Kinrix

DRUG DESCRIPTION

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is a noninfectious, sterile vaccine for intramuscular administration. Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussin toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett). The diphtheria, tetanus, and pertussis components of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) are the same as those in INFANRIX and PEDIARIX and the poliovirus component is the same as that in PEDIARIX.

The diphtheria toxin is produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract. Tetanus toxin is produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein. The bovine materials used in these extracts are sourced from countries which the United States Department of Agriculture (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration.

The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; pertactin is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde.

Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide.

The inactivated poliovirus component of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is an enhanced potency component. Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture. Calf serum is sourced from countries the USDA has determined neither have nor are at risk of BSE. After clarification, each viral suspension is purified by ultrafiltration, diafiltration, and successive chromatographic steps, and inactivated with formaldehyde. The 3 purified viral strains are then pooled to form a trivalent concentrate.

Diphtheria and tetanus toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT, FHA, and pertactin) is determined by enzyme-linked immunosorbent assay (ELISA) on sera from previously immunized mice. The potency of the inactivated poliovirus component is determined by using the D-antigen ELISA and by a poliovirus neutralizing cell culture assay on sera from previously immunized rats.

Each 0.5-mL dose contains 4.5 mg of NaCl and aluminum adjuvant (not more than 0.6 mg aluminum by assay). Each dose also contains ? 100 mcg of residual formaldehyde and ? 100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ? 0.05 ng neomycin and ? 0.01 ng polymyxin B per dose. KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) does not contain a preservative.

What are the possible side effects of this vaccine (Kinrix)?

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. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots 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. Like any medicine, this...

Read All Potential Side Effects and See Pictures of Kinrix

What are the precautions when taking diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine (Kinrix)?

Before receiving the vaccine, tell the doctor or pharmacist if you are allergic to it; or to any other vaccine; or to neomycin or polymyxin B; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell the doctor or pharmacist your medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits...

Read All Potential Precautions of Kinrix


Kinrix Consumer (continued)

SIDE EFFECTS: Pain/swelling/redness at the injection site may occur. Mild fever, sleepiness, and loss of appetite may also occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly. Consult the doctor or pharmacist about the temporary use of acetaminophen to treat pain and fever due to this vaccine.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you 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 serious side effects occur: persistent crying (beginning within 48 hours of the injection and lasting longer than 3 hours), high fever (105 degrees F/40 degrees C or higher), little or no response to sound/touch, weak/floppy muscles, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 the 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.

PRECAUTIONS: Before receiving the vaccine, tell the doctor or pharmacist if you are allergic to it; or to any other vaccine; or to neomycin or polymyxin B; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before receiving this vaccination, tell the doctor or pharmacist your medical history, especially of: current fever/illness, bleeding/blood clotting problems (such as hemophilia, low platelets), immune system problems (such as HIV infection), cancer, brain/nervous system disorders (such as seizures), history of Guillain-Barre syndrome.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Kinrix Patient Information Including Side Effects

Brand Names: Kinrix

Generic Name: diphtheria, pertussis acellular, tetanus, and polio (Pronunciation: dif THEER ee a, per TUS is a SEL yoo lar, TET a nus, POE lee oh)

  • What is diphtheria, pertussis acellular, tetanus, and polio vaccine (Kinrix)?
  • What are the possible side effects of this vaccine (Kinrix)?
  • What is the most important information I should know about this vaccine (Kinrix)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Kinrix)?
  • How is this vaccine given (Kinrix)?
  • What happens if I miss a dose (Kinrix)?
  • What happens if I overdose (Kinrix)?
  • What should I avoid before or after receiving this vaccine (Kinrix)?
  • What other drugs will affect diphtheria, pertussis acellular, tetanus, and polio vaccine (Kinrix)?
  • Where can I get more information?

What is diphtheria, pertussis acellular, tetanus, and polio vaccine (Kinrix)?

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.

What are the possible side effects of this vaccine (Kinrix)?

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. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots 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. 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 serious side effects:

  • extreme drowsiness, fainting;
  • fussiness, irritability, crying for an hour or longer;
  • seizure (black-out or convulsions); or
  • high fever.

Less serious side effects may include:

  • redness, pain, tenderness, or swelling where the shot was given;
  • drowsiness;
  • mild fussiness or crying;
  • low fever; or
  • loss of appetite.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about this vaccine (Kinrix)?

The diphtheria, pertussis acellular, tetanus, and polio 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.

Be sure your child receives all recommended doses in the DTaP and IPV series. If your child does not receive the full series of vaccines, he or she may not be fully protected against the disease.

Your child can still receive a vaccine if he or she has a cold or fever. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Your child should not receive this vaccine if he or she had a life-threatening allergic reaction to a vaccine containing diphtheria, pertussis, tetanus, or polio.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots 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. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Related Drug Centers
  • Kinrix


Related Drugs Index: