Romidepsin (Istodax)

Trade Name : ISTODAX

Celgene Corporation

KIT

Strength
In Stock

Storage/Handling:

Store at room temperature of 20° to 25°C


Uses of Romidepsin (Istodax):

This medication is prescribed for the treatment of T cell Lymphoma (CTCL) and peripheral T cell lymphoma (PTCL), in patients who have already undergone a systemic therapy.


Product Introduction:

Romidepsin Istodax kit works by blocking specific enzymes in the body, which disrupts the growth of cancer cells.

This prescription medicine is used to treat a skin cancer called cutaneous T-cell lymphoma (CTCL) when other treatments have not been successful.

Romidepsin, the active ingredient in Istodax, hinders the growth of cancer cells, but it can also affect normal body cells, leading to potential side effects. Some of these side effects can be severe, so it's crucial to discuss both the benefits and risks with your doctor before starting treatment. Istodax's safety and effectiveness in children under 18 years of age are not known.

Additionally, it's important to regularly monitor blood counts during Istodax treatment and adjust the dosage as needed.


Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Side Effects of Romidepsin (Istodax):

Common side effects
# low blood cells counts, infections
# nausea, vomiting, loss of appetite
# constipation
# itching
# tiredness
# changes in your sense of taste

Some serious side effects
# fever, flu symptoms, muscle ache
# worsening skin symptoms;
# burning when you urinate or
# Cough
# chest discomfort
# feeling short of breath.

Istodax has the potential to lead to a severe heart issue. This risk could be elevated if you're taking specific medications for infections, asthma, heart conditions, high blood pressure, depression, mental health disorders, cancer, malaria, or HIV.


Drug Interactions:

Certain products, like disulfiram and "blood thinners" such as warfarin, could interact with this medication. These interactions might affect how your drugs perform or raise the chance of serious side effects.


How Romidepsin (Istodax) Works:

This medication is given by kit into a vein by a health care professional. It is given as directed by your doctor, usually over 4 hours on days 1, 8, and 15 of a 28-day treatment cycle. This cycle is then repeated as directed by your doctor.The dosage is based on your medic,al condition, body size, and response to treatment.You should receive this medication regularly to get the most benefit from it.


Safety Instructions For Romidepsin (Istodax):

Pregnancy svgPREGNANCY (not recommended) Romidepsin could harm an unborn baby. Your doctor should conduct a pregnancy test within 7 days before you begin this medication. Alcohol svgALCOHOL (use with caution)While consuming alcohol with Istodax Romidepsin kit is not well-known, it's advisable to consult your doctor regarding this. BREAST FEEDINGBREAST FEEDING (consult your doctor)Breastfeeding is not recommended while using this medication and for 1 week after the final dose due to potential risks to the infant. Be sure to consult your doctor before breastfeeding. Driving svgDRIVING (unknown) The impact of this medication on your ability to drive is uncertain.
LIVER svgLIVER (be cautious) Inform your doctor about any liver disease before taking the medication, as it may lead to increased effects due to slower removal of the medicine from the body. KIDNEY svgKIDNEY (be cautious) Notify your doctor of any kidney disease before taking the medication, as it may have an impact on you.


Habit Forming:

No


Remember:

1. Always get your doctor's approval before starting, stopping, or altering the dose of any medication.
2. When deciding to use a medication, you and your doctor should consider the risks versus the benefits. This is a joint decision.
3. The effects of romidepsin kit on children have not been adequately studied, so its safety and effectiveness in pediatric patients are uncertain.
4. Remember to store Istodax out of children's reach, never share your medications, and only use Istodax as prescribed by your doctor.
5. Seek immediate medical help if you experience allergic reactions to Istodax, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
6. Consult your doctor or pharmacist about the need for additional reliable birth control methods while using this medication and for one month after discontinuing treatment.


FAQs:

1. What if we missed the dose?

If you miss a dose, it's crucial to stick to the prescribed schedule. Contact your doctor or pharmacist promptly for a new dosing plan.

