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Chronic GVHD can occur after a stem cell transplant when the stem cells from your donor (the graft) starts attacking your body (the host) because they see it as foreign. It can affect almost any part of your body lasting from months to a lifetime causing inflammation and fibrosis (scarring and hardening of tissues).

No, not everyone who undergoes a stem cell transplant develops chronic GVHD. 30%-70% of patients who receive a stem cell transplant from a donor develop chronic GVHD.

REZUROCK is a prescription medication used to treat adults and adolescents aged 12 years and older with chronic GVHD who have received two or more prior treatments that did not work.

REZUROCK blocks a specific protein in the body that is involved in inflammation and fibrosis. This may help to decrease symptoms of chronic GVHD like inflammation and fibrotic symptoms such as scarring.

Talk to your healthcare professional if you experience any of the following side effects:

• Infections: fever and chills, fatigue, generally feeling unwell.
• Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness.
• Gastrointestinal problems: stomach pain, decreased appetite, diarrhea, nausea, vomiting.
• High blood pressure: headache, shortness of breath, nosebleeds.
• Low blood pressure: dizziness, fainting, light-headedness, blurred vision, nausea, tiredness (may occur when you stand up from lying or sitting).
• Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, tiredness, itchy skin.
• Pneumonia (infection in the lungs): high fever with chills, fast breathing, chest pain when you cough, cough which may produce phlegm, fatigue, nausea, vomiting or diarrhea, shortness of breath.
• Thrombocytopenia (low blood platelets): bleeding gums, nosebleeds, bruising or bleeding for longer than usual if you hurt yourself, fatigue and weakness
• Sensitivity to sunlight: itchy, red skin when exposed to sunlight.

Other possible side effects include the following listed below. If these side effects become severe, tell your doctor.

Other side effects may include:

• Infections,
• Tiredness or weakness,
• Nausea or vomiting,
• Difficulty swallowing,
• Diarrhea or constipation,
• Cough,
• Shortness of breath,
• Cold symptoms,
• Swelling,
• Bleeding,
• Stomach pain,
• Muscle,
• Bone or joint pain,
• Muscle spasms,
• Headache,
• High blood pressure,
• Itchy skin, rash.

These are not all the possible side effects you may feel when taking REZUROCK. If you experience any side effects not listed here, tell your healthcare professional.

Pregnancy and breastfeeding:

Female patients:

•  If you are pregnant, able to get pregnant or think you are pregnant, there are specific risks you should discuss with your healthcare professional. 
•  You should not take REZUROCK if you are pregnant. It may harm your unborn baby.
•  If you are able to become pregnant:
  •  Your healthcare professional will do a pregnancy test before you start taking REZUROCK. This test must show that you are not pregnant.
  •  Avoid becoming pregnant while you are taking REZUROCK. Use effective birth control during your treatment and for at least 1 week after your last dose. Ask your healthcare professional about methods of birth control available to you. 
  • Tell your healthcare professional right away if you become pregnant or think you may be pregnant during your treatment with REZUROCK. 
• Do not breastfeed while you are taking REZUROCK and for at least 1 week after your last dose. 

Male patients

•  Avoid fathering a child while you are taking REZUROCK.
•  During your treatment with REZUROCK, use effective birth control each time you have sex with a woman who is pregnant, may be pregnant or could get pregnant. Continue using birth control for at least 3 months after your last dose.
• If, during your treatment with REZUROCK, your sexual partner becomes pregnant or thinks she may be pregnant, tell your healthcare professional right away. 

Fertility in female and male patients: REZUROCK may affect your fertility. Talk to your healthcare practitioner if you are planning on having children.
 

The time to response of REZUROCK will be different from other medications you may have taken. It is important that you take REZUROCK as long as your doctor has recommended.

How long you will stay on REZUROCK will depend on how well your body responds to it. It is important you take REZUROCK for as long as your doctor recommends.

REZUROCK 200mg tablet is to be taken by mouth once a day with a meal approximately at the same time each day.

If you miss a dose, take the missed tablet as soon as possible on the same day. Take the next dose at your usual time. DO NOT TAKE AN EXTRA DOSE to make up for the missed dose. REZUROCK should be swallowed whole. Do not crush or chew the tablet.

If you take too much REZUROCK, tell your doctor or go to the nearest hospital right away. Take the medicine pack with you. Take your next dose at your regular time on the next day.

Your health care team may choose to prescribe REZUROCK along with other medicines for chronic GVHD.

Tell your healthcare professional about all medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines. REZUROCK may affect the way other medicines work, and other medicines may affect the way REZUROCK works. Know the medicines you take. Keep a list of them to show your healthcare professionals when you get a new medicine.

The following may interact with REZUROCK:

• Medicines for bacterial infections such as rifampin.
• Medicines for excess stomach acid or ulcers, such as omeprazole and rabeprazole.
• Medicines for HIV treatment such as raltegravir.
• Medicines for sedation such as midazolam.
• Medicines for blood clots such as dabigatran.
• Medicines for lowering cholesterol levels in the blood such as rosuvastatin.

• Store at 15⁰C to 30⁰C in the original container.
• Keep REZUROCK in its original container. The REZUROCK bottle contains a desiccant packet to help keep your tablets dry (protect from moisture).
• Replace cap securely each time after opening. Do not remove desiccant (a small pack inside the bottle which protects the pills from moisture damage) from bottle.
• Keep out of the reach and sight of children.