Zoleta

How old is patient? < 1 1-5 6-15 16-29 30-45 46-60 > 60

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• Read drug prescription
• What is Zoleta
• Zoleta side effects
• Zoleta dosing
• Compare prices at online shops
• Select the most affordable brand or generic drug
• Frequently asked Questions
• How should I take Zoleta?
• Who should not take Zoleta?
• What other drugs will affect Zoleta?
• Zoleta reviews

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What is Zoleta

Zoleta interferes with the growth of some cancer cells.
Zoleta is used to treat certain types of leukemia, bone marrow disorders, and skin cancer, or certain tumors of the stomach and digestive system.
Zoleta may also be used for purposes not listed in Zoleta guide.

Zoleta side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:

• fever, chills, body aches, flu symptoms;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• swelling, rapid weight gain, feeling short of breath (even with mild exertion);
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• lower back pain, blood in your urine, little or no urinating;
• numbness or tingly feeling around your mouth;
• muscle weakness, tightness, or contraction, overactive reflexes;
• fast or slow heart rate, weak pulse, confusion, fainting; or
• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• mild nausea or stomach pain, vomiting, diarrhea;
• joint or muscle pain; or
• headache, feeling tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)

Zoleta dosing

Usual Adult Dose for Chronic Myelogenous Leukemia:

Chronic phase: 400 mg orally once a day.
Accelerated phase: 600 mg orally once a day.
Disease progression chronic phase: 600 mg orally once a day.
Disease progression accelerated phase: 400 mg orally twice a day.
A dose increase from 400 mg to 600 mg in adult patients with chronic phase disease, or from 600 mg to 800 mg in adult patients in accelerated phase or blast crisis may be considered in the absence of severe adverse drug reaction and severe non-leukemia related neutropenia or thrombocytopenia in the following circumstances: disease progression (at any time), failure to achieve a satisfactory hematologic response after at least three months of treatment, failure to achieve a cytogenetic response after six to twelve months of treatment, or loss of a previously achieved hematologic or cytogenetic response.
Dose adjustments for Chronic Phase CML (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).
Dose adjustments for Ph+ CML: Accelerated Phase and Blast Crisis (starting dose 600 mg)
ANC less than 0.5 x 10(9)/L and/or Platelets less than 10 x 10(9)/L:
1. Check if cytopenia is related to leukemia (marrow aspirate or biopsy).
2. If cytopenia is unrelated to leukemia, reduce dose of Zoleta to 400 mg.
3. If cytopenia persists 2 weeks, reduce further to 300 mg.
4. If cytopenia persists 4 weeks and is still unrelated to leukemia, stop Zoleta until ANC greater than or equal to 1 x 10(9)/L and platelets greater than or equal to 20 x 109/L and then resume treatment at 300 mg.

Usual Adult Dose for Gastrointestinal Stromal Tumor:

For adult patients with unresectable and/or metastatic, malignant GIST:
Recommended dose: 400 mg/day
A dose increase up to 800 mg daily (given as 400 mg twice daily) may be considered, as clinically indicated, in patients showing clear signs or symptoms of disease progression at a lower dose and in the absence of severe adverse drug reactions.
For the adjuvant treatment of adult patients following complete gross resection of GIST:
Recommended dose: 400 mg/day
In the clinical study, Zoleta was administered for one year. The optimal treatment duration with Zoleta is not known.
Dose adjustments for GIST (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at the original starting dose of 400 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at a reduced dose of 300 mg.

Usual Adult Dose for Acute Lymphoblastic Leukemia:

For use in the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia :
Recommended dose: 600 mg/day for adult patients with relapsed/refractory Ph+ ALL
Dose adjustments for ALL (starting dose 600 mg)
ANC less than 0.5 x 10(9)/L and/or Platelets less than 10 x 10(9)/L:
1. Check if cytopenia is related to leukemia (marrow aspirate or biopsy).
2. If cytopenia is unrelated to leukemia, reduce dose of Zoleta to 400 mg.
3. If cytopenia persists 2 weeks, reduce further to 300 mg.
4. If cytopenia persists 4 weeks and is still unrelated to leukemia, stop Zoleta until ANC greater than or equal to 1 x 10(9)/L and platelets greater than or equal to 20 x 109/L and then resume treatment at 300 mg.

