BOSULIF® (bosutinib) 16 HOW SUPPLIED/STORAGE AND HANDLING

(bosutinib)

Prescribing Information

16 HOW SUPPLIED/STORAGE AND HANDLING

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.

Table 17: Tablet Presentations
BOSULIF Tablets
Package Configuration	Tablet Strength (mg)	NDC	Tablet Description
Abbreviation: NDC=National drug code.
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).

Table 18: Capsule Presentations
Abbreviation: NDC=National drug code.
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.

Medication Guide

MEDICATION GUIDE

PATIENT INFORMATION
BOSULIF® (BAH-su-lif) (bosutinib) tablets		BOSULIF® (BAH-su-lif) (bosutinib) capsules
What is BOSULIF? BOSULIF is a prescription medicine used to treat: • adults and children 1 year of age and older who have a certain type of leukemia called chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) who are newly-diagnosed or who no longer benefit from or did not tolerate other treatment. • adults with accelerated phase (AP), or blast phase (BP) Ph+ CML who can no longer benefit from or did not tolerate other treatment. It is not known if BOSULIF is safe and effective in children less than 1 year of age with CP Ph+ CML who are newly‑diagnosed or who no longer benefit from or did not tolerate other treatment or in children with AP Ph+ CML or BP Ph+ CML.
Do not take BOSULIF if you are allergic to bosutinib or any of the ingredients in BOSULIF. See the end of this leaflet for a complete list of ingredients of BOSULIF.
Before taking BOSULIF, tell your doctor about all of your medical conditions, including if you: • have liver problems • have heart problems • have kidney problems • have high blood pressure • have diabetes • are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. Females who are able to become pregnant should have a pregnancy test before starting treatment with BOSULIF. Tell your doctor right away if you become pregnant during treatment with BOSULIF. o Females who are able to become pregnant should use effective birth control (contraception) during treatment with BOSULIF and for 2 weeks after the last dose. Talk to your doctor about birth control methods that may be right for you. • are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. Do not breastfeed during treatment with BOSULIF and for 2 weeks after the last dose. Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. When taken together, BOSULIF and certain other medicines can affect each other. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
How should I take BOSULIF? • Take BOSULIF exactly as prescribed by your doctor. • Do not change your dose or stop taking BOSULIF without first talking with your doctor. • If your child takes BOSULIF, your healthcare provider will change the dose as your child grows. • Take BOSULIF with food. • Swallow BOSULIF tablets whole. Do not crush, break, chew or cut BOSULIF tablets. Do not touch or handle crushed or broken BOSULIF tablets. • Swallow BOSULIF capsules whole. If you cannot swallow BOSULIF capsules whole, tell your healthcare provider. • If you cannot swallow BOSULIF capsules whole, see the “Instructions for Use” for detailed instructions on how to prepare and give a dose of BOSULIF capsules by opening the capsules and mixing the capsule contents with applesauce or yogurt. • If you take an antacid or H2 blocker medicine, take it at least 2 hours before or 2 hours after BOSULIF. If you take a Proton Pump Inhibitor (PPI) medicine, talk to your doctor or pharmacist. • You should avoid grapefruit, grapefruit juice, and supplements that contain grapefruit extract during treatment with BOSULIF. Grapefruit products increase the amount of BOSULIF in your body. • If you miss a dose of BOSULIF, take it as soon as you remember. If you miss a dose by more than 12 hours, skip that dose and take your next dose at your regular time. Do not take 2 doses at the same time. • If you take too much BOSULIF, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of BOSULIF? BOSULIF may cause serious side effects, including: • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, vomiting, or blood in your stools. Get medical help right away for any stomach problems. • Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection. • Liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark "tea color" urine. • Heart problems. BOSULIF may cause heart problems, including heart failure and decreased blood flow to the heart which can lead to heart attack. Get medical help right away if you get shortness of breath, weight gain, chest pain, or swelling in your hands, ankles or feet. • Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Get medical help right away if you get any of the following symptoms during your treatment with BOSULIF:
	o shortness of breath and cough o chest pain o swelling in your hands, ankles, or feet	o swelling all over your body o weight gain
• Kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF: o you urinate more often than normal o you urinate less often than normal o you make a much larger amount of urine than normal o you make a much smaller amount of urine than normal The most common side effects of BOSULIF in adults and children with CML include:
• diarrhea • stomach (abdominal) pain • vomiting • nausea • rash • tiredness • liver problems		• headache • fever • decreased appetite • respiratory tract infections (infections in nose, throat or lungs) • constipation • changes in certain blood tests. Your doctor may do blood tests during treatment with BOSULIF to check for changes
Tell your doctor or get medical help right away if you get respiratory tract infections, loss of appetite, headache, dizziness, back pain, joint pain, rash or itching while taking BOSULIF. These may be symptoms of a severe allergic reaction. Your doctor may change your dose, temporarily stop, or permanently stop treatment with BOSULIF if you have certain side effects. BOSULIF may cause fertility problems in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of BOSULIF. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store BOSULIF? • Store BOSULIF tablets and capsules at room temperature between 68°F to 77°F (20°C to 25°C). • The BOSULIF tablets and capsules bottle has a child-resistant closure. • The BOSULIF tablets bottle contains a desiccant to help keep your medicine dry (protect it from moisture). Keep the desiccant in the bottle. Do not eat the desiccant. • Store the BOSULIF capsules in the original bottle. • Ask your doctor or pharmacist about the right way to throw away outdated or unused BOSULIF. Keep BOSULIF and all medicines out of the reach of children.
General information about the safe and effective use of BOSULIF. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BOSULIF for a condition for which it is not prescribed. Do not give BOSULIF to other people even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about BOSULIF that is written for health professionals.
What are the ingredients in BOSULIF? Active ingredient: bosutinib. Inactive ingredients: Tablets: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. Capsules: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution. For more information, go to www.Bosulif.com or www.pfizermedicalinformation.com or call 1-800-438-1985.

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 12/2024

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