Buy Ninlaro (ixazomib)

What is Ninlaro (ixazomib) for?

 

Ninlaro (Ixazomib) is a proteasome inhibitor indicated in combination with lenalidomide (Revlimid®) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

A package is available containing capsules of 2.3mg, 3mg or 4mg.

 

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 lines^[1].

 

Where has Ninlaro (ixazomib) been approved?

 

Ixazomib was approved or the treatment of patients with multiple myeloma who have received at least one prior therapy^[1] 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, 2016^[5]

• Health Canada September 21, 2016^[7]

• Pharmaceuticals and Medical Devices Agency (PMDA), Japan May 27, 2021

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

Please be aware that any decision to use a prescription generic or brand name medicine should always be taken in consultation with a medical professional. The FDA has sent warning letters to drugmakers in India concerning the quality of their medicines.

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

• 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

Treatment dose should be taken at least one hour before or at least two hours after food.

Complete information about ixazomib dosing and administration can be found in the references section.

Consult your treating doctor to determine how much ixazomib you will need.

Are there any known adverse reactions or side effects of Ninlaro (ixazomib)?

Common adverse reactions

The most common side effects (≥20% of patients) listed in the prescribing information include:^[1]

• diarrhea
• constipation
• thrombocytopenia
• peripheral neuropathy
• nausea
• peripheral edema
• vomiting
• back pain

Serious adverse reactions

The serious adverse effects listed in the prescribing information include:^[1]

• thrombocytopenia
• diarrhea

Use in a specific population

Ninlaro (ixazomib) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding. It is recommended that men and women of childbearing potential should use effective contraception during and for 90 days following treatment.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

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) [PDF]
    Takeda, Nov 2016

7. Product mongraph [Health Canada]: Ninlaro (ixazomib) [PDF] Takeda Canada, Aug 2016