Description
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 also used to treat neuromyelitis optica spectrum disorder (NMOSD), a rare disorder that causes inflammation of the nerves of the eyes and spinal cord. It is used in patients who are anti-aquaporin-4 (AQP4) 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 paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in children 1 month of age and older. However, safety and efficacy have not been established to treat PNH and aHUS in children younger than 1 month of age, or to treat generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) in children.
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. This medicine must be given slowly. The IV will usually remain in place for 1 hour or less. In some cases, the IV may need to remain in place up to 4 hours.
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 receive your starting dose of Ultomiris® at your next scheduled dose of Soliris®.
Missed 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 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.
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
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chills
- confusion
- cough
- decreased urine
- difficult, burning, or painful urination
- difficulty with breathing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- ear congestion
- extremely high fever or body temperature
- fast, shallow breathing
- fast, weak heartbeat
- fever
- frequent urge to urinate
- headache
- increased thirst
- irregular heartbeat
- loss of appetite
- loss of taste or smell
- loss of voice
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea or vomiting
- nervousness
- numbness or tingling in hands, feet, or lips
- pale, clammy skin
- pounding in the ears
- rapid weight gain
- runny or stuffy nose
- sneezing
- slow or fast heartbeat
- sore throat
- sweating
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- swollen glands
- thirst
- tingling of the hands or feet
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Chest tightness
- difficulty swallowing
- hives, itching, or skin rash
- 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
- Back pain
- 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
- constipation
- diarrhea
- difficulty having a bowel movement (stool)
- difficulty with moving
- hair loss or thinning of the hair
- heartburn
- joint pain
- muscle pain, stiffness ,or spasms
- nausea or vomiting
- pain in the arms or legs
- 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.
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