Ruxolitinib, RUSODX, Ruxolitinib5mg Manufacturer: Laos Daxiong Pharmaceutical Export to China 3% customs value-added tax

Introduction: In November 2011, ruxolitinib tablets were first approved for marketing in the United States for the treatment of myelofibrosis. Subsequently, new indications were continuously expanded, including graft-versus-graft disease (GVHD) and polycythemia vera. In September 2021, ruxolitinib cream was launched in the United States for short-term and non-continuous long-term treatment of mild to moderate atopic dermatitis in non-immunocompromised patients aged 12 years and above.

【Product name】

Name: Ruxolitinib

Product Name:RUSODX

【Specification】

5 mg

【Indications】

• Learn about solutions for certain types of myelofibrosis (MF).

• Patients with polycythemia vera (PV) who are already taking a complementary medication but it is not working well or they cannot tolerate it.

• Adults and children 12 years and older with acute graft-versus-graft disease (aGVHD) who have been treated with Barbara but have not responded well.

• Adults and children 12 years and older with chronic graft-versus-graft disease (cGVHD) who have not responded to one or two prior therapies.

It is not known whether RUSODX is safe or effective for treating myelofibrosis or erythrocytosis vera in children.

【Recommended dose】

• Take RUSODX exactly as your healthcare provider tells you to.

• Do not change your dose or stop taking RUSODX without talking to your healthcare provider first.

• You can take RUSODX with or without food.

• RUSODX can also be dosed via certain nasogastric tubes.

• Tell your healthcare provider if you cannot get RUSODX in. Your healthcare provider will decide if you can take RUSODX by nasogastric tube.

• Ask your healthcare provider to give you specific instructions on how to properly take RUSODX by nasogastric tube.

• If you miss one RUSODX medicine, take the next medicine at your regular time. Do not take 2 medicines at the same time.

• If you take an overdose of RUSODX, call your healthcare provider right away or go to the nearest hospital emergency room.

• You will have regular blood tests while you are being treated with RUSODX. Your healthcare provider may change your RUSODX dose or stop your treatment based on your blood test results.

【Included】

o Low blood cell counts. RUSODX may cause low collagen (epithelium), low red blood cell counts (anemia), and low white blood cells (neutropenia). If you develop blood clots, stop RUSODX and call your healthcare provider. Your healthcare provider will do blood tests before you start RUSODX and regularly during your treatment with RUSODX to check your blood cell counts. Tell your healthcare provider right away if you have any symptoms or feel unwell:

• Abnormal blood clotting • Shortness of breath • Blood stasis

• Fever • Fatigue

oInfection . You may be at risk for developing a serious infection during treatment with RUSODX.

Tell your healthcare provider if you have any of the following symptoms of infection:

• Chills • Vomiting • Pain • Weakness

• Fever • Rash or painful blisters • Eating

o Cancer. Some people get certain types of non-melanoma skin cancer during treatment with RUSODX. Your healthcare provider will check your skin regularly during your treatment with RUSODX. Tell your healthcare provider if you develop any new or changing skin lesions during treatment with RUSODX.

o Increased cholesterol. Your blood cholesterol levels may change during treatment with RUSODX. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking RUSODX, and as needed.

o An increase in major cardiovascular events such as dangerous heart attack, stroke, or death.

Cardiovascular risk factors and current or former smokers when using another JAK for rheumatoid arthritis.

Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RUSODX, including:

• Interruption of central pain lasting more than 30 years, or disappearing and returning • Interruption, severe tightness, pain, pressure, or heaviness in the neck, neck, or jaw

• Pain in the arms, neck, neck, jaw, or stomach that does not stop • Shortness of breath that does not stop

• Break out in a cold sweat • Stomach or vomiting

• Feeling dizzy • Partial or weak body

• Slurred speech

o Increased risk of blood clots. People taking another JAK for rheumatoid arthritis have had blood clots in the veins (deep vein thrombosis, DVT) or in the lungs (pulmonary embolism, PE), which can be life-threatening.

Tell your healthcare provider right away if you have any signs or symptoms of blood clots during treatment with RUSODX, including:

• Swelling, pain, or tenderness in one or both legs • Sudden confusion or upper body pain • Shortness of breath or difficulty breathing

o May increase the risk of new (secondary) cancers.

People who take another JAK therapy for rheumatoid arthritis have an increased risk of developing new (secondary) cancers, including breast and other cancers. People who smoke or have smoked in the past have an increased risk of developing new cancers.

The most common results of RUSODX in certain types of MF and PV solutions include:

• Low routine counts • Dizziness • Low red blood cell counts

• Anemia • Blood stasis • Diarrhea

The most common side effects of RUSODX in patients with aGVHD include:

• Low red blood cell count • Infection • Low count

• Swelling • Low white blood cell count

The most common side effects of RUSODX in patients with cGVHD include:

• Low red blood cell count • Current low count • Infections, including viral infections

These are not all the possible consequences of RUSODX.

Please call your doctor for more details and medical advice.

【Survivor】

• Store RUSODX at 68°F to 86°F (20°C to 30°C).

Keep RUSODX and all medicines out of the reach of children.