2. What happens if I overdose?

If someone overdoses on this medication and experiences severe symptoms like fainting or difficulty breathing, call for immediate assistance.

3. What should I avoid while receiving Istodax romidepsin kit?

Abide by your doctor's guidance regarding any dietary or activity restrictions while receiving Istodax.

4. What special dietary instructions should I follow?

Unless your doctor advises otherwise, you can maintain your regular diet while taking romidepsin kit.

5. Can Istodax cause any allergy?

Istodax romidepsin may contain inactive components that could trigger allergic reactions or other issues. Consult your pharmacist for more information.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Romidepsin (Istodax) which is also known as ISTODAX and Manufactured by Celgene Corporation. It is available in strength of per ml. Read more

Romidepsin (Istodax) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for:
  • Treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ().
  • Treatment of peripheral T-cell lymphoma (PTCL) in adult patients who have received at least one prior therapy (). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials ().
  • No data
  • 14 mg/m administered intravenously (IV) 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/m) to manage drug toxicity ().
  • Reduce starting dose in patients with moderate and severe hepatic impairment ().
  • ISTODAX is supplied as a kit which includes a sterile, lyophilized powder in a 10 mg single-dose vial containing 11 mg of romidepsin, 22 mg of the bulking agent, tttttttpovidone, USP, and hydrochloric acid, NF, as a pH adjuster. In addition, each kit includes a single-dose sterile vial containing 2.4 mL (2.2 mL deliverable volume) of the diluent composed of 80% propylene glycol, USP, and ttttttt20% dehydrated alcohol, USP.
  • For injection: 10 mg of romidepsin as a lyophilized powder in single-dose vial for reconstitution. ().
  • None.
  • None ().
  • No data
  • Myelosuppression: ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts during treatment with ISTODAX; interrupt and/or modify the dose as necessary ().
  • Infections: Fatal and serious infections. Reactivation of DNA viruses (Epstein Barr and hepatitis B). Consider monitoring and prophylaxis in patients with evidence of prior hepatitis B ().
  • Electrocardiographic (ECG) changes: Consider cardiovascular monitoring in patients with congenital long QT syndrome, a history of significant cardiovascular disease, and patients taking medicinal products that lead to significant QT prolongation. Ensure that potassium and magnesium are within the normal range before administration of ISTODAX ().
  • Tumor lysis syndrome: Patients with advanced stage disease and/or high tumor burden are at greater risk and should be closely monitored and appropriate precautions taken ().
  • Embryo-fetal toxicity: Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving ISTODAX (, , ).
  • The following adverse reactions are described in more detail in other sections of the prescribing information.
  • 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 safety of ISTODAX was evaluated in 185 patients with CTCL in 2 single arm clinical studies in which patients received a starting dose of 14 mg/m. The mean duration of treatment in these studies was 5.6 months (range: <1 to 83.4 months).
  • The most common adverse reactions were neutropenia, lymphopenia, thrombocytopenia, infections, nausea, fatigue, vomiting, anorexia, anemia, and ECG T-wave changes ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • 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 ().
  • No data
  • No specific information is available on the treatment of overdosage of ISTODAX.
  • Toxicities in a single-dose study i rats or dogs, at intravenous romidepsin doses up to 2.2-fold the recommended human dose based on the body surface area, included irregular respiration, irregular heartbeat, staggering gait, tremor, and tonic convulsions.
  • In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., clinical monitoring and supportive therapy, if required. There is no known antidote for ISTODAX and it is not known if ISTODAX is dialyzable.
  • Romidepsin, a histone deacetylase (HDAC) inhibitor, is a bicyclic depsipeptide. At room temperature, romidepsin is a white powder and is described chemically as (1,4,7,10,16,21)-7-ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone. The empirical formula is CHNOS.
