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ISTODAX
 
 
 
 

ISTODAX® is indicated for treatment of cutaneous T-cell
lymphoma (CTCL) in patients who have received at
least one prior systemic therapy.

ISTODAX® is indicated for treatment of peripheral T-cell
lymphoma (PTCL) in patients who have received at
least one prior therapy.

These indications are based on response rate. Clinical
benefit such as improvement in overall survival has not
been demonstrated.

 

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Important Safety Information

WARNINGS AND PRECAUTIONS

  • Myelosuppression: ISTODAX® (romidepsin) can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts regularly during treatment with ISTODAX; interrupt and/or modify the dose as necessary
  • Infections: Fatal and serious infections, including pneumonia, sepsis, and viral reactivation, including Epstein Barr and hepatitis B viruses, have been reported during and within 30 days after treatment with ISTODAX in clinical trials. The risk of life threatening infections may be greater in patients with a history of prior treatment with monoclonal antibodies directed against lymphocyte antigens and in patients with disease involvement of the bone marrow. Reactivation of Epstein Barr viral infection led to liver failure. Consider monitoring for reactivation and antiviral prophylaxis in patients with evidence of prior hepatitis B infection. Ganciclovir prophylaxis failed to prevent Epstein Barr viral reactivation in one case
  • Electrocardiographic (ECG) changes: ECG changes have been observed with ISTODAX. In patients with congenital long QT syndrome, patients with a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, consider cardiovascular monitoring of ECGs at baseline and periodically during treatment. Confirm that potassium and magnesium levels are within the normal range before administration of ISTODAX
  • Tumor lysis syndrome: TLS (Tumor lysis syndrome) has been reported during treatment with ISTODAX. Patients with advanced stage disease and/or high tumor burden are at greater risk and should be closely monitored and managed as appropriate
  • Embryo-fetal toxicity: ISTODAX may cause fetal harm when administered to a pregnant woman. Advise women of potential hazard to the fetus and to avoid pregnancy while receiving ISTODAX

ADVERSE REACTIONS

Peripheral T-Cell Lymphoma

The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 3 (N=131) were thrombocytopenia (24%), neutropenia (20%), anemia (11%), asthenia/fatigue (8%), and leukopenia (6%), and in Study 4 (N=47) were neutropenia (47%), leukopenia (45%), thrombocytopenia (36%), anemia (28%), asthenia/fatigue (19%), pyrexia (17%), vomiting (9%), and nausea (6%).

Infections were the most common type of serious adverse event reported in Study 3 (N=131) and Study 4 (N=47). In Study 3, 26 patients (20%) 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.

The most common adverse reactions regardless of causality in Study 3 (N=131) were nausea (59%), asthenia/fatigue (55%), thrombocytopenia (41%), vomiting (39%), diarrhea (36%), and pyrexia (35%), and in Study 4 (N=47) were asthenia/fatigue (77%), nausea (75%), thrombocytopenia (72%), neutropenia (66%), anemia (62%), leukopenia (55%), pyrexia (47%), anorexia (45%), vomiting (40%), constipation (40%), and diarrhea (36%).

Cutaneous T-Cell Lymphoma

The most common Grade 3/4 adverse reactions (>5%) regardless of causality in Study 1 (N=102) were infections (11%) and asthenia/fatigue (8%), and in Study 2 (N=83) were lymphopenia (37%), infections (33%), neutropenia (27%), leukopenia (22%), anemia (16%), asthenia/fatigue (14%), thrombocytopenia (14%), hypophosphatemia (10%), vomiting (10%), dermatitis/exfoliative dermatitis (8%), hypermagnesemia (8%), hyperuricemia (8%), hypocalcemia (6%), nausea (6%), and pruritus (6%).

Infections were the most common type of serious adverse event reported in both Study 1 (N=102) and Study 2 (N=83) with 8 patients (8%) in Study 1 and 26 patients (31%) in Study 2 experiencing a serious infection.

