Remestemcel-l-rknd Injection

WHY is this medicine prescribed?

Remestemcel-l-rknd injection is used to treat a certain type of acute graft versus host disease (aGVHD; a life-threatening complication that can happen after a stem-cell transplant). Remestemcel-l-rknd is in a class of medications called cellular therapy. It works by slowing down the immune system and decreasing inflammation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Remestemcel-l-rknd injection comes as a suspension (liquid) to be slowly injected intravenously (into a vein) by a doctor or nurse in a hospital. It is injected twice a week (at least 3 days apart) for 8 or more doses. Your doctor may order additional doses depending on how your body responds to the medication.

Remestemcel-l-rkndinjection may cause serious or life-threatening reactions during an infusion. You may be given other medications to help prevent reactions to remestemcel-l-rknd injection. A doctor or nurse will watch you closely while you receive the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms: chills or shaking, itching, rash, flushing, difficulty breathing, dizziness, fever, or feeling faint.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving remestemcel-l-rknd injection,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs,foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have or have ever had high or low blood pressure or any other medical problem.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving remestemcel-l-rknd injection, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive remestemcel-l-rknd injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Remestemcel-l-rknd injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vomiting
• diarrhea
• stomach pain
• rash
• joint pain
• swelling of the arms, hands, feet, ankles, or lower legs

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• flu-like symptoms, fever, chills, cough, sore throat, and other signs of infection
• unusual bleeding or bruising
• fast or irregular heartbeat
• shortness of breath; drowsiness; confusion; or gray or blue colored skin

Remestemcel-l-rknd injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.