Ryoncil 6.68 x 10exp6 cell/mL intravenous suspension

Generic name:
Remestemcel - injection

Pronunciation
(REM-e-STEM-sel)

Brand name(s)
Ryoncil

This medication is used to treat a certain problem that may happen after a stem cell transplant (acute graft-versus-host disease) that has not gotten better or that has come back after other kinds of treatment. This problem causes immune system responses which lead to swelling and damage to parts of your body. Remestemcel is made from special cells (mesenchymal stromal cells) which help reduce those immune system responses.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually twice weekly, at least 3 days apart.

The dosage is based on your weight and response to treatment.

Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications (such as steroids, antihistamines) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as fever, shortness of breath, or low blood pressure. Your doctor may slow down or stop your treatment for some time.

Diarrhea, vomiting, or stomach pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of infection (such as chills, sore throat that doesn't go away)
• swelling of arms/legs/feet
• unusual growths/lumps

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using remestemcel, tell your doctor or pharmacist if you are allergic to it; or dimethyl sulfoxide (DMSO); or beef or pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• past/current/recent infection

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using remestemcel. Remestemcel may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this product passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood counts) may be done while you are receiving this product. Keep all medical and lab appointments.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This product is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.