BOSULIF- bosutinib tablet, film coated BOSULIF- bosutinib capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

BOSUTINIB MONOHYDRATE (UNII: 844ZJE6I55) (BOSUTINIB - UNII:5018V4AEZ0)

Mevcut itibaren:

Pfizer Laboratories Div Pfizer Inc

INN (International Adı):

BOSUTINIB MONOHYDRATE

Kompozisyon:

BOSUTINIB MONOHYDRATE 100 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

BOSULIF is indicated for the treatment of: BOSULIF is contraindicated in patients with a history of hypersensitivity to BOSULIF. Reactions have included anaphylaxis [see Adverse Reactions (6.1)] . Risk Summary Based on findings from animal studies and its mechanism of action, BOSULIF can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] . There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies conducted in rats and rabbits, oral administration of bosutinib during organogenesis caused adverse developmental outcomes, including structural abnormalities, embryo-fetal mortality, and alterations to growth at maternal exposures (AUC) as low as 1.2 times the human exposure at the dose of 500 mg/day (see Data ). Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2–4% and 15–20%, respectively. Data Animal Data In a rat fertility and early embryonic development study, bosutinib was administered orally to female rats for approximately 3 to 6 weeks, depending on day of mating (2 weeks prior to cohabitation with untreated breeder males until gestation day [GD] 7). Increased embryonic resorptions occurred at greater than or equal to 10 mg/kg/day of bosutinib (1.6 and 1.2 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively), and decreased implantations and reduced number of viable embryos at 30 mg/kg/day of bosutinib (3.4 and 2.5 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively). In an embryo-fetal development study conducted in rabbits, bosutinib was administered orally to pregnant animals during the period of organogenesis at doses of 3, 10, and 30 mg/kg/day. At the maternally-toxic dose of 30 mg/kg/day of bosutinib, there were fetal anomalies (fused sternebrae, and 2 fetuses had various visceral observations), and an approximate 6% decrease in fetal body weight. The dose of 30 mg/kg/day resulted in exposures (AUC) approximately 5.1 and 3.8 times the human exposures at the recommended doses of 400 and 500 mg/day, respectively. Fetal exposure to bosutinib-derived radioactivity during pregnancy was demonstrated in a placental-transfer study in pregnant rats. In a rat pre- and postnatal development study, bosutinib was administered orally to pregnant animals during the period of organogenesis through lactation day 20 at doses of 10, 30, and 70 mg/kg/day. Reduced number of pups born occurred at greater than or equal to 30 mg/kg/day bosutinib (3.4 and 2.5 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively), and increased incidence of total litter loss and decreased growth of offspring after birth occurred at 70 mg/kg/day bosutinib (6.9 and 5.1 times the human exposure at the recommended doses of 400 or 500 mg/day, respectively). Risk Summary No data are available regarding the presence of bosutinib or its metabolites in human milk or its effects on a breastfed child or on milk production. However, bosutinib is present in the milk of lactating rats. Because of the potential for serious adverse reactions in a nursing child, breastfeeding is not recommended during treatment with BOSULIF and for 2 weeks after the last dose. Animal Data After a single radiolabeled bosutinib dose to lactating rats, radioactivity was present in the plasma of suckling offspring for 24 to 48 hours. Based on findings from animal studies, BOSULIF can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Females of reproductive potential should have a pregnancy test prior to starting treatment with BOSULIF. Contraception Females Advise females of reproductive potential to use effective contraception (methods that result in less than 1% pregnancy rates) during treatment with BOSULIF and for 2 weeks after the last dose. Infertility The risk of infertility in females or males of reproductive potential has not been studied in humans. Based on findings from animal studies, BOSULIF may cause reduced fertility in females and males of reproductive potential [see Nonclinical Toxicology (13.1)] . The safety and effectiveness of BOSULIF have been established in pediatric patients 1 year of age and older with newly-diagnosed CP Ph+ CML and CP Ph+ CML that is resistant or intolerant to prior therapy. Use of BOSULIF for