Ponaxen-15/45mg-Ponatinib

Description

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

Description

Ponaxen-15/45mg-Ponatinib is a type of multi-targeted tyrosine-kinase inhibitor that has been developed by ARIAD Pharmaceuticals. 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. (1)

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

Ponaxen-15/45mg-Ponatinib, a type of medication called tyrosine kinase inhibitor, received approval from the US FDA in 2012. The approval was specifically for patients who had chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL) who were either unable to tolerate or resistant to other treatments. However, the FDA Accelerated Approval program required further studies to be conducted, which were completed in 2016. After the completion of these studies, full approval was granted, and the label was updated. The updated label included patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia as well as Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL). Additionally, approval was granted for patients who tested positive for T315I and Philadelphia chromosome-positive acute lymphoblastic leukemia. (2)

Mechanism of Action

Ponaxen-15/45mg-Ponatinib is a medication that specifically targets BCR-ABL, which 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.

Currently, front-line therapies like nilotinib and/or Dasatinib are given to patients, but 22-33% of them discontinue the therapy within two years due to adverse events, treatment failure, and other causes. (3)

Dosage and Administration

The recommended dose and schedule for 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 may be taken with or without food. Tablets should be swallowed whole.

Dosage adjustments

• Hepatic impairment: Reduce the starting dose to 30 mg once daily in patients with pre-existing hepatic impairment (Child-Pugh A, B, or C).
• Concomitant use of strong CYP3A inhibitors: Reduce the dose to 30 mg once daily 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

Patients taking Ponaxen should be monitored 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. (4)

Side Effects of Ponaxen-15/45mg-Ponatinib

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

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. (5)

Ponatinib | ICLUSIG price

The price of Iclusig (ponatinib) can vary depending on several factors, including your insurance coverage, the pharmacy you use, and your location. 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.

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 Ponaxen-15/45mg-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.

Buy Ponatinix15/45mg, Lorbrexen 100mg, Ventoxen-100mg, Dasanix-50mg,

Read about signs and symptoms of lung cancer

FAQ about Ponaxen-15/45mg-Ponatinib