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.
Imbruvica (Ibrutinib)
Prescription Required
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Product Details
Description
Imbruvica (ibrutinib) is a medication used to treat certain cancers in adults, including:
- Mantle cell lymphoma (MCL)
- Chronic lymphocytic leukemia (CLL)/Small lymphocytic leukemia (SLL)
- Waldenström’s macroglobulinemia (WM)
- Marginal zone lymphoma (MZL)
It's also used to treat chronic graft versus host disease (cGVHD) in adult and pediatric patients who are at least one years old.
Imbruvica is available in the following dosage forms and strengths:
- 70 mg and 140 mg oral capsules
- 140 mg, 280 mg, 420 mg, and 560 mg oral tablets
- 70 mg/mL oral suspension
Imbruvica is not right for everyone. Discuss treatment options with your doctor that may be best for you.
Fact Table
Formula
C25H24N6O2
License
US FDA, US DailyMed, EU EMA
Bioavailability
Less than 4%
Legal status
Rx-Only
Chemical Name
Ibrutinib
Elimination half-life
4–6 hours
Dosage (Strength)
140mg
Pregnancy
Not Recommended
Brands
Imbruvica
Protein binding
97.3%
PubChem CID
24821094
MedlinePlus
a614007
ChEBI
76612
ATC code
L01EL01
DrugBank
DB09053
KEGG
D10223
Routes of administration
By mouth
Directions
Each patient's dose depends on the condition being treated. You should follow your doctor's instructions on taking Imbruvica. If you have any questions or concerns, talk to your doctor or pharmacist.
Recommended dose for MCL and MZL: 560 mg by mouth once daily
Recommended dose for CLL/SLL and WM: 420 mg by mouth once daily
Recommended dose for cGVHD in patients who are least 12 years old: 420 mg by mouth once daily
Recommended dose for cGVHD in patients 1 to 11 years of age: 240 mg/m2 by mouth once daily (up to a maximum dose of 420 mg)
Patients with liver problems may require a dose adjustment.
Ingredients
Each Imbruvica capsule, tablet, and oral suspension contains ibrutinib, a kinase inhibitor.
Contraindications
There are no known contraindications.
Cautions
- Before you begin treatment with Imbruvica, you should discuss the following with your doctor:
- All the medications you take
- Your allergies
- Your medical history and health problems
- Your pregnancy or breastfeeding status
- Severe bleeding can occur with the use of Imbruvica. You should seek immediate medical care if you have black, tarry stools; bleeding from the gums; blood in your vomit; nosebleeds that won't stop after 10-15 minutes of applied pressure; or experienced a fall or head trauma.
- Infections can occur with the use of Imbruvica.
- Serious heart arrhythmias, heart failure, and sudden death can occur with the use of Imbruvica.
- High blood pressure can occur with the use of Imbruvica.
- Abnormal blood cell counts can occur with the use of Imbruvica.
- Skin cancers and other malignancies have occurred with the use of Imbruvica.
- Although rare, tumor lysis syndrome can occur with the use of Imbruvica.
- Imbruvica can cause harm to an unborn baby. Women who take Imbruvica should use effective birth control methods during treatment and for one month after stopping Imbruvica.
Side Effects
Abnormal blood cell counts, diarrhea, fatigue, musculoskeletal pain, rash, anemia, bruising, serious bleeding, muscle spasms, stomach pain, headache, pneumonia, sores and swelling of the mouth can be caused by Imbruvica. However, these are not the only side effects that can occur with Imbruvica.
You should contact your doctor right away if you develop side effects that bother you or won't go away.
Reference:
- Imbruvica (ibrutinib). South San Francisco, CA: Pharmacyclics LLC; 2022.
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 : 13698
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