healthcare professional to the US Department of Health and Human Services (DHHS). The National Vaccine Injury Compensation Program requires that the manufacturer and lot number of the vaccine administered be recorded by the healthcare professional in the vaccine recipient's permanent medical record (or in a permanent office log or file), along with the date of administration of the vaccine and the name, address, and title of the person administering the vaccine. The DHHS has established the Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986.42 The VAERS FDA web site is: http://www.fda.gov/cber/vaers/vaers.htm

The VAERS toll-free number for VAERS forms and information is 800-822-7967.

Read the entire FDA prescribing information for HibTITER (Diphtheria CRM197 Protein Conjugate) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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