these indications is based on data from BCHILD [NCT04258943]. The study included pediatric patients with newly diagnosed CP Ph+ CML in the following age groups: 2 patients 1 year of age to less than 6 years of age, 3 patients 6 years of age to less than 12 years of age, and 10 patients 12 years of age to less than 17 years of age. The study also included pediatric patients with CP Ph+ CML that was resistant or intolerant to prior therapy in the following age groups: 4 patients 1 year of age to less than 6 years of age, 10 patients 6 years of age to less than 12 years of age, and 10 patients 12 years of age to less than 17 years of age [see Adverse Reactions (6.1) and Clinical Studies (14.3) ] . BSA-normalized apparent clearance in 27 pediatric patients aged 4 to <17 years (141.3 L/h/m2 ) was 29% higher than BSA-normalized apparent clearance in adult patients with CP Ph+ CML (109.2 L/h/m2 ) [see Clinical Pharmacology (12.3)] . The recommended dosage of BOSULIF in pediatric patients is based on body-surface area (BSA) [see Dosage and Administration (2.1)]. The safety and effectiveness of BOSULIF in pediatric patients younger than 1 year of age with newly diagnosed CP Ph+ CML, pediatric patients younger than 1 year of age with CP Ph+ CML that is resistant or intolerant to prior therapy, and pediatric patients with AP Ph+ CML or BP Ph+ CML have not been established. In the single-arm study in patients with CML who were resistant or intolerant to prior therapy of BOSULIF in patients with Ph+ CML, 20% were age 65 and over, 4% were 75 and over. Of the 268 patients who received bosutinib in the study for newly diagnosed CML, 20% were age 65 and over, 5% were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Reduce the BOSULIF starting dose in patients with moderate (creatinine clearance [CLcr ] 30 to 50 mL/min, estimated by Cockcroft-Gault (C-G)) and severe (CLcr less than 30 mL/min, C-G) renal impairment at baseline. For patients who have declining renal function while on BOSULIF who cannot tolerate the starting dose, follow dose adjustment recommendations for toxicity [see Dosage and Administration (2.3, 2.5) and Clinical Pharmacology (12.3)] . BOSULIF has not been studied in patients undergoing hemodialysis. Reduce the BOSULIF dosage in patients with hepatic impairment (Child-Pugh A, B, or C) [see Dosage and Administration (2.3, 2.5) and Clinical Pharmacology (12.3)]. BOSULIF® (BAH-su-lif) (bosutinib) capsules This Instructions for Use contains information on how to prepare and give a dose of BOSULIF capsules by opening the capsules and mixing the contents with applesauce or yogurt for people who cannot swallow capsules whole. Read this Instructions for Use before you prepare or give the first dose of BOSULIF, and each time you get a refill. Ask your healthcare provider or pharmacist if you have any questions. Important information you need to know before preparing a dose of BOSULIF capsules: Preparing a dose of BOSULIF capsules: Gather the following supplies: Giving a dose of BOSULIF capsules: Step 1: Choose a clean, flat work surface. Place all supplies on the work surface. Step 2: Wash and dry your hands well. Step 3: Put on disposable gloves Step 4: Get the prescribed number of BOSULIF capsule(s) needed to prepare the dose. Step 5: Add the amount of applesauce or yogurt needed for the prescribed dose to the container. Dose Amount of Applesauce or Yogurt 100 mg 10 mL (2 teaspoons) 150 mg 15 mL (3 teaspoons) 200 mg 20 mL (4 teaspoons) 250 mg 25 mL (5 teaspoons) 300 mg 30 mL (6 teaspoons) 350 mg 30 mL (6 teaspoons) 400 mg 35 mL (7 teaspoons) 450 mg 40 mL (8 teaspoons) 500 mg 45 mL (9 teaspoons) 550 mg 45 mL (9 teaspoons) 600 mg 50 mL (10 teaspoons) Step 6: Carefully open each of the BOSULIF capsule(s) needed for the dose and empty the entire contents into the applesauce or yogurt. Mix the entire capsule contents with the applesauce or yogurt in the container. Step 7: Swallow all of the mixture right away, without chewing. Step 8: Dispose of (throw away) the empty BOSULIF capsule shell(s) in the household trash. Step 9: Wash teaspoon and the container with soap and warm water. Step 10: Remove disposable gloves and throw them away in the household trash. Step 11: Wash and dry your hands. How should I store BOSULIF capsules? Keep BOSULIF and all medicines out of the reach of children. LAB-0639-12.0 For more information, go to www.Bosulif.com or www.pfizermedicalinformation.com or call 1-800-438-1985. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Issued: 9 2023

Ürün özeti:

