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Istodax is the brand name for romidepsin and is available as an injection for IV use.

Istodax is available as a single-dose vial that contains 10 mg of romidepsin.

Istodax is a histone deacetylase (HDAC) inhibitor indicated for the treatment of
cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior
systemic therapy

Istodax works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

Istodax is dosed as follows:
14 mg/m2 administered intravenously over a 4-hour period on days 1, 8, and 15 of
a 28-day cycle. Repeat cycles every 28 days provided that the patient continues to
benefit from and tolerates the drug.
Discontinue or interrupt treatment (with or without dose reduction to 10 mg/m2) to
manage drug toxicity.
Reduce starting dose in patients with moderate and severe hepatic impairment.

Istodax is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Istodax:

• Nausea
• Fatigue
• Infections
• Vomiting
• Weight loss
• Heart rhythm changes
• Altered taste
• Constipation

Serious side effects are rare with Istodax. Contact your doctor or seek medical help if you experience any of the following.
Low blood cell counts
Serious infections
Changes in your heartbeat
Tumor lysis syndrome

The following medications may interact with Istodax:

• Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in
• patients concurrently administered Istodax and warfarin or coumarin derivatives.
• Monitor for toxicities related to increased romidepsin exposure when co-administering
• romidepsin with strong CYP3A4 inhibitors.
• Avoid use with rifampin and strong CYP3A4 inducers.

Bristol-Myers Squibb

Istodax may harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider will perform a pregnancy test within 7 days before you start treatment with Istodax.
You should avoid becoming pregnant during treatment with Istodax and for 1 month after the last dose.
You should use effective birth control (contraception) during treatment with Istodax and for 1 month after your last dose.
Istodax may affect the way estrogen-containing birth control works. Talk to your healthcare provider for more information about other types of birth control to use during treatment with Istodax.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during
treatment with Istodax.

Males with a female sexual partner who can become pregnant:
Istodax can harm the unborn baby of your partner.
You should use a condom and avoid fathering a child during treatment with Istodax and for 1 month after treatment with Istodax. Talk to your healthcare provider if this is a concern for you.

• Romidepsin