Farydak is a prescription medication taken in combination with Velcade + dexamethasone to treat patients with myeloma who have already been treated with Velcade and an immunomodulatory drug. Immune modulators include Thalomid® (thalidomide), Revlimid® (lenalidomide), and Pomalyst® (pomalidomide, known in Europe as Imnovid®). Farydak is the first histone deacetylase (HDAC) inhibitor approved for use in treating myeloma.
For more information about Farydak, please visit their website www.farydak.com
Farydak is a prescription medicine used, in combination with bortezomib and dexamethasone, to treat adults with a type of cancer called multiple myeloma after at least 2 other types of treatment have been tried.
Highlights of prescribing information for US patients.
Farydak (panobinostat) capsules is part of a comprehensive co-pau support program offered by Novartis Oncology.
Farydak is the first histone deacetylase (HDAC) inhibitor approved for use in treating myeloma. Farydak is an oral prescription medication taken in capsule form in combination with Velcade® (bortezomib) and dexamethasone. This booklet provides information about how Farydak works, how and when to take it, at what point in myeloma treatment it is used most effectively, its possible side effects, and how to manage those side effects.
Possible side effects
Diarrhea (defined as three or more loose stools per day) is common with Farydak and may be severe. In the PANORAMA-1 study, diarrhea occurred in 68% of patients treated with Farydak + Velcade+ dexamethasone compared to 42% treated with placebo + Velcade + dexamethasone. As mentioned earlier in this booklet, severe diarrhea (defined as 7 or more stools per day requiring treatment with intravenous fluids or hospitalization) occurred in 25% of Farydak-treated patients in the PANORAMA-1 study. Tell your healthcare provider right away if you have stomach cramps, loose stool, frequent bowel movements, or if you feel like you’re becoming dehydrated. Thirst and dark-colored urine are early symptoms of dehydration.
Farydak can cause severe heart problems, which can lead to death. Your risk of heart problems may be increased if you have a pre-existing condition called “long QT syndrome,” a heart rhythm condition that can potentially cause fast, chaotic heartbeats, or if you have other heart problems.
Severe bleeding (from low platelet count)
Farydak can cause severe bleeding (hemorrhage), which can lead to death. In the PANORAMA-1 trial, severe bleeding occurred in the gastrointestinal tract or the lungs of 4% of the patients treated with Farydak, and 2% of the patients in the control arm. It may take longer than normal to stop bleeding while you are taking Farydak. Low platelet levels were com-mon among patients in the PANORAMA-1 study, occurring in 97% of patients in the Farydak + Velcade + dexamethasone arm and 83% of the patients in the placebo + Velcade + dexamethasone arm.
Fatigue is commonly associated with cancer and with cancer therapy. Caution is advised if you are operating machinery, including driving a car. For more detailed information, please read the IMF publication Understanding Fatigue.
Nausea and vomiting
In the PANORAMA-1 trial, 36% of Farydak patients experienced nausea, 6% of which was serious enough to require hospitalization, while 26% of patients experienced vomiting, 7% of which was serious enough to require hospitalization or urgent intervention.
Peripheral edema is accumulation of fluid that causes swelling, usually in the ankles, feet, and legs. This swelling is the result of the accumulation of excess fluid under the skin in the spaces within the tissues, or “interstitial” spaces. Peripheral edema can be a side effect of long-term use of anti-inflammatory medications (such as the corticosteroid dexamethasone), which increase fluid pressure from sodium and water retention, and thereby upset the balance of inflow and drainage of interstitial fluid. Peripheral edema can also result from many other causes, including immobility, obesity, varicose veins, cardiac, kidney, or liver dysfunction, gastrointestinal disorders, medications for diabetes such as insulin and pioglitazone, and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. Usually, peripheral edema affects both of the legs, ankles, and/or feet. If you have swelling in one leg only, you should tell your healthcare team immediately, as it might signal the presence of a blood clot. 29% of the patients in the Farydak arm of the PANORAMA-1 study, and 19% of those in the placebo arm had peripheral edema.
There are many causes for loss of appetite during treatment with FVD, includng other side effects of treatment such as diarrhea and nausea. Lack of exercise, anxiety, depression, and pain can also contribute to the problem. Good communication with your healthcare team members will help them understand how you’re feeling physically and mentally, and will help determine the source of your appetite loss.
Fever can be the sign of a bacterial or viral infection, an adverse reaction to a drug or, in rare cases, an aggressive myeloma relapse. Since fever could be the sign of a life-threatening condition, you should report the problem to your healthcare provider immediately.
Low WBC count
White blood cells constitute the immune system, the body’s defense against infection. When the WBC count is low, the body’s normal defenses against viral, bacterial, and fungal infections are reduced. Both Farydak and Velcade can lower the WBC count, while dexamethasone prevents the remaining white cells from reaching the sites of infected tissues. Each of these drugs can contribute to an increased risk of infection. The addition of Farydak to Velcade and dexamethasone caused almost twice as much reduction in WBC count in the PANORAMA-1 trial than occurred in the control arm of the study.
Low RBC count (anemia)
Red blood cells (RBCs) contain hemoglobin, a protein that contains iron and transports oxygen from the lungs to the body’s organs and tissues. When a patient has anemia, the result is low levels of oxygen in the body, which may cause shortness of breath, paleness, and feelings of exhaustion. 62% of the patients in the Farydak arm of the PANORAMA-1 study developed anemia, as compared to 52% in the placebo arm.
Electrolytes (which include sodium, potassium, calcium, magnesium, chloride, and phosphorus) are electrically charged substances in the blood and other fluids that are involved in such important functions as regulating the amount of water in the body, the acidity of the blood, nerve and muscle function (including the heart muscle), and other important processes. Electrolyte abnormalities can be caused by poor intake of fluid or nutrition (loss of appetite), by loss of body fluid (vomiting or diarrhea), or by kidney dysfunction (as evidenced by increasing creatinine levels).
Creatinine is a substance that is normally secreted by the kidneys into the urine. When the kidney is impaired, the amount of creatinine in the blood increases. The kidneys may function poorly because of myeloma light chain deposits in the tubules of the kidney, or because of the effects of treatment related to hydration, or both. In the PANORAMA-1 study, 41% of the patients in the Farydak arm had increased creatinine, as opposed to 23% in the placebo arm. However, only one Farydak-treated patient had a serious increase in creatinine, as opposed to two in the placebo arm. Among the treatment-related reasons for increased creatinine are other side effects such as loose watery stool, vomiting, loss of appetite, and dehydration.
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.