Panobinostat is an anticancer medicine used in combination with bortezomib and dexamethasone, to treat people with multiple myeloma (a type of cancer) after trying at least 2 other types of treatment.
Panobinostat capsules are used in combination with drugs such as bortezomib and dexamethasone, to treat multiple myeloma. It is used in patients who have received at least 2 previous regimens including bortezomib and an immunomodulatory agent.
It should not be used in patients who are having allergy to panobinostat.
The recommended initial dose is 20 mg, taken by mouth once every alternate day for 3 doses per week. Continue this for every 1st 2 weeks of a 21-day cycle for up to 8 cycles.
Continue treatment for an additional 8 cycles in patients who do not experience severe side effects.
The total duration of treatment that can be given is up to 16 cycles or for 48 weeks.
It is given along with bortezomib and dexamethasone. Bortezomib is given as 1.3 mg/m2 injection and dexamethasone is given as 20 mg tablet on a full stomach.
If a panobinostat capsule is missed, it can be taken till 12 hours after the specified dose time. The patient should not repeat the dose if vomiting occurs but, should take the next dose as scheduled.
Panobinostat Capsules are taken by mouth (orally) in doses 10 mg, 15 mg, or 20 mg.
Patients are advised not to change the prescribed dose or stop taking the capsules suddenly.
• Panobinostat should not be used during pregnancy and breastfeeding. There is a high chance of side effects in the developing baby if taken during pregnancy.
• There is more risk of gastric and lung hemorrhage (blood loss). So, frequent blood tests to monitor platelet count is required.
• Effective contraception should be used for at least one month after the last dose of panobinostat.
• Safety is not evaluated in patients with liver diseases.
• Patients above 65years may have more chance of side effects.
Gastrointestinal: Diarrhea, fatigue, nausea, peripheral edema (accumulation of water), decreased appetite, and vomiting.
Hematological: low platelet count), low white blood cell count, anemia (low Hemoglobin), low phosphorous, potassium levels in the blood.
Nervous system: dizziness, headache , syncope (fainting), dysgeusia (altered taste)
Cardiovascular: palpitations (increased heart rate)
Respiratory: cough , dyspnea, respiratory failure, wheezing (abnormal lung sounds)
Vascular system: hypotension (low blood pressure), hypertension (High blood pressure)
Skin and subcutaneous disorders: skin rash, erythema (redness of skin)
Musculoskeletal disorders: joint swelling.
Renal and urinary disorders: Kidney failure, urinary incontinence (uncontrolled leak of urine)
General disorders and administration site conditions: chills.
Lab monitoring: blood urea, glomerular filtration rate, blood alkaline phosphatase levels should be monitored.
• Women in reproductive age should use effective contraception until 1 month of the last dose of panobinostat.
• Men should use condoms for at least 3 months of the last dose of panobinostat.
• Panobinostat capsules contact with the skin or mucous membranes should be avoided. Wash thoroughly if such contact occurs.
• Exposure to crushed and/or broken capsules should be avoided.
• Keep away from children.
• Patients should report chest pain or discomfort or changes in heartbeat, fever, swelling in legs, hands and skin, diarrhea, bleeding, immediately to consulting doctor.
The initial dose should be reduced to 10 mg when administered with boceprevir, clarithromycin, conivaptan, itraconazole, ketoconazole (antifungal drugs) lopinavir or ritonavir (anti-HIV drugs).
Patients are advised to avoid star fruit, pomegranate or pomegranate juice, and grapefruit or grapefruit juice because these foods will change the blood levels of Panobinostat.
Panobinostat may increase the blood levels of atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, and drugs that have a narrow safety margin like thioridazine, pimozide.
Frequent ECG monitoring may be required when given along with anti-arrhythmic drugs (drugs which are used to maintain normal heart rhythm).
Store at room temperature (20°C to 25°C).
Capsules should be protected from direct sunlight and excess moisture.
Capsules should not be crushed or chewed.
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