Ninlaro (ixazomib)

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Ninlaro (ixazomib)

 Ninlaro (ixazomib) is a medication used for the treatment of multiple myeloma.

How to buy Ninlaro (ixazomib): You can order Ninlaro (ixazomib) 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 Multiple Myeloma
Marketing Authorisation Holder Takeda Pharma A/S
Mode of Action Proteasome inhibitor (chemotherapy)
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Package 3 Capsules

What is Ninlaro (ixazomib) for?

Ninlaro (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.

How does Ninlaro (ixazomib) work?

Ninlaro (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 lines1.

Is Ninlaro (ixazomib) approved?

Ixazomib was approved or the treatment of patients with multiple myeloma who have received at least one prior therapy1 by:

  • Food and Drug Administration (FDA) (USA) September 20, 2015

  • Therapeutic Goods Administration (TGA) (AUS) November 15, 2016

  • European Medicines Agency (EMA) (EUR) EMA November 24, 20165

How do I take Ninlaro (ixazomib)?

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

Complete information about ixazomib dosage and administration can be found in the resources section.

Consult your treating doctor for personalised dosing.

More Information
Working ingredient ixazomib
Shipping method Controlled room temperature (temperature controlled)
Package 3
Therapeutic Area Oncology
Oncology Multiple Myeloma
Indication Relapsed multiple myeloma
Administration Oral
Mode of Action Proteasome inhibitor (chemotherapy)
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Takeda Pharma A/S
HS Code 29319080
CAS Number 1072833-77-2

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.

Common side effects of Ninlaro (ixazomib)

The more common (>20%) adverse reactions associated with an increased rate on the ixazomib combination arm compared to the placebo combination arm were4:

  • diarrhoea
  • constipation
  • thrombocytopenia
  • peripheral neuropathy
  • nausea
  • peripheral edema
  • vomiting
  • back pain.

1. Summary of Product Characteristics: Ninlaro (ixazomib) [PDF]
    Takeda Pharmaceuticals America, Inc., FDA, Nov 2015

2. FDA archive. Ixazomib
    FDA archive, cited Aug 2016

3. Human Medicines: Ninlaro (ixazomib)
    EMA, cited April 2017

4. Summary of Product Characteristics: Ninlaro (ixazomib) [PDF]
    Takeda Pharmaceuticals, EMA, Nov 2016

5. Ninlaro (ixazomib) Receives Conditional Approval from the European Commission to Treat Multiple Myeloma
    Takeda Press Release, Nov 2016

6. TGA Public Summary: Ninlaro (ixazomib)
    TGA, Nov 2016

Shipping Type Cold Chain
Shipping method Controlled room temperature (temperature controlled)
Dynamic Weight No
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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.