Istodax

Warnings and Precautions

Low blood counts

Istodax can lower platelets, white cells and red cells. Severe drops in lymphocytes, neutrophils, haemoglobin or platelets were among the common lab changes. Blood counts are checked regularly, and doses are delayed until they recover.

Infections

Serious and fatal infections, including pneumonia and sepsis, have occurred. Old viral infections such as hepatitis B and Epstein-Barr virus can flare up again. Patients who have had hepatitis B may need monitoring or preventive treatment. The risk may be higher in people who have had antibody treatments against lymphocytes.

Heart rhythm (ECG changes)

ECG changes (ST-T wave changes) are common. Potassium and magnesium must be normal before each dose. People with congenital long QT syndrome, significant heart disease, or who take medicines that prolong the QT interval need heart monitoring.

Tumour lysis syndrome

When many lymphoma cells die quickly, salts released into the blood can harm the kidneys. People with advanced disease or a large tumour burden are watched closely.

Pregnancy and contraception

Istodax can harm an unborn baby. Women who can become pregnant and men with female partners should use effective contraception during treatment and for 1 month after the last dose. It may make oestrogen-containing birth control pills less effective, so non-hormonal methods such as condoms or an IUD are advised. Do not breastfeed during treatment and for 1 week after the last dose.

Common side effects

Nausea, tiredness, infections, vomiting, loss of appetite, taste changes, constipation and itching. This is not a complete list.

This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

How to Get Istodax in India: Step by Step

Istodax is not sold in India, so it is imported for one named patient at a time. Each 28-day cycle has three infusions, so we plan the supply cycle by cycle.

Step 1: Share the treatment plan

Send the prescription with the patient's height and weight and the planned cycles. Each kit contains one 10 mg vial. For example, a patient with a body surface area of 1.7 m² needs about 24 mg per infusion, which is three kits per infusion and nine per cycle. Our pharmacist confirms the count.

Step 2: Document check

A registered pharmacist checks the prescription, the skin or lymph node biopsy confirming CTCL, the list of earlier treatments and the patient's ID, and tells you at once if anything is missing.

Step 3: Quote per cycle

The Istodax price in India is quoted for the kits needed per 28-day cycle, plus freight and customs clearance.

Step 4: Form 12A application and Form 12B permit

We prepare the Form 12A application to CDSCO under Rule 36 of the Drugs and Cosmetics Rules. CDSCO states the Form 12B permit is usually issued within one to two days and stays valid for six months.

Step 5: Import at controlled room temperature

Istodax kits are stored at 20°C to 25°C, so no fridge is needed, but they are protected from Indian summer heat in transit.

Step 6: Delivery before day 1

We deliver to the hospital pharmacy or day-care unit before the first infusion of each cycle.

How much time does the process take?

The permit step usually takes one to two working days once all documents are complete. We share the expected delivery date with the quote, as it depends on stock at source and the flight route.

Documents Needed to Import Istodax

• A prescription that names Istodax (romidepsin), the dose, the number of kits and cycles, with the doctor's medical council registration number
• The biopsy report confirming cutaneous T-cell lymphoma and a summary of earlier systemic treatment
• Recent blood counts and hepatitis B test results
• Patient ID proof issued by the Government of India
• The signed Form 12A, which our team prepares for you

Is Istodax available in India?

No. Istodax (romidepsin) has no marketing approval in India. An Indian company applied to make a generic romidepsin, but in May 2024 a CDSCO technical committee asked for a local Phase III trial first, and no approval appears in CDSCO's expert committee minutes up to November 2026. It can still be imported legally for a named patient under Rule 36, with a Form 12A application and a Form 12B permit.

Istodax 10 mg kit: what is inside?

Each Istodax kit has one 10 mg vial of romidepsin powder and one vial of special diluent (propylene glycol and alcohol). The hospital pharmacy dissolves the powder in this diluent, then dilutes it in saline for the 4-hour infusion. People often search for the romidepsin 10 mg price, but the cycle cost depends on body size.

Can you buy Istodax online in India?

Not from an open online store, because a medicine without Indian approval cannot be sold off the shelf. The legal way is to send the prescription to NPP, and we arrange the permit and import in the patient's name.

Access from SAARC and Gulf countries

Patients from Nepal, Bangladesh, Bhutan, Sri Lanka and the Gulf can also ask us, subject to each country's import rules. Read our guide to Indian import regulations for the full legal process.

Sourcing & Delivery of Istodax

Istodax is made by Celgene, a Bristol Myers Squibb company. As an Istodax supplier in India under the named patient route, NPP buys it only through authorised channels and only after the patient's permit is issued, so every kit can be traced to one patient and one prescription.

Storage

Store the carton at 20°C to 25°C; short periods between 15°C and 30°C are allowed. Keep both vials (drug and diluent) in their carton. We ship in insulated packs that protect against heat; see our temperature-controlled shipping.

Hazardous drug handling

The label classes Istodax as a hazardous drug, so the hospital pharmacy follows special handling and disposal procedures when preparing it.

Checked before dispatch

A registered pharmacist matches every order with the prescription and the permit before it leaves New Delhi.

For the Istodax cost in India and current availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Istodax Access Across Major Cities in India

Istodax is infused in hospital day-care units three times in each 28-day cycle, so we deliver to the treating hospital before each cycle.

• Delhi NCR: Orders leave from New Delhi, so hospitals in Delhi, Gurgaon, Noida and Faridabad get the quickest delivery. See imported medicines in Delhi NCR.
• Mumbai: Lymphoma patients treated in Mumbai and Navi Mumbai can receive it at their hospital pharmacy. See imported medicines in Mumbai.
• Bangalore: Delivery to the treating hospital before day 1. See imported medicines in Bangalore.
• Chennai and Vellore: Delivery to the haematology or dermatology unit. See imported medicines in Chennai.
• Kolkata: Delivery for patients from eastern India and the North-East. See imported medicines in Kolkata.
• Other cities: Hyderabad, Pune, Ahmedabad, Kerala, Lucknow, Jaipur and more.

See how we arrange delivery of imported medicines to hospitals across India.