Tibsovo (Ivosidenib)
- Medicine Name: Tibsovo
- Generic Name: Ivosidenib
- Dosage Form & Strength: Tablets: 250 mg
- Manufactured By: Servier Pharmaceuticals
Tibsovo is an isocitrate dehydrogenase-1 (IDH1) inhibitor used:
- in combination with medicine azacitidine or as monotherapy for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in adults aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
- for the treatment of adult individuals with relapsed/refractory Acute Myeloid Leukemia (AML).
- for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (bile duct cancer) who have been previously treated.
Note: Tibsovo 250 mg Tablet is used for patients with a susceptible IDH1 mutation as detected by an FDA-approved test.
Recommended Dosage: Select patients for the treatment of AML and Cholangiocarcinoma based on the presence of IDH1 mutations. Patients with AML without IDH1 mutations at diagnosis need to be retested at relapse because a mutation in IDH1 may occur during treatment and at relapse.
Newly Diagnosed AML (Combination Regimen): The recommended dosage is 500 mg taken by mouth once daily until the disease is progressive or unacceptable toxicity occurs. Start the administration of Tibsovo on Cycle-1 Day 1 along with medicine azacitidine 75 mg/m2 subcutaneously or intravenously once daily on Days 1’st to 7’th (or Days 1’st to 5’th & 8’th to 9’th) of each 28-day cycle.
For those without disease progression or unacceptable toxicity, continue ivosidenib 250 mg, along with medicine azacitidine, for a minimum of six months in order to allow time for clinical response.
Newly Diagnosed AML and Relapsed or Refractory AML (Monotherapy Regimen): The recommended dosage is 500 mg taken by mouth once daily until the disease is progressive or unacceptable toxicity occurs.
For those without disease progression or unacceptable toxicity, continue treatment for a minimum of six months in order to allow time for clinical response.
Cholangiocarcinoma: The recommended dosage is 500 mg taken by mouth once daily until the disease is progressive or unacceptable toxicity occurs.
Administer tibsovo tablet with or without food. Do not administer this medicine with a high-fat meal because it may increase the concentration of ivosidenib. Do not chew, split, or crush tablets. Administer it orally about the same time every day. If a dose is vomited, do not take a replacement dose; wait until the very next scheduled dose is due. If a dose is missed or not administered at the usual time, take the dose as quickly as possible and at least 12 hours before the next scheduled dose. Follow the standard schedule the following day. Do not administer a couple of doses within 12 hours.
- Electrocardiogram (ECG) should be obtained prior to initiating treatment. Monitor ECGs at least once in week for the initial 3 weeks of therapy and then at least once in a month for the duration of therapy. Manage any abnormalities quickly.
- Evaluate blood counts and blood chemistries before initiating tibsovo tablet 250mg, at least once in a week for the initial month, once every other week for the second month, and once in a month for the duration of therapy. Monitor blood creatine phosphokinase on a weekly basis for the initial month of therapy.
- Differentiation syndrome in patients with AML may occur as early as one day after the start of therapy and during the initial three months on treatment. In case it is suspected, start dexamethasone 10 mg IV every twelve hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until enhancement. In case concomitant noninfectious leukocytosis occured, start treatment with leukapheresis or hydroxyurea, as clinically required.
- Concomitant use of Ivosidenib with medicines known to prolong the QTc interval (e.g., triazole anti-fungals, anti-arrhythmic drugs, fluoroquinolones, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may be responsible for increasing the probability of QTc interval prolongation.
- Interrupt tibsovo tablets if QTc increases to higher than 480 msec and less than 500 msec. Interrupt and reduce dosage if QTc increases to higher than 500 msec. Permanently interrupt treatment in those who develop QTc interval prolongation with signs/symptoms of hazardous arrhythmia.
- Ivosidenib may cause fetal harm if administered to a pregnant woman. Nursing mothers should not breastfeed during treatment and for 1 month after the final dose. Ivosidenib may cause fertility complications in both females and males, which may affect the ability to have children. Talk to your health specialist if you have concerns about fertility.
What documents are required to import TIBSOVO® to India?
