Tibsovo
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.
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Product Details
Description
Tibsovo (ivosidenib) is an oral medication prescribed to treat acute myeloid leukemia (newly diagnosed, relapsed, or refractory), myelodysplastic syndromes (relapsed or refractory), and cholangiocarcinoma that has advanced or spread to other parts of the body.
Tibsovo 250 mg tablets are available for oral administration.
Directions
Take Tibsovo exactly as prescribed by your doctor. The recommended dose is to take 500 mg by mouth once daily. You may take it with or without food; however, avoid taking it with a meal that is high in fat.
For further usage instructions, you may refer to the medication guide that accompanies your Tibsovo prescription.
Store Tibsovo tablets at 20°C to 25°C (68°F to 77°F); keep out of reach of children.
Talk to your doctor or pharmacist about any questions or concerns you may have.
Ingredients
The active ingredient in Tibsovo is ivosidenib.
Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet coating includes FD&C blue #2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
Contraindications
According to the most recent Tibosovo Prescribing Information, there are no contraindications.
Cautions
- Tibsovo contains the following FDA Boxed Warning:
- Symptoms of differentiation syndrome, which can be fatal, have been experienced by patients receiving Tibsovo. Corticosteroid therapy and hemodynamic monitoring should be initiated until symptoms have resolved if differentiation syndrome is suspected.
- Before you begin treatment with Tibsovo, talk to your doctor about:
- All the medications you take, including prescription and over-the-counter medications
- Your allergies
- Your current health problems and past medical history
- If you are pregnant or breastfeeding
- Tibsovo contains the following warnings and precautions:
- QTc interval prolongation
- Guillain-Barre´ Syndrome
Side Effects
The most common Tibsovo side effects in patients with acute myeloid leukemia: blood cell count abnormalities, electrolyte abnormalities, diarrhea, fatigue, nausea, vomiting, appetite decrease, swelling, elevated liver enzymes, abdominal pain, joint pain, shortness of breath, elevated uric acid, rash, mucositis, QT prolongation, differentiation syndrome, and muscle pain
The most common Tibsovo side effects in patients with relapsed or refractory myelodysplastic syndrome: laboratory abnormalities, fatigue, joint pain, diarrhea, cough, mucositis, appetite decrease, muscle pain, itching, and rash
The most common Tibsovo side effects in patients with cholangiocarcinoma: lab abnormalities, fatigue, nausea, abdominal pain, diarrhea, cough, appetite decrease, fluid retention, vomiting, anemia, and rash
Other side effects can also occur. Inform your doctor right away of any bothersome or persistent side effects.
Ask your doctor about Tibsovo.
Reference
- Tibsovo. Boston, MA: Servier Pharmaceuticals LLC; 2023.
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 : 14209
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