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Telpegfilgrastim

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Telpegfilgrastim

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: Telpegfilgrastim
Generic Name (API): Telpegfilgrastim
Dosage Form & Strength: 2 mg/1 mL; 1 mg/0.5 mL
Route: Subcutaneous (SC) injection
Drug Class: Long-acting pegylated G-CSF (40 kDa Y-shaped PEG-rhG-CSF)

Manufacturer / Innovator:

China

Regulatory Approval:

  • NMPA (China)
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What Is Telpegfilgrastim Used For?

Telpegfilgrastim is a long-acting white blood cell booster for people having chemotherapy. Many chemotherapy drugs knock down neutrophils, the white cells that fight bacteria, and a fever during that low point can turn into a serious infection. This medicine helps the bone marrow make neutrophils again, with just one injection under the skin per chemotherapy cycle. It was developed by Xiamen Amoytop Biotech in China and is sold there as 珮金® (Peijin).

China's National Medical Products Administration (NMPA) approved it on 30 June 2023 for:

  • Patients with non-myeloid cancers (solid tumours and other cancers that do not start in the bone marrow's myeloid cells)
  • Who are receiving myelosuppressive anti-cancer treatment that carries a clinically significant risk of febrile neutropenia
  • To lower the rate of infection, seen as febrile neutropenia (fever with a low neutrophil count)

The label states it is not for mobilising stem cells before a stem cell transplant. It is a prescription cancer supportive-care medicine and should be used only under an oncologist.

How It Works

G-CSF (granulocyte colony-stimulating factor) is the body's own signal telling the bone marrow to produce and release neutrophils. Telpegfilgrastim is a lab-made human G-CSF with a large 40 kDa Y-shaped (branched) polyethylene glycol, or PEG, attached. The PEG slows down how fast the body clears the protein, so its half-life is about 57 to 77 hours instead of a few hours. That is why a single dose can cover a whole cycle.

What the Trials Showed

Two phase 3 trials in China, led from the National Cancer Center in Beijing, compared it with standard G-CSF treatment:

  • Lung cancer (NSCLC), 133 patients on a standard two-drug chemotherapy: in cycle 1, severe (grade 4) neutropenia lasted on average 0.02 days with the 2 mg dose and 0.09 days with 33 µg/kg, against 0.16 days with daily G-CSF injections. Febrile neutropenia in cycle 1 was 0%, 2.2% and 2.3%. Both doses met the non-inferiority goal (BMC Cancer, 2025).
  • Breast cancer, 265 patients on the TAC regimen: severe neutropenia in cycle 1 lasted 0.58 days (2 mg), 0.74 days (33 µg/kg) and 0.48 days with the comparison treatment, again within the non-inferiority margin. Febrile neutropenia rates did not differ significantly between groups (Chinese Medical Journal, 2025).

In short, one injection per cycle worked about as well as the established options, and the fixed 2 mg dose proved the more convenient choice.

Recommended Dosage

According to the Chinese prescribing information:

  • Timing: one injection under the skin about 48 hours (±12 hours) after the chemotherapy in each cycle has finished
  • Body weight 45 kg or more: a fixed dose of 2 mg is preferred
  • Body weight under 45 kg: 33 µg per kg of body weight
  • Do not give it from 14 days before chemotherapy until 24 hours after it

It comes as a clear solution in ready-to-use prefilled syringes or vials, 2 mg/1 mL and 1 mg/0.5 mL. Check that the liquid is clear before injecting and do not use it if it looks cloudy or has particles. Your oncologist sets the exact plan.

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

Warnings and Precautions

Who should not use it: people allergic to pegylated G-CSF, G-CSF or other products made in E. coli bacteria, and people with severe liver, kidney, heart or lung problems.

  • Allergic reactions: severe reactions, including anaphylaxis, can happen, most often after the first dose. Anyone who has a serious reaction should stop for good.
  • Very high white cell count: counts above 100 × 10⁹/L can occur, so full blood counts are checked during treatment.
  • Spleen rupture: rare but possibly fatal with this group of medicines. Report pain in the upper left belly or the tip of the shoulder straight away.
  • Lung problems: breathing difficulty, lung infiltrates or acute respiratory distress syndrome (ARDS) have been reported with similar medicines. Tell your doctor about fever, cough or breathlessness.
  • Other rare class effects: kidney inflammation (glomerulonephritis), capillary leak syndrome, aortitis, Sweet's syndrome, and sickle cell crises in people with sickle cell disease.
  • Tumour growth: G-CSF receptors are found on some tumour cells, so a growth-promoting effect on cancer cells cannot be ruled out.

Side effects in studies: the label pools 356 treated patients. Every drug-related side effect occurred in fewer than 10% of people, and most were mild to moderate. Those seen in 1% or more included bone, muscle, back and joint pain; tiredness and fever; nausea, constipation or vomiting; and changes in blood tests such as raised liver enzymes or a lower platelet count. In the lung cancer trial, serious side effects linked to the study drug were rare (0 of 88 people on telpegfilgrastim).

Safety in pregnancy, breastfeeding and children has not been established. Lithium can boost neutrophil release, so counts need closer checks. Bone scans may light up temporarily while on G-CSF.

How to Access Telpegfilgrastim 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, cold-chain 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 Telpegfilgrastim 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 or haematologist
  • Diagnostic reports confirming the cancer, with the planned chemotherapy regimen and number of 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 Telpegfilgrastim available in India?

No. It 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. For another long-acting option used once per chemotherapy cycle, see our page on Ryzneuta.

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. The syringes and vials must be kept at 2°C to 8°C, away from light, and must not be frozen or shaken hard, so they travel under temperature-controlled shipping all the way to the hospital. Because one injection is needed for each chemotherapy cycle, we can plan supply to match the full course. 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 specialist's prescription.

Delhi

Large cancer centres here run day-care chemotherapy for patients from across North India, and our New Delhi dispatch point keeps the cold-chain journey short.

Mumbai

The injection can be delivered to the hospital pharmacy so it is ready for the day after chemotherapy.

Bangalore

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

Chennai

A major referral hub for breast and lung cancer care in South India, used to handling refrigerated imported medicines.

Hyderabad

We time each delivery to the chemotherapy calendar so the dose is on hand about 48 hours after treatment.

Kolkata

Shipments to Kolkata and the eastern states are routed to stay within 2°C to 8°C throughout.

Pune

Patients in Pune can use the same documented import route, with updates at each stage.

Ahmedabad

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

Vellore

Patients treated at hospitals in Vellore can have each cycle's injection sent directly to the hospital.

Chandigarh

Serves patients from Punjab, Haryana and Himachal Pradesh, with delivery to the treating cancer centre.

Lucknow

We coordinate cold-chain delivery to public and private oncology hospitals across Uttar Pradesh.

Kochi

Patients across Kerala can receive the medicine 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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