Usual Adult Dose for Systemic Mastocytosis:

Recommended dose: 400 mg/day for patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation. If c-Kit mutational status is not known or unavailable, treatment with Zoleta 400 mg/day may be considered for patients with ASM not responding satisfactorily to other therapies.
Dose adjustments for ASM (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).
For patients with ASM associated with eosinophilia (a clonal hematological disease related to the fusion kinase FIP1L1-PDGFRalpha):
Recommended starting dose: 100 mg/day
A dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Dose adjustments for ASM associated with eosinophilia (starting dose 100 mg)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at previous dose (i.e. before severe adverse reaction).

Usual Adult Dose for Hypereosinophilic Syndrome:

For patients with hypereosinophilic syndrome/chronic eosinophilic leukemia :
Recommended dose: 400 mg/day
Dose adjustments for HES/CEL (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).
For patients with HES/CEL patients with demonstrated FIP1L1-PDGFRalpha fusion kinase:
Recommended starting dose: 100 mg/day
Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Dose adjustments for HES/CEL with FIP1L1-PDGFRalpha fusion kinase (starting dose 100 mg)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at previous dose (i.e. before severe adverse reaction).

Usual Adult Dose for Chronic Eosinophilic Leukemia:

For patients with hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL):
Recommended dose: 400 mg/day
Dose adjustments for HES/CEL (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).
For patients with HES/CEL patients with demonstrated FIP1L1-PDGFRalpha fusion kinase:
Recommended starting dose: 100 mg/day
Dose increase from 100 mg to 400 mg for these patients may be considered in the absence of adverse drug reactions if assessments demonstrate an insufficient response to therapy.
Dose adjustments for HES/CEL with FIP1L1-PDGFRalpha fusion kinase (starting dose 100 mg)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at previous dose (i.e. before severe adverse reaction).

Usual Adult Dose for Dermatofibrosarcoma Protuberans:

Recommended dose: 800 mg/day for patients with dermatofibrosarcoma protuberans
Dose adjustments for DFSP (starting dose 800 mg)
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 X 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at 600 mg.
3. In the event of recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at reduced dose of 400 mg.

Usual Adult Dose for Myeloproliferative Disorders:

Recommended dose: 400 mg/day for patients with myelodysplastic/myeloproliferative diseases (MDS/MPD)
MDS/MPD (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).

Usual Adult Dose for Myelodysplastic Diseases:

Recommended dose: 400 mg/day for patients with myelodysplastic/myeloproliferative diseases
MDS/MPD (starting dose 400 mg)
ANC less than 1.0 x 10(9)/L and/or Platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at the original starting dose of 400 mg or 600 mg.
3. If recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at a reduced dose (300 mg if starting dose was 400 mg, 400 mg if starting dose was 600 mg).

Usual Pediatric Dose for Chronic Myelogenous Leukemia:

Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase:
340 mg/m2 orally once a day or 170 mg/m2 orally twice a day
Maximum Dose: 600 mg daily
Duration of therapy: Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.
Comments: There is no experience with Zoleta treatment in children under 1 year of age.
Dose adjustments for newly diagnosed pediatric chronic phase CML (starting dose 340 mg/m2):
ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L:
1. Stop Zoleta until ANC greater than or equal to 1.5 x 10(9)/L and platelets greater than or equal to 75 x 10(9)/L.
2. Resume treatment with Zoleta at previous dose (i.e. before severe adverse reaction).
3. In the event of recurrence of ANC less than 1.0 x 10(9)/L and/or platelets less than 50 x 10(9)/L, repeat step 1 and resume Zoleta at reduced dose of 260 mg/m2.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia:

Newly diagnosed Ph+ ALL in combination with chemotherapy:
340 mg/m2 orally once a day
Maximum Dose: 600 mg once a day
Duration of therapy: Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.
Comments: There is no experience with Zoleta treatment in children under 1 year of age.

