Glasdegib

What is Glasdegib?

• Glasdegib (Daurismo) is a hedgehog pathway inhibitor used in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML).

Glasdegib

What are the uses of this medicine?

Glasdegib (Daurismo) is a prescription medicine that is used with the medicine cytarabine to treat newly-diagnosed acute myeloid leukemia (AML) in adults who:

• are 75 years of age or older, or
• have other medical conditions that prevent the use of standard chemotherapy

How does this medicine work?

• Glasdegib (glas deg' ib) is a potent small molecule inhibitor of hedgehog, a signaling molecule that is frequently overexpressed in cancer cells including leukemia stem cells in patients with acute myeloid leukemia (AML).
• The hedgehog intracellular signaling cascade promotes cell growth and proliferation.
• Mutations in hedgehog are found in many types of cancer cells and can lead to unregulated cell growth.
• Glasdegib in combination with cytarabine with or without daunorubicin has been found to induce disease remissions and prolong overall survival in patients with AML and high-risk myelodysplastic syndromes who are unsuitable for conventional chemotherapy regimens.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following:

• amiodarone (Nexterone, Pacerone), carbamazepine (Carbatrol, Equetro, Tegretol, others), chlorpromazine, cilostazol, citalopram (Celexa), clarithromycin, disopyramide (Norpace), dofetilide, donepezil (Aricept), dronedarone (Multaq), efavirenz (Sustiva, in Atripla, Symfi), escitalopram (Lexapro), flecainide (Tambocor), fluconazole (Diflucan), haloperidol (Haldol), ibutilide (Corvert), indinavir (Crixivan), itraconazole (Sporanox, Onmel), ketaconazole, methadone (Dolophine, Methadose), nefazodone, nelfinavir (Viracept), nevirapine (Viramune), ondansetron (Zofran, Zuplenz), phenobarbital, phenytoin (Dilantin, Phenytek), pimozide (Orap), pioglitazone (Actos, in Oseni, Duetact, Actoplus Met), procainamide, quinidine (in Nuedexta), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifater, Rifamate), ritonavir (Norvir, in Viekira Pak, Kaletra, Technivie), sotalol (Betapace, Sorine, Sotylize), and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Many other medications may also interact with glasdegib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• Tell your doctor what herbal products you are taking, especially St. John's wort.
• Tell your doctor if you have or have ever had prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), heart failure (condition in which the heart cannot pump enough blood to other parts of the body), or low levels of magnesium or potassium in your blood.

Is this medicine FDA approved?

• Glasdegib received accelerated approval for this indication in the United States in 2018 and is available in tablets of 40 mg under the brand name Daurismo.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Daurismo is 100 mg orally once daily on days 1 to 28 in combination with cytarabine 20 mg subcutaneously twice daily on days 1 to 10 of each 28-day cycle in the absence of unacceptable toxicity or loss of disease control.

Administration:

• Take Daurismo with the medicine cytarabine exactly as your healthcare provider tells you.
• Take Daurismo 1 time each day, at about the same time each day.
• Take Daurismo with or without food.
• Do not chew, split or crush Daurismo tablets.
• If you miss a dose, take it as soon as you remember. If it is less than 12 hours before your next dose, just skip the missed dose and take your next dose at your regular time. Do not take 2 doses of Daurismo within 12 hours.
• If you vomit after taking a dose of Daurismo, do not take an extra dose, just take your next dose at your regular time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 100 mg, 25 mg

This medicine is available in fallowing brand namesː

• Daurismo

What side effects can this medication cause?

The most common side effects of this medicine include:

• low red blood cell count (anemia)
• tiredness
• bleeding
• fever with low white blood cell count
• muscle pain
• nausea
• swelling of arms or legs
• low platelet count
• shortness of breath
• decreased appetite
• changes in taste
• pain or sores in your mouth or throat
• constipation
• rash

Daurismo can cause serious side effects, including:

• cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects

What special precautions should I follow?

• Based on its mechanism of action and findings from animal embryo-fetal developmental toxicity studies, Daurismo can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus.
• Patients treated with Daurismo can develop QTc prolongation and ventricular arrhythmias, including ventricular fibrillation and ventricular tachycardia. Interrupt Daurismo if QTc increases to greater than 500 ms. Discontinue Daurismo permanently for patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.
• Advise patients not to donate blood or blood products during treatment with Daurismo and for at least 30 days after the last dose.
• Do not donate semen during treatment with Daurismo and for at least 30 days after the last dose.
• Advise males of reproductive potential of the potential for impaired fertility from Daurismo. Advise male patients to seek advice on effective fertility preservation before treatment.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea
• vomiting
• dehydration
• hypotension
• fatigue
• dizziness

Management of overdosage:

• There is no specific antidote for Daurismo.
• Management of Daurismo overdose should include symptomatic treatment and ECG monitoring.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings in animal embryo-fetal developmental toxicity studies, Daurismo can cause fetal harm when administered to a pregnant woman.
• Daurismo is not recommended for use during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Daurismo have not been established in pediatric patients.
• It is not known if Daurismo is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: glasdegib
• Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
• Film-coating:
• 25 mg tablets: Opadry II Yellow (33G120011) containing hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, and iron oxide yellow.
• 100 mg tablets: Opadry II Beige (33G170003) containing hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin, iron oxide yellow, and iron oxide red.

Who manufactures and distributes this medicine?

Packager: Pfizer Laboratories Div Pfizer Inc

What should I know about storage and disposal of this medication?

• Store Daurismo at room temperature between 68°F to 77°F (20°C to 25°C).

Alphabetic list of antineoplastic agents - 0-9 - A1 - A2 - A3 - A4 - A5 -A6 - B - C - D - E - F - G - H - I - JK - L - M - NO - PQ - R - S - T - UVW - XYZ

• Dailymed label info on Glasdegib
• FDA Glasdegib

Glasdegib Resources
Latest articles Most recent articles Ongoing trials	Wikipedia

Glasdegib Resources
Latest articles Most recent articles Ongoing trials	Wikipedia