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

Romidepsin 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

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

Romidepsin 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.

Romidepsin 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 Romidepsin:

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

Serious side effects are rare with Romidepsin. 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 Romidepsin:

• Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in
• patients concurrently administered Romidepsin 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.

Various FDA-approved generic manufacturers

Romidepsin 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 Romidepsin.
You should avoid becoming pregnant during treatment with Romidepsin and for 1 month after the last dose.
You should use effective birth control (contraception) during treatment with Romidepsin and for 1 month after your last dose.
Romidepsin 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 Romidepsin.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during
treatment with Romidepsin.

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

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