Description
Crizanlizumab-tmca injection is used to prevent vaso-occlusive crisis in patients with sickle cell disease. Vaso-occlusive crisis is a common and painful complication of sickle cell disease that occurs when blood circulation is blocked by sickled red blood cells and may lead to organ damage.
This medicine is to be given only by or under the direct supervision of your doctor.
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 crizanlizumab-tmca injection in children 16 years of age and older. However, safety and efficacy have not been established in children younger than 16 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of crizanlizumab-tmca 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.
- Exagamglogene Autotemcel
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.
Proper Use
A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through an IV catheter that is placed into one of your veins. The medicine must be injected slowly, so your IV will need to stay in place for 30 minutes.
You will receive your first infusion, and then a second infusion 2 weeks later. After that, you will receive an infusion every 4 weeks.
Your doctor may want you to take hydroxyurea (Hydrea®) while you are receiving this medicine.
This medicine usually comes with patient information leaflet. Read and follow the instructions carefully and make sure you understand them before receiving this medicine.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.
Precautions
Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
This medicine may cause infusion-related reactions, which can be life-threatening and require medical attention. Tell your doctor right away if you or your child have a fever, chills, nausea, vomiting, dizziness, itching skin or rash, sweating, trouble breathing, or unusual tiredness or weakness after receiving this medicine.
Do not change your dose or suddenly stop receiving this medicine without checking first with your doctor.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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, joint, or body pain
- chest pain or discomfort
- diarrhea
- difficulty with moving
- fever
- muscle pain or stiffness
- nausea and vomiting
- sore throat
- stomach pain
Less common
- Chest tightness
- chills
- dizziness
- flushing
- headache
- itching skin or rash
- sweating
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Confusion
- cough
- numbness or tingling in the face, arms, or legs
- trouble walking or speaking
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
- 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.
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