Once-Daily
Dosing Regimen

ALUNBRIG® (brigatinib) is the only FDA-approved ALK-inhibitor with a one-tablet, once-daily recommended dosing regimen that can be taken with or without food.

1 Tablet
Once a Day with or without food at the recommended dosing regimen

 

  • The recommended dosing regimen for ALUNBRIG is:
    • 90 mg orally once daily for the first 7 days;
    • If 90 mg is tolerated during the first 7 days, increase the dose to 180 mg orally once daily
1 Tablet
Once a Day with or without food at the recommended dosing regimen

Please see dose modifications based on adverse reactions.

Week 1
Days 1-7
90 mg Once Daily
One 90-mg tablet

If Tolerated…

Week 2+
Days 8 and
Beyond
180 mg Once Daily
One 180-mg tablet


ALUNBRIG may be taken with or without food

  • Administer ALUNBRIG until disease progression or unacceptable toxicity
  • If ALUNBRIG is interrupted for 14 days or longer for reasons other than adverse reactions, resume treatment at 90 mg once daily for 7 days before increasing to the previously tolerated dose
  • Inform patients to avoid grapefruit or grapefruit juice while taking ALUNBRIG
     

 
 
 
 
 

ALUNBRIG tablets should be swallowed whole. Do not crush or chew tablets.

If a dose of ALUNBRIG is missed or vomiting occurs after taking a dose, do not administer an additional dose. The next dose should be taken at the scheduled time.


 
 

  • To assist patients starting on ALUNBRIG, the first-month supply of the recommended dosing regimen is available in an Initiation Pack that contains one bottle of 90-mg tablets (7 count) and one bottle of 180-mg tablets (23 count)
  • ALUNBRIG is available in 180-mg, 90-mg, and 30-mg tablets

Dosage Forms and Storage

  • ALUNBRIG is available in:
    • 180-mg tablets: oval, white to off-white film-coated tablet with “U13” debossed on one side and plain on the other side
    • 90-mg tablets: oval, white to off-white film-coated tablet with “U7” debossed on one side and plain on the other side
    • 30-mg tablets: round, white to off-white film-coated tablet with “U3” debossed on one side and plain on the other side

      Not actual size.

  • Store at controlled room temperature 68°F to 77°F (20°C to 25°C). Excursion is permitted between 59°F to 86°F (15°C to 30°C)

 

Drug Interactions

  • Avoid concomitant use with strong CYP3A inhibitors. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG
  • Avoid concomitant use with strong CYP3A inducers
  • ALUNBRIG induces CYP3A in vitro and may decrease concentrations of CYP3A substrates
  • Coadministration of ALUNBRIG with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of efficacy of CYP3A substrates

 

Special Populations

  • Pregnancy: ALUNBRIG can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus
  • Lactation: There are no data regarding the secretion of brigatinib in human milk or its effects on the breastfed infant or milk production. Because of the potential adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with ALUNBRIG
  • Females and Males of Reproductive Potential: Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after final dose. ALUNBRIG may cause reduced fertility in males
  • Pediatric: The safety and efficacy of ALUNBRIG in pediatric patients have not been established
  • Geriatric: Clinical studies of ALUNBRIG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Of the 222 patients in ALTA, 19.4% were 65-74 years and 4.1% were 75 years or older. No clinically relevant differences in safety or efficacy were observed between patients ≥65 and younger patients
  • Hepatic and Renal Impairment: No dose adjustment is recommended for patients with mild hepatic impairment or mild or moderate renal impairment. The safety of ALUNBRIG in patients with moderate or severe hepatic impairment or severe renal impairment has not been studied

You are now leaving ALUNBRIG.com, the official site for ALUNBRIG® (brigatinib) and entering one that is not owned or controlled by Takeda Oncology.

Takeda Oncology makes no representation as to the accuracy of the information contained on sites we do not own or control. Takeda Oncology does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

Cancel Continue >
Close

You are now leaving ALUNBRIG.com, the official site for ALUNBRIG® (brigatinib) and entering one that is not owned or controlled by Takeda Oncology.

This link will take you to the corporate ARIAD Pharmaceuticals, Inc. website.

Cancel Continue >
Close

You are now leaving ALUNBRIG.com, the official site for ALUNBRIG® (brigatinib).

This link will take you to another Takeda Oncology website.

Cancel Continue >
Close

The site you are about to enter is intended for US healthcare professionals only.

Please confirm that you are a US healthcare professional.

Yes, I confirm that I am a US healthcare professional Cancel
Close