  • The molecular weight is 540.71 and the structural formula is:
  • ISTODAX (romidepsin) for injection is intended for intravenous infusion only after reconstitution with the supplied diluent and after further dilution with 0.9% Sodium Chloride, USP.
  • ISTODAX is supplied as a kit containing 2 vials.
  • ISTODAX (romidepsin) for injection is a sterile lyophilized white powder and is supplied in a 10 mg single-dose vial containing 11 mg romidepsin, 22 mg povidone, USP, and hydrochloric acid, NF, as a pH adjuster.
  • Diluent for ISTODAX is a sterile clear solution and is supplied in a single-dose vial containing 2.4 mL (2.2 mL deliverable volume). Diluent for ISTODAX contains ttttttt80% (v/v) propylene glycol, USP and 20% (v/v) dehydrated alcohol, USP.
  • No data
  • Carcinogenicity studies have not been performed with romidepsin. Romidepsin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Romidepsin was not clastogenic in an in vivo rat bone marrow micronucleus assay when tested to the maximum tolerated dose (MTD) of 1 mg/kg in males and 3 mg/kg in females (6 and 18 mg/m in males and females, respectively). These doses were up to 1.3-fold the recommended human dose, based on body surface area.
  • Based on nonclinical findings, male and female fertility may be compromised by treatment with ISTODAX. In a 26-week toxicology study, romidepsin administration resulted in testicular degeneration in rats at 0.33 mg/kg/dose (2 mg/m/dose) following the clinical dosing schedule. This dose resulted in AUC values that were approximately 2% the exposure level in patients receiving the recommended dose of 14 mg/m/dose. A similar effect was seen in mice after 4 weeks of drug administration at higher doses. Seminal vesicle and prostate organ weights were decreased in a separate study in rats after 4 weeks of daily drug administration at 0.1 mg/kg/day (0.6 mg/m/day), approximately 30% the estimated human daily dose based on body surface area. Romidepsin showed high affinity for binding to estrogen receptors in pharmacology studies. In a 26-week toxicology study in rats, atrophy was seen in the ovary, uterus, vagina and mammary gland of females administered doses as low as 0.1 mg/kg/dose (0.6 mg/m/dose) following the clinical dosing schedule. This dose resulted in AUC values that were 0.3% of those in patients receiving the recommended dose of 14 mg/m/dose. Maturation arrest of ovarian follicles and decreased weight of ovaries were observed in a separate study in rats after 4 weeks of daily drug administration at 0.1 mg/kg/day (0.6 mg/m/day). This dose is approximately 30% the estimated human daily dose based on body surface area.
  • No data
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling ().
  • Manufactured for:u00a0u00a0u00a0u00a0u00a0u00a0u00a0Celgene Corporationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 tttttttttu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Summit, NJ 07901
  • Manufactured by:u00a0u00a0u00a0u00a0u00a0u00a0u00a0Baxter Oncology GmbHu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 tttttttttu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0tu00a0u00a0u00a0u00a0u00a0Halle/Westfalen, Germany
  • ISTODAX is a registered trademark of Celgene Corporation
  • Pat. www.celgene.com/therapies
  • u00a9 2010-2020 Celgene Corporation. All Rights Reserved.
  • ISTBAXPI.009/PPI.009
  • No data
  • NDC 59572-984-01
  • ISTODAX Kit(romidepsin) for injection
  • 10 mg/vial
  • Rx Only
  • Reconstitution and dilution required.
  • Each kit contains:
  • For Intravenous Use Only
  • Single-Dose Vial - Discard Unused Portion
  • Made in Germany
  • NDC 59572-962-10
  • ISTODAXn (romidepsin) for injection
  • Rx Only
  • 10 mg/vial
  • FOR INTRAVENOUS USE ONLY.
  • Directions For Use: See accompanying packageinsert for complete reconstitution directions.Product MUST be reconstituted with 2.2 mLof supplied Diluent for a concentration of5 mg/mL and then further diluted in 500 mLof 0.9% sodium chloride injection, USP.
  • DILUENTfor ISTODAXn
  • NDC 59572-973-02
  • Rx Only
  • 2.2 mL per single-dose vialEach vial contains 80% propylene glycoland 20% dehydrated alcohol.Dosage and Administration:Withdraw 2.2 mL of Diluent to reconstitute10 mg vial of ISTODAX.
  • LOT/EXP:

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