Decavac (Intramuscular)

Diphtheria and tetanus vaccine is a combination vaccine that protects against infections caused by diphtheria and tetanus (lockjaw). The vaccine helps the body create its own protection (antibodies) against these diseases. This vaccine is given to children 6 weeks of age and older, teenagers, and adults.

Diphtheria is a serious illness that can lead to breathing problems, heart issues, nerve damage, pneumonia, and possibly death. The risk of serious illness is higher in very young children and older adults.

Tetanus (also known as lockjaw) is a very serious illness that causes severe muscle spasms, making the muscles very rigid or stiff. These spasms can be strong enough to break bones in the spine. The disease can also cause breathing difficulties, swallowing problems, seizures, and possibly death.

This vaccine is to be given only by or under the direct supervision of a doctor.

It is very important that you or your child return to your doctor’s office at the right time for the next dose. Be sure to tell your doctor about any unwanted effects that happen after you receive the vaccine.

If you or your child develop a skin rash, hives, or any allergic reaction after receiving this vaccine, inform your doctor immediately.

Tell your doctor right away if you or your child are allergic to latex rubber. The prefilled syringes or bottle of vaccine may contain natural rubber latex. This may cause an allergic reaction in patients who are sensitive to latex.

This vaccine will not treat an active infection. If you or your child have an infection due to diphtheria or tetanus, you will need medicine to treat the infection.

In deciding to use a vaccine, you and your doctor need to consider the risks of the vaccine compared to the benefits it may provide. Here are some important points to think about for this vaccine:

Allergies

Inform your doctor if you have ever had any strange or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other allergies, including to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Research has not been done to see how age affects the Diphtheria and Tetanus Toxoids Vaccine for Pediatric Use in children 7 years old and older. Safety and effectiveness have not been established.

Research has not been done to see how age affects the Decavac® vaccine in children younger than 7 years old. Safety and effectiveness have not been established.

Geriatric

Although research on how age affects the Decavac® vaccine in older adults has not been conducted, no specific problems for older adults have been reported so far.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the possible benefits against the potential risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if interactions might happen. In those situations, your doctor might adjust the dose, or other precautions may be needed. It is particularly important that your healthcare professional knows if you are taking any of the medicines listed below while receiving this vaccine. The following interactions are highlighted due to their potential importance, but this list may not include all possible interactions.

Using this vaccine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Elivaldogene Autotemcel
• Teplizumab-mzwv
• Ublituximab-xiiy

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this vaccine. Make sure to inform your doctor if you have any other health problems, especially:

• Allergic reaction to a tetanus vaccine (for example, Arthus-type reaction) or
• Guillain-Barré syndrome (a nerve disease that causes paralysis) after a tetanus vaccine—Your doctor will determine if you should receive this vaccine.

• Immunodeficiency disorder (low white blood cell or platelet counts) or
• Weakened immune system—This vaccine may not be as effective in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

Less common

• Fever
• general feeling of discomfort or illness
• unusual tiredness or weakness

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• convulsions
• cough
• difficulty swallowing
• dizziness
• fainting
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• shortness of breath
• skin rash
• swelling or puffiness of the face
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tightness in the chest
• tingling of the hands or feet
• unusual weight gain or loss
• wheezing

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Hard lumps, redness, tenderness, or warmth at the injection site

Less common

• Headache

Incidence not known

• Difficulty moving
• joint pain
• lack or loss of strength
• muscle aching or cramping
• muscle stiffness
• nausea
• pain in the arms or legs
• swollen joints
• vomiting

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.

In the U.S.

• Decavac
• Tenivac

Available Dosage Forms:

• Suspension

Therapeutic Class: Toxoid

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles, usually in the upper leg for infants or in the shoulder for older children, teenagers, and adults.

Depending on the age of the child, this vaccine is given as a series of 3 or 4 doses. Teenagers and adults will receive a total of 3 doses.

After the first set of shots, you or your child should get a booster shot every 10 years.

It is important that you or your child receive all of the doses of vaccine in this series. Try to keep all of your scheduled appointments. If you miss a dose, make another appointment as soon as possible.