Description
Remestemcel-L-rknd injection is used treat acute graft-versus-host disease (aGVHD) in patients who have been treated with other medicines (eg, steroids) that did not work well.
This medicine is to be given only by or under the immediate supervision of your doctor.
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 remestemcel-L-rknd injection in children 2 months of age and older. Safety and efficacy have been established.
Geriatric
No information is available on the relationship of age to the effects of remestemcel-L-rknd injection in geriatric patients.
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:
- Allergy to dimethyl sulfoxide (DMSO)
- Allergy to porcine (pork) or bovine (beef) products—Should not be used in patients with these conditions.
Proper Use
A doctor or other trained health professional will give your child this medicine in a hospital. It is given through an IV catheter that is placed in a vein. This medicine must be given slowly, so the IV will need to stay in place for at least 60 minutes.
Your child may also receive other medicines (eg, allergy medicine or steroid) 30 to 60 minutes before receiving this medicine.
Precautions
It is very important that your child's doctor check your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which may be life-threatening and require immediate medical attention. Check with your child's doctor right away if your child complains of blurred vision, chest tightness, confusion, rash, itching, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast heartbeat, trouble breathing or swallowing, sweating, or unusual tiredness or weakness while using this medicine.
This medicine may cause infusion reactions, which can be life-threatening and require immediate medical attention. Tell your child's doctor right away if your child complains of dizziness, facial swelling, fever or chills, headache, nausea or vomiting, skin rash, trouble breathing, or weakness while receiving this medicine.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, HIV, hepatitis B or C) or genetic diseases to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your child's doctor if you have concerns about this risk.
This medicine may increased risk of ectopic tissue formation (tissue growth outside normal location). Talk with your doctor if you have concerns about this risk.
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
- Bleeding gums
- blue lips, fingernails, or skin
- blurred vision
- chills
- confusion
- cough or hoarseness
- coughing up blood
- difficulty breathing or swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- headache
- increased menstrual flow or vaginal bleeding
- lower back or side pain
- nervousness
- nosebleeds
- painful or difficult urination
- paralysis
- pinpoint red spots on skin
- pounding in the ears
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- slow or fast heartbeat
- sweating
- swelling
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Chest tightness
- facial swelling
- nausea or vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin itching, rash, or redness
- swelling of the face, throat, 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
- Diarrhea
- difficulty in moving
- joint pain
- muscle pains or stiffness
- 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.
CON-XXXXXXXX
