Penbraya (cvx 316) (Penbraya)

This medication guide is specific to Penbraya.

Meningococcal disease is a bacterial infection that can affect the spinal cord and brain, leading to meningitis that can be life-threatening or cause lasting and serious health issues.

Meningococcal disease can be spread from one person to another through tiny droplets of saliva released into the air when an infected person coughs or sneezes. The bacteria typically spreads through close contact with an infected person, especially through kissing, or sharing a glass or eating utensil.

Meningococcal group ABCWY vaccine is used to prevent infection from serogroup ABCWY meningococcal bacteria.

This vaccine helps your body build immunity to meningitis, but it will not treat an active infection that you already have.

Meningococcal group ABCWY vaccine is intended for children and young adults aged 10 to 25 years.

This vaccine can only be used when all serogroups (ABCWY) of the meningococcal ABCWY vaccines are needed during the same visit.

Like any vaccine, the meningococcal group ABCWY vaccine may not protect every person from the disease.

You should not receive Penbraya (cvx 316) if you had a life threatening allergic reaction after the first shot.

You should not receive this vaccine if you've ever had an allergic reaction to meningococcal vaccine.

Tell your doctor if you have ever had nervous system problems such as numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, or trouble breathing after receiving a vaccine.

This vaccine may need to be postponed or not given at all if you have:

• received a vaccine for meningitis;
• a severe illness with a fever or any type of infection; or
• a weak immune system caused by disease or by using certain medicine (this vaccine may not be as effective if you are immunosuppressed).

You may still receive a vaccine if you have a minor cold.

Make sure you are current on all vaccines. This vaccine protects against meningococcal disease, but it does not provide protection against tetanus.

Your doctor should determine if it is safe to receive this vaccine during pregnancy or while breastfeeding.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of this vaccine on the baby.

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

Keep track of all side effects you experience, and make sure to inform the vaccination provider if the previous shot caused any side effects.

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

Getting meningococcal disease and developing meningitis is much more harmful to your health than receiving this vaccine. Any vaccine may cause side effects, but the risk of serious side effects is low.

Common side effects of Penbraya (cvx 316) may include:

• headache;
• feeling tired;
• muscle or joint pain;
• chills; or
• pain, redness, swelling, or irritation where the medicine was injected.

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.

This vaccine is given as an injection (shot) into a muscle. You will receive this injection in a doctor's office or clinic setting.

Meningococcal group ABCWY vaccine is usually given in a series of 2 shots, the second shot is given 6 months after the first shot.

You will be watched for a short time to make sure you do not feel faint after receiving this vaccine.

Be sure to receive all recommended doses of this vaccine or you may not be fully protected against disease.

There are other types of meningococcal vaccine available. When you receive your second dose, make sure you are receiving a vaccine for meningococcal serogroup A, B, C, W, or Y and not only for serogroup B, unless otherwise directed by your doctor or vaccination provider.

Contact your vaccination provider if you miss the second dose or if you fall behind schedule.

An overdose of this vaccine is unlikely to happen.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Before getting this vaccine, inform your doctor about all other vaccines you have recently received.

Other medicines may impact the meningococcal group ABCWY vaccine, which includes prescription and over-the-counter drugs, vitamins, and herbal products. Let your doctor know about all other medicines you are using.