TIBSOVO® (ivosidenib) tablets can be imported by patients or government hospitals on the name of the patients only.
The following documentation required to import the product:
- Valid prescription from a qualified doctor.
- Patients diagnostic reports
- Patients Identity Proof (issued by government of India)
How does order be confirmed?
The order will be confirmed only after the receipt of:
- Valid prescription of Doctor
- Import permit if applicable
Is TIBSOVO® available in India?
TIBSOVO® (ivosidenib tablets) is a (prescription drug, prescription medication or prescription medicine) pharmaceutical drug that legally requires a medical prescription to be dispensed.
IPN (Indian Pharma Network) helps import cancer medicines on the named patient supply (NPS). Indian Pharma Network is facilitator providing input
- On availability of tibsovo tablets in India (Delhi, Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Bangalore and Pune etc.)
- Medicine Price.
- Finding Genuine and reliable source from Canada, Europe, USA and Australia
- Ensuring 100% transparency.
TIBSOVO® can be made available to patients, doctors and hospitals at Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow and Pune and other cities in India. The order will be confirmed only after the receipt of a valid prescription from the doctor and import permit.
IPN (Indian Pharma Network) can facilitate the supply of TIBSOVO® (prescription medicines) to all locations in the world and in India after fulfilling the legal requirement (if applicable)
Please contact +91-9310090915 | Toll-Free Number: 1800-889-1064 or write us at info@indianpharmanetwork.in for tibsovo 250 mg tablet price in India.
We take guarantee of quality and delivery anywhere in the world as per the buyer’s requirements.
Indian Pharma Network is able to source the TIBSOVO® (Cancer Treatment Medicines) from across the globe, and has the ability to supply. Indian Pharma Network offers its customers worldwide access to the best available treatment.
Indian Pharma Network is able to dispense any valid prescription in the shortest possible time. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the Patient’s address only from New Delhi, India.
What is the Generic Name for the trade name drug Tibsovo®?
Ivosidenib is Generic Name for the trade name drug Tibsovo®.
What is the Manufacturer Name of Tibsovo®?
Tibsovo® is manufactured by Servier Pharmaceuticals.
Is Tibsovo® approved by the FDA?
Yes, Tibsovo® is approved by the FDA. Date of first/initial approval: July 20, 2018.
Where can I get Tibsovo® at the best price in India?
To get the best tibsovo 250 mg tablet price in India, contact Indian Pharma Network (WHO-GDP & ISO 9001:2008 authorized Company). A medical prescription is required while buying Tibsovo®.
What is the dosage and form of Tibsovo® supplied?
Tibsovo® is supplied as Tablets: 250 mg for oral administration.
What are the most common side effects with Tibsovo® when used along with azacitidine or alone in adults with AML?
The most common side effects with Tibsovo® when used in along with azacitidine or alone in adults with AML include: changes in certain blood cell counts, diarrhea, increased blood sugar, fatigue, changes in certain liver function tests, swelling of arms or legs, decreased levels of electrolytes in the blood, nausea, vomiting, decreased appetite, joint pain, shortness of breath, uric acid increased, stomach (abdominal) pain, changes in certain kidney function tests, pain or sores in your mouth or throat, rash, irregular heart rhythm or heartbeat (QTc
prolongation), differentiation syndrome, and muscle pain.
What are the most common side effects with Tibsovo® when used in patients with cholangiocarcinoma?
The most common side effects (≥15%) in patients with cholangiocarcinoma are fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash.
How much does Tibsovo® cost in India?
Tibsovo cost in India is less and can vary. To buy/procure this IDH1 inhibitor authentically, you can Call/WhatsApp +91-9310090915 or send mail to info@indianpharmanetwork.in.
What are the storage conditions of Tibsovo®?
Tibsovo® is available as 250 mg tablets. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Is it safe to buy Tibsovo® online from India?
Yes, You can buy tibsovo tablets in India online at the best price from Indian Pharma Network if Tibsovo® has not been approved or is not available in your country.
What are the Highlights of prescribing information for Tibsovo®?
Click Here to download full Tibsovo prescribing information.
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