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Ultomiris

Generic Name: ravulizumab-cwvz (RAV ue LIZ ue mab)
Brand Names: Ultomiris

Medically reviewed by J. Stewart, BPharm. Last updated on Mar 12, 2019.

What is Ultomiris?

Ultomiris (ravulizumab) is a monoclonal antibody. Monoclonal antibodies are man-made antibodies that fight antigens (harmful substances) in the body.

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

PNH is a rare genetic disorder in which defective red blood cells break down prematurely and leak hemoglobin into your blood. Hemoglobin is the iron-rich protein that gives blood its red color. When hemoglobin passes into your urine, it can appear dark or tea-colored (especially in the morning or after sleep, when the urine is most concentrated).

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

Important Information

Ultomiris affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or your eyes are more sensitive to light.

You will need to be vaccinated against meningococcal infections before you start using Ultomiris.

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

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.

Before taking this medicine

You should not be treated with Ultomiris if you are allergic to ravulizumab, or if you have a meningococcal infection (such as meningitis or sepsis).

You will need to receive a vaccine to protect against meningococcal infections at least 2 weeks before you start using Ultomiris. If you have already received a meningococcal vaccine, your doctor will decide if you need a booster dose.

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 Ultomiris treatment.

To make sure Ultomiris is safe for you, tell your doctor if you have:

  • never received a meningococcal vaccine; or

  • 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.

Do not breast-feed while using this medicine, and for at least 8 months after your last dose.

How is Ultomiris given?

Ultomiris injection 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 8 weeks.

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 Ultomiris.

This medicine must be given slowly, and the infusion can take at least 2 hours to complete.

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.

Ultomiris 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.

Ultomiris can have long lasting effects on your body. You may need frequent medical tests while using this medicine and for up to 16 weeks after your last dose.

Tell your doctor if you have signs of red blood cell breakdown: stomach pain, trouble swallowing, blood in your urine, feeling tired or short of breath, or (in men) trouble having an erection.

Ultomiris dosing information

Usual Adult Dose for Paroxysmal Nocturnal Hemoglobinuria:

40 kg to less than 60 kg:
-Loading dose: 2400 mg IV at a maximum rate of 257 mL/min
-Maintenance dose: 3000 mg IV once every 8 weeks starting 2 weeks after the loading dose

60 kg to less than 100 kg:
-Loading dose: 2700 mg IV at a maximum rate of 257 mL/min
-Maintenance dose: 3300 mg at a maximum rate of 257 mL/min once every 8 weeks starting 2 weeks after the loading dose

100 kg and greater:
-Loading dose: 3000 mg IV at a maximum rate of 333 mL/min
-Maintenance dose: 3600 mg IV at a maximum rate of 327 mL/min once every 8 weeks starting 2 weeks after the loading dose

Comments:
-Healthcare professionals who prescribe this drug must enroll in the ULTOMIRIS REMS.
-Vaccinate patients for meningococcal disease according to current guidelines to reduce the risk of serious infection.
-The dosing schedule is allowed to vary within 7 days of the scheduled infusion day (except for the first maintenance dose) but the subsequent dose should be administered according to the original schedule.
-Provide 2 weeks of antibacterial drug prophylaxis to patients if this drug must be initiated immediately and vaccines are administered less than 2 weeks before.
-When converting from eculizumab to this drug, administer the loading dose of this drug 2 weeks after the last eculizumab dose and then administer maintenance doses once every 8 weeks (beginning 2 weeks after the loading dose).
-If an adverse reaction occurs during administration, the infusion may be slowed or stopped at the discretion of the physician.
-Monitor for at least one hour following completion of the infusion for an infusion reaction.

Use: For the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Ultomiris injection.

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 Ultomiris?

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

Ultomiris side effects

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

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.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • 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.

Call your doctor at once if you have symptoms of gonorrhea, such as:

  • 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.

Common Ultomiris side effects may include:

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 Ultomiris?

Other drugs may interact with 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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Ultomiris only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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