RECOMMENDED DOSAGE

Once-Daily Dosing Regimen That Fits Into Patients' Lives

The recommended dosage for ALUNBRIG® (brigatinib) is 90 mg orally once daily for the first 7 days; then increase the dose to 180 mg orally once daily.

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
  • ALUNBRIG may be taken with or without food. Instruct patients to swallow tablets 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 and take the next dose of ALUNBRIG at the scheduled time
  • Inform patients to avoid grapefruit or grapefruit juice while taking ALUNBRIG

Special Considerations for Patients

  • Advise patients to avoid grapefruit
  • Advise patients to limit sun exposure
  • Advise females and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception

Find Out if ALUNBRIG is Right For Your Patients

The ALUNBRIG SMART™ Program can help you and your patients with ALK+ metastatic NSCLC assess whether ALUNBRIG is right for them by offering a 1-month free trial.

Learn More About the
ALUNBRIG SMART Program

ALUNBRIG Is Available in 180-mg, 90-mg, and 30-mg Tablets

Tablets shown are not actual size.

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.

Store at controlled room temperature of 68°F to 77°F (20°C to 25°C).

Drug Interactions

  • Avoid coadministration with strong or moderate CYP3A inhibitors. If coadministration of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of ALUNBRIG
  • Avoid coadministration with strong or moderate CYP3A inducers. If coadministration of moderate CYP3A inducers cannot be avoided, increase the dose of ALUNBRIG

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: Verify pregnancy status in females of reproductive potential prior to initiating ALUNBRIG. 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 effectiveness of ALUNBRIG in pediatric patients have not been established
  • Geriatric: Of the 359 patients enrolled in the ALTA 1L ALUNBRIG arm and in ALTA, 26.7% were 65 and older and 7.5% were 75 and older. No overall differences in safety or effectiveness were observed between patients ≥65 years and younger patients
  • Hepatic and Renal Impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment or mild or moderate renal impairment. Reduce the dose of ALUNBRIG for patients with severe hepatic impairment or severe renal impairment

 

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In Vitro: ALUNBRIG Inhibited 17
ALK-Inhibitor—Resistant Mutations1,2

ALUNBRIG exhibited in vivo antitumor activity against 4 mutant forms of EML4-ALK, including the G1202R and L1196M mutants identified in NSCLC tumors in patients who had progressed on crizotinib.


 
 

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