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Fosrolapitant and Palonosetron

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Fosrolapitant and Palonosetron

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: Fosrolapitant and Palonosetron
Generic Name (API): Fosrolapitant, Palonosetron
Dosage Form & Strength: 218 mg / 0.25 mg
Route: Intravenous (IV) infusion
Drug Class: Antiemetic: NK-1 receptor antagonist prodrug + 5-HT3 receptor antagonist (fixed-dose combination)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Fosrolapitant and Palonosetron Used For?

Fosrolapitant and palonosetron is a single injection that helps prevent the nausea and vomiting caused by strong chemotherapy. It was developed in China by Fujian Shengdi Pharmaceutical, a subsidiary of Jiangsu Hengrui Pharmaceuticals, where it was tested under the code HR20013 and is sold as 瑞坦宁® (Ritanine®). Its Chinese name is 注射用磷罗拉匹坦帕洛诺司琼.

China's National Medical Products Administration (NMPA) approved it in May 2025 for adults:

  • To prevent acute and delayed nausea and vomiting
  • Caused by highly emetogenic chemotherapy (the chemotherapy most likely to make people sick, such as cisplatin-based regimens)

It is a supportive-care medicine used alongside cancer treatment, and it should be prescribed by the oncologist who plans the chemotherapy.

How It Works

Chemotherapy triggers vomiting through two main chemical signals. One, serotonin, acts quickly in the first day. The other, substance P, keeps the sickness going for several days afterwards. This medicine blocks both at once. Palonosetron blocks the serotonin (5-HT3) receptor, and fosrolapitant is turned in the body into a long-acting blocker of the substance P (NK-1) receptor. Because both parts stay in the body a long time (about 188 hours and 52 hours on average), one drip on day 1 covers the whole chemotherapy cycle.

What the Trial Showed

The phase 3 PROFIT trial, published in the Journal of Clinical Oncology in 2025, included 750 people in China starting cisplatin-based chemotherapy for the first time. With dexamethasone, 77.7% of people on this injection had no vomiting and needed no rescue medicine over the first five days, compared with 78.2% on a standard three-medicine regimen given as separate injections. That met the trial's goal of showing it works as well as the standard approach. In days 6 to 7, 90.3% stayed free of vomiting against 86.5%, a difference that was not statistically significant. In the second cycle, more patients said nausea and vomiting had no impact on their daily life.

Recommended Dosage

In the trials, the plan for each chemotherapy cycle was:

  • One dose (fosrolapitant 218 mg with palonosetron 0.25 mg) as a drip over about 1 hour on day 1, finished before chemotherapy starts
  • Dexamethasone by mouth, 12 mg on day 1, then 3.75 mg twice a day on days 2 to 4
  • Given once per cycle only

A study in people with moderate liver impairment found no need to change the dose. Your oncologist will set the exact plan from the Chinese prescribing information.

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

Warnings and Precautions

Overall safety: in the PROFIT trial, side effects judged to be caused by the antiemetic treatment were seen in 35.7% of patients in the first cycle and 42.1% across the whole study, slightly fewer than with the standard regimen (38.2% and 44.0%).

  • Constipation and bloating: in a smaller study of 22 patients, the most common related side effects were constipation (22.7%), abdominal distension (13.6%) and injection-site pain (9.1%). All were mild or moderate.
  • Allergy: a liver-impairment study excluded anyone with a known allergy to either ingredient. Tell your doctor about any past reaction to anti-sickness medicines.
  • Heart rhythm: the same study excluded people with a prolonged QT interval on their ECG, so the doctor may check an ECG first if you have a heart rhythm problem.
  • Other medicines: palonosetron is broken down mainly by the liver enzyme CYP2D6, and the long-acting part by CYP3A4. Give your oncologist a full list of your medicines and supplements.
  • Dexamethasone: the steroid given with it can raise blood sugar, so people with diabetes may need closer checks.

Safety in pregnancy, breastfeeding and children has not been established in the published studies. Rescue medicine for breakthrough sickness can still be used if the doctor allows it.

How to Access Fosrolapitant and Palonosetron in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation & Availability

What documents are required to import Fosrolapitant and Palonosetron to India?

The injection can be imported only in the patient's name, by the patient or a government hospital, in line with India's import regulations for unapproved medicines. You will need:

  • A valid prescription from a qualified medical oncologist
  • The chemotherapy plan, showing the regimen and the number of planned cycles
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

Once we have received and checked a valid prescription and, where needed, an import permit.

Is Fosrolapitant and Palonosetron available in India?

No. This combination is approved only in China. It has no CDSCO approval, it is not sold in Indian pharmacies, and the US FDA and European Medicines Agency have not approved it either.

Patients can still get it legally through the Named Patient Program (NPP), which allows a medicine not registered in India to be imported for one specific patient on a prescription. NPP also arranges other cancer medicines that are not registered in India, such as Trodelvy and Datroway.

It can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only after receipt of a valid doctor's prescription and an import permit, where applicable.

Sourcing & Delivery

NamedPatientProgram.com (NPP) sources this medicine through the manufacturer's authorised supply channels in China and arranges supply to patients, doctors, and hospitals under applicable legal provisions. It is stored as directed on the pack and travels in its sealed original packaging under temperature-controlled shipping. Because one dose is needed for each chemotherapy cycle, we plan quantities around the oncologist's cycle dates. All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

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

Availability Across Major Cities in India

Patients across India can access this medicine through regulated import pathways, with delivery arranged to the treating hospital on a valid oncologist's prescription.

Delhi

Large chemotherapy day-care units in Delhi treat patients from across North India, and our New Delhi dispatch point keeps delivery times short.

Mumbai

Doses can be delivered to the hospital pharmacy ahead of each planned cisplatin cycle.

Bangalore

Oncologists in Bangalore can request it for a named patient, and the quote is shared before anything is ordered.

Chennai

A major cancer referral centre for South India, where patients often travel in for each chemotherapy cycle.

Hyderabad

We line up delivery with the day-1 date in the chemotherapy plan, so the dose is ready before treatment begins.

Kolkata

Patients from Kolkata and the eastern states can have each cycle's dose sent straight to the treating hospital.

Pune

Patients in Pune can use the same documented import route, with updates shared at every step.

Ahmedabad

The treating oncologist can send us the prescription and chemotherapy plan to begin the import.

Vellore

Patients having chemotherapy at hospitals in Vellore can have each dose delivered directly to the hospital.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the cancer centre where chemotherapy is given.

Lucknow

We coordinate delivery to public and private cancer hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the dose at their hospital in Kochi and nearby cities.

Access can also be coordinated for patients in other Indian cities, subject to a valid prescription and regulatory requirements.

Author Details

Nitin Goswami

Written By

Nitin Goswami

Deputy Manager – Content & Social Media, Ikris Pharma Network

Sources: NMPA • CDSCO

Dr. Chirag C Shah

Medically Reviewed By

Dr. Chirag C Shah

MBBS

Last Updated: 19 October 2026

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