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XTANDI is a brand name for Enzalutamide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Xtandi® (enzalutamide) is indicated for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk of metastasis (high-risk BCR) (see 14 CLINICAL TRIALS). Xtandi® (enzalutamide) is indicated for the treatment of patients with metastatic…
Verbatim from this product's HC label. Tap a section to expand.
1. of the PM Guidance) or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART 1: HEALTHCARE PROFESSIONAL INFORMATION .............................................................
5 1 INDICATIONS .................................................................................................................... 1 Pediatrics ...................................................................................................................
2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS .......................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.................................................................. 6 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration ........................................................................................................... 5 Missed Dose ..............................................................................................................
7 5 OVERDOSE........................................................................................................................ 7
, Cardiovascular). 1% on the placebo plus ADT arm. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue Xtandi for Grade 3-4 ischemic heart disease.
Patients with clinically significant cardiovascular disease, including recent myocardial infarction (in the past 6 months) or unstable angina (in the past 3 months), New York Heart Association Class (NYHA) III or IV heart failure, except if Left Ventricular Ejection Fraction (LVEF) ≥ 45%, bradycardia or uncontrolled hypertension (resting systolic blood pressure > 170 mm Hg and/or diastolic blood pressure > 105 mm Hg) were excluded from the Phase 3 clinical trials (see 14 CLINICAL TRIALS).
Therefore, the safety of Xtandi in these patients has not been established. 2 CLINICAL PHARMACOLOGY, Cardiac Electrophysiology). 4 msec observed at week 37. g. hypokalemia) or patients who are taking medications known to prolong the QT interval (see 9 DRUG-DRUG INTERACTIONS, Drugs that Cause QT/QTc Prolongation).
Hypertension:
Xtandi was associated with increases in systolic and diastolic blood pressure and an increased risk of hypertension or worsening of pre-existing hypertension when administered to patients in the Phase 3 clinical trials (see 10 CLINICAL PHARMACOLOGY, Blood Pressure).
2% vs. 4%). Hypertension rarely led to discontinuation or dose modification and, in general, was not associated with major cardiovascular adverse sequelae. However, approximately 75% of patients with this adverse event required initiation of new antihypertensive treatment or increase in dose of prior therapy.
Blood pressure should be measured at baseline and periodically during treatment. Treatment-emergent hypertension should be treated appropriately. Driving and Operating Machinery No studies on the effects on the ability to drive and use machines have been performed.
1. of the PM Guidance) or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART 1: HEALTHCARE PROFESSIONAL INFORMATION .............................................................
5 1 INDICATIONS .................................................................................................................... 1 Pediatrics ...................................................................................................................
2 Geriatrics ................................................................................................................... 5 2 CONTRAINDICATIONS .......................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.................................................................. 6 4 DOSAGE AND ADMINISTRATION ...................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment .......................................................... 4 Administration ........................................................................................................... 5 Missed Dose ..............................................................................................................
7 5 OVERDOSE........................................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION, AND PACKAGING ..................................... 7 7 WARNINGS AND PRECAUTIONS........................................................................................
Xtandi is contraindicated in: • patients who are hypersensitive to enzalutamide or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING section of the product monograph.
• women who are or may become pregnant, or who are lactating. XTANDI (enzalutamide) Page 6 of 84 Unclassified / Non classifié
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Ear/Nose/Throat Dysphagia Related to Product Size:
There have been reports of patients experiencing difficulty swallowing Xtandi, including reports of choking, due to product size. The swallowing difficulties were mostly reported with the capsule formulation. Advise patients to swallow the capsules whole with a sufficient amount of water.
XTANDI (enzalutamide) Page 10 of 84 Unclassified / Non classifié Hepatic/Biliary/Pancreatic Mild, moderate or severe hepatic impairment (Child-Pugh Class A, B or C) had no significant effects on the pharmacokinetics of enzalutamide (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
Patients with baseline severe hepatic impairment (Child-Pugh C) were excluded from both the AFFIRM and PREVAIL trials. Immune Hypersensitivity reactions manifested by symptoms including, but not limited to face, tongue, lip and pharyngeal oedema have been observed with enzalutamide (see 8 ADVERSE REACTIONS, Post-Market Adverse Drug Reactions).
Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue Xtandi and promptly seek medical care. Permanently discontinue Xtandi for serious hypersensitivity reactions. Monitoring and Laboratory Tests Monitoring for laboratory or clinical parameters should be conducted as per routine practice.
Blood pressure should be measured at baseline and periodically during treatment. Monitoring of ECG and serum electrolyte levels at baseline and during treatment should be considered for patients at risk for electrolyte abnormality and QTc prolongation.
Enzalutamide is a moderate inducer of CYP2C9. g. warfarin or acenocoumarol), additional International Normalised Ratio (INR) monitoring should be conducted. Patients with cardiac history should be assessed for active cardiac disease before starting therapy with Xtandi.
Patients with nm-CSPC with high-risk BCR or nm-CRPC should be monitored for disease progression radiographically at the discretion of their treating physician in addition to serum Prostate Specific Antigen (PSA). 1%) of patients treated with Xtandi monotherapy reported radiographic progression without PSA progression.
PSA progression was defined as the date that a ≥25% increase and an absolute increase of ≥2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 25) and that was confirmed by a second consecutive value at least 3 weeks later.
In the PROSPER trial, 104 out of 219 nm-CRPC patients treated with Xtandi in the PROSPER trial reported radiographic progression without PSA progression.
Musculoskeletal Bone Fractures:
Xtandi is indicated for use in patients who are maintaining castration status through GnRH analogue therapy or surgical castration. In the Phase 3 clinical trials, a higher incidence of non-pathological bone fractures was reported in the Xtandi plus ADT group compared to the placebo plus ADT group (see 8 ADVERSE REACTIONS); no assessments of bone mineral density were conducted in these trials (see 14 CLINICAL TRIALS).
Falls and Fall-related Injuries:
In Phase 3 clinical […]
8 XTANDI (enzalutamide) Page 3 of 84 Unclassified / Non classifié General .................................................................................................................................. 8 Carcinogenesis and Genotoxicity ...........................................................................................
8 Cardiovascular ....................................................................................................................... 9 Driving and Operating Machinery ..........................................................................................
9 Ear/Nose/Throat .................................................................................................................... 9 Hepatic/Biliary/Pancreatic ...................................................................................................
10 Immune ............................................................................................................................... 10 Monitoring and Laboratory Tests ........................................................................................
10 Musculoskeletal ................................................................................................................... 10 Neurologic ...........................................................................................................................
11 Renal .................................................................................................................................... 12 Reproductive Health ............................................................................................................
1 Special Populations.................................................................................................. 1 Pregnancy ........................................................................................................
2 Breastfeeding .................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ......................................................................................................... 13 8 ADVERSE REACTIONS......................................................................................................
1 Adverse Reaction Overview ..................................................................................... 2 Clinical Trial Adverse Reactions ............................................................................... 3 Less Common Clinical Trial Adverse Reactions ........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry, and Other Quantitative Data ................................................................................................................ 5 Post-Market Adverse Reactions ..............................................................................
23 9 DRUG INTERACTIONS ..................................................................................................... 2 Drug Interactions Overview .....................................................................................
4 Drug-Drug Interactions ............................................................................................ 5 Drug-Food […]