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Daurismo (Generic Glasdegib)

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WARNING

Those who are pregnant or may become pregnant should not take Glasdegib. There is a significant chance that glasdegib will result in serious birth abnormalities (physical issues present at birth) or the unborn child’s demise.

Before beginning therapy with glasdegib, female patients who are capable of becoming pregnant must have a pregnancy test and have a negative result within 7 days. Throughout your treatment with glasdegib and for at least 30 days following your last dose, you must take an effective form of birth control. See your doctor about effective birth control methods for you.

You should be aware that glasdegib may be present in the semen and could harm an unborn child if you’re a man dating a woman who can get pregnant or is pregnant. Even if you have had a vasectomy, use a condom while receiving therapy with glasdegib and for at least 30 days following the last dose (surgery to prevent sperm from leaving your body and causing pregnancy). Don’t give away your sperm while you’re receiving therapy and for at least 30 days following your last dose.

If you believe your birth control has failed, had unprotected sex, or believe you or your female partner may be pregnant, call your doctor immediately once.

Don’t give blood or blood products while receiving glasdegib medication and for at least 30 days following your final dosage.

If you need a prescription refill for glasdegib, your doctor or chemist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Why is this medication prescribed?

When treating adults over 75 or those with severe medical issues who cannot receive treatment with other chemotherapy drugs for acute myeloid leukaemia (AML; a form of cancer that starts in the white blood cells), glasdegib and cytarabine are used as a first line of treatment. Glasdegib belongs to a group of drugs known as hedgehog pathway inhibitors. It functions by preventing a protein from signalling cancer cells to proliferate. This aids in halting or reducing the growth of cancer cells.

How should this medicine be used?

Glasdegib is available as an oral tablet. It is typically administered once daily, with or without food, for at least six months or for whatever long your doctor prescribes treatment. Take glasdegib every day at around the same time. Ask your doctor or chemist to explain any instructions on your prescription label that you are unsure about following. Take glasdegib as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not chew, break, or crush the tablets; instead, swallow them whole.

Do not take another dose of glasdegib if you vomit after taking it. Continue taking your medication as usual.

Depending on how you react to the drug and any side effects you have, your doctor may need to pause your therapy, lower the amount, or terminate it altogether. During your glasdegib treatment, be careful to let your doctor know how you are feeling.

Other uses for this medicine

Ask your doctor or chemist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking glasdegib,

  • If you have an allergy to glasdegib, any other medications, or any of the substances in glasdegib tablets, inform your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
  • Inform your doctor and chemist about any prescription and over-the-counter drugs, vitamins, and dietary supplements you are currently taking or intend to take. Incorporate any of the following: carbamazepine, amiodarone (Nexterone, Pacerone) (Carbatrol, Equetro, Tegretol, others), dofetilide, donepezil (Aricept), clarithromycin, disopyramide (Norpace), dronedarone (Multaq), efavirenz (Sustiva, in Atripla, Symfi), citalopram (Celexa), escitalopram (Lexapro), flecainide, and cilostazol (Tambocor), itraconazole (Sporanox, Onmel), ketaconazole, haloperidol (Haldol), ibutilide (Corvert), indinavir (Crixivan), fluconazole (Diflucan), and methadone (Dolophine, Methadose), ondansetron (Zofran, Zuplenz), phenobarbital, phenytoin (Dilantin, Phenytek), pimozide (Orap), pioglitazone (Actos, in Oseni, Duetact, Actoplus Met), nelfinavir (Viracept), nevirapine (Viramune), procainamide, thioridazine, sotalol (Betapace, Sorine, Sotylize), ritonavir (Norvir, in Viekira Pak, Kaletra, Technivie), quinidine (in Nuedexta), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifater, Rifamate), and rifampin. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all of the medications you are taking, even any not on this list, since many other drugs may also interact with glasdegib.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you have or have ever had heart failure, prolonged QT interval (a 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. Prolonged QT interval is a rare heart condition that can result in irregular heartbeat, fainting, or sudden death.
  • Inform your doctor if you are nursing a baby. While receiving therapy with glasdegib and for at least 30 days following your last dosage, you shouldn’t breastfeed.
  • You should be aware that this drug may reduce male fertility. You should discuss the dangers of taking glasdegib with your doctor.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. When your next dose is less than 12 hours away, omit the missed dose and carry on with your regular dosing regimen. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Glasdegib could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Muscles cramping
  • Joint, muscle, or muscle ache
  • Extreme fatigue
  • Nausea
  • Vomiting
  • Abdomen ache
  • Constipation
  • Discomfort or blisters in your throat or mouth
  • Reduction in appetite
  • Alteration in the flavour of items
  • Slim down
  • Headache
  • Rash
  • Hair loss, swollen hands or legs
  • Toothache

Certain adverse effects can be very harmful. Call your doctor right away if any of these symptoms occur to you:

  • Feeling dizzy or faint; having a rapid or erratic heartbeat
  • Significant bruising or bleeding
  • Weakness, a fever with or without chills. or more infections symptoms
  • Less urinations
  • Chest ache

Glasdegib may result in additional adverse effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

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

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Symptoms of overdose may include:

  • Nausea
  • Vomiting
  • Extreme fatigue
  • Dizziness

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests such as electrocardiograms (EKG, test that records the electrical activity of the heart) and blood tests before and during therapy to make sure it is safe for you to take glasdegib and to check your body’s response to the medication.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Daurismo®
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