Ninlaro (ixazomib)

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Ninlaro (ixazomib)

How to buy Ninlaro: You can order Ninlaro (ixazomib) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Takeda Pharmaceuticals
Disease Blood Cancer
Indication Multiple Myeloma
Mode of Action Proteasome inhibitor (chemotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 1072833-77-2
HS Code 29319080
Strength 4 mg, 2.3 mg, 3 mg

Who is ixazomib for?

Ixazomib is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy [1][3][6].

Recommended dose

Complete information about ixazomib dosage and administration can be found here [1][4].
The standard dosage is:
  • 4 mg taken orally on Days 1, 8, and 15 of a 28-day cycle
  • Dose should be taken at least one hour before or at least two hours after food
  • The dose may be reduced to 3 mg and to 2.3 mg in patients with moderately or severely reduced liver function and patients with severely reduced kidney function
Consult your treating doctor for personalised dosing.

What is ixazomib and how does it work?

Ixazomib is a proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Ixazomib targets and reversibly inhibits the proteasome enzyme complex within the cell. Proteasome is part of the cellular machinery, and among its functions, it regulates cellular division and survival. By interfering with proteasome’s function, ixazomib can lead to apoptosis (cell death) [2].

Ixazomib demonstrated in vitro cytotoxicity against myeloma cells from patients who had relapsed after multiple prior therapies, including bortezomib, lenalidomide, and dexamethasone. The combination of ixazomib and lenalidomide demonstrated synergistic cytotoxic effects in multiple myeloma cell lines [1].

What is ixazomib's approval status?

Ixazomib was approved by the Food and Drug Administration (FDA) in the United States on September 20, 2015, for the treatment of patients with multiple myeloma who have received at least one prior therapy [1]. On November 15, 2016, the TGA approved ixazomib [6]. The EMA approved ixazomib on November 24, 2016 [5].

The approval was based on an improvement in progression-free survival (PFS) in a multicentre, randomised, double-blind, placebo-controlled trial enrolling 722 patients with multiple myeloma who had received 1 to 3 prior lines of therapy. Patients were randomised in a 1:1 ratio to receive either a combination of ixazomib, lenalidomide and dexamethasone (n = 360) or the combination of placebo, lenalidomide and dexamethasone (n = 362). Patients continued treatment until disease progression or unacceptable toxicity. The trial showed a statistically significant improvement in PFS. The median PFS on the combination arm of ixazomib, lenalidomide and dexamethasone was 20.6 months (95 % CI: 17.0, NE) compared to a median PFS of 14.7 months (95 % CI: 12.9, 17.6) on the combination arm of placebo, lenalidomide and dexamethasone (PFS HR 0.74, 95 % CI: 0.59, 0.94; p value=0.012) [4].
The more common (>20 %) adverse reactions associated with an increased rate on the ixazomib combination arm compared to the placebo combination arm were: diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain [4].
References
[1] Summary of Product Characteristics: Ninlaro (ixazomib), Takeda Pharmaceuticals America, Inc., FDA, Nov. 2015.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208462lbl.pdf
[2] FDA archive. Ixazomib, 20/11/2015, cited on 24/08/2016.
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm473804.htm
[3] EMA. Human Medicines: Ninlaro (ixazomib), 7/12/2016, cited on 18/04/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003844/human_med_001998.jsp&mid=WC0b01ac058001d124
[4] Summary of Product Characteristics: Ninlaro (ixazomib), Takeda Pharmaceuticals, EMA, Nov. 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003844/WC500217620.pdf
[5] Takeda Press Release. Ninlaro (ixazomib) Receives Conditional Approval from the European Commission to Treat Multiple Myeloma, 24/11/2016.
http://www.takeda.com/news/2016/20161124_7626.html
[6] TGA Public Summary. Ninlaro (ixazomib), 15/11/2016.
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=952408661B4A5520CA25806C003C9AB9&agid=(PrintDetailsPublic)&actionid=1









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