Pronunciation:

rem-e-STEM-sel - el - rknd

Brand Names:

• Ryoncil

Uses of This Medicine:

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 This Medicine:

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.

Children—

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.

Older adults—

No information is available on the relationship of age to the effects of remestemcel-L-rknd injection in geriatric patients.

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.