Romidepsin

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Generic Name: Romidepsin Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: D

Uses

What is Romidepsin used for?

Romidepsin is used to treat certain types of cancer (cutaneous or peripheral T-cell lymphoma). Romidepsin works by stopping the growth of cancer cells.

How should I take Romidepsin?

This medication is mixed in a solution and given slowly into a vein over 4 hours by a health care professional as directed by your doctor. It is usually given on day 1, day 8, and day 15, every 28 days.

The dosage is based on your medical condition, body size, and response to treatment. Before each cycle, you should have blood tests to find the best dose for you and to see whether you need to wait before receiving this drug again.

How do I store Romidepsin?

Romidepsin for Injection is supplied as a kit containing 2 vials in a single carton. The carton must be stored at 20° to 25°C, excursions permitted between 15° to 30°C. Romidepsin is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Romidepsin in the bathroom or the freezer. There may be different brands of Romidepsin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Romidepsin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Romidepsin?

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), current/recent infection.

This drug may make you tired. Alcohol or marijuana can make you more tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Romidepsin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using romidepsin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using romidepsin safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Romidepsin can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. See also Drug Interactions section.

It is unknown if this drug passes into breast milk and may harm nursing infants. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Romidepsin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Romidepsin. Romidepsin is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Romidepsin?

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

People using this medication may 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 ofside 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. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. These infections can occur during treatment and within 30 days after stopping treatment. Your doctor will order blood tests to check for side effects. It is important to keep all medical/lab test appointments. Tell your doctor right away if you develop any of the following symptoms: easy bruising/bleeding, pale skin, unusual tiredness, signs of infection (such as fever, chills, cough, shortness of breath, 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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Romidepsin?

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

People using this medication may 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 ofside 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. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. These infections can occur during treatment and within 30 days after stopping treatment. Your doctor will order blood tests to check for side effects. It is important to keep all medical/lab test appointments. Tell your doctor right away if you develop any of the following symptoms: easy bruising/bleeding, pale skin, unusual tiredness, signs of infection (such as fever, chills, cough, shortness of breath, 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.

Romidepsin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Romidepsin?

Romidepsin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Romidepsin?

Romidepsin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Romidepsin.

What is the dose of Romidepsin for an adult?

Usual Adult Dose for Cutaneous T-cell Lymphoma

14 mg/m2 IV over 4 hours on days 1, 8, and 15 of a 28-day cycle

Repeat cycle every 28 days provided patient continues to benefit and is tolerating therapy.

Comments:

-Dose reduction, discontinuation or interruption of therapy may be necessary to manage adverse reactions.

-Avoid use with rifampin and strong CYP450 3A4 inducers.

Uses:

Treatment of cutaneous T-cell Lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) in patients who have received at least 1 prior systemic therapy.

Usual Adult Dose for Peripheral T-cell Lymphoma

14 mg/m2 IV over 4 hours on days 1, 8, and 15 of a 28-day cycle

Repeat cycle every 28 days provided patient continues to benefit and is tolerating therapy.

Comments:

-Dose reduction, discontinuation or interruption of therapy may be necessary to manage adverse reactions.

-Avoid use with rifampin and strong CYP450 3A4 inducers.

Uses:

Treatment of cutaneous T-cell Lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL) in patients who have received at least 1 prior systemic therapy.

Renal Dose Adjustments

Use with caution in patients with end stage renal disease (ESRD).

Liver Dose Adjustments

Use with caution in patients with moderate and severe hepatic impairment.

Dose Adjustments

Hematologic toxicities:

-Grade 3 or 4 neutropenia or thrombocytopenia: Delay treatment until specific cytopenia returns to absolute neutrophil count (ANC) of 1.5 x 10(9)/L or greater and/or platelet count is 75 x 10(9)/L or baseline; restart at 14 mg/m2

-Grade 4 febrile (38.5C or greater) neutropenia or thrombocytopenia requiring platelet transfusion: Delay treatment until specific cytopenia returns to Grade 1 or less or baseline; permanently reduce dose to 10 mg/m2.

Nonhematologic toxicities except alopecia:

-Grade 2 or 3: delay treatment until toxicity returns to grade 1 or less or baseline; resume at 14 mg/m2.

-Grade 3 recurrence: Delay treatment until toxicity returns to grade 1 or less or baseline; permanently reduce dose to 10 mg/m2.

-Grade 4: Delay treatment until toxicity returns to grade 1 or less or baseline; permanently reduce dose to 10 mg/m2.

-Grade 3 or 4 recurrence after dose reduction: Drug should be discontinued.

What is the dose of Romidepsin for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Romidepsin available?

Romidepsin is available in the following dosage forms and strengths:

  • Intravenous powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Romidepsin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: August 10, 2018 | Last Modified: August 10, 2018

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