Pronunciation:

POE-lee-oh VYE-rus VAX-een, in-AK-ti-vated

Brand Names:

• Ipol

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Vaccine

Uses of This Medicine:

Poliovirus vaccine is an active immunizing agent used to prevent poliomyelitis (polio). It works by causing your body to produce its own protection (antibodies) against the virus that causes polio.

There are two types of polio vaccine that are given by injection, poliovirus vaccine inactivated (IPV) and poliovirus vaccine inactivated enhanced potency (eIPV). In the U.S. and Canada, the type of vaccine that is given by injection is eIPV. The type of vaccine that is given by mouth is called poliovirus vaccine live oral (OPV).

Polio is a very serious infection that causes paralysis of the muscles, including the muscles that enable you to walk and breathe. A polio infection may leave a person unable to breathe without the help of an iron lung, unable to walk without leg braces, or confined to a wheelchair. There is no cure for polio.

Immunization against polio is recommended for all infants from 6 to 12 weeks of age, all children, all adolescents up to 18 years of age, and certain adults who are at greater risk for exposure to polioviruses than the general population, including:

• Persons traveling to areas or countries where polio is uncontrolled, whether or not they have been vaccinated against polio in the past.
• Persons who live in areas where polio infection still occurs.
• Adults who have not been vaccinated or who have not had the complete series of vaccinations against polio and who live in households with children who are to be given the oral polio vaccine (OPV).
• Employees in day-care centers and group homes for children, such as orphanages.
• Employees in medical facilities, such as hospitals and doctors' offices.
• Laboratory workers handling samples that may contain polio viruses.

Immunization against polio is not recommended for infants younger than 6 weeks of age, because antibodies they received from their mothers before birth may interfere with the effectiveness of the vaccine. Infants who were immunized against polio before 6 weeks of age should receive the complete polio immunization series.

This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

For a while after you are immunized, there is a very small risk (1 in 2.2 million) that any persons living in your household who have not yet been immunized against polio or who have or had an immune deficiency condition may develop poliomyelitis (polio) from being around you. Talk to your doctor if you have any questions about this.

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Use is not recommended for infants up to 6 weeks of age. For infants and children 6 weeks of age and older, polio vaccine is not expected to cause different side effects or problems than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of polio vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older persons than it does in younger adults.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atidarsagene Autotemcel
• Elivaldogene Autotemcel
• Ocrelizumab
• Teplizumab-mzwv
• Ublituximab-xiiy

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Virus infection or
• Vomiting—These conditions may reduce the useful effect of the vaccine.

• Fever or
• Illness (moderate or severe) or
• Weakness (severe)—The symptoms of these conditions may be confused with possible side effects of the vaccine.

• Immune deficiency condition, family history of—May increase the chance of side effects with the vaccine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this vaccine in a hospital. This vaccine is given as a shot into your muscle or under your skin.

In children, a total of 4 shots of polio vaccine are given. The shots are usually given at 2 months, 4 months, 6 to 18 months, and 4 to 6 years of age. Each dose of this vaccine is usually given at least 4 weeks apart. The first dose of this vaccine may be given to infants 6 weeks of age.

This vaccine needs to be given on a fixed schedule. If you or your child miss a scheduled shot, call your doctor to make another appointment as soon as possible.

Precautions While Using This Medicine:

Tell your doctor that you have received this vaccine if you plan to get any live virus vaccines within 1 month after receiving this vaccine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Symptoms of allergic reaction

Difficulty with breathing or swallowing

hives

itching, especially of the feet or hands

reddening of the skin, especially around ears

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness (sudden and severe)

More common

Fever over 102° F (39° C)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Irritability

loss of appetite

tiredness

Less common

Itching or skin rash

redness, soreness, hard lump, tenderness, or pain at the place of injection

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.