Unituxin

Warnings and Precautions

Boxed warning: serious infusion reactions

Serious and potentially life-threatening infusion reactions occurred in 26% of children. Signs include swelling of the face and airway, breathing difficulty, wheezing, hives and low blood pressure, usually during or within 24 hours of the infusion. Unituxin is given only in a hospital that can treat these reactions straight away.

Boxed warning: nerve pain and nerve damage

Pain is very common: 85% of children had pain despite morphine, and it was severe in 51%. It is usually tummy, back, limb or joint pain during the infusion. Severe nerve damage affecting feeling (2% to 9%) and movement has also been reported.

Eyes, bladder and spinal cord

Report blurred vision, a large pupil that reacts slowly to light, or difficulty passing urine. Rarely, inflammation of the spinal cord (transverse myelitis) and a brain swelling syndrome (RPLS) have occurred.

Capillary leak and low blood pressure

Fluid can leak from blood vessels, causing swelling and low blood pressure. The child is given fluids before each infusion and watched closely.

Infections, blood counts and blood salts

Serious infections, low blood counts and low sodium, potassium and calcium are common, so blood tests are done often. Treatment is paused during a serious infection. A rare kidney and blood condition called atypical haemolytic uraemic syndrome has also been reported.

Pregnancy

For young women of child-bearing age, effective contraception is needed during treatment and for 2 months after the last dose. Breastfeeding should stop during treatment.

Other common side effects

Fever, vomiting, diarrhoea, hives, low albumin and raised liver enzymes were also common. 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 Unituxin in India: Step by Step

Unituxin is not sold in India, so it is imported for one named child at a time. Each cycle uses four infusion days, so we plan the supply cycle by cycle with the paediatric oncology team.

Step 1: Share the treatment plan

Send the prescription with the child's height and weight (to work out body surface area), the cycle schedule and the start date. Each vial holds 17.5 mg, so a child with a body surface area of 0.6 m² needs about 10.5 mg a day, which is one vial per day, or four vials per cycle. Our pharmacist confirms the count.

Step 2: Document check

A registered pharmacist checks the prescription, the neuroblastoma diagnosis, the summary of first-line treatment and the parent's and child's ID, and tells you at once if anything is missing.

Step 3: Quote per cycle

The Unituxin price in India is quoted for the vials needed per cycle, plus cold-chain 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: 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 the cycle starts

We deliver to the hospital pharmacy before day 1 of the cycle, so the four infusion days are not delayed.

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 Unituxin

• A prescription from the paediatric oncologist that names Unituxin (dinutuximab), the dose, the number of vials and cycles, with the doctor's medical council registration number
• Reports confirming high-risk neuroblastoma and a summary of first-line treatment, including transplant
• ID proof of the child and of the parent or guardian who will receive the consignment
• The signed Form 12A, which our team prepares for you

Is Unituxin available in India?

No. Unituxin (dinutuximab) 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 dinutuximab does not appear in them. Its European authorisation was withdrawn in 2017, so supply comes from the United States. It can still be imported legally for a named patient under Rule 36, with a Form 12A application and a Form 12B permit.

Unituxin 17.5 mg vial: how many are needed?

Unituxin comes as a 17.5 mg/5 mL single-dose vial. The number of vials depends on the child's body surface area: a child with a body surface area up to 1 m² needs one vial a day, and a larger child needs two. The dinutuximab price per cycle therefore depends on the child's size.

Can you buy Unituxin online in India?

No. It is a hospital-only medicine and 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

Families 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 Unituxin

Unituxin is made by United Therapeutics in the United States. As a Unituxin 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 outer carton to protect them from light, and must not be frozen or shaken. 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 dilutes the dose in a 100 mL saline bag. Per the US label, the diluted bag is kept in the fridge, the infusion must start within 4 hours of preparation, and any bag not used within 24 hours is discarded. A new bag is prepared each infusion day, which is why we deliver the whole cycle's vials before day 1.

Checked before dispatch

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

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

Unituxin Access Across Major Cities in India

Unituxin is given only in paediatric oncology units that can manage infusion reactions and continuous pain relief, so we deliver to the treating hospital.

• Delhi NCR: Orders leave from New Delhi, so hospitals in Delhi, Gurgaon and Noida have the shortest cold-chain route. See imported medicines in Delhi NCR.
• Mumbai: Children treated at paediatric cancer centres in Mumbai can receive it at the hospital pharmacy. See imported medicines in Mumbai.
• Bangalore: Delivery to the treating hospital before each cycle. See imported medicines in Bangalore.
• Chennai and Vellore: Cold-chain delivery to the paediatric oncology unit. See imported medicines in Chennai.
• Kolkata: Delivery for families from eastern India and the North-East. See imported medicines in Kolkata.
• Other cities: Hyderabad, Pune, Ahmedabad, Kerala, Lucknow and more, by air cold chain to the hospital pharmacy.

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