Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Ultomiris

Descriptions


Ravulizumab-cwvz injection is used to treat a type of blood disease called paroxysmal nocturnal hemoglobinuria (PNH). This medicine helps reduce red blood cell destruction or breakdown (hemolysis) in patients with PNH.

Ravulizumab-cwvz injection is also used to treat atypical hemolytic uremic syndrome (aHUS) in adults and children.

Ravulizumab-cwvz injection is a monoclonal antibody that works on the immune system.

This medicine is available only under a restricted distribution program called Ultomiris™ REMS (Risk Evaluation and Mitigation Strategy) Program.

This product is available in the following dosage forms:

  • Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ravulizumab-cwvz injection to treat PNH in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ravulizumab-cwvz injection to treat atypical hemolytic uremic syndrome in children 1 month of age and older. However, safety and efficacy have not been established in children younger than 1 month of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ravulizumab-cwvz injection in the elderly.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Infection (eg, gonorrhea, influenza, pneumonia)—Use with caution. This medicine may decrease your body’s ability to fight infection.
  • Meningococcal infection—Should not be given to patients with this condition.
  • No current vaccination against meningitis infection—Should not be given to patients with this condition unless the doctor decides that urgent treatment is needed.

Proper Use

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be injected slowly, so your IV tube will need to stay in place for at least 2 hours.

Your doctor will monitor you for at least 1 hour for any unwanted effects after the infusion.

It is very important that you understand the requirements of the Ultomiris™ REMS program, and become familiar with the Ultomiris™ Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.

If you miss a dose, call your doctor or pharmacist for instructions.

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Ravulizumab-cwvz may increase your chance of having serious infections, including a meningococcal infection. Avoid people who are sick or have infections. Tell your doctor right away if you or your child develop headaches, nausea, vomiting, fever, a stiff neck or back, rash, confusion, muscle aches, or if your eyes have become sensitive to light. Make sure you have received a vaccine to prevent meningococcus infections at least 2 weeks before you receive this medicine. You may also be given antibiotic medicines for 2 weeks to prevent infections if you are to use this medicine right away. If you have already received the meningococcal vaccine in the past, your doctor will decide if you need another dose.

Ask your doctor for a patient safety card. This card will list the symptoms of meningococcus infections and what to do if you have them. Carry the card with you at all times during treatment and for 8 months after your last dose. You will need to show the card to any doctor who treats you.

You could develop hemolysis (breakdown of red blood cells) when you stop receiving this medicine for PNH. Your doctor will monitor you closely for at least 16 weeks after the last dose of this medicine. Be sure to keep all appointments.

Ravulizumab-cwvz may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

You could also develop a condition called thrombotic microangiopathy (TMA) when you or your child stop receiving this medicine for aHUS. Tell your doctor right away if you or your child have confusion, seizures, chest pain, trouble breathing, blood clots, or stroke.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  1. Bloating or swelling of the face, arms, hands, lower legs, or feet
  2. blurred vision
  3. body aches or pain
  4. chills
  5. cough
  6. difficulty with breathing
  7. dizziness
  8. ear congestion
  9. extremely high fever or body temperature
  10. fast, shallow breathing
  11. fast, weak heartbeat
  12. fever
  13. headache
  14. loss of voice
  15. muscle cramps
  16. nervousness
  17. pale, clammy skin
  18. pounding in the ears
  19. rapid weight gain
  20. runny or stuffy nose
  21. sneezing
  22. slow or fast heartbeat
  23. sore throat
  24. thirst
  25. tingling of the hands or feet
  26. unusual bleeding or bruising
  27. unusual tiredness or weakness
  28. unusual weight gain or loss

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

More common

  1. Diarrhea
  2. difficulty having a bowel movement (stool)
  3. fear
  4. hair loss or thinning of the hair
  5. muscle spasms
  6. nausea or vomiting
  7. pain in the arms or legs
  8. stomach pain

Less common

  1. Difficulty with moving
  2. joint pain
  3. muscle pain or stiffness

Incidence not known

  1. Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.