cataracts in patients presenting with cataracts at start of Xpovio therapy. Treatment of cataracts usually requires surgical removal of the cataract.
Embryo-fetal toxicity Xpovio can cause fetal harm, based on its mechanism of action as well as on data from animal studies. Females of reproductive potential and males with a female partner of reproductive potential must use effective contraception during treatment with Xpovio and for 1 week after the last dose. Do not use Xpovio if you are pregnant. Contact your doctor promptly if you become pregnant or if pregnancy is suspected during treatment with Xpovio.
Lactation There is no information about the presence of Xpovio in human milk, or its effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in a breastfed child, women should not breastfeed during treatment with Xpovio and for 1 week after the last dose.
Infertility Based on findings in animals, Xpovio may harm fertility in males and females of reproductive potential.
Possible side effects of Xpovio and how they are managed
Good communication with your doctor is extremely important while you are receiving treatment for myeloma. If you experience any side effects, alert your doctor as soon as possible. Your side effects may be managed with supportive care, dose reductions, or dose interruptions. It is always better to deal with a problem immediately than to let it get worse. In the STORM phase IIb clinical trial of Xd, side effects that occurred in 20% or more of the study patients were thrombocytopenia, fatigue, nausea, anemia, decreased appetite, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection. In the BOSTON phase III clinical trial of XVd, the most frequent Grade 3 or Grade 4 side effects were thrombocytopenia (39% in the XVd group vs. 17% in the Vd group), fatigue (13% vs. 1%), anemia (16% vs. 10%), and pneumonia (11% in both study arms).
Thrombocytopenia Thrombocytopenia is a low number of platelets in the blood. Platelets help blood to clot; fewer platelets can lead to easier bruising, bleeding, and slower healing. The “normal” level varies from laboratory to laboratory. For example, at Mayo Clinic the “normal” level is ≥ 150,000 platelets per microliter of circulating blood. If the platelet count is less than 50,000, myeloma.org
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