Ponaxen Tablet
Ponatinib
15 mg
Everest Pharmaceuticals Ltd.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 656.60 AED |
Available as:
Indications
Ponaxen Tablet is used for:
Chronic Myeloid Leukemia, Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Adult Dose
Chronic Myeloid Leukemia
Chronic phase (CP) chronic myeloid leukemia (CML), Accelerated phase (AP) or blast phase (BP) CML, Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy
is indicated, Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
45 mg taken orally once daily
Hepatic Impairment
The recommended starting dose is 30 mg once daily in patients with hepatic impairment (Child-Pugh A, B, or C)
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment is required
Severe (CrCl <30 mL/min): Not studied
Administration
Can be taken with or without food
Contra Indications
Precautions
Hypertension: Monitor for high blood pressure and manage as clinically indicated.
Pancreatitis: Monitor serum lipase monthly; interrupt or discontinue.
Neuropathy: Monitor for symptoms of peripheral and cranial neuropathy.
Ocular Toxicity: Conduct comprehensive eye exams at baseline and periodically during treatment.
Hemorrhage: Interrupt ponatinib for serious or severe hemorrhage.
Fluid Retention: Monitor patients for fluid retention; interrupt, reduce, or discontinue.
Cardiac Arrhythmias: Monitor for symptoms of arrhythmias.
Myelosuppression: Thrombocytopenia, neutropenia, and anemia may require dose interruption or reduction.
Monitor complete blood counts every 2 weeks for 3 months and then monthly and as clinically indicated. Interrupt ponatinib for ANC
Pregnancy-Lactation
Pregnancy
Based on findings in animals and its mechanism of action, fetal harm when administered to pregnant females
No data available on use in pregnant females
Verify pregnancy status of females of reproductive potential before initiation
Contraception
Females of reproductive potential: Use effective contraception during treatment and for 3 weeks after final dose
Infertility
Based on animal data, impair fertility in females of reproductive potential may occur
Unknown whether these effects on fertility are reversible
Animal data
Oral administration to pregnant rats during organogenesis caused adverse developmental effects at doses lower than human exposures at the recommended human dose
Advise pregnant females of potential risk to a fetus
Lactation
There is no data on drug presence in human milk or the effects on breastfed children, or on milk production
Advise females not to breastfeed during treatment and for 6 days following last dose
Interactions
Adverse Effects
Side effects of Ponatinib :
>10%
Hypertension (53-71%)
Neutropenia (24-63%)
Leukopenia (14-63%)
Anemia (9-55%)
Thrombocytopenia (36-57%)
Rash (34-54%)
Abdominal pain (34-49%)
Constipation (24-47%)
Fatigue or asthenia (31-39%)
Headache (25-39%)
Dry skin (24-39%)
Lymphopenia (10-37%)
Pyrexia (23-32%)
Nausea (22-32%)
Arthralgia (13-31%)
Decreased appetite (8-31%)
Diarrhea (13-26%)
Febrile neutropenia (1-25%)
Vomiting (13-24%)
Oral mucositis (9-23%)
Edema, peripheral (13-22%)
Myalgia (6-22%)
Sepsis (1-22%)
Dyspnea (7-21%)
Pleural effusion (3-19%)
Cough (6-18%)
Pain in extremity (9-17%)
Back pain (11-16%)
Pain (6-16%)
Cardiac failure (6-15%)
Chills (7-13%)
Peripheral neuropathy (6-13%)
Muscle spasms (5-13%)
Weight decreased (5-13%)
Arterial ischemia (3-13%)
Pneumonia (3-13%)
Bone pain (9-12%)
Urinary tract infection (7-12%)
Insomnia (7-12%)
Nasopharyngitis (3-12%)
Upper respiratory tract infection (8-11%)
Dizziness (3-11%)
GI hemorrhage (2-11%)
Cellulitis (2-11%)
1-10%
Arterial ischemic event (8%)
MI (5%)
Pancreatitis (5%)
Abdominal pain (4%)
Hemorrhage (4%)
Cardiac failure (4%)
Pneumonia, severe (4%)
Effusions (3%)
Febrile neutropenia (3%)
Thrombocytopenia, severe (3%)
Pyrexia, severe (3%)
Sepsis, severe (2%)
Anemia, severe (2%)
Atrial fibrillation (2%)
Venous thromboembolism (2%)
Hypertension (2%)
Stroke or TIA (2%)
Peripheral arterial disease (2%)
CNS hemorrhage (2%)
GI hemorrhage (2%)
Mechanism of Action
Ponatinib is a kinase inhibitor. Ponatinib inhibited the in vitro tyrosine kinase activity of ABL and T315I mutant ABL with IC 50 concentrations of 0.4 nM and 2.0 nM, respectively. Ponatinib inhibited the in vitro activity of additional kinases with IC 50 concentrations between 0.1 nM and 20 nM, including members of the VEGFR, PDGFR, FGFR, EPH receptors and SRC families of kinases, and KIT, RET, TIE2, and FLT3. Ponatinib inhibited the in vitro viability of cells expressing native or mutant BCR-ABL, including T315I. In mice, treatment with ponatinib reduced the size of tumors expressing native or T315I mutant BCR-ABL when compared to controls.
Note
Ponaxen 15 mg Tablet manufactured by Everest Pharmaceuticals Ltd.. Its generic name is Ponatinib. Ponaxen is availble in Bangladesh.
Farmaco BD drug index information on Ponaxen Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.