Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Myelofibrosis (Adults): The recommended starting dose is 5 to 20 mg twice daily. The maximum dose is 25 mg twice daily.
• Polycythaemia vera (Adults): The recommended starting dose is 10 mg twice daily. The maximum dose is 25 mg twice daily.
• Acute and chronic graft-versus-host disease: Children 6–12 years old: the recommended starting dose is 5 mg twice daily. Children 12 years and older and adults: the recommended starting dose is 10 mg twice daily.
• If you forget to take Jaklitinib: Simply take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

Myelofibrosis and polycythaemia vera — Very common:

• Any sign of bleeding in the stomach or intestine, such as passing black or bloodstained stools, or vomiting blood.
• Unexpected bruising and/or bleeding, unusual tiredness, shortness of breath, unusually pale skin, or frequent infections.
• Painful skin rash with blisters (possible symptoms of shingles).
• Fever, chills or other symptoms of infections.
• Low level of red blood cells (anaemia), white blood cells (neutropenia), or platelets (thrombocytopenia).

Graft-versus-host disease (GvHD) — Very common:

• Fever, pain, redness, and/or difficulty breathing (possible cytomegalovirus infection).
• Fever, pain when urinating (possible urinary tract infection).
• Fast heart rate, fever, confusion and rapid breathing (possible sepsis).
• Tiredness, fatigue, pale skin, frequent infections, fever, chills, sore throat or mouth ulcers (possible anaemia or neutropenia).
• Spontaneous bleeding or bruising (possible thrombocytopenia).
• Low counts of all three types of blood cells (pancytopenia).

Other side effects — Very common:

• High level of cholesterol (hypercholesterolaemia), headache, high blood pressure (hypertension), feeling sick (nausea).
• Abnormal liver function test results.
• Increased blood level of creatine phosphokinase and increased blood creatinine.

Do not take Jaklitinib

• If you are allergic to ruxolitinib or any of the other ingredients of this medicine.
• If you are pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Jaklitinib if:

• You have any infections. It may be necessary to treat your infection before starting Jaklitinib.
• You have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
• You have ever had hepatitis B.
• You have kidney problems.
• You have or have ever had liver problems. Your doctor may need to prescribe a different dose of Jaklitinib.
• You have ever had cancer, in particular skin cancer.
• You have or have had heart problems.
• You are 65 years of age or older.
• You are a smoker or have smoked in the past.