Kinrix

Generic Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
Date of Approval: June 24, 2008
Company: GlaxoSmithKline

Treatment for: Immunization

FDA Approves Kinrix

The U.S. Food and Drug Administration (FDA) has approved Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], the first combination vaccine to offer protection against diphtheria, tetanus, pertussis and polio diseases in one shot.

Clinical studies of Kinrix have demonstrated that this new combination vaccine offers similar protection to the separately administered Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) and Inactivated Poliovirus (IPV) vaccines, with a comparable safety profile. These results were confirmed in the pivotal Phase III trial of Kinrix, which was a randomized, controlled study conducted in the U.S. in which 3,156 children 4 to 6 years of age were vaccinated with Kinrix. All children studied had previously received four doses of DTaP (Infanrix) and three doses of IPV (IPOL). All children in the study also received the second dose of U.S.-licensed measles, mumps and rubella (MMR) vaccine (M-M-RII) at the same time.

About Kinrix and Combination Vaccines

Kinrix is approved for children 4 to 6 years of age whose previous Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) vaccinations have been with Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] and/or Infanrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed].

Health experts recommend combination vaccines to reduce the number of shots children receive in a single doctor visit. In fact, combination vaccines, such as DTP [diphtheria, tetanus and pertussis], have been available and effectively used for almost 60 years. Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine], manufactured by GlaxoSmithKline, is the latest combination vaccine.

Important Safety Information

In clinical studies, common adverse events were injection-site reactions (pain, redness, swelling, or increase in arm circumference), drowsiness, fever, and loss of appetite. Previous hypersensitivity to any component of Kinrix, including neomycin and polymyxin B, is a contraindication. Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. The decision to give Kinrix should be based on potential benefits and risks, if Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events have occurred in temporal relation to receipt of a pertussis-containing vaccine. The needleless, prefilled syringes contain dry natural latex rubber and may cause allergic reactions. For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination. Vaccination with Kinrix may not protect all individuals who received the vaccine.

Patient Information

What is Kinrix?

Kinrix is a vaccine given by injection (shot) to eligible children 4 through 6 years of age to prevent four serious diseases: diphtheria, tetanus (lockjaw), pertussis (whooping cough), and poliomyelitis (polio). The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. The vaccine cannot cause any of these diseases.

Diphtheria: Diphtheria causes a thick covering in the back of the throat. It can lead to breathing problems, paralysis, heart failure, and even death.

Tetanus (lockjaw): Tetanus enters the body through cuts, scratches, or wounds in the skin. Tetanus can cause muscle stiffness, painful muscle spasms, seizures, and even death. The painful tightening of the muscles of the jaw, called "lockjaw", can prevent a person from opening his/her mouth or swallowing.

Pertussis (whooping cough): Pertussis is a highly infectious illness that causes severe spells of coughing that may interfere with normal breathing. The coughing is often accompanied by a "whooping" sound, and so pertussis is often called "whooping cough". The cough may last for weeks. Pertussis can also cause pneumonia, seizures, brain damage, and even death.

Poliomyelitis (polio): Polio is a viral illness that in some people causes paralysis of the muscles, including those muscles needed for breathing and walking. In its most serious form, polio infection may lead to permanent damage or even death.

Vaccination is the best way to protect against these diseases. As with any vaccine, Kinrix may not protect all individuals receiving the vaccine (especially those with immune system disorders), and is not recommended for treatment of these diseases.

Who should be given Kinrix?

Kinrix is used in children 4 through 6 years of age (prior to the seventh birthday) as the fifth dose in the diphtheria, tetanus, and pertussis (DTaP) vaccine series and the fourth dose in the poliomyelitis (IPV) vaccine series. Whether your child should be given Kinrix will depend on your child's medical history, including their vaccination history. Your doctor will determine whether Kinrix is right for your child.

Who should not be given Kinrix?

Before your child receives Kinrix, you must tell your doctor or other healthcare professional if your child:

ˇ                     is younger than 4 years of age.

ˇ                     is 7 years of age or older.

ˇ                     previously had an allergic reaction to any vaccine that protects against diphtheria, tetanus, pertussis, or polio diseases, or to any ingredient in Kinrix, including neomycin and polymyxin B (see "What are the ingredients in Kinrix?"). Signs of a severe allergic reaction may include hives, difficulty breathing, and swelling of the throat.

ˇ                     experienced symptoms of brain or nervous system disorder within 7 days after receiving a pertussis-containing vaccine.

Also, tell your doctor if your child:

ˇ                     had Guillain-Barré syndrome after a vaccine containing tetanus toxoid.

ˇ                     has an allergy to latex.

ˇ                     had any of the following problems after a dose of a pertussis-containing vaccine:

o                                            A high temperature (105°F or higher) within 48 hours of vaccination.

o                                            A collapse or shock-like state within 48 hours of vaccination.

o                                            Persistent crying lasting 3 hours or more within 48 hours of vaccination.

ˇ                     Seizures with or without a fever within 3 days of vaccination.

ˇ                     has a tendency to have seizures.

ˇ                     has a weakened immune system.

ˇ                     is taking any other medicine or has recently received any other vaccine.

What are the possible side effects of Kinrix?

As with any vaccine, there may be some side effects, but it is possible that your child will have no side effects.

The most common side effects of Kinrix are:

ˇ                     pain, redness, or swelling of the arm where your child got the shot

ˇ                     drowsiness

ˇ                     fever

ˇ                     loss of appetite

These side effects usually are mild and generally go away on their own. If these side effects or any other side effects continue or become severe, tell your child's doctor. These are not all the possible side effects of Kinrix. You can ask your child's healthcare provider for a more complete list.

As with any vaccine, there is a risk of allergic reactions. Signs of a severe allergic reaction may include hives, difficulty breathing, and swelling of the throat. If any of these events occur, you should seek medical treatment immediately. Such rare reactions usually occur before leaving the doctor's office.

How is Kinrix given?

Kinrix is given as a single injection (shot) into a muscle in your child's arm.

What are the ingredients in Kinrix?

Kinrix contains noninfectious proteins from diphtheria, tetanus, and pertussis bacteria and inactivated polio viruses. The vaccine also contains sodium chloride and aluminum salts. Low levels of formaldehyde, polysorbate 80, neomycin sulfate (antibiotic) and polymyxin B (antibiotic) are present.

Kinrix contains no preservatives.

Kinrix is indicated for the fifth DTaP and fourth dose IPV in 4 to 6 year olds whose previous DTaP vaccine doses have been with Infanrix and/or Pediarix.

Important Safety Information

In clinical studies, common adverse events were injection-site reactions (pain, redness, swelling, or increase in arm circumference), drowsiness, fever, and loss of appetite. Previous hypersensitivity to any component of Kinrix, including neomycin and polymyxin B, is a contraindication. Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. The decision to give Kinrix should be based on potential benefits and risks, if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, or if adverse events have occurred in temporal relation to receipt of a pertussis-containing vaccine. The needleless, prefilled syringes contain dry natural latex rubber and may cause allergic reactions. For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination. Vaccination with Kinrix may not protect all individuals who received the vaccine.

For more information on Kinrix, please visit www.kinrix.com.