Active ingredients: Imatinib

Compare prices at online shops

Strength	Quantity	Price, USD	Country
Ranbaxy Laboratories Ltd.,
100 mg	10 Capsule	$14.00	India

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IMATIB film-coated tab 400 mg x 10's		$39.44	Cipla
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IMATIB 100MG CAPSULE 1 strip(s) (10 capsules each)		$13.13	Cipla Ltd
Imatinib
100 mg	10	$109.99	Canada, Mauritius, Singapore, Turkey, UK, USA
100 mg	30	$248.40	Australia, Canada, India, Mauritius, NZ, Turkey, UK, USA
100 mg	90	$318.00	Australia, Canada, Mauritius, NZ, Singapore, Turkey, UK, USA
400 mg	30	$328.00	Australia, Canada, Mauritius, NZ, Singapore, Turkey, UK, USA
400 mg	90	$1.00	Australia, Canada, Mauritius, NZ, Singapore, Turkey, UK, USA
400 mg	90	$848.00	Australia, Canada, Mauritius, NZ, Singapore, Turkey, UK, USA
Imatinib 400mg Tablet		$3.50	Sun Pharmaceutical Industries Ltd
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References

1. "Imatinib". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
2. "Imatinib". http://www.drugbank.ca/drugs/DB0061... (accessed August 28, 2018).
3. "Bkj8m8g5hi: the unique ingredient identifier (unii) is an alphanumeric substance identifier from the joint fda/usp substance registration system (srs).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).

Zoleta - Frequently asked Questions

Can Zoleta be stopped immediately or do I have to stop the consumption gradually to ween off?

In some cases, it always advisable to stop the intake of some medicines gradually because of the rebound effect of the medicine.

It's wise to get in touch with your doctor as a professional advice is needed in this case regarding your health, medications and further recommendation to give you a stable health condition.

How should I take Zoleta?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a large glass of water.

You may dissolve the Zoleta tablet in water or apple juice to make swallowing easier.

Zoleta should be taken with a meal. Do not take Zoleta on an empty stomach.

Zoleta can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Store at room temperature away from moisture and heat.

Who should not take Zoleta?

You should not use this medication if you are allergic to Zoleta.

To make sure Zoleta is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease;

• underactive thyroid, recent or upcoming thyroid surgery;

• heart disease, congestive heart failure;

• history of stomach ulcer or bleeding; or

• if you are receiving chemotherapy.

FDA pregnancy category D. Do not use Zoleta if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether Zoleta passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 1 year old without medical advice.

Zoleta can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

What other drugs will affect Zoleta?

Many drugs can interact with Zoleta. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Zoleta, especially:

• acetaminophen (Tylenol);

• aprepitant;

• bosentan;

• cimetidine;

• cyclosporine;

• haloperidol;

• St. John's wort;

• an antibiotic--clarithromycin, ciprofloxacin, doxycycline, erythromycin, metronidazole, nafcillin, norfloxacin, rifabutin, rifampin, rifapentine, tetracycline;

• antifungal medication--clotrimazole, fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole;

• an antidepressant--desipramine, nefazodone, sertraline;

• a blood thinner such as warfarin, Coumadin;

• heart or blood pressure medication--amiodarone, diltiazem, dronedarone, lidocaine, nicardipine, quinidine, verapamil;

• hepatitis C medications--boceprevir, telaprevir;

• HIV/AIDS medication--atazanavir, delavirdine, darunavir when given with ritonavir, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir; or

• seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone.

This list is not complete and many other drugs can interact with Zoleta. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Can Zoleta be taken or consumed while pregnant?

Please visit your doctor for a recommendation as such case requires special attention.

Can Zoleta be taken for nursing mothers or during breastfeeding?

Kindly explain your state and condition to your doctor and seek medical advice from an expert.

Reviews

Following the study conducted by gmedication.com on Zoleta, the result is highlighted below. However, it must be clearly stated that the survey and result is based solely on the perception and impression of visitors and users of the website as well as consumers of Zoleta. We, therefore, urge readers not to base their medical judgment strictly on the result of this study but on test/diagnosis duly conducted by a certified medical practitioners or physician.

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The information was verified by Dr. Vishal Pawar, MD Pharmacology