Kinrix

This vaccine is given as an injection into a muscle. Your child will receive this injection in a doctor's office or other clinic setting.

Diphtheria, pertussis acellular, polio, and tetanus vaccine is given as the 5th dose in a series of DTaP immunizations and the 4th dose in a series of IPV immunizations. The shot is usually given to a child who is at least 4 years old or has not yet reached his or her 7th birthday. Your child's individual dose 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.

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 give your child.

It is especially important to prevent fever from occurring in a child who has a seizure disorder such as epilepsy.

An overdose of this vaccine is unlikely to occur.

Contact your doctor if you will 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 in the DTaP and IPV series. Your child may not be fully protected if he or she does not receive the full series.

Diphtheria, pertussis acellular, tetanus, and polio are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life-threatening condition because it can paralyze the muscles that help you breathe.

Diphtheria, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

The diphtheria, pertussis acellular, tetanus, and polio vaccine is used to help prevent these diseases in children who are ages 4 through 6 years (before the 7th birthday) who have received prior vaccination with a DTaP and IPV series.

This vaccine works by exposing your child to a small dose of the bacteria or a protein from the bacteria, 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.

Like any vaccine, the diphtheria, pertussis acellular, tetanus, and polio vaccine may not provide protection from disease in every person.

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.

A total of 4,013 children were vaccinated with a single dose of KINRIX in 4 clinical trials. Of these, 381 children received a non-US formulation of KINRIX (containing ≤ 2.5 mg 2-phenoxyethanol per dose as preservative).

The primary study (Study 048), conducted in the United States, was a randomized, controlled clinical trial in which children 4 to 6 years of age were vaccinated with KINRIX (N = 3,156) or control vaccines (INFANRIX and IPOL® vaccine [IPV, Sanofi Pasteur SA]; N = 1,053) as a fifth DTaP vaccine dose following 4 doses of INFANRIX and as a fourth IPV dose following 3 doses of IPOL. Subjects also received the second dose of US-licensed measles, mumps, and rubella (MMR) vaccine (Merck & Co., Inc.) administered concomitantly, at separate sites.

Data on adverse events were collected by parents/guardians using standardized forms for 4 consecutive days following vaccination with KINRIX or control vaccines (i.e., day of vaccination and the next 3 days). The reported frequencies of solicited local reactions and general adverse events in Study 048 are presented in Table 1.

In 3 studies (Studies 046, 047, and 048), children were monitored for unsolicited adverse events, including serious adverse events, that occurred in the 31-day period following vaccination and in 2 studies (Studies 047 and 048), parents/guardians were actively queried about changes in the child's health status, including the occurrence of serious adverse events, through 6 months post-vaccination.

Table 1: Percentage of Children 4 to 6 Years of Age Reporting Solicited Local Reactions or General Adverse Events Within 4 Days of Vaccinationa With KINRIX or Separate Concomitant Administration of INFANRIX and IPV When Coadministered With MMR Vaccine (Study 048) (Total Vaccinated Cohort)

In Study 048, KINRIX was non-inferior to INFANRIX with regard to swelling that involved > 50% of the injected upper arm length and that was associated with a > 30 mm increase in mid-upper arm circumference within 4 days following vaccination (upper limit of two-sided 95% Confidence Interval for difference in percentage of KINRIX [0.6%, n = 20] minus INFANRIX [1.0%, n = 11] ≤ 2%).

Within the 31-day period following study vaccination in 3 studies (Studies 046, 047, and 048), in which all subjects received concomitant MMR vaccine (US-licensed MMR vaccine [Merck & Co., Inc.] in Studies 047 and 048; non-US-licensed MMR vaccine in Study 046), 3 subjects (0.1% [3/3,537]) who received KINRIX reported serious adverse events (dehydration and hypernatremia; cerebrovascular accident; dehydration and gastroenteritis) and 4 subjects (0.3% [4/1,434]) who received INFANRIX and inactivated poliovirus vaccine (Sanofi Pasteur SA) reported serious adverse events (cellulitis, constipation, foreign body trauma, fever without identified etiology).

Postmarketing Experience

In addition to reports in clinical trials, the following adverse events, for which a causal relationship to components of KINRIX is plausible, have been reported since market introduction. 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 vaccination.

General Disorders and Administration Site Conditions: Injection site vesicles.

Nervous System Disorders: Syncope.

Skin and Subcutaneous Tissue Disorders: Pruritus.

Additional adverse events reported following postmarketing use of INFANRIX, for which a causal relationship to vaccination is plausible, are: Allergic reactions, including anaphylactoid reactions, anaphylaxis, angioedema, and urticaria; apnea; collapse or shock-like state (hypotonic-hyporesponsive episode); convulsions (with or without fever); lymphadenopathy; and thrombocytopenia.

Read the entire FDA prescribing information for Kinrix (Diptheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Especially tell your doctor if you use:

• immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids

This is not a complete list of Kinrix drug interactions. Ask your doctor or pharmacist for more information. 

Kinrix is given by a healthcare provider as a shot into the upper arm. 

Kinrix is administered by a healthcare provider in a medical setting. It is unlikely that an overdose will occur in this setting. However, if overdoes is suspected, seek emergency medical attention. 

Diphtheria, pertussis acellular, polio, and tetanus are serious diseases caused by bacteria or virus.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, or death.

Pertussis (whooping cough) causes coughing so severe that it interferes with eating, drinking, or breathing. These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage, and death.

Polio affects the central nervous system and spinal cord. It can cause muscle weakness and paralysis. Polio is a life threatening condition because it can paralyze the muscles that help you breathe.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Diphtheria, pertussis, and polio are spread from person to person. Tetanus enters the body through a cut or wound.

