Trumenba

Pregnancy Category: B

Lactation: Unknown if distributed in human breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

This vaccine is given as an injection (shot) into a muscle. A healthcare provider will give you this injection.

Meningococcal group B vaccine is given in a series of 3 shots. Booster shots are given at 2 months and 6 months after the first shot.

Your booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

An overdose of this vaccine is unlikely to occur.

Contact your doctor if you 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 to receive all recommended doses of this vaccine. You may not be fully protected if you do not receive the full series.

Included as part of the PRECAUTIONS section.

Trumenba is used to prevent disease caused by Neisseria meningitidis serogroup B. Trumenba helps to protect against Neisseria meningitidis which is a leading cause of bacterial meningitis.

This vaccine is available in an injectable form to be given by a healthcare professional as a 3-dose series at months 0, 2 and 6.

Common side effects of Trumenba include pain at the injection site, fatigue, headache, muscle pain, and chills.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Trumenba, there are no specific foods that you must exclude from your diet when receiving this medication.

Since Trumenba is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

If you miss a dose of Trumenba, make a follow up appointment with your doctor immediately. 

You should not receive this vaccine if you have ever had an allergic reaction to meningococcal group B vaccine.

If you have any of these other conditions, your vaccine may need to be postponed or not given at all:

• an allergy to latex rubber;

• any condition that weakens the immune system (such as HIV, AIDS, or cancer); or

• a condition for which you are receiving steroids, chemotherapy, or radiation treatments.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until you get better before receiving this vaccine.

It is not known whether meningococcal group B vaccine will harm an unborn baby. However, if you are pregnant, your doctor should determine whether you need this vaccine.

It is not known whether meningococcal group B passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Becoming infected with meningococcal disease and developing meningitis (infection of the spinal cord and lining of the brain) is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

You may feel faint after receiving this vaccine. Some people have had seizure-like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Common side effects may include:

• headache;

• feeling tired;

• muscle or joint pain;

• chills;

• nausea; or

• pain, redness, or a hard lump 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Shortness of breath.
• Very bad dizziness or passing out.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain where the shot was given.
• Irritation where the shot is given.
• Feeling tired or weak.
• Headache.
• Muscle or joint pain.
• Chills.
• Loose stools (diarrhea).
• Upset stomach.
• Fever.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.