Generic Imatinib Mesylate (Veenat Tablets)

Generic Imatinib Mesylate Tablets
© Clearsky Pharmacy
Generic Imatinib Mesylate (Veenat Tablets) is used to
treat certain types of cancer (such as acute
lymphoblastic leukemia, chronic myeloid leukemia,
gastrointestinal stromal tumors, and
myelodysplastic/myeloproliferative diseases). This
medicine is a chemotherapy drug that works by slowing
or stopping the growth of cancer cells.

Veenat Tablets
Veenat Tablets are manufactured by
Natco Pharma Limited, India.
(Website: www.natcopharma.co.in)

Imatinib Mesylate Tablets – Brand Names
Imatinib Mesylate tablets are available
as Gleevec, Veenat, Imatib, Celonib,
Imalek, Glivec, Lupinib, Mesylonib,
Mitinab Imatinib Shantinib Unitinib
Levin and Imanib.

Active Ingredient
The active ingredient contained in Veenat
tablets is Imatinib Mesylate. Each Veenat
tablet contains 100 mg or 400 mg of Imatinib
Mesylate.

Chemical Structure
The structure of Imatinib Mesylate is given
below:

Uses of Veenat Tablets
Veenat tablets are used to treat newly
Diagnosed Philadelphia Positive Chronic
Myeloid Leukemia (Ph+ CML), Ph+ CML in Blast
Crisis (BC), Accelerated Phase (AP) or Chronic
Phase (CP) After Interferon-alpha (IFN)
Therapy, Adult patients with Ph+ Acute
Lymphoblastic Leukemia (ALL),
Myelodysplastic/Myeloproliferative Diseases
(MDS/MPD), Aggressive Systemic Mastocytosis
(ASM), Hypereosinophilic Syndrome (HES)
and/or Chronic Eosinophilic Leukemia (CEL)
and Dermatofibrosarcoma Protuberans (DFSP).

Generic Imatinib Dosage
➢Adult Patients with Ph+ CML CP, AP, or BC : The
recommended dose of Generic Imatinib Mesylate
tablets is 400 mg/day for adult patients in chronic
phase CML and 600 mg/day for adult patients in
accelerated phase or blast crisis.
The dosage of Veenat tablets (Generic Imatinib
Mesylate) is given below. The prescribed dose must
be administered orally, along with a meal and a large
glass of water. Doses of 400 mg or 600 mg should be
administered once daily, whereas a dose of 800 mg
should be administered as 400 mg twice a day. Imatinib
tablets should not be crushed.

Veenat Tablets - Dosage
➢Adult Patients with Ph+ ALL: The recommended dose
of imatinib mesylate tablets is 600 mg/day for adult
patients with relapsed/refractory Ph+ ALL.
➢ Adult Patients with MDS/MPD: Determine PDGFRb
gene rearrangements status prior to initiating treatment.
The recommended dose of imatinib mesylate tablets is
400 mg/day for adult patients with MDS/MPD.
➢Adult Patients with ASM: Determine D816V c-Kit
mutation status prior to initiating treatment. The
recommended dose of imatinib mesylate tablets is 400
mg/day for adult patients with ASM without the D816V
c-Kit mutation
The dosage of Generic Imatinib Mesylate (Veenat
Tablets) is given below:

Veenat Tablets - Dosage
➢Adult Patients with DFSP: The recommended dose
of imatinib mesylate tablets is 800 mg/day for adult
patients with DFSP.Adult Patients with HES/CEL:
The recommended dose of imatinib mesylate tablets
is 400 mg/day for adult patients with HES/CEL.
The dosage of Generic Imatinib Mesylate (Veenat
Tablets) is given below:

Storage Instructions
Generic Imatinib Mesylate (Veenat
tablets ) have to be stored at controlled
room temperature i.e. 25°C (77°F)
with excursions permitted between 15°
to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

Generic Imatinib Warnings
Edema and severe fluid retention have occurred in
patients undergoing treatment with this medicine.
Weigh patients regularly and manage unexpected
rapid weight gain by drug interruption and diuretics.
Cytopenias, particularly anemia, neutropenia, and
thrombocytopenia, have occurred. Manage with dose
reduction,dose interruption, or discontinuation of
treatment. Perform complete blood counts weekly for
the first month, biweekly for the second month, and
periodically thereafter.
Severe congestive heart failure and left ventricular
dysfunction have been reported, particularly in
patients with comorbidities and risk factors. Monitor
and treat patients with cardiac disease or risk factors
for cardiac failure.

