Ponaxen-15/45mg-Ponatinib | Leukemia Targeted Therapy

Package Insert of Ponaxen-15/45mg-Ponatinib| ICLUSIG

Description

Ponaxen-15/45mg-Ponatinib is a type of multi-targeted tyrosine-kinase inhibitor. Bangladeshi pharmaceutical Everest is the manufacturer of Ponaxen.

It is primarily used for treating chronic myeloid leukemia (CML) and Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

The medicine targets CML with the T315I mutation, which is generally resistant to current therapies such as imatinib. Due to its effectiveness against these tumors, Ponaxen has proven to be a valuable treatment option.

Ponaxen-15/45mg-Ponatinib FDA Approval and Indications

Ponaxen-15/45mg-Ponatinib is a tyrosine kinase inhibitor, received approval from the US FDA in 2012.

The approval was for patients with chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL). Who were either unable to tolerate or resistant to other treatments.

FDA gave full approval of Ponatinib in 2016 and updated it’s label. The updated label included patients with CML, chronic phase, accelerated phase, or blast phase. The label also included Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL).

Ponatinib Mechanism of Action

Ponaxen-15/45mg-Ponatinib is a BCR-ABL tyrosine kinase inhibitor, that specifically targets BCR-ABL. BCR-ABL is an abnormal tyrosine kinase found in both CML and Ph+ ALL.

CML is a condition that is characterized by excessive production of white blood cells due to a genetic abnormality. Which can lead to aggressive phases like accelerated or blast crises.

Ph+ ALL, on the other hand, is a subtype of acute lymphoblastic leukemia (ALL). That carries the Ph+ chromosome, which produces BCR-ABL.

Both of these diseases express the BCR-ABL protein, which makes them potentially susceptible to ponatinib treatment. BCR-ABL is detected in 95% of patients with CML.

Dosage and Administration

The recommended dose of iclusig/Ponatinib is 45 mg administered orally once daily. Continue treatment as long as the patient does not show evidence of disease progression or unacceptable toxicity. Ponaxen can be taken with or without foods. Tablets should be swallowed whole.

Dosage adjustments

• Hepatic impairment:

Reduce the starting dose to 30 mg once a day in patients with pre-existing hepatic impairment (Child-Pugh A, B, or C).

• Concomitant use of strong CYP3A inhibitors:

Reduce the dose to once a day in patients who are taking strong CYP3A inhibitors.

• Adverse reactions:

Dose reductions may be necessary for adverse reactions, such as blood clots, arterial occlusion, heart problems, and liver damage.

Dose reduction schedule

• First reduction: 30 mg PO q Day
• Second reduction: 15 mg PO q Day
• Third reduction: 10 mg PO q Day
• Unable to tolerate 10 mg/day: Permanently discontinue

Monitoring

Doctor should monitor the patients closely for adverse reactions including blood clots, arterial occlusion, heart problems, and liver damage.

Complete blood counts (CBCs) should be performed at least weekly for the first 2 months of therapy and then monthly thereafter.

Liver function tests (LFTs) should be performed at least monthly for the first 3 months of therapy and then every 3 months thereafter.

Storage

Ponaxen tablets should be stored at room temperature (15-30°C) in a dry place.

Ponatinib Side Effects

Ponaxen-15/45mg-Ponatinib is a tyrosine kinase inhibitor (TKI) used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) in adults. However, it can cause serious side effects.

The most common side effects of Ponaxen include:

• Skin rash
• Joint pain
• Stomach ache
• Headache
• Constipation
• Blood pressure
• Shortness of breath
• Dry skin

Other side effects of Ponaxen include:

• Increased risk of infection
• Breathlessness and looking pale
• Bruising, bleeding gums, or nosebleeds

Ponaxen can also cause serious side effects, including:

• Blood clots: Ponaxen can increase the risk of blood clots in the arteries and veins. This can lead to serious problems, such as stroke, heart attack, and blood clots in the lungs.
• Arterial occlusion: Ponaxen can cause narrowing of the arteries (arterial occlusion). This can lead to serious problems, such as stroke, heart attack, and gangrene.
• Heart problems: Ponaxen can cause heart problems, such as heart failure, irregular heartbeat, and heart attack.
• Liver damage: Ponaxen can cause liver damage. This can lead to serious problems, such as liver failure.

