【Drug Name】

Name: Selinexor Tablets

Product Name: SALLYDX

【Specification】

20mg

【Indications】

SALLYDX is a prescription medicine, taken along with the medicine dexamethasone, used to treat adults with multiple myeloma (MM) that has come back (relapsed) or that did not respond to previous treatment (refractory), and: 

• who have received at least 4 prior therapies, and 

• their disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine. 

It is not known if SALLYDX is safe and effective in children less than 18 years of age. 

【Recommended Dosage】

• Take SALLYDX and dexamethasone exactly as prescribed by your healthcare provider. 

• Your healthcare provider will tell you how much SALLYDX to take and when to take it. Do not change your dose or stop taking SALLYDX without talking to your healthcare provider first. 

• Swallow SALLYDX tablets whole with water. Do not break, chew, crush, or divide the tablets. 

• Be sure to take any medicines prescribed by your healthcare provider before and during treatment with SALLYDX to help prevent nausea and vomiting. Tell your healthcare provider if the prescribed medicine does not control your nausea and vomiting. 

• It is important for you to drink enough fluids to help prevent dehydration and to eat enough calories to help prevent weight loss during treatment with SALLYDX. Talk to your healthcare provider if this is a problem for you.

• If you miss a dose of SALLYDX, take your next dose at your next regularly scheduled day and time. 

• If you vomit after taking a dose of SALLYDX, do not take an extra dose. Take your next dose at your next regularly scheduled day and time. 

• If you take too much SALLYDX, call your healthcare provider right away. 

【Side Effects】

• Low platelet counts. Low platelet counts are common with SALLYDX and can lead to bleeding which can be severe and can sometimes cause death. Your healthcare provider may prescribe platelet transfusions or other treatments for your low platelet counts. 

Tell your healthcare provider right away if you have any bleeding or easy bruising during treatment with SALLYDX. 

• Low white blood cell counts. Low white blood cell counts are common with SALLYDX and can sometimes be severe. You may have an increased risk of getting bacterial infections during treatment with SALLYDX. Your healthcare provider may prescribe antibiotics if you have signs or symptoms of infection, or certain medicines to help increase your white blood cell count, if needed. 

Your healthcare provider will do blood tests before you start taking SALLYDX, and often during the first 2 months of treatment, and then as needed during treatment to monitor you for side effects. 

Your healthcare provider may change your dose of SALLYDX, stop your treatment for a period of time, or completely stop your treatment if you have certain side effects during treatment with SALLYDX. 

• Nausea and vomiting. Nausea and vomiting are common with SALLYDX and can sometimes be severe. Nausea and vomiting may affect your ability to eat and drink well. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive intravenous (IV) fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-nausea medicines for you to take before you start and during treatment with SALLYDX. 

• Diarrhea. Diarrhea is common with SALLYDX and can sometimes be severe. You can lose too much body fluid and body salts (electrolytes) and may be at risk for becoming dehydrated. You may need to receive IV fluids or other treatments to help prevent dehydration. Your healthcare provider will prescribe anti-diarrhea medicine for you as needed. 

• Loss of appetite and weight loss. Loss of appetite and weight loss are common with SALLYDX and can sometimes be severe. Tell your healthcare provider if you have a decrease or loss of appetite and if you notice that you are losing weight. Your healthcare provider may prescribe medicines that can help increase your appetite or prescribe other kinds of nutritional support. 

• Decreased sodium levels in your blood. Decreased sodium levels in your blood is common with SALLYDX but can also sometimes be severe. You may not have any symptoms. Your healthcareprovider may talk with you about your diet and prescribe IV fluids or salt tablets for you based on the sodium levels in your blood. 

• Infections. Infections are common with SALLYDX and can be serious and can sometimes cause death. SALLYDX can cause infections including upper respiratory tract infections, pneumonia, and an infection throughout your body (sepsis). Tell your healthcare provider right away if you have any signs or symptoms of an infection such as cough, chills or fever, during treatment with SALLYDX. 

• Neurologic side effects. SALLYDX can cause dizziness, fainting, decreased alertness, and changes in your mental status including confusion and decreased awareness of things around you (delirium). These problems can sometimes be severe. Tell your healthcare provider right away if you get any of these signs or symptoms. 

Common side effects of SALLYDX include: 

• tiredness 

• low red blood cell count (anemia). Symptoms may include tiredness and shortness of breath. 

• constipation 

• shortness of breath 

SALLYDX may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility. 

These are not all the possible side effects of SALLYDX. 

【Storage】

• Store SALLYDX at or below 86°F (30°C).  

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