This vaccine is used to help prevent these diseases in children who are ages 4 through 6 years (before the 7th birthday) who have received prior vaccination with a DTaP and IPV series.

This vaccine works by exposing your child to a small dose of the virus, bacteria or a protein from the bacteria, 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.

Like any vaccine, the diphtheria, pertussis acellular, polio, and tetanus vaccine may not provide protection from disease in every person.

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 diphtheria, pertussis, tetanus, or polio is much more dangerous to your child's health than receiving the vaccine to protect against these diseases. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have 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 the child has any of these side effects:

• irritability, crying for an hour or longer;

• very high fever; or

• extreme drowsiness, fainting.

Common side effects may include:

• drowsiness;

• loss of appetite; or

• redness, pain, tenderness, or swelling 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.

It is very important that the doctor check your child at regular visits to make sure this vaccine is working properly and to check for unwanted effects.

Tell your child’s doctor about all other vaccines your child has had, especially if those vaccines were part of a series. This vaccine might be used to finish a series of vaccines.

Contact your doctor immediately if your child has sudden weakness in the arms and legs. This could be a sign of a serious condition called Guillain-Barré syndrome.

It is very important to tell the doctor if your child is allergic to latex rubber. The tip caps of the prefilled syringes may contain dry natural latex rubber, which may cause an allergic reaction if your child has a latex allergy. .

This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, pertussis, or polio, your child will need medicines to treat these infections.

Syncope (fainting) may occur after receiving this vaccine. Your doctor may want your child to be observed after receiving the injection to prevent and manage fainting.

Be sure to tell your child’s doctor about any serious side effects that occur after your child receives the vaccine. This may include seizures, a high fever, crying that will not stop, or severe redness or swelling where the shot was given.

Make sure your doctor knows if you are using medicines that weaken your immune system such as cancer medicines, radiation treatment, or steroids.

• If your child's symptoms or health problems do not get better or if they become worse, call your child's doctor.
• Do not share your child's drug with others and do not give anyone else's drug to your child.
• Keep a list of all your child's drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child's doctor.
• Talk with your child's doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. If you have any questions about Kinrix, please talk with your child's doctor, nurse, pharmacist, or other health care provider.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Kinrix or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Kinrix. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

A single dose of Kinrix® is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first three doses and INFANRIX for the fourth dose.

Hypersensitivity

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid, tetanus toxoid, pertussis- or poliovirus-containing vaccine, or to any component of Kinrix, including neomycin and polymyxin B, is a contraindication to administration of Kinrix [see Description (11)]. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with any of these components should be given. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered.

Encephalopathy

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine, including Kinrix.

Progressive Neurologic Disorder

Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine, including Kinrix. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized.

1. Vitek CR and Wharton M. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:139-156.
2. Wassilak SGF, Roper MH, Kretsinger K, and Orenstein WA. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:805-839.
3. Department of Health and Human Services, Food and Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review; Proposed rule. Federal Register December 13, 1985;50(240):51002-51117.
4. Centers for Disease Control and Prevention. General Recommendations on Immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.
5. Sutter RW, Pallansch MA, Sawyer LA, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, Goldenthal KL, Burns DL, Lewis Jr BP, eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences; 1995:289-299.

Parents or guardians should be:

• informed of the potential benefits and risks of immunization with Kinrix.
• informed about the potential for adverse reactions that have been temporally associated with administration of Kinrix or other vaccines containing similar components.
• instructed to report any adverse events to their healthcare provider.
• given 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).

INFANRIX, Kinrix, PEDIARIX, and TIP-LOK are registered trademarks of GlaxoSmithKline. IPOL is a registered trademark of Sanofi Pasteur Limited.

Manufactured by GlaxoSmithKline Biologicals

Rixensart, Belgium, US License 1617, and

Novartis Vaccines and Diagnostics GmbH & Co. KG

Marburg, Germany, US License 1754

Distributed by GlaxoSmithKline

Research Triangle Park, NC 27709

©2010, GlaxoSmithKline. All rights reserved.

August 2010

KNX:6PI

Principal Display Panel

NDC 58160-812-11

KinrixTM

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine

DTaP-IPV

10 X 0.5 mL Single-Dose Vials

Store refrigerated between 2o and 8oC (36o and 46oF). Do not freeze. Discard if frozen.

Each 0.5 mL dose is formulated to contain 25 Lf diphtheria toxoid, 10 Lf tetanus toxoid, 25 mcg inactivated pertussis toxin, 25 mcg filamentous hemagglutinin, 8 mcg pertactin, 40 D-antigen Units (DU) Type 1 poliovirus, 8 DU Type 2 poliovirus, and 32 DU Type 3 poliovirus. Derived from C. diphtheriae, C. tetani, B. pertussis, and poliovirus strains Types 1, 2, and 3. Contains 4.5 mg sodium chloride and aluminum adjuvant (not more than 0.6 mg aluminum by assay). Inactivated with glutaraldehyde and formaldehyde. Each dose contains ≤0.05 ng neomycin sulfate and ≤0.01 ng polymyxin B. Contains no preservative. See complete prescribing information for additional details.

Do not dilute; shake well before using. For intramuscular administration only.

Dosage: 0.5 mL equals one dose. See complete prescribing information for vaccination schedule.

Kinrix is a trademark of GlaxoSmithKline.

U.S. License 1617

Manufactured by GlaxoSmithKline Biologicals, Rixensart, Belgium

Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709

©2007, GlaxoSmithKline