Buy Onivyde (irinotecan hydrochloride trihydrate)

What is Onivyde (irinotecan) for?

Onivyde (liposomal irinotecan) is indicated in combination with 5-fluorouracil and leucovorin (two other cancer medicines^[6,7]) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy^[1,2,5].

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 longer.^[1]

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, 2015^[4]
• European Medicines Administration (EMA) (EU) on October 14, 2016^[1]
• Therpeautic Goods Administration (TGA) (AUS) on December 19, 2016^[5]
• Health Canada on October 4, 2017^[9]
• Medsafe (New Zealand) on September 20, 2018^[10]

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 injection^[3]. The latter is the strength approved by the FDA and TGA^[2,5 ].

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 leucovorin^[3].

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 leucovorin^[2,5].

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

Note: Consult your doctor for a personalised dosing.

References

1. Human Medicines: Onivyde (irinotecan hydrochloride trihydrate)
    EMA, cited Jan 2017

2. Summary of Product Characteristics [FDA]: Onivyde (irinotecan liposome injection) [PDF] Merrimack Pharmaceuticals Inc., Oct. 2015.

3. Summary of Product Characteristics [EMA]: Onivyde (liposomal irinotecan) [PDF] Baxalta Innovations GmbH, Jul. 2017.

4. FDA approves new treatment for advanced pancreatic cancer
    FDA, Oct 2015.

5. Summary of Product Characteristics [TGA]: Onivyde (liposomal irinotecan)
    Baxalta Australia Pty Ltd, Dec. 2016.

6. Fluorouracil
    Wikipedia, cited Jan 2017

7. Folinic acid
    Wikipedia, cited Jan 2017

8. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial
    (abstract) Wang-Gillam A., et al. The Lancet, Feb 2016.

9. Product monograph [Health Canada]: Onivyde (irinotecan liposome injection) [PDF] Servier, Jan. 2019.

10. Product detail [Medsafe]: Onivyde (liposomal irinotecan)
Baxter, Jun. 2019.