Frequently Asked Questions about Daurismo® (glasdegib)
Generic Name: glasdegib
Trade Name: Daurismo®
For which conditions is Daurismo approved for? Daurismo in combination with cytarabine is indicated for the treatment of adults 75 years of age or older with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy due to comorbidities. Daurismo has not been studied in patients with severe kidney impairment or moderate-to-severe liver impairment. The labeling contains a boxed warning to alert healthcare professionals and patients that Daurismo can cause severe birth defects and death to an unborn baby.
What is the mechanism of action? Daurismo is a “Hedgehog pathway inhibitor.” The Hedgehog signaling pathway plays an essential role in embryogenesis, the process by which human embryos are developed. In adults, the abnormal activation of the hedgehog pathway appears to contribute to the development and persistence of cancer stem cells. Daurismo disruption of this pathway prevents the development and survival of these cancer stem cells.
How is Daurismo typically given (administered)? Daurismo is taken orally, once per day at the same time each day. Daurismo should be swallowed whole (do not chew or split) with or without food. If you miss a dose or vomit immediately after you have taken Daurismo, take the dose of Daurismo as soon as possible on the same day and take your next dose the next day at your regularly scheduled time; do not take two doses within 12 hours. However, do not take two doses at the same time to make up for a missed dose.
How are patients typically monitored? During treatment with Daurismo, at a minimum your healthcare provider will do blood tests to check your blood counts as well as monitor electrocardiograms and electrolytes.
What are the common (occur in 20% or more of patients) side effects of treatment with Daurismo?
- Low red blood cell count (anemia)
- Fever with low white blood cell count
- Muscle pain
- Swelling of arms or legs
- Low platelet count
- Shortness of breath
- Decreased appetite
- Changes in taste
- Mouth sores
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here and Daurismo may affect fertility in males. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious. Tell your doctor right away if you feel faint, lightheaded, dizzy or experience irregularity in your heart beat during treatment.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
Do not donate semen, blood for at least 30 days after your last dose.
What can patients do to help alleviate or prevent discomfort and side effects?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor right away if you or your partner become pregnant during treatment with Daurismo.
Are there any special precautions patients should be aware of before starting treatment?
Tell your doctor about all of your medical conditions including if you have heart problems, experience abnormal electrolyte levels or if you are pregnant or plan on becoming pregnant. Do not breastfeed during treatment with Daurismo and for at least 30 days after the last dose.
When should patients notify their physician? Tell your doctor if you experience any side effects that bother you or don’t go away. Contact your doctor right away if you feel dizzy, lightheaded, faint or experience weakness or tingling in your extremities, numbness, sensory changes or difficulty breathing.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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