Description and Brand Names

Drug information provided by: Merative, 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 also used to treat a nerve and muscle problem called generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody positive.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ravulizumab-cwvz injection to treat to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), given as an IV placed into one of the veins in children 1 month of age and older. However, safety and efficacy have not been established to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), given as an IV placed into one of the veins in children younger than 1 month of age, or to treat generalized myasthenia gravis (gMG), given as an IV placed into one of the veins in children.

Appropriate studies have not been performed on the relationship of age to the effects of ravulizumab-cwvz injection to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), given as a shot under the skin in children. Safety and efficacy have not been established.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Immune Globulin

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.

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 an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV will need to stay in place for at least 2 hours.

You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach, thigh, or upper arm. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

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

It is very important that you understand the requirements of the Ultomiris® REMS program, and become familiar with the Ultomiris® Medication Guide and patient instructions. 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 are changing treatment from Soliris® to Ultomiris®, you should start receiving Ultomiris® 2 weeks after your last dose of Soliris®.

This medicine is available in two forms: a vial (glass container) or a prefilled cartridge with on-body injector. The prefilled cartridge with on-body injector is the dosage form you can use at home.

Allow the prefilled cartridge with on-body injector to warm to room temperature for 45 minutes, without removing the medicine from the carton, before you use it. Do not warm the medicine in any other way or return to the refrigerator.

To use the prefilled cartridge with on-body injector:

  • You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections. Do not inject into areas where the skin is tender, bruised, red, hard, or in areas with scars, stretch marks, moles, or excess hair.
  • Check the liquid in the cartridge. It should be clear and colorless to slightly yellow. Do not use the medicine if it is cloudy, discolored, or has flakes or large particles in it. Do not shake.
  • Use a new needle and cartridge each time you inject your medicine.
  • Do not use the cartridge if it is cracked, broken, or if there are missing pieces. Do not remove the needle cover until you are ready to use it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injectable dosage form (prefilled cartridge with on-body injector):
    • For paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS):
      • From intravenous (an IV placed into one of your veins) to subcutaneous (injected under the skin):
        • Adults weighing 40 kilograms (kg) or more—490 milligrams (mg) prefilled cartridge with on-body injector injected under your skin at different body areas once a week 8 weeks after your last dose.
        • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

Keep the medicine in its original carton until you are ready to use it. Protect from light. If removed from the refrigerator, you may store it at room temperature for up to 3 days. Do not return to the refrigerator. Throw away unused cartridge after 3 days.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

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 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.

Tell your doctor if you are also receiving other procedures (eg, plasma exchange, plasmapheresis) or medicines (eg, efgartigimod, immunoglobulin injection) for myasthenia gravis.

The on-body injector contains acrylic adhesive, which may cause allergic reactions in people who are sensitive to the adhesive.

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. Bladder pain
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. bloody or cloudy urine
  4. blurred vision
  5. body aches or pain
  6. chills
  7. confusion
  8. cough
  9. decreased urine
  10. difficult, burning, or painful urination
  11. difficulty with breathing
  12. dizziness
  13. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  14. dry mouth
  15. ear congestion
  16. extremely high fever or body temperature
  17. fast, shallow breathing
  18. fast, weak heartbeat
  19. fever
  20. frequent urge to urinate
  21. headache
  22. increased thirst
  23. irregular heartbeat
  24. loss of appetite
  25. loss of voice
  26. lower back or side pain
  27. mood changes
  28. muscle pain or cramps
  29. nausea or vomiting
  30. nervousness
  31. numbness or tingling in hands, feet, or lips
  32. pale, clammy skin
  33. pounding in the ears
  34. rapid weight gain
  35. runny or stuffy nose
  36. sneezing
  37. slow or fast heartbeat
  38. sore throat
  39. sweating
  40. swollen glands
  41. thirst
  42. tingling of the hands or feet
  43. trouble breathing
  44. unusual bleeding or bruising
  45. unusual tiredness or weakness
  46. unusual weight gain or loss

Incidence not known

  1. Chest tightness
  2. difficulty swallowing
  3. hives, itching, or skin rash
  4. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

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. Back pain
  2. 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
  3. diarrhea
  4. difficulty having a bowel movement (stool)
  5. difficulty with moving
  6. fear
  7. hair loss or thinning of the hair
  8. joint pain
  9. muscle pain, stiffness ,or spasms
  10. nausea or vomiting
  11. pain in the arms or legs
  12. stomach pain

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.

Portions of this document last updated: March 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/ravulizumab-cwvz-intravenous-route/proper-use/drg-20454109