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Istodax

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Istodax

Istodax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Istodax (romidepsin) for Injection is a histone deacetylase (HDAC) inhibitor used to treat T-cell lymphoma affecting the skin (cutaneous T-cell lymphoma, or CTCL). It is usually given after other medications have been tried without successful treatment of symptoms. Common side effects include nausea, vomiting, tiredness, and loss of appetite.

The recommended dose of Istodax is 14 mg/mē administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Istodax may interact with dexamethasone, isoniazid, St. John's wort, antibiotics, antifungal medications, antidepressants, anti-malarials, barbiturates, blood thinners, heart or blood pressure medications, heart rhythm medicines, HIV or AIDS medications, medicines used to prevent organ transplant rejection, medicine to prevent or treat nausea and vomiting, medicines to treat a psychiatric disorder, migraine headache medicines, narcotics, or seizure medications. Tell your doctor all medications and supplements you use. Istodax is not recommended for use during pregnancy. It may harm a fetus. It is unknown if this drug passes into breast milk and may harm nursing infants. Breastfeeding while using Istodax is not recommended.

Our Istodax (romidepsin) for Injection 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Istodax in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • severe nausea or vomiting;
  • chest pain, fast or uneven heartbeats, feeling short of breath;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • low magnesium (depression, muscle cramps, feeling tired or irritable, severe or ongoing diarrhea);
  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);
  • pain or burning when you urinate; or
  • worsening of CTCL skin symptoms.

Less serious side effects may include:

  • nausea, vomiting, loss of appetite;
  • diarrhea, constipation;
  • tired feeling; or
  • mild itching.

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 Istodax (Romidepsin for Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Istodax Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, tiredness, and loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Your doctor will order blood tests to check for this side effect. It is important to keep all medical/lab test appointments. Tell your doctor immediately if you develop any of the following symptoms: easy bruising/bleeding, pale skin, unusual tiredness, signs of infection (such as fever, chills, cough, persistent sore throat, painful/burning urination).

Seek immediate medical attention if any of these unlikely but serious side effects occur: chest pain, fast/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Istodax (Romidepsin for Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Istodax FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

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.

Cutaneous T-Cell Lymphoma

The safety of ISTODAX was evaluated in 185 patients with CTCL in 2 single arm clinical studies in which patients received a starting dose of 14 mg/m² . The mean duration of treatment in these studies was 5.6 months (range: < 1 to 83.4 months).

Common Adverse Reactions

Table 1 summarizes the most frequent adverse reactions ( > 20%) regardless of causality using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 3.0). Due to methodological differences between the studies, the AE data are presented separately for Study 1 and Study 2. Adverse reactions are ranked by their incidence in Study 1. Laboratory abnormalities commonly reported ( > 20%) as adverse reactions are included in Table 1.

Table 1: Adverse Reactions Occurring in > 20% of Patients in Either CTCL Study (N=185)

