Farydak

Last updated on RxList: 8/27/2018
Farydak Side Effects Center

Last reviewed on RxList 8/27/2018

Farydak (panobinostat lactate) is a histone deacetylase inhibitor used in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent. Common side effects of Farydak include:

The recommended starting dose of Farydak is 20 mg, taken orally once every other day for 3 doses per week in Weeks 1 and 2 of each 21-day cycle for up to 8 cycles. Farydak may interact with antiviral drugs, azole antifungals, macrolide antibiotics, strong CYP3A inducers, tomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, thioridazine, pimozide, amiodarone, disopyramide, procainamide, quinidine, sotalol, chloroquine, halofantrine, clarithromycin, methadone, moxifloxacin, bepridil, and pimozide. Tell your doctor all medications and supplements you use. Farydak is not recommended for use during pregnancy; it may harm a fetus. Women should talk to their doctor about using contraception while receiving Farydak and for at least 1 month after the last dose of the drug. Men are advised to use condoms while receiving Farydak and for at least 3 months following the last dose of the drug. Breastfeeding is not recommended while receiving Farydak.

Our Farydak (panobinostat lactate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Understanding Cancer: Metastasis, Stages of Cancer, and More See Slideshow
Farydak Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Panobinostat can cause serious or fatal heart problems. Get medical attention if you have:

  • chest pain, fast or slow heartbeats;
  • dizziness, or feeling like you might pass out;
  • blue-colored lips;
  • swelling in your lower legs; or
  • shortness of breath.

Call your doctor at once if you have:

  • severe or ongoing diarrhea or stomach cramps;
  • easy bruising or bleeding, bleeding that will not stop;
  • signs of bleeding inside your body--headache, dizziness, confusion; pink or brown urine; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, cold hands and feet;
  • signs of infection--fever, chills, sweating, trouble breathing, cough with mucus, skin sores, feeling very tired;
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
  • liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, loss of appetite;
  • fever; or
  • swelling in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Farydak (Panobinostat Capsules)

Farydak Professional Information

SIDE EFFECTS

The following adverse reactions are described in detail in other sections of the label:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

The safety data reflect subject exposure to FARYDAK from a clinical trial, in which 758 subjects with relapsed multiple myeloma received FARYDAK in combination with bortezomib and dexamethasone or placebo in combination with bortezomib and dexamethasone (referred to as the control arm). The median duration of exposure to FARYDAK was 5 months with 16% of patients exposed to study treatment for > 48 weeks.

Serious adverse events (SAEs) occurred in 60% of patients in the FARYDAK, bortezomib, and dexamethasone compared to 42% of patients in the control arm. The most frequent ( ≥ 5%) treatment-emergent SAEs reported for patients treated with FARYDAK were pneumonia (18%), diarrhea, (11%), thrombocytopenia (7%), fatigue (6%), and sepsis (6%).

Adverse reactions that led to discontinuation of FARYDAK occurred in 36% of patients. The most common adverse reactions leading to treatment discontinuations were diarrhea, fatigue, and pneumonia.

Deaths occurred in 8% of patients in the FARYDAK arm versus 5% on the control arm. The most frequent causes of death were infection and hemorrhage.

Table 4 summarizes the adverse reactions occurring in at least 10% of patients with ≥ 5% greater incidence in the FARYDAK arm, and Table 5 summarizes the treatment-emergent laboratory abnormalities.

Table 4: Adverse Reactions ( ≥ 10% Incidence and ≥ 5% Greater Incidence in FARYDAK-Arm) in Patients with Multiple Myeloma

