IONS (5.7)].
Females and Males of Reproductive Potential
Embryo-Fetal Toxicity
Advise females and males of reproductive potential that ALUNBRIG can cause fetal harm [see WARNINGS AND PRECAUTIONS (5.8) and USE IN SPECIFIC POPULATIONS (8.1)].
Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy and to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months after the final dose [see USE IN SPECIFIC POPULATIONS (8.3].
Advise males with female partners of reproductive potential to use effective contraception during treatment with ALUNBRIG and for at least 3 months after the final dose [see USE IN SPECIFIC POPULATIONS (8.3)].
Lactation
Advise females not to breastfeed during treatment with ALUNBRIG and for at least 1 week following the final dose [see USE IN SPECIFIC POPULATIONS (8.2)].
Infertility
Advise males of reproductive potential of the potential for reduced fertility from ALUNBRIG [see USE IN SPECIFIC POPULATIONS (8.3) and NONCLINICAL TOXICOLOGY (13.1)].
Drug Interactions
Advise patients to inform their health care provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products. Inform patients to avoid grapefruit or grapefruit juice while taking ALUNBRIG [see DRUG INTERACTIONS (7)].
Dosing and Administration
Instruct patients to start with 90 mg of ALUNBRIG once daily for the first 7 days and if tolerated, increase the dose to 180 mg once daily. Advise patients to take ALUNBRIG with or without food [see DOSAGE AND ADMINISTRATION (2.1)].
Missed Dose
Advise patients that if a dose of ALUNBRIG is missed or if the patient vomits after taking a dose of ALUNBRIG, not to take an extra dose, but to take the next dose at the regular time [see DOSAGE AND ADMINISTRATION (2.1)].
SPL UNCLASSIFIED SECTION
Manufactured for:
ARIAD Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
Cambridge, MA
PATIENT PACKAGE INSERT
PATIENT INFORMATION
ALUNBRIG (uh-lun-brig)
(brigatinib)
tablets
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: April 2017
What is the most important information I should know about ALUNBRIG?
ALUNBRIG can cause serious side effects, including:
Lung problems. ALUNBRIG may cause severe or life-threatening swelling (inflammation) of the lungs any time during treatment, and can lead to death. These lung problems happen especially within the first week of treatment with ALUNBRIG. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including:
trouble breathing or shortness of breath
chest pain
cough with or without mucous
fever
High blood pressure (hypertension). ALUNBRIG may cause high blood pressure. Your healthcare provider will check your blood pressure before starting and during treatment with ALUNBRIG. Tell your healthcare provider right away if you get headaches, dizziness, blurred vision, chest pain or shortness of breath.
Slow heart rate (bradycardia). ALUNBRIG may cause very slow heartbeats that can be severe. Your healthcare provider will check your heart rate during treatment with ALUNBRIG. Tell your healthcare provider right away if you feel dizzy, lightheaded, or faint during treatment with ALUNBRIG. Tell your hea |