Severe hepatotoxicity including fatalities may
occur. Assess liver function before initiation of
treatment and monthly thereafter or as clinically
indicated. Monitor liver function when combined
with chemotherapy known to be associated
with liver dysfunction.
Grade 3/4 hemorrhage has been reported in
clinical studies in patients with newly diagnosed
CML and with GIST. GI tumor sites may be the
source of GI bleeds in GIST.
Gastrointestinal perforations, some fatal, have
been reported.

Cardiogenic shock/left ventricular dysfunction
has been associated with the initiation of
Veenat in patients with conditions associated
with high eosinophil levels (e.g. HES,
MDS/MPD and ASM).
Bullous dermatologic reactions (e.g., erythema
multiforme and Stevens-Johnson syndrome)
have been reported with the use of Imatinib
tablets (Veenat).
Hypothyroidism has been reported in
thyroidectomy patients undergoing
Levothyroxine replacement. Closely monitor
TSH levels in such patients.

Fetal harm can occur when Generic Imatinib is
administered to a pregnant woman. Apprise
women of the potential harm to the fetus, and to
avoid pregnancy when taking Imatinib tablets.
Growth retardation occurring in children and pre-
adolescents receiving Imatinib Mesylate tablets
has been reported.
Close monitoring of growth in children under
Veenat treatment is recommended.
Tumor lysis syndrome. Close monitoring is
recommended in such patients.

Veenat Tablets Warnings
Reports of motor vehicle accidents have been
received in patients receiving Imatinib
Mesylate tablets (Veenat). Caution patients
about driving a car or operating machinery.
Renal toxicity. A decline in renal function may
occur in patients receiving Imatinib Mesylate
tablets (Veenat). Evaluate renal function at
baseline and during therapy, with attention to
risk factors for renal dysfunction.

Veenat Tablets
Contraindications
Veenat tablets are contraindicated in
patients with a hypersensitivity to
Imatinib Mesylate or any other
component of this medication.

Imatinib (Veenat Tablets) Side Effects
➢The most frequently reported side effects of Imatinib
Mesylate (Veenat Tablets) with an incidence rate equal to
or greater than 30% were edema, nausea, vomiting,
muscle cramps, musculoskeletal pain, diarrhea, rash,
fatigue and abdominal pain.
➢The following are serious side effects of this medicine:
Fluid Retention and Edema, Hematologic Toxicity,
Congestive Heart Failure and Left Ventricular Dysfunction,
Hepatotoxicity, Hemorrhage, Gastrointestinal Disorders,
Hypereosinophilic Cardiac Toxicity, Dermatologic
Toxicities, Hypothyroidism, Growth Retardation in
Children and Adolescents, Tumor Lysis Syndrome,
Impairments Related to Driving and Using Machinery and
Renal Toxicity.

Veenat Tablets Overdose
Experience with doses greater than 800 mg is
limited. The following adverse effects occurred in the
following reported cases of adult overdose.
1,200 mg –1,600 mg (duration varying between 1 to
10 days): Nausea, vomiting, diarrhoea, rash
erythema, oedema, swelling, fatigue, muscle
spasms, thrombocytopenia, pancytopenia,
abdominal pain, headache, decreased appetite.
1,800 mg –3,200 mg (as high as 3,200 mg daily for
6 days): Weakness, myalgia, increased CPK
(creatine phosphokinase), increased bilirubin, GI
pain.

Veenat Tablets Overdose
6,400 mg (single dose): One case in the
literature reported 1 patient who
experienced nausea, vomiting, abdominal
pain, pyrexia, facial swelling, neutrophil
count decreased, and increased
transaminases.
8 g to 10 g (single dose): Vomiting and GI
pain have been reported.

Imatinib Tablets Overdose
In the event of Imatinib Mesylate (Veenat
Tablets) overdosage, the patient should be
observed and appropriate supportive
treatment given.

Imatinib Mesylate During Pregnancy
Imatinib Mesylate (Veenat tablets) has been
classified by the US FDA as Pregnancy Category D.
Women of childbearing potential should be advised
to avoid becoming pregnant while taking Veenat
tablets. Imatinib can cause fetal harm when
administered to a pregnant woman.
Imatinib and its active metabolite are excreted into
human milk. Because of the potential for serious
adverse reactions in breastfed infants from Imatinib
Mesylate, a lactating woman must be advised not
to breastfeed during treatment and for one1 month
after the last dose.

Veenat Tablets
For more details on
Veenat Tablets click here
Veenat (Imatinib Mesylate tablets) by
Natco Pharma Limited, India.

Generic Imatinib Mesylate (Veenat Tablets)

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