oral Bcr-Abl tyrosine kinase inhibitor Dasatinib CAS NO.302962-49-8

Anidulafungin

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Drug Type:  Dasatinib is a targeted therapy. Dasatinib is classified as a signal transduction inhibitor - tyrosine kinase inhibitor. (For more detail, see "How this drug works

What Dasatinib Is Used For

Treatment of chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapyTreatment of Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Dasatinib Is Given:

Dasatinib is a tablet to be taken by mouth.

Dasatinib may be taken with or without food.

Do not break, crush or chew Dasatinib tablets.

If you miss a dose of Dasatinib, take your next scheduled dose at its regular time.  Do not take 2 doses of Dasatinib at the same time.  Call your healthcare provider if you are not sure what to do. 

The amount of Dasatinib that you will receive depends on many factors, such as the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Dasatinib Side Effects:

Important things to remember about the side effects of Dasatinib:

You will not get all of the Dasatinib side effects mentioned below.

Dasatinib side effects are often predictable in terms of their onset, duration, and severity.

Dasatinib side effects are almost always reversible and will go away after therapy is complete.

Dasatinib side effects are quite manageable. There are many options to minimize or prevent them.

When To Contact Your Doctor or Health Care Provider

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

Fever of 100.5° F (38° C) or higher, chills (possible signs of infection)

Experience bleeding or easy bruising. 

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

Swelling, weight gain, or increasing shortness of breath.

Nausea (interferes with ability to eat and unrelieved with prescribed medication).

Vomiting (vomiting more than 4-5 times in a 24 hour period).

Diarrhea (4-6 episodes in a 24-hour period).

Unusual bleeding or bruising.

Black or tarry stools, or blood in your stools.

Blood in the urine.

Pain or burning with urination.

Extreme fatigue (unable to carry on self-care activities).

Mouth sores (painful redness, swelling or ulcers).

Always inform your health care provider if you experience any unusual symptoms.

Dasatinib Precautions:

Before starting Dasatinib treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.

Dasatinib interacts with many common medications. Be sure to notify your doctor before starting any new medications.

Do not receive any kind of immunization or vaccination without your doctor’s approval while taking Dasatinib.

Inform your health care professional if you are pregnant or may be pregnant prior to starting Dasatinib treatment.  Pregnancy category D (Dasatinib may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)

For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking dasatinib. Barrier methods of contraception, such as condoms, are recommended.

Do not breast feed while taking Dasatinib.

Dasatinib Self-Care Tips:

Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.

You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.

Wash your hands often.

To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.

Use an electric razor and a soft toothbrush to minimize bleeding.

Avoid contact sports or activities that could cause injury.

To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.

Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.

In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.

Get plenty of rest.

Maintain good nutrition.

If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Dasatinib:

You will be checked regularly by your doctor while you are taking dasatinib, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Dasatinib Works:

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells.  To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that divide rapidly.  Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects. 

Targeted therapy is about identifying other features of cancer cells.  Scientists look for specific differences in the cancer cells and the normal cells.  This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects.  Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells. 

There are different types of targeted therapies, defined in three broad categories.  Some targeted therapies focus on the internal components and function of the cancer cell.  The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die.  There are several types of targeted therapy that focus on the inner parts of the cells.   Other targeted therapies target receptors that are on the outside of the cell.   Therapies that target receptors are also known as monoclonal antibodies.  Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Researchers agree that targeted therapies are not a replacement for traditional therapies.  They may best be used in combination with traditional therapies.  More research is needed to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer. 

Dasatinib belongs to the signal transduction inhibitor category of targeted therapies.  It particularly interferes with multiple protein-tyrosine kinases.

Product Details

Dasatinib, previously known as BMS-354825, is a cancer drug produced by Bristol-Myers Squibb and sold under the trade name Sprycel.

Dasatinib is an oral Bcr-Abl tyrosine kinase inhibitor (inhibits the "Philadelphia chromosome") and Src family tyrosine kinase inhibitor approved for

first line use in patients with chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

It is being evaluated for use in numerous other cancers, including advanced prostate cancer.
Efficacy
In a Phase I dose escalation study published in June 2006, dasatinib was tested in patients who were resistant to or who could not tolerate imatinib.

Complete hematological responses were seen in 37 of 40 patients with chronic-phase CML. Major hematologic responses were seen in 31 of 44 patients

with accelerated-phase CML, CML in blast crisis, or Ph+ ALL.
Molecular targets

Crystal structure (PDB 2GQG) of Abl kinase domain (blue) in complex with dasatinib (red).The main targets of dasatinib are BCR/Abl (the "Philadelphia chromosome"),

Src, c-Kit, ephrin receptors, and several other tyrosine kinases, but not erbB kinases such as EGFR or Her2.
Duration of benefit[edit]Responses were maintained in 95% of patients with chronic-phase CML, with a median follow-up time of >12 months.

In patients with accelerated-phase CML, 82% remained in remission, although with a median follow-up of only 5 months. Nearly all patients with CML

in blast crisis or Ph+ ALL relapsed within 6 months.Susceptible genotypes[edit]Responses were seen in patients with all BCR/Abl genotypes, with the

exception of T315I mutation, which confers resistance to dasatinib, nilotinib and imatinib in vitro.
Toxicities[edit]Neutropenia and myelosuppression were common toxic effects. Fifteen patients (of 84, i.e. 18%) in the above-mentioned study developed

pleural effusions, which were felt to be a side effect of dasatinib. Some of these patients required thoracentesis or pleurodesis to treat the effusions.

Other adverse events included mild to moderate diarrhea, peripheral edema, and headache. A small number of patients developed abnormal liver function

tests which returned to normal without dose adjustments. Mild hypocalcemia was also noted, but did not appear to cause any significant problems.Several

cases of pulmonary arterial hypertension (PAH) were found in patients treated with dasatinib.[7]
Adverse effects[edit]On October 11, 2011 the U.S. Food and Drug Administration (FDA) announced that dasatinib may increase the risk of a rare but serious

condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary hypertension, PAH). Symptoms of PAH may include shortness

of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting dasatinib, including

after more than one year of treatment.
Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.[8]
Cost[edit]The Union for Affordable Cancer Treatment objected to the price of dasatinib, in a letter to the U.S. trade representative. The average wholesale

price in the U.S. is $367 per day, twice the price in other high income countries. The price in India, where the average annual per capita income is $1,570,

and where most patients pay out of pocket, is Rs6627 ($108) a day. Indian manufacturers offered to supply generic versions for $4 a day, but, under pressure

from the U.S., the Indian Department of Industrial Policy and Promotion refused to issue a compulsory license.[9]
Bristol-Myers Squibb justified the high prices of cancer drugs with the high R&D costs, but the Union of Affordable Cancer Treatment said that most of the R&D

costs came from the U.S. government, including National Institutes of Health funded research and clinical trials, and a 50% tax credit. In England and Wales,

the National Institute for Health and Care Excellence recommended against dasatinib because of the high cost-benefit ratio.[9]
The Union for Affordable Cancer Treatment said that “the dasatinib dispute illustrates the shortcomings of US trade policy and its impact on cancer patients.”

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Top Pharm Chemical Group is specialized in the New Drug Researching and Developing, and mainly manufacture Chemical Intermediates,  Pharmaceutical APIs and Pilot Production. To meet customers regulatory needs, we can offer products from gram to kilo and tons scale, and we can also support our customers with the DMF and other documents to Complete the registration.  

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