PANOBINOSTAT / FARYDAK IXAPANA MEDICATION PATIENT INFORMATION

https://www.911globalmeds.com/info/114-1-Panobinostat-Farydak-Ixapana-Medication-Patient-Information-In-English.pdf

Panobinostat may cause severe diarrhea and other serious gastrointestinal (GI; affecting the stomach or intestines) side effects. If you experience any of the following symptoms, call your doctor immediately: stomach cramps; loose stools; diarrhea; vomiting; or dry mouth, dark urine, decreased sweating, dry skin, and other signs of dehydration. Talk to your doctor about what you should do if you develop diarrhea during your treatment with panobinostat. Also talk to your doctor before taking any laxatives or stool softeners while you are taking this medication.

Panobinostat may cause serious or life-threatening heart problems during your treatment. Tell your doctor if you have recently had a heart attack or if you have long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause fainting or sudden death), angina (chest pain), or other heart problems. Your doctor will order tests such as an electrocardiogram (ECG; test that records the electrical activity of the heart) before and during your treatment to see if it is safe for you to take panobinostat. If you experience any of the following symptoms, call your doctor immediately: chest pain, rapid, pounding, or irregular heart beat, lightheadedness, feeling faint, dizziness, blue-colored lips, shortness of breath, or swelling of the hands, arms, feet, ankles, or lower legs.

Panobinostat for treating multiple myeloma after at least 2 previous treatments

https://www.nice.org.uk/guidance/ta380/resources/panobinostat-for-treating-multiple-myeloma-after-at-least-2-previous-treatments-pdf-82602842988229

The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Panobinostat in combination with bortezomib and dexamethasone is recommended, within its marketing authorisation, as an option for treating multiple myeloma, that is, for 'adult patients with relapsed and/or refractory multiple myeloma who have received at least 2 prior regimens including bortezomib and an immunomodulatory agent' when the company provides panobinostat with the discount agreed in the patient access scheme.

Panobinostat: a novel mechanism of action shows promise in multiple myeloma

https://cdn.mdedge.com/files/s3fs-public/Document/July-2017/jcso_aug_278_abraham.pdf

Following an initial “no” vote from the Oncologic Drugs Advisory Committee (ODAC) in late 2014, the US Food and Drug Administration eventually awarded accelerated approval in February 2015 to the histone deacetylase (HDAC) inhibitor panobinostat for use in select patients with relapsed multiple myeloma. Panobinostat has a novel mechanism of action that demonstrates synergy with the proteasome inhibitor bortezomib and the immunomodulatory agent dexamethasone, which translated into improved progression-free survival (PFS) for patients with multiple myeloma who had received at least 2 prior therapies, according to data from a prespecifed subgroup analysis from the Panorama-1 trial. Data from an overall analysis of the Panorama-1 trial was initially submitted to the FDA for approval of panobinostat in patients with relapsed multiple myeloma. Tat multicenter, randomized, placebo-controlled, double-blind phase 3 trial enrolled 768 patients at 215 centers across 34 countries from January 21, 2010 to February 29, 2012. Patients were randomized 1:1 to a combination of panobinostat, bortezomib, and dexamethasone or a combination of placebo, bortezomib, and dexamethasone. Tey were stratifed by previous treatment strategies and previous use of bortezomib. No crossover was permitted.

How is panobinostat given?

https://www.myeloma.org.uk/wp-content/uploads/2023/04/Myeloma-UK-Panobinostat-Treatment-Guide.pdf

Panobinostat is a capsule which is taken orally (by mouth). The capsule should be swallowed whole, with water

Panobinostat is usually given in combination with the proteasome inhibitor bortezomib (Velcade®) and the steroid dexamethasone.

Panobinostat is usually taken on days 1, 3, 5, 8, 10 and 12 of a 21 day (3 week) cycle. Panobinostat can be taken for up to 16 cycles. You should take panobinostat at approximately the same time on each day that it is scheduled. Individual treatment plans may vary. Your exact dose of panobinostat and your length of treatment will be discussed with you by your healthcare team.

Other information about Panobinostat

Panobinostat is expected to be harmful to an unborn baby. This means you must use effective methods of contraception while on this treatment and for 6 months afterwards if you or your partner could become pregnant.

You should not breastfeed when taking panobinostat as it is not known if the drug can pass to your baby in the milk.

You should avoid pomegranate, grapefruit and starfruit (including juices) when taking panobinostat, as they can interfere with the way the drug works.