What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Iclusig (Ponatinib)
Prescription Required
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Product Details
Description
Inclusig (ponatinib) is prescribed for the treatment of Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia and Chronic Myeloid Leukemia in adults.
Inclusig is available in 10 mg, 15 mg, 30 mg, and 45 mg oral tablets.
Fact Table
Formula
C29H27F3N6O
License
US FDA, EMA
Bioavailability
52%
Legal status
Prescription only (Rx)
Chemical Name
3-(2-Imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-{(4-methylpiperazin-1-yl)methyl}-3-(trifluoromethyl)phenyl]benzamide
Elimination half-life
24 hours
Dosage (Strength)
15 mg, 30 mg, 45 mg tablets
Pregnancy
Contraindicated
Brands
Iclusig
Protein binding
>99%
PubChem CID
24826799
MedlinePlus
a613020
ChEBI
CHEBI:78543
ATC code
L01XE24
DrugBank
DB08943
KEGG
D09925
Routes of administration
Oral
Directions
Take Inclusig as prescribed by your doctor, who will determine an appropriate Inclusig dosage for you based on the condition being treated.
Keep Inclusig tablets stored between 20°C to 25°C (68°F to 77°F) and out of reach of children.
For additional information regarding the use of Inclusig, refer to the medication guide that comes with your prescription.
If you have any questions or concerns, speak with your doctor or pharmacist.
Ingredients
The active ingredient in Inclusig is ponatinib.
Inactive ingredients include lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type B), colloidal silicon dioxide, magnesium stearate and a tablet coating that consists of talc, polyethylene glycol, polyvinyl alcohol, and titanium dioxide.
Contraindications
According to the most recent Prescribing Information, there are no contraindications to taking Inclusig.
Cautions
- Inclusig contains the following FDA Boxed Warning:
- Patients treated with Inclusig, including those with and without cardiovascular risk factors and younger than 50 years old, have had arterial occlusive events (AOEs), including mortality, heart attack, stroke, stenosis of large arterial brain vessels, severe peripheral vascular disease, and the need for urgent revascularization procedures. Evidence of AOEs should be monitored. Inclusig should be interrupted or stopped based on severity. Before restarting Inclusig, consider the benefits and risks.
- Patients treated with Inclusig have experienced venous blood clotting. Monitoring should occur. Inclusig should be interrupted or stopped based on severity.
- Patients treated with Inclusig had heart failure, including mortality. Heart failure should be monitored and managed when clinically indicated. Inclusig should be interrupted or stopped if new or worsening heart failure develops.
- Patients treated with Inclusig have had liver toxicity, liver failure, and death. Liver function tests should be monitored. Inclusig should be interrupted or stopped based on severity.
- Before you start treatment with Inclusig, talk to your doctor about:
- All the prescription and over-the-counter medications you take
- Your allergies
- Your current health problems and past medical history
- Your pregnancy or breastfeeding status
- Inclusig contains the following warnings and precautions:
- High blood pressure
- Pancreatitis
- Neuropathy
- Eye problems
- Major bleeding
- Fluid retention
- Heart arrhythmias
- Decreased bone marrow activity
- Tumor lysis syndrome
- Reversible posterior leukoencephalopathy syndrome
- Delayed wound healing and perforation of the stomach and intestines
- Harm to an unborn baby; females who are capable of reproducing should use effective contraceptive methods during Inclusig treatment and for 3 weeks after taking the final dose.
Side Effects
Rash and related conditions, joint pain, abdominal pain, headache, constipation, dry skin, high blood pressure, fatigue, fluid retention and swelling, fever, nausea, pancreatitis/lipase elevation, major bleeding, anemia, liver problems, AOEs, and abnormal labs (decreased platelets, neutrophils, and white blood cells) are the most common side effects when using Inclusig by itself.
Liver problems, joint pain, rash and related conditions, headache, fever, abdominal pain, constipation, fatigue, nausea, oral mucositis, high blood pressure, pancreatitis/lipase elevation, neuropathy peripheral, major bleeding, febrile neutropenia, fluid retention and swelling, vomiting, tingling/numbness, heart arrhythmias, and abnormal labs (decreased white blood cells, neutrophils, platelets, lymphocytes, and hemoglobin and increased lipase and alanine aminotransferase) are the most common side effects when using Inclusig with chemotherapy.
Other side effects may occur. Immediately inform your doctor of any side effects that bother you or won’t go away.
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Reference
Inclusig. Lexington, MA: Takeda Pharmaceuticals America, Inc.; 2024.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14938
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