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Sylvant

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Sylvant

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Sylvant
Generic Name (API): Siltuximab
Dosage Form & Strength: Powder for infusion: 100 mg, 400 mg
Route: Intravenous (IV) infusion
Drug Class: Interleukin-6 (IL-6) antagonist monoclonal antibody

Manufacturer / Innovator:

Recordati Rare Diseases

Regulatory Approval:

  • US FDA
  • EMA (Europe)
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What Is Sylvant Used For?

Sylvant (siltuximab) is an antibody infusion for multicentric Castleman disease (MCD), a rare disorder in which lymph nodes in several parts of the body grow too large. Too much of an inflammatory messenger called interleukin-6 (IL-6) is linked to its body-wide symptoms, such as tiredness and anaemia.

It is approved in the United States and the European Union for MCD in patients who are HIV-negative and HHV-8-negative (often called idiopathic MCD). It has not been studied in MCD linked to HIV or HHV-8, because Sylvant does not bind the IL-6 made by that virus. It is a prescription haematology medicine, given in hospital under a haematologist.

How It Works

Siltuximab is a monoclonal antibody that binds IL-6 and stops it from reaching its receptors. Too much IL-6 is linked to the fever, anaemia and other body-wide symptoms of MCD, so blocking it can calm the disease and shrink the lymph nodes.

What the Trial Showed

In a randomised, placebo-controlled study of 79 patients with MCD (53 on Sylvant, 26 on placebo, all with best supportive care):

  • 34% of patients on Sylvant had a lasting response in both tumour size and symptoms, against 0% on placebo.
  • Lymph nodes shrank in 38% against 4%.
  • Among patients who were anaemic at the start, 61% had their haemoglobin rise by at least 1.5 g/dL by week 13, against 0% on placebo.

Recommended Dosage

The dose is 11 mg per kg of body weight, given as a 1-hour intravenous infusion every 3 weeks, and continued until the treatment stops working. A blood count is done before each dose for the first 12 months and then every 3 doses. The dose is not lowered; instead, a dose may be delayed if neutrophils, platelets or haemoglobin are outside the set limits.

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

Warnings and Precautions

Infections

Sylvant must not be given during a severe infection; the dose waits until the infection clears. Because it blocks IL-6, it can hide the usual signs of infection, such as fever and a raised CRP blood test. Patients and doctors need to watch closely for infection and treat it early.

No live vaccines

Live vaccines must not be given during treatment, and not to babies born to mothers on Sylvant, because the immune response may not work normally. Check your vaccination plan with the doctor before starting.

Infusion reactions and allergy

Infusion reactions occurred in about 5% of patients on Sylvant alone and in about 6% during long-term treatment. Signs include back or chest pain, nausea, flushing, redness and palpitations. One patient out of about 945 in the trials had anaphylaxis. Sylvant is given only where resuscitation equipment and trained staff are available.

Bowel perforation

A hole in the stomach or bowel has been reported in trials (not in MCD trials). Tell your doctor at once about severe stomach pain, especially with fever.

Pregnancy and breastfeeding

Sylvant may harm an unborn baby. Women who can become pregnant should use effective contraception during treatment and for 3 months after the last dose. Breastfeeding is not recommended during treatment and for 3 months after the last dose.

Common side effects

Rash, itching, upper respiratory infections, weight gain and raised uric acid in the blood were the most common side effects. 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 Sylvant in India: Step by Step

Sylvant is not sold in Indian pharmacies, so every order is arranged for one named patient. Treatment continues every 3 weeks for as long as it keeps working, so we plan a steady supply.

Step 1: Share the treatment plan

Send the prescription with the patient's current weight and the planned number of doses. The dose is 11 mg/kg, so a 60 kg patient needs 660 mg per infusion. Sylvant comes as 100 mg and 400 mg vials, and our pharmacist works out the best mix (for 660 mg, one 400 mg and three 100 mg vials).

Step 2: Document check

A registered pharmacist checks the prescription, the lymph node biopsy confirming MCD, the HIV and HHV-8 test results and the patient's ID, and tells you at once if anything is missing.

Step 3: Quote per dose

The Sylvant price in India is quoted for the vials needed for each infusion, plus cold-chain freight and customs clearance. If the weight changes, we update the vial plan.

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: Cold-chain import

The vials travel at 2°C to 8°C in their original cartons, with a temperature logger in every box.

Step 6: Delivery before each infusion

We deliver to the hospital pharmacy or day-care unit, timed to the 3-weekly infusion day.

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 Sylvant

  • A prescription that names Sylvant (siltuximab), the dose, the number of vials and the length of treatment, with the doctor's medical council registration number
  • The lymph node biopsy report confirming multicentric Castleman disease
  • HIV and HHV-8 test reports, as Sylvant is approved only when both are negative
  • Patient ID proof issued by the Government of India
  • The signed Form 12A, which our team prepares for you

Is Sylvant available in India?

No. Sylvant (siltuximab) has no marketing approval in India and is not sold in Indian pharmacies. We checked the published minutes of CDSCO's oncology and haematology expert committees from 2018 to November 2026, and siltuximab does not appear in them. It can still be imported legally for a named patient under Rule 36, with a Form 12A application and a Form 12B permit.

Sylvant 100 mg or 400 mg: which one will you get?

Sylvant comes as a powder in single-dose vials of 100 mg and 400 mg, made into a solution by the hospital pharmacy. Most adults need a mix of both. People often search for the siltuximab 400 mg price, but the cost per infusion depends on body weight.

Can you buy Sylvant 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 online, 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 Sylvant

Sylvant is marketed by Recordati Rare Diseases. As a Sylvant 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 vial can be traced to one patient and one prescription.

Cold storage

Unopened vials must be kept in a refrigerator at 2°C to 8°C, in the original carton to protect them from light, and must not be frozen. We ship in validated insulated boxes with a data logger and check the temperature record on arrival. Read more about our temperature-controlled shipping.

At the hospital

The hospital pharmacy dissolves the powder in sterile water, then dilutes it to 250 mL with 5% dextrose. Per the US label, the dissolved vial must be added to the bag within 2 hours, and the infusion must be finished within 4 hours of dilution. This is why we time each delivery close to the infusion day.

Checked before dispatch

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

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

Sylvant Access Across Major Cities in India

Sylvant is infused in hospital every 3 weeks, so we deliver to the haematology unit where the patient is treated.

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

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 10 November 2026

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