Onivyde (irinotecan hydrochloride trihydrate)

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Onivyde (irinotecan hydrochloride trihydrate)

How to buy Onivyde (irinotecan): You can order Onivyde (irinotecan) from TheSocialMedwork if the drug has not been approved or is not available in your country. We help patients and doctors get access to medicines at the lowest price worldwide. 

Oncology Pancreatic Cancer
Marketing Authorisation Holder Baxalta Innovations GmbH
Mode of Action Topoisomerase inhibitor
Administration Intravenous
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 5 milligram / millilitre
Package 1 vial of 50 mg/10 ml - Vials

What is Onivyde (irinotecan) for?

Onivyde (liposomal irinotecan) is indicated in combination with 5-fluorouracil and leucovorin (two other cancer medicines6,7) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy1,2,5 .

How does Onivyde (irinotecan) work?

The active substance in Onivyde, irinotecan, is a topoisomerase inhibitor. It blocks an enzyme called topoisomerase I. This enzyme is involved in copying cell DNA, which is needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die. In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes’. The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby allowing it to act for longer1.

Is Onivyde (irinotecan) approved?

Onivyde (irinotecan liposome injection or irinotecan hydrochloride trihydrate) was approved for metastatic adenocarcinoma of the pancreas for use in combination with 5-fluorouracil and leucovorin in adults whose cancer has gotten worse despite treatment containing the cancer medicine gemcitabine by:

  • Food and Drugs Administration (FDA) (USA) on October 22, 20154
  • European Medicines Administration (EMA) (EU) on October 14, 20161
  • Therpeautic Goods Administration (TGA) (AUS) on December 19, 20165

How do I take Onivyde (irinotecan)?

Note that 1 mL of the EMA approved Onivyde marketed by Baxalta Innovations GmbH contains the equivalent of 5 mg irinotecan hydrochloride trihydrate (as irinotecan sucrosofate salt in a pegylated liposomal formulation which corresponds to 4.3 mg/1 mL irinotecan liposome injection3. The latter is the strength approved by the FDA and TGA2,5 .

The standard EMA dosage (Onivyde (irinotecan hydrochloride trihydrate) 5 mg/mL) is:

  • 80 mg/m2 administered by intravenous infusion every 2 weeks followed by 5‑fluorouracil and leucovorin3.

The standard FDA dosage (Onivyde ((irinotecan liposome injection) 4.3 mg/mL) is:

  • 70 mg/m2 administered by intravenous infusion every 2 weeks followed by 5‑fluorouracil and leucovorin2,5.

Complete information about Onivyde (liposomal irinotecan) dosage and administration can be found in the resources section. 

Note: Consult your doctor for a personalised dosing.

More Information
Working ingredient irinotecan hydrochloride trihydrate
Shipping method Cold chain (temperature controlled)
Package 1 vial of 50 mg/10 ml -
Therapeutic Area Oncology
Oncology Pancreatic Cancer
Indication Metastatic adenocarcinoma of the pancreas
Administration Intravenous
Mode of Action Topoisomerase inhibitor
Strength 5
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Baxalta Innovations GmbH
CAS Number 97682-44-5

The approvals were based on a study (NAPOLI–18) involving a total of 417 adults with metastatic adenocarcinoma of the pancreas whose cancer worsened despite cancer treatment that contained gemcitabine. Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination. The main measure of effectiveness was that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients’ lives. Patients taking the three medicines together lived for around 6.1 months (95 % CI: 4.8, 8.5), compared with 4.2 months(95 % CI: 3.3, 5.3) for patients taking 5-fluorouracil plus leucovorin4,5, and 4.9 months for patients taking Onivyde alone1

The most common side effects with Onivyde are diarrhoea, nausea, vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts) stomatitis (inflammation of the lining of the mouth) and fever1.

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.