ravulizumab

What is the most important information I should know about ravulizumab?

You will need to receive certain vaccinations before you start using ravulizumab.

Ravulizumab comes with a Patient Safety Card listing symptoms of meningococcal infection. Keep this card with you at all times while using ravulizumab and for at least 8 months after your last dose. Your infection risk could last for several months after you stop using ravulizumab.

Some people may have an increased risk of gonorrhea (a sexually transmitted disease) while using this medicine. Talk with your doctor about safe ways to keep from getting an infection during sex.

What is ravulizumab?

Ravulizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults.

Ravulizumab is also used to treat a rare chronic blood disease called atypical hemolytic uremic syndrome (aHUS) in adults and children who are at least 1 month old. This medicine is not for use in treating HUS that is related to Shiga toxin E. coli.

Ravulizumab is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Ravulizumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving ravulizumab?

You will need to receive a vaccine to protect against meningococcal infections at least 2 weeks before you start using ravulizumab. If your child is treated with ravulizumab, make sure he or she is vaccinated against pneumonia and influenza type B (Hib).

If you need to start receiving this medicine before you are vaccinated, you may be given antibiotic medicine to take during the first 2 weeks of ravulizumab treatment.

Tell your doctor if:

• you have never received a meningococcal vaccine; or
• you have recently had any symptoms of infection (fever, chills, or flu-like symptoms).

Tell your doctor if you are pregnant. It is not known whether ravulizumab will harm an unborn baby. However, having PNH during pregnancy may cause complications in the baby or the mother, including blood clots, infections, bleeding, miscarriage, premature delivery, or death. The benefit of treating PNH may outweigh any risks to the baby or the mother.

How is ravulizumab given?

If you have been using another drug called eculizumab (Soliris), you will need to wait 2 weeks after your last dose of eculizumab before starting treatment with ravulizumab.

Ravulizumab is given as an infusion into a vein. A healthcare provider will give you this injection. The first two infusions are usually given 2 weeks apart, followed by an infusion once every 4-8 weeks.

After each infusion, you will be watched closely for at least 1 hour to make sure you do not have an allergic reaction.

Ravulizumab doses are based on weight. Your dose needs may change if you gain or lose weight.

Ravulizumab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Some people may have an increased risk of gonorrhea (a sexually transmitted disease). Talk with your doctor about safe ways to keep from getting an infection during sex.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving ravulizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of ravulizumab?

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed or if you have chest pain, trouble breathing, or swelling in your face.

• muscle pain with flu-like symptoms;
• fever and a rash;
• fever and a headache;
• headache and stiffness in your neck or back;
• headache and nausea or vomiting;
• confusion; or
• your eyes may be more sensitive to light.

• pain or burning when you urinate;
• pain or swelling of the genital or rectal area;
• unusual vaginal bleeding; or
• foul discharge from the penis or vagina.

If you stop using ravulizumab, tell your doctor if you have any new or worsening symptoms, such as: tiredness, confusion, stomach pain, chest pain, trouble breathing or swallowing, (in men) trouble having an erection, blood in your urine, a seizure, or loss of consciousness.

Common side effects may include:

• fever;
• high blood pressure;
• diarrhea, nausea, vomiting;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ravulizumab?

Other drugs may affect ravulizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about ravulizumab.