Description
Exagamglogene autotemcel injection is used to treat sickle cell disease (red blood cell disease) in patients who have frequent vaso-occlusive crisis. It is also used to treat beta thalassemia in patients who need regular blood transfusions. This medicine is made from human blood stem cells. It is used to increase the production of a special type of hemoglobin called hemoglobin F (fetal hemoglobin) which helps improve the production and formation of red blood cells.
This medicine is to be given only by or under the immediate supervision of your doctor.
This product is available in the following dosage forms:
- Suspension
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 exagamglogene autotemcel injection in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of exagamglogene autotemcel injection have not been performed in the geriatric population.
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.
- Crizanlizumab
- Deferasirox
- Deferiprone
- Deferoxamine Mesylate
- Hydroxyurea
- Voxelotor
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:
- Allergy to dimethyl sulfoxide (DMSO), history of—Use with caution. May increase the risk of an allergic reaction.
- Kidney disease or
- Liver disease—Use with caution. This medicine has not been studied in patients with these conditions.
Proper Use
A doctor or other trained health professional will give you this medicine in a hospital. It is given through an IV placed in a vein.
This medicine should come with a Medication Guide and patient instructions. Read and follow the instructions carefully and make sure you understand them before receiving this medicine.
You may also receive other medicines (eg, fever medicine or allergy medicine) before receiving this medicine.
This medicine is made specifically for each patient, using the patient's own blood cells. Your doctor will collect your blood through a procedure called mobilization and apheresis. Talk with your doctor if you have any concerns about this.
Your doctor will also want you to stay in the hospital or center for at least 4 to 6 weeks after your infusion.
Do not use crizanlizumab, hydroxyurea, and voxelotor for at least 8 weeks and an iron chelator for at least 7 days before having a procedure to collect your blood.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check for unwanted effects.
If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before having a procedure to collect your blood. Female patients and male patients with female partners should use an effective form of birth control before having a procedure to collect your blood and for at least 6 months after the last dose.
Exagamglogene autotemcel injection will lower the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
This medicine may cause a serious allergic reaction, including anaphylaxis, which may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, dizziness, fainting, fast heartbeat, trouble breathing or swallowing, or chest tightness while you are using this medicine.
Do not donate blood, organs, tissues, or cells during treatment with 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
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain
- chills
- cough
- fever
- gaseous stomach pain
- lower back or side pain
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sore throat
- stomach fullness
- swollen glands
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Less common
- Back pain
- bloated stomach
- chest tightness
- fast heartbeat
- flushing
- headache
- nausea and vomiting
- pain and fullness in the right upper abdomen
- weight gain
Incidence not known
- Difficulty swallowing
- dizziness
- hives, itching, 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
- Bloody nose
- cracked lips
- decreased appetite
- diarrhea
- muscle or bone 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.
CON-XXXXXXXX
