Xpovio

Generic name: Selinexor
Drug class: Miscellaneous antineoplastics

Usage of Xpovio

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.

Xpovio side effects

Get emergency medical help if you have signs of an allergic reaction to Xpovio: hives; difficult 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.

Before taking Xpovio

To make sure Xpovio is safe for you, tell your doctor if you have:

cataracts;

bleeding problems; or

an active or recent infection.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Selinexor can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Xpovio.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because selinexor can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Xpovio is not approved for use by anyone younger than 18 years old.

Relate drugs

How to use Xpovio

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

Warnings

Xpovio affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, flu symptoms, cough, mouth ulcers, or trouble breathing,

Xpovio can also cause low platelet counts in your blood. Tell your doctor right away if you have unusual bruising or bleeding.

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.

Disclaimer

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