Adverse Reactions
n (%)
Study 1 (n=102) Study 2 (n=83)
All Grade 3 or 4 All Grade 3 or 4
Any adverse reaction 99 (97) 36 (35) 83 (100) 68 (82)
Nausea 57 (56) 3 (3) 71 (86) 5 (6)
Asthenia/Fatigue 54 (53) 8 (8) 64 (77) 12 (14)
Infections 47 (46) 11 (11) 45 (54) 27 (33)
Vomiting 35 (34) 1 ( < 1) 43 (52) 8 (10)
Anorexia 23 (23) 1 ( < 1) 45 (54) 3 (4)
Hypomagnesemia 22 (22) 1 ( < 1) 23 (28) 0
Diarrhea 20 (20) 1 ( < 1) 22 (27) 1 (1)
Pyrexia 20 (20) 4 (4) 19 (23) 1 (1)
Anemia 19 (19) 3 (3) 60 (72) 13 (16)
Thrombocytopenia 17 (17) 0 54 (65) 12 (14)
Dysgeusia 15 (15) 0 33 (40) 0
Constipation 12 (12) 2 (2) 32 (39) 1 (1)
Neutropenia 11 (11) 4 (4) 47 (57) 22 (27)
Hypotension 7 (7) 3 (3) 19 (23) 3 (4)
Pruritus 7 (7) 0 26 (31) 5 (6)
Hypokalemia 6 (6) 0 17 (20) 2 (2)
Dermatitis/Exfoliative dermatitis 4 (4) 1 ( < 1) 22 (27) 7 (8)
Hypocalcemia 4 (4) 0 43 (52) 5 (6)
Leukopenia 4 (4) 0 38 (46) 18 (22)
Lymphopenia 4 (4) 0 47 (57) 31 (37)
Alanine aminotransferase increased 3 (3) 0 18 (22) 2 (2)
Aspartate aminotransferase increased 3 (3) 0 23 (28) 3 (4)
Hypoalbuminemia 3 (3) 1 ( < 1) 40 (48) 3 (4)
Electrocardiogram ST-T wave changes 2 (2) 0 52 (63) 0
Hyperglycemia 2 (2) 2 (2) 42 (51) 1 (1)
Hyponatremia 1 ( < 1) 1 ( < 1) 17 (20) 2 (2)
Hypermagnesemia 0 0 22 (27) 7 (8)
Hypophosphatemia 0 0 22 (27) 8 (10)
Hyperuricemia 0 0 27 (33) 7 (8)

Serious Adverse Reactions

Infections were the most common type of SAE reported in both studies with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection. Serious adverse reactions reported in > 2% of patients in Study 1 were sepsis and pyrexia (3%). In Study 2, serious adverse reactions in > 2% of patients were fatigue (7%), supraventricular arrhythmia, central line infection, neutropenia (6%), hypotension, hyperuricemia, edema (5%), ventricular arrhythmia, thrombocytopenia, nausea, leukopenia, dehydration, pyrexia, aspartate aminotransferase increased, sepsis, catheter related infection, hypophosphatemia and dyspnea (4%).

Most deaths were due to disease progression. In Study 1, there were two deaths due to cardiopulmonary failure and acute renal failure. In Study 2, there were six deaths due to infection (4), myocardial ischemia, and acute respiratory distress syndrome.

Discontinuations

Discontinuation due to an adverse event occurred in 21% of patients in Study 1 and 11% in Study 2. Discontinuations occurring in at least 2% of patients in either study included infection, fatigue, dyspnea, QT prolongation, and hypomagnesemia.

Peripheral T-Cell Lymphoma

The safety of ISTODAX was evaluated in 178 patients with PTCL in a sponsor-conducted pivotal study (Study 3) and a secondary NCI-sponsored study (Study 4) in which patients received a starting dose of 14 mg/m² . The mean duration of treatment and number of cycles in these studies were 5.6 months and 6 cycles.

Common Adverse Reactions

Table 2 summarizes the most frequent adverse reactions ( ≥ 10%) regardless of causality, using the NCI-CTCAE, Version 3.0. The AE data are presented separately for Study 3 and Study 4. Laboratory abnormalities commonly reported ( ≥ 10%) as adverse reactions are included in Table 2.

Table 2: Adverse Reactions Occurring in ≥ 10% of Patients with PTCL in Study 3 and Corresponding Incidence in Study 4 (N=178)

Adverse Reactions
n (%)
Study 3
(N=131)
Study 4
(N=47)
All Grade 3 or 4 All Grade 3 or 4
Any adverse reactions Gastrointestinal disorders 127 (97) 86 (66) 47 (100) 40 (85)
Nausea 77 (59) 3 (2) 35 (75) 3 (6)
Vomiting 51 (39) 6 (5) 19 (40) 4 (9)
Diarrhea 47 (36) 3 (2) 17 (36) 1 (2)
Constipation 39 (30) 1 ( < 1) 19 (40) 1 (2)
Abdominal pain 18 (14) 3 (2) 6 (13) 1 (2)
Stomatitis General disorders and administration site conditions 13 (10) 0 3 (6) 0
Asthenia/Fatigue 72 (55) 11 (8) 36 (77) 9 (19)
Pyrexia 46 (35) 7 (5) 22 (47) 8 (17)
Chills 14 (11) 1 ( < 1) 8 (17) 0
Edema peripheral Blood and lymphatic system disorders 13 (10) 1 ( < 1) 3 (6) 0
Thrombocytopenia 53 (41) 32 (24) 34 (72) 17 (36)
Neutropenia 39 (30) 26 (20) 31 (66) 22 (47)
Anemia 32 (24) 14 (11) 29 (62) 13 (28)
Leukopenia Metabolism and nutrition disorders 16 (12) 8 (6) 26 (55) 21 (45)
Anorexia 37 (28) 2 (2) 21 (45) 1 (2)
Hypokalemia Nervous system disorders 14 (11) 3 (2) 8 (17) 1 (2)
Dysgeusia 27 (21) 0 13 (28) 0
Headache Respiratory, thoracic and mediastinal disorders 19 (15) 0 16 (34) 1 (2)
Cough 23 (18) 0 10 (21) 0
Dyspnea Investigations 17 (13) 3 (2) 10 (21) 2 (4)
Weight decreased Cardiac disorders 13 (10) 0 7 (15) 0
Tachycardia 13 (10) 0 0 0

Serious Adverse Reactions

Infections were the most common type of SAE reported. In Study 3, 25 patients (19%) experienced a serious infection, including 6 patients (5%) with serious treatment-related infections. In Study 4, 11 patients (23%) experienced a serious infection, including 8 patients (17%) with serious treatment-related infections. Serious adverse reactions reported in ≥ 2% of patients in Study 3 were pyrexia (7%), pneumonia, sepsis, vomiting (5%), cellulitis, deep vein thrombosis, (4%), febrile neutropenia, abdominal pain (3%), chest pain, neutropenia, pulmonary embolism, dyspnea, and dehydration (2%). In Study 4, serious adverse reactions in ≥ 2 patients were pyrexia (17%), aspartate aminotransferase increased, hypotension (13%), anemia, thrombocytopenia, alanine aminotransferase increased (11%), infection, dehydration, dyspnea (9%), lymphopenia, neutropenia, hyperbilirubinemia, hypocalcemia, hypoxia (6%), febrile neutropenia, leukopenia, ventricular arrhythmia, vomiting, hypersensitivity, catheter related infection, hyperuricemia, hypoalbuminemia, syncope, pneumonitis, packed red blood cell transfusion, and platelet transfusion (4%).

Deaths due to all causes within 30 days of the last dose of ISTODAX occurred in 7% of patients in Study 3 and 17% of patients in Study 4. In Study 3, there were 5 deaths unrelated to disease progression that were due to infections, including multi-organ failure/sepsis, pneumonia, septic shock, candida sepsis, and sepsis/cardiogenic shock. In Study 4, there were 3 deaths unrelated to disease progression that were due to sepsis, aspartate aminotransferase elevation in the setting of Epstein Barr virus reactivation, and death of unknown cause.

Discontinuations

Discontinuation due to an adverse event occurred in 19% of patients in Study 3 and in 28% of patients in Study 4. In Study 3, thrombocytopenia and pneumonia were the only events leading to treatment discontinuation in at least 2% of patients. In Study 4, events leading to treatment discontinuation in ≥ 2 patients were thrombocytopenia (11%), anemia, infection, and alanine aminotransferase increased (4%).

Postmarketing Experience

No additional safety signals have been observed from postmarketing experience.

Read the entire FDA prescribing information for Istodax (Romidepsin for Injection) »

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Istodax - User Reviews

Istodax User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Istodax sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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