Generic Name: Dasatinib Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: D

Uses

What is Dasatinib used for?

Dasatinib is used to treat certain types of cancer (chronic myeloid leukemia-CML, acute lymphoblastic leukemia-ALL). It works by slowing or stopping the growth of cancer cells.

How should I take Dasatinib?

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablets whole. Do not crush, chew, or break the tablets.

The dosage is based on your medical condition, response to treatment, lab tests, and other medications you may be taking. Children’s dosage is also based on weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Avoid taking antacids (such as aluminum/magnesium hydroxide, calcium carbonate) within 2 hours before or after taking this medication because they will prevent your body from fully absorbing this drug.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

How do I store Dasatinib?

Dasatinib is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Dasatinib in the bathroom or the freezer. There may be different brands of Dasatinib that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Dasatinib down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Dasatinib?

Before taking dasatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as lactose), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, current/recent infection, heart problems (such as irregular heartbeat), liver problems (such as hepatitis B).

Dasatinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using dasatinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dasatinib safely.

Dasatinib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This medication may affect a child’s bone growth and development. Consult the doctor or pharmacist for more details.

Older adults may be more sensitive to the side effects of this drug, especially diarrhea, swelling hands/ankles/feet, sudden/unexplained weight gain, unusual tiredness, shortness of breath, and QT prolongation (see above).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dasatinib. Dasatinib may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 30 days after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Dasatinib during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Dasatinib. Dasatinib is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Dasatinib?

Diarrhea, nausea/vomiting, muscle/joint pain, stomach/abdominal pain, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: dry cough, swelling/pain in the hands/ankles/feet, sudden/unexplained weight gain, shortness of breath.

Get medical help right away if you have any very serious side effects, including: vomit that looks like coffee grounds, black/bloody stools, severe dizziness, fainting, fast/slow/irregular heartbeat, chest pain, confusion, weakness on one side of the body.

Dasatinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body’s ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: unusual tiredness, pale skin, signs of infection (such as sore throat that doesn’t go away, fever, chills), easy bruising/bleeding.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Dasatinib?

Some products that may interact with this drug are: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, “blood thinners” such as warfarin/dabigatran), drugs that reduce stomach acid (for example, antacids, H2 blockers such as famotidine/ranitidine, proton pump inhibitors such as omeprazole).

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of dasatinib from your body, which may affect how dasatinib works. Examples include azole antifungals (such as itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (such as clarithromycin), rifamycins (such as rifampin, rifabutin), saquinavir, St. John’s wort, telithromycin, among others.

Dasatinib may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Dasatinib?

Dasatinib may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

What health conditions may interact with Dasatinib?

Dasatinib may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Dasatinib.

What is the dose of Dasatinib for an adult?

Usual Adult Dose for Leukemia

Chronic Phase CML:

100 mg orally once a day

Duration of therapy: Until disease progression or patient is intolerant.

Accelerated Phase CML, Myeloid or Lymphoid Blast Phase CML, Ph+ ALL:

140 mg orally once a day

Duration of therapy: Until disease progression or patient is intolerant

Comments:

-This drug should be used at the lowest effective dose in order to achieve therapeutic efficacy and minimize adverse effects.

-The effect of discontinuing therapy after complete cytogenetic response is achieved has not been investigated.

Uses: Chronic phase, accelerated phase, or myeloid or lymphoid blast phase Philadelphia chromosome-positive chronic myelogenous leukemia; Philadelphia chromosome-positive acute lymphoblastic leukemia

Renal Dose Adjustments

Data are not available; however, renal insufficiency is not expected to affect clearance as renal excretion accounts for less than 4% of this drug’s elimination.

Liver Dose Adjustments

No adjustment recommended. Caution is recommended when using in patients with liver impairment.

Dose Adjustments

Dose Adjustments for Neutropenia or Thrombocytopenia:

Chronic Phase CML:

1.) Stop therapy until the ANC is greater than or equal to 1.0 x 10(9)/L and platelets are greater than or equal to 50 x 10(9)/L.

2.) Resume treatment at the original starting dose if recovery occurs in less than or equal to 7 days.

3.) If platelets are less than 25 x 10(9)/L and/or recurrence of ANC less than 0.5 x 10(9)/L for greater than 7 days, repeat Step 1 and resume drug at a reduced dose of 80 mg once a day (second episode) or for a third episode, further reduce dose to 50 mg once a day (for newly diagnosed patients) or discontinue this drug (for patients resistant or intolerant to prior therapy including imatinib).

Accelerated Phase CML, Blast Phase CML and Ph+ ALL:

1.) Check if cytopenia is related to leukemia (marrow aspirate or biopsy).

2.) If cytopenia is unrelated to leukemia, stop this drug until the ANC is greater than or equal to 1.0 x 10(9)/L and platelets are greater than or equal to 20 x 10(9)/L and resume at the original starting dose.

3.) If recurrence of cytopenia, repeat Step 1 and resume this drug at a reduced dose of 100 mg once a day (second episode) or 80 mg once a day (third episode).

  1. If cytopenia is related to leukemia, consider dose escalation to 180 mg once a day.

Dose Adjustment with Non-hematological Adverse Reactions:

If a severe non-hematological adverse reaction develops, treatment must be withheld until the event has resolved or improved. Thereafter, treatment can be resumed as appropriate at a reduced dose depending on the initial severity of the event.

Dose Escalation:

In clinical studies of adult CML and Ph+ ALL patients, dose escalation to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML and Ph+ ALL) was allowed in patients who did not achieve a hematologic or cytogenetic response at the recommended dosage.

Dose Adjustment with concomitant Strong CYP450 3A4 Inducers:

The use of strong CYP450 3A4 inducers should be avoided. If this drug is used with an inducer, the dose of this drug should be increased followed by careful monitoring for adverse reactions.

Dose Adjustment with concomitant Strong CYP450 3A4 Inhibitors:

The use of strong CYP450 3A4 inhibitors should be avoided. If this drug is used with an inhibitor, a dose decrease should be considered. Patients taking 100 mg orally once daily should have dose decreased to 20 mg and patients taking 140 mg orally once daily should have dose decreased to 40 mg. Following dose reduction, if this drug is not tolerated, either the strong CYP450 3A4 inhibitor should be discontinued or this drug should be discontinued until treatment with the inhibitor is discontinued. After the strong inhibitor is discontinued, a washout period of approximately 1 week should be allowed to transpire prior to increasing the dasatinib dose.

What is the dose of Dasatinib for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Dasatinib available?

Dasatinib is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Dasatinib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 31, 2018 | Last Modified: August 31, 2018

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