Description
Crovalimab-akkz 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.
This medicine is available only under a restricted distribution program called Piasky™ 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 crovalimab-akkz injection in children younger than 13 years of age weighing less than 40 kilograms (kg). 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 crovalimab-akkz injection in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution in patients receiving this medicine.
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—Use with caution. May increase risk of serious infections.
- Meningococcal infection, serious and unresolved—Should not be used in patients with this condition.
Proper Use
A nurse or other trained health professional will give you this medicine. The first loading dose is given through an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV may need to stay in place for at least 60 to 90 minutes on Day 1. Another loading dose will be given as a shot under your skin, usually in the stomach, on Days 2, 8, 15, and 22. The maintenance doses will begin on Day 29 and be given every 4 weeks as a shot under your skin.
It is very important that you understand the requirements of the Piasky™ REMS program, and become familiar with the Piasky™ 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 are changing treatment from Soliris® or Ultomiris® to Piasky™, you should start receiving Piasky™ as soon as possible. Your doctor will monitor you for 30 days after you switch medicines.
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 this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine can increase your risk for serious infections, including meningococcal infection, gonorrhea, pneumonia, and flu-like infection. You will need to be vaccinated against meningococcal infection at least 2 weeks before you start treatment with this medicine. You may also be given antibiotic medicine to prevent infections if you are to use this medicine right away. Avoid people who are sick or have infections. Tell your doctor right away if you develop headaches, nausea, vomiting, fever, a stiff neck or back, a rash, confusion, muscle aches, or if your eyes have become sensitive to light.
You will be given a patient safety card that lists the symptoms of infection and what to do if you have them. Carry the card with you at all times during treatment and for 11 months after treatment. Show the card to any doctor who treats you.
When this medicine is stopped, you may develop hemolysis (red blood cell breakdown). Your doctor will need to monitor you closely for at least 20 weeks after you stop using this medicine. Be sure to keep all appointments.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have difficulty breathing or swallowing, a fast heartbeat, itching, rash, or redness, or swelling of the face, throat, or tongue.
This medicine may cause infusion-related or injection-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of 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, fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.
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
- Back pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- chest tightness
- chills
- cough
- diarrhea
- difficulty swallowing
- ear congestion
- fast heartbeat
- fever
- frequent or painful urination
- flushing
- headache
- joint pain, stiffness, or swelling
- loss of voice
- lower back or side pain
- muscle aches
- nausea or vomiting
- new loss of taste or smell
- rapid weight gain
- skin itching, rash, or redness
- sneezing
- sore throat
- stomach pain
- stuffy or runny nose
- swelling of the face, throat, or tongue
- swelling of the feet or lower legs
- tingling of the hands or feet
- trouble breathing
- unusual tiredness or weakness
- 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
- Difficulty in moving
- joint pain
- muscle pain or stiffness
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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