Primary System Organ Class
Preferred term
FARYDAK, BTZ [1], Dex [2]
N=381
All grades %
FARYDAK, BTZ [1], Dex [2]
N=381
Grade 3/4 %
Placebo, BTZ [1], Dex [2]
N=377
All grades %
Placebo, BTZ [1], Dex [2]
N=377
Grade 3/4 %
Cardiac disorders
Arrhythmia[3] 12 3 5 2
Gastrointestinal disorders
Diarrhea 68 25 42 8
Nausea 36 6 21 1
Vomiting 26 7 13 1
General disorders and administration site conditions
Fatigue[4] 60 25 42 12
Peripheral edema 29 2 19 < 1
Pyrexia 26 1 15 2
Investigations
Weight decreased 12 2 5 1
Metabolism and nutrition disorders
Decreased appetite 28 3 12 1
1 BTZ = bortezomib
2 Dex = dexamethasone
3 Arrhythmia includes the terms: arrhythmia, arrhythmia supraventricular, atrial fibrillation, atrial flutter, atrial tachycardia, bradycardia, cardiac arrest, cardio-respiratory arrest, sinus bradycardia, sinus tachycardia, supraventricular extra-systoles, tachycardia, ventricular arrhythmia, and ventricular tachycardia
4 Fatigue includes the terms: fatigue, malaise, asthenia, and lethargy

Other Adverse Reactions

Other notable adverse drug reactions of FARYDAK not described above, which were either clinically significant, or occurred with a frequency less than 10% but had a frequency in the FARYDAK arm greater than 2% over the control arm in the multiple myeloma clinical trial are listed below:

Infections and infestations: hepatitis B.

Endocrine disorders: hypothyroidism.

Metabolism and nutrition disorders: hyperglycemia, dehydration, fluid retention, hyperuricemia, hypomagnesemia.

Nervous system disorders: dizziness, headache, syncope, tremor, dysgeusia.

Cardiac disorders: palpitations.

Vascular disorders: hypotension, hypertension, orthostatic hypotension.

Respiratory, thoracic and mediastinal disorders: cough, dyspnea, respiratory failure, rales, wheezing.

Gastrointestinal disorders: abdominal pain, dyspepsia, gastritis, cheilitis, abdominal distension, dry mouth, flatulence, colitis, gastrointestinal pain.

Skin and subcutaneous disorders: skin lesions, rash, erythema.

Musculoskeletal and connective tissue disorders: joint swelling.

Renal and urinary disorders: renal failure, urinary incontinence.

General disorders and administration site conditions: chills.

Investigations: blood urea increased, glomerular filtration rate decreased, blood alkaline phosphatase increased.

Psychiatric disorders: insomnia.

Table 5: Treatment-emergent Laboratory Abnormalities ( ≥ 10% Incidence and ≥ 5% Greater Incidence in FARYDAK-arm) in Patients with Multiple Myeloma

Investigations FARYDAK, BTZ[1], Dex[2]
N=381
Any grade %

FARYDAK, BTZ[1], Dex[2]
N=381 Grade 3/4 %

Placebo, BTZ[1], Dex[2]
N=377
Any grade %

Placebo, BTZ[1], Dex[2]
N=377
Grade 3/4 %

Hematology
Thrombocytopenia 97 67 83 31
Anemia 62 18 52 19
Neutropenia 75 34 36 11
Leukopenia 81 23 48 8
Lymphopenia 82 53 74 40
Chemistry
Blood creatinine increased 41 1 23 2
Hypokalemia 52 18 36 7
Hypophosphatemia 63 20 45 12
Hyponatremia 49 13 36 7
Hyperbilirubinemia 21 1 13 < 1
Hypocalcemia 67 5 55 2
Hypoalbuminemia 63 2 38 2
Hyperphosphatem ia 29 2 20 < 1
Hypermagnesemia 27 5 14 1
1 BTZ = bortezomib
2 Dex = dexamethasone

Fatigue And Asthenia

Grade 1 to Grade 4 asthenic conditions (fatigue, malaise, asthenia, and lethargy) were reported in 60% of the patients in the FARYDAK arm compared to 42% of patients in the control arm. Grade ≥ 3 asthenic conditions were reported in 25% of the patients in the FARYDAK arm compared to 12% of patients in the control arm. Asthenic conditions led to treatment discontinuation in 6% of patients in the FARYDAK arm versus 3% of patients in the control arm.

The prespecified sub-group upon which the efficacy and safety of FARYDAK was based had a similar adverse reaction profile to the entire safety population of patients treated with FARYDAK, bortezomib, and dexamethasone.

Read the entire FDA prescribing information for Farydak (Panobinostat Capsules)

© Farydak Patient Information is supplied by Cerner Multum, Inc. and Farydak Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors