Istodax Side Effects Center

Last updated on RxList: 1/21/2022
Istodax Side Effects Center

What Is Istodax?

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). Istodax is usually given after other medications have been tried without successful treatment of symptoms.

What Are Side Effects of Istodax?

Common side effects of Istodax include:

Dosage for Istodax

The recommended dose of Istodax is 14 mg/m2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle.

What Drugs, Substances, or Supplements Interact with Istodax?

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 During Pregnancy and Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Skin Cancer Symptoms, Types, Images See Slideshow
Istodax 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.

You may get infections more easily, even serious or fatal infections, during and after treatment. Call your doctor right away if you have signs of infection such as:

  • fever, flu symptoms, muscle aches;
  • worsening skin symptoms;
  • burning when you urinate; or
  • cough, chest discomfort, feeling short of breath.

Also call your doctor at once if you have:

  • chest pain, feeling short of breath;
  • fast or pounding heartbeats, fluttering in your chest, sudden dizziness (like you might pass out);
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • low blood cells counts, infections;
  • nausea, vomiting, loss of appetite;
  • constipation;
  • itching;
  • tiredness; or
  • changes in your sense of taste.

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.

Istodax Professional Information

SIDE EFFECTS

The following adverse reactions are described in more detail in other sections of the prescribing information.

  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Electrocardiographic Changes [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]

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.

The data in the WARNINGS AND PRECAUTIONS reflect exposure to ISTODAX in four clinical trials involving 363 patients with T-cell lymphoma, including 185 patients with CTCL. ISTODAX was administered as a single agent at a dosage of 14 mg/m2on days 1, 8, and 15 of a 28-day cycle. Among 363 patients who received ISTODAX, 21% were exposed for 6 months or longer and 13% were exposed for greater than one year.

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 dosage of 14 mg/m2on days 1, 8, and 15 of a 28-day cycle. Treatment continued as long as the patient benefitted from and tolerated the drug. The mean duration of treatment in these studies was 5.6 months (range: <1 to 83.4 months).

Common Adverse Reactions

Table 2 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 2.

Table 2. 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 grades Grade 3 or 4 All grades Grade 3 or 4
Any adverse reactions 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%).

There were eight deaths not due to disease progression. In Study 1, there were two deaths: one due to cardiopulmonary failure and one due to acute renal failure. There were six deaths in Study 2: four due to infection and one each due to 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.

Other Clinical Trials Experience

The following common adverse reactions have been reported following administration of ISTODAX as a single agent in 178 patients with peripheral T-cell lymphoma, for which ISTODAX is not indicated or recommended. The most common adverse reactions (≥30%) included nausea (63%), fatigue (61%), thrombocytopenia (49%), vomiting (39%), neutropenia (39%), pyrexia (38%), diarrhea (36%) and anemia (35%). Other common (≥10%) clinically significant adverse reactions included dysgeusia (22%), headache (20%), cough (19%), dyspnea (15%), abdominal pain (13%) and stomatitis (10%). Grade 3 and higher adverse reactions in ≥10% were hematologic toxicities (including thrombocytopenia, neutropenia, leukopenia and anemia) and fatigue.

DRUG INTERACTIONS

Warfarin Or Coumarin Derivatives

Prolongation of PT and elevation of INR were observed in a patient receiving ISTODAX concomitantly with warfarin. Monitor PT and INR more frequently in patients concurrently receiving ISTODAX and warfarin [see CLINICAL PHARMACOLOGY].

Drugs That Inhibit CYP3A4 Enzymes

Strong CYP3A4 inhibitors increase concentrations of romidepsin [see CLINICAL PHARMACOLOGY]. Monitor for toxicity related to increased romidepsin exposure and follow the dose modifications for toxicity [see DOSAGE AND ADMINISTRATION] when ISTODAX is initially co-administered with strong CYP3A4 inhibitors.

Drugs That Induce CYP3A4 Enzymes

Rifampin (a potent CYP3A4 inducer) increased the concentrations of romidepsin [see CLINICAL PHARMACOLOGY]. Avoid co-administration of ISTODAX with rifampin. The use of other potent CYP3A4 inducers should be avoided when possible.

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

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

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