HibTITER
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HibTITER
HibTITER Side Effects Center
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 in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
HibTITER in Detail - Patient Information: Side Effects
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 shots caused any side effects.
Becoming infected with haemophilus B is much more dangerous to your child's 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.
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if your child has any of these serious side effects:
- pale skin, severe weakness, dizziness, fast heartbeat;
- extreme drowsiness, fainting;
- fussiness, irritability, crying for an hour or longer;
- seizure (black-out or convulsions); or
- high fever (within a few hours or a few days after the vaccine).
Less serious side effects may be more likely to occur, such as:
- redness, pain, swelling, or a lump where the shot was given;
- low fever;
- mild fussiness or crying;
- joint pain, body aches;
- drowsiness; or
- diarrhea.
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.
Read the entire detailed patient monograph for HibTITER (Diphtheria CRM197 Protein Conjugate) »
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
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) »
Additional HibTITER Information
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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