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Pomalidomide PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr POMALYST® pomalidomide 1 mg, 2 mg, 3 mg and 4 mg Capsules for Oral Use Antineoplastic Agent Immunomodulatory Agent ATC Code: L04AX06 Celgene Inc.* Date of Initial Approval: 2344 Alfred-Nobel Blvd January 17, 2014 Suite 300 Saint-Laurent, QC Date of Revision: H4S 0A4 February 2, 2021 Submission Control No: 243491 * a Bristol-Myers Squibb company © 2021 Celgene Corporation. ® POMALYST is a registered trademark of Celgene Corporation. Page 1 of 65 RECENT MAJOR LABEL CHANGES 1 Indications 06/2019 3 Serious Warnings and Precautions Box, Infections 06/2019 3 Serious Warnings and Precautions Box, Hepatitis B 06/2019 3 Serious Warnings and Precautions Box, Severe dermatologic 06/2019 reactions 3 Serious Warnings and Precautions Box, Tumour lysis syndrome 06/2019 3 Serious Warnings and Precautions Box, Anaphylaxis 08/2019 4 Dosage and Administration, 4.2 Recommended Dose and Dosage 08/2019 Adjustment 7 Warnings and Precautions, Infections 01/2021 7 Warnings and Precautions, 7.1.3 Pediatrics 07/2019 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ......................................................................................2 TABLE OF CONTENTS ..............................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4 1 INDICATIONS....................................................................................................................4 1.1 Pediatrics ....................................................................................................................4 1.2 Geriatrics ....................................................................................................................4 2 CONTRAINDICATIONS ..................................................................................................4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................6 4 DOSAGE AND ADMINISTRATION ...............................................................................6 4.1 Dosing Considerations ...............................................................................................6 4.2 Recommended Dose and Dosage Adjustment ...........................................................7 4.3 Administration ...........................................................................................................9 4.5 Missed Dose ...............................................................................................................9 5 OVERDOSAGE .................................................................................................................9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................9 7 WARNINGS AND PRECAUTIONS .............................................................................10 7.1 Special Populations ..................................................................................................14 7.1.1 Pregnant Women ................................................................................................. 14 7.1.2 Breast-feeding ..................................................................................................... 17 7.1.3 Pediatrics ............................................................................................................. 17 7.1.4 Geriatrics ............................................................................................................. 17 7.1.5 Patients with Hepatic Impairment ....................................................................... 18 Page 2 of 65 7.1.6 Patients with Renal Impairment .......................................................................... 18 8 ADVERSE REACTIONS................................................................................................18 8.1 Adverse Reaction Overview ....................................................................................18 8.2 Clinical Trial Adverse Reactions .............................................................................19 8.3 Less Common Clinical Trial Adverse Reactions .....................................................25 8.4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...............................................................................................................27 8.6 Post-Market Adverse Drug Reactions .....................................................................29 9 DRUG INTERACTIONS .................................................................................................30 9.2 Overview ..................................................................................................................30 9.3 Drug-Drug Interactions ............................................................................................30 9.4 Drug-Food Interactions ............................................................................................32 9.5 Drug-Herb Interactions ............................................................................................32 9.6 Drug-Laboratory Interactions ..................................................................................32 9.7 Drug-Lifestyle Interactions ......................................................................................32 10 ACTION AND CLINICAL PHARMACOLOGY ...........................................................32 10.1 Mechanism of Action ...........................................................................................32 10.2 Pharmacodynamics...............................................................................................33 10.3 Pharmacokinetics .................................................................................................34 11 STORAGE, STABILITY AND DISPOSAL..................................................................36 12 SPECIAL HANDLING INSTRUCTIONS .....................................................................37 13 PHARMACEUTICAL INFORMATION ........................................................................38 14 CLINICAL TRIALS .........................................................................................................38 14.1 Trial Design and Study Demographics ................................................................39 14.2 Study Results ........................................................................................................46 16 NON-CLINICAL TOXICOLOGY ...................................................................................53 17 SUPPORTING PRODUCT MONOGRAPHS..............................................................56 PATIENT MEDICATION INFORMATION ...............................................................................57 Page 3 of 65 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS POMALYST® (pomalidomide) is indicated: • in combination with dexamethasone (dex) and bortezomib for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior treatment regimen that included lenalidomide. • in combination with dexamethasone for patients with multiple myeloma for whom both bortezomib and lenalidomide have failed and who have received at least two prior treatment regimens and have demonstrated disease progression on the last regimen. Distribution restrictions POMALYST® is only available through a controlled distribution program called RevAid®. Under this program, only prescribers and pharmacists registered with the program are able to prescribe and dispense the product. In addition, POMALYST® can only be dispensed to patients who are registered and meet all the conditions of the RevAid® program. Please call 1-888-RevAid1 (1-888-738-2431) or log onto www.RevAid.ca. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (> 65 years of age): The concomitant administration of dexamethasone may increase the risk of infection, particularly pneumonia, in patients > 65 years of age treated with POMALYST® (see DOSAGE AND ADMINISTRATION, Dosing Considerations). There is limited information on the safety of POMALYST® in combination with dexamethasone in patients > 75 years of age (see CLINICAL TRIALS and DOSAGE AND ADMINISTRATION, Dosing Considerations). 2 CONTRAINDICATIONS POMALYST® (pomalidomide) is contraindicated in patients who are hypersensitive to it or to thalidomide, lenalidomide or to any ingredient in the formulation or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • POMALYST® is contraindicated in pregnant women and women at risk of becoming pregnant (see WARNINGS AND PRECAUTIONS, Special Populations). Pomalidomide is structurally related to thalidomide, a known human teratogen that causes severe and life-threatening birth defects. Pomalidomide induced malformations in rats and rabbits similar to those described with thalidomide. If POMALYST® is taken Page 4 of 65 during pregnancy, it may cause severe birth defects or death to the fetus (see WARNINGS AND PRECAUTIONS, Special Populations). Females of Child-Bearing Potential may be treated with POMALYST® provided that adequate contraception, with two simultaneous effective methods of contraception, is used to prevent fetal exposure to the drug. The choice of the two simultaneously effective contraceptive
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