The most common adverse reactions regardless of causality in Study 1 (N=102) were nausea (56%), asthenia/fatigue (53%), infections (46%), vomiting (34%), and anorexia (23%), and in Study 2 (N=83) were nausea (86%), asthenia/fatigue (77%), anemia (72%), thrombocytopenia (65%), ECG ST-T wave changes (63%), neutropenia (57%), lymphopenia (57%), infections (54%), anorexia (54%), vomiting (52%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), leukopenia (46%), dysgeusia (40%), and constipation (39%).

DRUG INTERACTIONS

  • Monitor more frequently prothrombin time and International Normalized Ratio in patients concurrently administered ISTODAX and warfarin or coumarin derivatives
  • Romidepsin is metabolized by CYP3A4
    • Monitor patients for toxicity related to increased romidepsin exposure and follow dose modifications for toxicity when ISTODAX is initially co‑administered with strong CYP3A4 inhibitors
    • Avoid co-administration of ISTODAX (romidepsin) with rifampin and other potent inducers of CYP3A4
  • Exercise caution with concomitant use of ISTODAX and P-glycoprotein (P‑gp, ABCB1) inhibitors

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category D: If this drug is used during pregnancy, or if the patient becomes pregnant while taking ISTODAX, the patient should be apprised of the potential hazard to the fetus
  • Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ISTODAX, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
  • Patients with moderate and severe hepatic impairment and/or patients with end-stage renal disease should be treated with caution

Please see Full Prescribing Information, including WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS.

 
If you have any questions, please call 1-888-423-5436.
 

ISTODAX® is a registered trademark of Celgene Corperation.

 
Celgene Corporation www.celgene.com
 
 

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TO BEGIN: Select and drag a manifestation to the appropriate area on the body.
Step 1. Patient Profile

Use this Calculator to help determine the appropriate dose of ISTODAX for your patients. Begin by selecting one of the following patient profiles:

Step 2. Patient Adverse Reactions

If your patient is experiencing adverse drug reactions at the recommended starting dose (14 mg/m2), a dose modification may be required. Please select one of the following adverse reactions your patient is experiencing:

Nonhematologic toxicities:
Grade 2 or 3
Recurrent Grade 3
Grade 4
Post-dose reduction recurrent Grade 3 or 4
None of the above
Step 3. Patient Adverse Reactions (cont’d.)

If your patient is experiencing adverse drug reactions at the recommended starting dose (14 mg/m2), a dose modification may be required. Please select one of the following adverse reactions your patient is experiencing:

Hematologic toxicities:
Grade 3 or 4 neutropenia
Grade 3 or 4 thrombocytopenia
Grade 4 febrile (≥38.5°C or 101.3°F) neutropenia or thrombocytopenia that requires platelet transfusion
None of the above
Calculate

Based on the information you’ve provided, the appropriate dose (mg/m2) for this patient is:

Please provide the following patient information to calculate the amount of ISTODAX that should be administered after dose delay. You can enter the values by using the slider or by directly inputting the values into the fields below:

80
50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 300 310 320 330 340 350 360 370 380 390 400 410 420 430 440 450 460 470 480 490 500 510 520 530 540 550 560 570 580 590 600 610 620 630 640 650 660 670 680 690 700 710 720 730 740 750 760 770 780 790 800 810 820 830 840 850 860 870 880 890 900 910 920 930 940 950 960 970
lbs.
48
24 30 36 42 48 54 60 66 72 78 84 90 96 102 108 114 120 126
in.
Results

Based on the information you’ve provided, the recommended course of treatment is:

Delay dose until toxicity returns to ≤ Grade 1 or baseline, then therapy may be permanently reduced to 10 mg/m2

Results

Based on the information you’ve provided, the appropriate dose (mg/m2) for this patient is:

Results

Based on the information you’ve provided, the recommended course of treatment is: