XPOVIO (Selinexor)

What is this medication?

Xpovio is used together with bortezomib and/or dexamethasone to treat multiple myeloma in adults. It is used:

• in combination with the medicines bortezomib and dexamethasone to treat adults with multiple myeloma who have received at least one prior treatment for their disease.
• in combination with dexamethasone 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
• whose disease did not respond to (refractory) to at least 2 proteasome inhibitor medicines, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody medicine.

Xpovio is also used in adults to treat certain types of diffuse large B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory) and who have received at least 2 prior therapies.

Xpovio was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

How should I use this medication?

Take Xpovio exactly as prescribed by your doctor. Your doctor will perform tests to make sure this medicine is the right treatment for you.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Xpovio is usually taken only on specific days, once or twice per week. Follow your doctor's instructions very carefully about when and how to take Xpovio with dexamethasone and/or bortezomib.

Your doctor will determine how long to treat you with this medicine.

Take Xpovio with a full glass of water. Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking Xpovio, do not take another dose. Take your next dose as scheduled.

You may be given other medications to help prevent nausea, vomiting, or infections. Keep taking these medicines for as long as your doctor has prescribed.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests. You may need a transfusion if your blood platelets get too low.

Your blood sodium levels will need to be tested. If the levels get too low, your doctor may prescribe salt tablets or intravenous (IV) fluids to keep you from getting dehydrated.

Drink plenty of liquids to prevent dehydration, and eat enough calories to prevent weight loss.

Selinexor can affect your appetite or ability to eat. You will be weighed before and during treatment to make sure you are not losing weight while taking Xpovio.

Dosing information:

Usual Adult Dose for Multiple Myeloma:
IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE (SVd):

• 100 mg orally once weekly on Day 1 of each week until disease progression or unacceptable toxicity in combination with bortezomib 1.3 mg/m2 subcutaneously once weekly on Day 1 of each week for 4 weeks followed by 1 week off; dexamethasone 20 mg orally twice weekly on Days 1 and 2 of each week

IN COMBINATION WITH DEXAMETHASONE:

• 80 mg orally on Day 1 and 3 of each week until disease progression or unacceptable toxicity in combination with dexamethasone 20 mg orally with each dose of selinexor on Days 1 and 3 of each week

Comments:

• For additional information regarding the administration of bortezomib and dexamethasone, refer to its prescribing information.
• Consider IV hydration for patients at risk of dehydration.
• Provide prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents prior to and during therapy.

Uses:

• In combination with bortezomib and dexamethasone for patients with multiple myeloma who have received at least 1 prior therapy
• In combination with dexamethasone for patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody

Usual Adult Dose for Lymphoma:

• 60 mg orally on Day 1 and 3 of each week until disease progression or unacceptable toxicity

Comments:

• Consider IV hydration for patients at risk of dehydration.
• Provide prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents prior to and during therapy.

Use: For the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

What if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

How should I store this medication?

Store at room temperature away from moisture and heat. Keep each Xpovio tablet in the blister pack until you are ready to take your dose.

What should I avoid while taking Xpovio?

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

What are the possible side effects of using this medication?

Get emergency medical help if you have signs of an allergic reaction to Xpovio:

• hives;
• difficulty breathing;
• swelling of your face, lips, tongue, or throat.

Xpovio can cause serious or fatal side effects. Some side effects may not occur until you have been taking this medicine for several days or weeks.

Call your doctor at once if you have:

• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• severe ongoing nausea, vomiting, or diarrhea;
• loss of appetite that prevents you from eating and causes weight loss;
• confusion, dizziness, fainting, or changes in mental status;
• symptoms of sepsis - fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• signs of infection - fever, chills, flu symptoms, cough with mucus, mouth and throat ulcers, feeling short of breath, tingly or painful blistering rash on one side of your body; or
• low sodium level - headache, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Your treatments may be delayed or permanently discontinued if you have certain side effects.

Common Xpovio side effects may include:

• double vision, blurred vision, sensitivity to light or glare;
• tiredness;
• numbness, tingling, or burning pain in your hands or feet;
• anemia, bruising or bleeding;
• increased blood sugar;
• fever, infections, cold or flu symptoms;
• changes in sodium and mineral levels;
• abnormal liver or kidney function tests;
• nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• weight loss; or
• shortness of breath.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Xpovio?

Other drugs may interact with selinexor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.