Tablets – How Supplied BOSULIF (bosutinib) tablets are supplied for oral administration in 3 strengths: a 100 mg yellow, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "100" on the other; a 400 mg orange, oval, biconvex, film coated tablet debossed with "Pfizer" on one side and "400" on the other; and a 500 mg red, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "500" on the other. BOSULIF (bosutinib) tablets are available in the following packaging configurations with a child-resistant (CR) closure (Table 17) Bottles contain a desiccant. 120 tablets per bottle 100 mg 0069-0135-01 Yellow, oval, biconvex, film-coated tablets, debossed "Pfizer" on one side and "100" on the other. 30 tablets per bottle 400 mg 0069-0193-01 Orange, oval, biconvex, film-coated tablet debossed with "Pfizer" on one side and "400" on the other. 30 tablets per bottle 500 mg 0069-0136-01 Red, oval, biconvex, film-coated tablets, debossed "Pfizer" on one side and "500" on the other. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Handling and Disposal Procedures for proper disposal of anticancer drugs should be considered. Touching or handling crushed or broken tablets is to be avoided. Any unused product or waste material should be disposed of in accordance with local requirements, or drug take back programs. Capsules - How Supplied BOSULIF (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg capsule: size 2 capsule, white body/orange cap with “BOS 50” printed on the body and “Pfizer” printed on the cap in black ink. 100 mg capsule: size 0 capsule, white body/brownish-red cap with “BOS 100” printed on the body and “Pfizer” printed on the cap in black ink. BOSULIF (bosutinib) capsules are available in the following packaging configurations with a CR closure. (Table 18).  BOSULIF Capsules Package Configuration Count Capsule Strength (mg) NDC Capsule Description 30 capsules per bottle 50  0069-0504-30 Size 2 capsule, white body/orange cap with “BOS 50” printed on the body and “Pfizer” printed on the cap in black ink. 150 capsules per bottle 100  0069-1014-15 Size 0 capsule, white body/brownish-red cap with “BOS 100” printed on the body and “Pfizer” printed on the cap in black ink. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] and Store and Dispense in Original Container. Handling and Disposal Procedures for proper disposal of anticancer drugs should be considered. Patients and/or caregivers must wear gloves while handling the drug product, and wash their hands once finished. Any unused product or waste material should be disposed of in accordance with local requirements.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

BOSULIF- BOSUTINIB TABLET, FILM COATED
BOSULIF- BOSUTINIB CAPSULE
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BOSULIF SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BOSULIF.
BOSULIF (BOSUTINIB) TABLETS, FOR ORAL USE
BOSULIF (BOSUTINIB) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Indications and Usage (1)
9/2023
Dosage and Administration, Recommended Dosing (2.1)
9/2023
Dosage and Administration, Dose Escalation (2.2)
9/2023
Dosage and Administration, Dosage Adjustments for Non-Hematologic
Adverse Reactions (2.3)
9/2023
Dosage and Administration, Dosage Adjustments for Myelosuppression
(2.4)
9/2023
Dosage and Administration, Dosage Adjustments for Renal Impairment or
Hepatic Impairment
(2.5)
9/2023
Warnings and Precautions, Gastrointestinal Toxicity (5.1)
9/2023
Warnings and Precautions, Hepatic Toxicity (5.3)
9/2023
Warnings and Precautions, Cardiovascular Toxicity (5.4)
9/2023
Warnings and Precautions, Fluid Retention (5.5)
9/2023
Warnings and Precautions, Renal Toxicity (5.6)
9/2023
INDICATIONS AND USAGE
BOSULIF is a kinase inhibitor indicated for the treatment of
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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adult and pediatric patients 1 year of age and older with chronic
phase Ph+ chronic myelogenous
leukemia (CML), newly-diagnosed or resistant or intolerant to prior
therapy. (1)
adult patients with accelerated, or blast phase Ph+ CML with
resistance or intolerance to prior
therapy. (1)
Adult patients with newly-diagnosed chronic phase Ph+ CML: 400 mg
orally once daily with food. (2.1)
Adult patients with chronic, accelerated, or blast phase Ph+ CML with
resistance or intolerance to
prior therapy: 500 mg orally once daily with food. (2.1)
Pediatric patients with newly-diagnosed chronic phase Ph+ CML: 300
mg/m orally once daily with
food. (2.1)
2
Pediatric patients with chronic phase Ph+ CM