Ponatinib Price/Iclusig Price

The price of Iclusig 15mg and Iclusig 45mg (ponatinib) can vary depending on several factors. However, the wholesale acquisition cost (WAC) of Iclusig is $20,126 per bottle of 30 tablets, regardless of strength.

But the price of Ponaxen which is the generic version of ICLUSIG is much less than the ICLUSIG. As the price varies from time to time contact us to know the original price. Thank you.

To order ponaxen 15mg and ponaxen 45mg tablet contact us through WhatsApp (+8801304498958), Facebook, Instagram.

Clinical Trials

In 2010, ARIAD conducted a Phase I study on ponatinib in patients with resistant and refractory chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). The study showed that 66% of patients achieved a major cytogenetic response, including 100% with a T315I mutation.

The pivotal phase II trial, PACE, started enrolling patients in September 2010 and provided definitive clinical data for regulatory approval. The phase-III trial, EPIC, began in June 2012 and was halted on October 18, 2013.

Success Rate of Ponatinib

Ponatinib is a highly effective treatment for chronic myeloid leukemia (CML), even in patients resistant to other tyrosine kinase inhibitors. In the PACE trial, the 2-year overall survival rate was 85%, and the 2-year complete cytogenetic response rate was 46%. In the OPTIC trial, the 1-year overall survival rate was 79%, and the 1-year complete remission rate was 71%. Both trials demonstrate the effectiveness of ponatinib in treating CML and ALL in adults.

What is Reversible posterior leukoencephalopathy syndrome?

RPLS is a clinical radiographic syndrome of heterogeneous etiologies. That are grouped together because of similar findings on neuroimaging studies. It is also often referred to as

• Posterior reversible encephalopathy syndrome (PRES)
• Reversible posterior cerebral edema syndrome
• Posterior leukoencephalopathy syndrome
• Hyper fusion encephalopathy

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FAQ about Ponaxen-15/45mg-Ponatinib

How to use Ponaxen-15/45mg-Ponatinib?

Ponaxen-15/45mg-Ponatinib is an oral medicinethat comes in the fotabletswhichblet that means yotakee to taken it by mouth with or without f once in a day according to the prescription of your doctor.

What should I do if I miss doses of Pontinib ?

Contact immediately with your doctor if you miss a dose or several doses of Ponaxen.

What are the common side effects of Ponaxen-15/45mg-Ponatinib?

The common side effects of Ponatinib are bladder pain, cloudy urine, cough, coughing blood, decrease in urine output and so on.

How long can you take Ponatinib?

It actually depends on the condition of the patients or how their body react to the medicine. Normally doctors suggest to take Ponatinib untill it stop working or get too bad side effect.

Dose Ponatinib cause weight gains?

Contact your doctor if you face anything suspicious using this like rapid weight gain, decrease in the amount of urine .

Is ponatinib better than Dasatinib?

Research shows that in analysis in terms of using Ponatinib comparing to Dasatinib , Ponatinib is more effective than Dasatinib. It is more effective in blocking tumor cells than Dasatinib. We confirmed that ponatinib was more potent than dasatinib to induce apoptosis and inhibit proliferation of CML cells, in consensus with IPA and GO analysis results.

What class of drug is Ponatinib?

Ponatinib is a kinase Inhibitor. It works by blocking the action of an abnormal protein that signals cancer cells to multiply this helps stop the spread of cancer cells.

What generation is Ponatinib?

Ponaxen-15/45mg-Ponatinib is a third generation inhibitor for the patients who have CML.

Is Ponatinib approved for CML?

The approval of ponatinib for patients with chronic myeloid leukemia with resistance or intolerance of at least 2 prior kinase inhibitors, with appropriate monitoring and screening for AOE risk factors, provides another treatment option for patients with a poorer prognosis.