NINLARO® (ixazomib) Now Available for Patients

December 12, 2015

- Takeda’s NINLARO is the first and only oral proteasome inhibitor, backed by a clinically demonstrated safety and efficacy profile

 

Cambridge, Mass. and Osaka, Japan, December 11, 2015 – NINLARO® (ixazomib) capsules, the first and only oral proteasome inhibitor, are now available in the United States. NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Takeda Pharmaceutical Company Limited (TSE: 4502) recently received U.S. Food and Drug Administration (FDA) approval for NINLARO, four months prior to its Priority Review PDUFA date. NINLARO is a once-weekly pill for three weeks of a four week cycle. More information is available at www.NINLARO.com.

 

“With NINLARO now available in the U.S., we have taken our extensive research and turned it into a reality. In addition to the clinical investigators and patients, I would like to extend our thanks to the FDA for its expedited review of NINLARO. The need for new and differentiated treatment options is urgent, and their commitment allowed us to bring NINLARO to market within a rapid timeframe,” said Christophe Bianchi, M.D., President, Takeda Oncology. “In the short time since receiving FDA approval of NINLARO, we have seen an enthusiastic reception from providers and patients alike; in fact, prescriptions have already been written by physicians and approved by insurers. We are excited to realize our commitment to the multiple myeloma community as we bring NINLARO to patients.”

 

NINLARO is a pill that can be taken at home which may reduce some of the logistical burden for patients, because administration does not require an infusion or injection at a hospital, clinic or physician’s office. For patients prescribed NINLARO, Takeda is offering NINLARO 1Point, a comprehensive support program offering an array of access and coverage services. More information about NINLARO 1Point is available through www.NINLARO.com or by calling 1-844-N1POINT (1-844-617-6468).

 

“Access to therapy for patients in need is our first and foremost priority,” said Ryan Cohlhepp, Vice President of U.S. Marketing at Takeda. “And with NINLARO 1Point, we have created a robust suite of support services to help patients access NINLARO.”

 

NINLARO is available through an open distribution model that includes physician in-office dispensing.  Additionally, there is a specialty pharmacy network to assist patients and healthcare providers. The following specialty pharmacies are in the NINLARO 1Point network:

Pharmacy

Telephone Number

Accredo Specialty Pharmacy

1-877-732-3431

Advanced Care Scripts (ACS)/

Omnicare Specialty Care Group

1-877-985-6337

Avella Specialty Pharmacy

1-877-546-5779

Axium Healthcare Pharmacy, Inc.

1-888-315-3395

Biologics, Inc.

1-800-856-1984

CVS/specialty

1-800-237-2767

Diplomat Pharmacy, Inc.

1-877-977-9118

US Bioservices

1-877-757-0667

Walgreens

1-888-380-6188

 

To arrange for in-office dispensing, offices may call their normal distributor/wholesaler. If unavailable, please call 1-844-N1POINT (1-844-617-6468) for options to arrange for immediate access to product as distribution channels open up.

 

About NINLARO (ixazomib) capsules
NINLARO (ixazomib) is the first and only oral 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. NINLARO is administered orally, once-weekly on days 1, 8, and 15 of a 28-day treatment cycle. NINLARO is currently under review by the European Medicines Agency (EMA) and was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP). NINLARO also received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014.

 

The TOURMALINE clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing:

  • TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
  • TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
  • TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
  • TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
  • TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis

 

In addition to the TOURMALINE program, a large number of investigator initiated studies are evaluating ixazomib for patients globally.

 

For additional information on the ongoing Phase 3 studies please visit www.clinicaltrials.gov. To learn more about NINLARO, please visit www.NINLARO.com or call 1-844-N1POINT (1-844-617-6468).

 

Important Safety Information

 

WARNINGS AND PRECAUTIONS

  • Thrombocytopenia has been reported with NINLARO. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle.
  • Gastrointestinal Toxicities,including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Adjust dosing for severe symptoms.
  • Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.
  • Peripheral Edema was reported with NINLARO. Monitor for fluid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing as needed.
  • Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Manage rash with supportive care or with dose modification.
  • Hepatotoxicity has been reported with NINLARO. Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.
  • Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the final dose of NINLARO.

 

ADVERSE REACTIONS

The most common adverse reactions occurring in greater than or equal to 20% of patients treated with NINLARO were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting and back pain.

 

SPECIAL POPULATIONS

  • Hepatic Impairment: Reduce the NINLARO starting dose to 3mgin patients with moderate or severe hepatic impairment.
  • Renal Impairment: Reducethe NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.
  • Lactation: Advise women to discontinue nursing while on NINLARO.

 

DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.

 

Please see the full Prescribing Information for NINLARO.

 

About Multiple Myeloma

Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of plasma cells, or myeloma cells, becomes cancerous and multiplies, increasing the number of plasma cells to a higher than normal level. Because plasma cells circulate widely in the body, they have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with more than 26,000 new cases in the U.S. and 114,000 new cases globally per year.

 

About Takeda
Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.

 

Additional information about Takeda is available through its corporate website, www.takeda.com.

 

Contacts:

Japanese Media
Tsuyoshi Tada
tsuyoshi.tada@takeda.com
+81 (0) 3-3278-2417

Media outside Japan
Amy Atwood
amy.atwood@takeda.com
+1-617-444-2147