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PMS-ANAGRELIDE is a brand name for Anagrelide, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-ANAGRELIDE (anagrelide hydrochloride capsules) is indicated for: • Treatment of patients with thrombocythemia secondary to myeloproliferative neoplasms to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms, including thrombo-hemorrhagic events. pms-ANAGRELIDE is…
Verbatim from this product's HC label. Tap a section to expand.
5 Missed Dose 03/2022 7 WARNINGS AND PRECAUTIONS 03/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics .....................................................................................................................
2 Geriatrics ..................................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................... 5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 2 Recommended Dose and Dosage Adjustment ............................................................
4 Administration............................................................................................................. 5 Missed Dose ................................................................................................................
6 5 OVERDOSAGE .................................................................................................................... 6
) of anagrelide hydrochloride, it should be used with caution in patients with known or suspected heart disease, and only if the potential benefits of therapy outweigh the potential risks. A pre-treatment cardiovascular examination (including investigations such as echocardiograph, electrocardiogram) is recommended for all patients, along with careful monitoring during treatment and further investigations carried out as necessary.
In humans, therapeutic doses of anagrelide hydrochloride may cause cardiovascular effects, including vasodilation, tachycardia, palpitations, Prinzmetal angina and congestive heart failure. Anagrelide has been shown to increase the heart rate, resulting in an apparent increase in QTc interval of the electrocardiogram in healthy volunteers.
2 Pharmacodynamics, Effects on Heart Rate and QTc Interval). Caution should be taken when using anagrelide in patients with known risk factors for prolongation of the QT interval, such as congenital long QT syndrome, a known history of pms-ANAGRELIDE (anagrelide hydrochloride) Page 9 of 37 acquired QTc prolongation, medicinal products that can prolong QTc interval and hypokalemia, as cases of Torsades de pointes have been reported post market.
4 Drug-Drug Interactions). Cases of pulmonary hypertension have been reported in patients treated with anagrelide. Patients should be evaluated for signs and symptoms of underlying cardiopulmonary disease prior to initiating and during anagrelide therapy.
Driving and Operating Machinery Caution should be used when driving vehicles or machinery. 4 Drug-Drug Interactions). Hepatic/Biliary/Pancreatic Hepatic metabolism represents the major route of anagrelide clearance and liver function may therefore be expected to influence this process.
Anagrelide hydrochloride has not been studied in patients with severe hepatic impairment and is contraindicated (2 CONTRAINDICATIONS). Exposure to anagrelide is increased 8-fold in patients with moderate hepatic impairment (4 DOSAGE AND ADMINISTRATION; 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Hepatic Insufficiency).
03/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ..................................................................................................................... 1 Pediatrics .....................................................................................................................
2 Geriatrics ..................................................................................................................... 4 2 CONTRAINDICATIONS ........................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................... 5 4 DOSAGE AND ADMINISTRATION ........................................................................................ 2 Recommended Dose and Dosage Adjustment ............................................................
4 Administration............................................................................................................. 5 Missed Dose ................................................................................................................
6 5 OVERDOSAGE .................................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING......................................... 7 7 WARNINGS AND PRECAUTIONS .........................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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It is recommended that patients with mild and moderate hepatic impairment receive pms-ANAGRELIDE only if, in the physician's judgment, the potential benefits of therapy outweigh the potential risks. Patients with mild or moderate hepatic impairment should be carefully and regularly monitored for cardiovascular effects and hepatic toxicity while receiving pms-ANAGRELIDE (7 WARNINGS AND PRECAUTIONS, Cardiovascular; and 8 ADVERSE REACTIONS).
2 Recommended Dose and Dosage Adjustment). Monitoring and Laboratory Tests pms-ANAGRELIDE therapy requires close clinical supervision of the patient. To monitor the effect of pms-ANAGRELIDE and prevent the occurrence of thrombocytopenia, platelet counts should be performed every two days during the first week of treatment and at least weekly thereafter, until the maintenance dosage is reached.
Typically, platelet count begins to respond within 7 to 14 days at the proper dosage. The time to complete response, defined as platelet count ≤ 600,000/mcL, ranged from 4 to 12 weeks. 0 mg/day. In the event of dosage interruption or treatment withdrawal, the rebound in platelet count is pms-ANAGRELIDE (anagrelide hydrochloride) Page 10 of 37 variable, but platelet counts typically will start to rise within four days and return to baseline levels in one to two weeks, possibly rebounding above baseline values.
Therefore, platelets should be monitored frequently (3 SERIOUS WARNINGS AND PRECAUTIONS BOX, 7 WARNINGS AND PRECAUTIONS). In patients with hepatic insufficiency or renal insufficiency, liver function and kidney function tests should be performed at least once per month or when deemed necessary in the physician’s judgement (4 DOSAGE AND ADMINISTRATION).
Electrolytes (potassium, magnesium and calcium) should also be monitored. As cases of hepatitis have been reported from post-marketing surveillance, it is recommended that liver functions (ALT and AST) tests are performed before anagrelide treatment is initiated and at regular intervals thereafter (4 DOSAGE AND ADMINISTRATION; 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/ Pancreatic; 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
73 m2) receive pms-ANAGRELIDE when, in the physician's judgment, the potential benefits of therapy outweigh the potential risks. These patients should be monitored closely for signs of renal toxicity while receiving pms-ANAGRELIDE (8 ADVERSE REACTIONS).
Respiratory Interstitial Lung Diseases Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) have been reported to be associated with the use of anagrelide in post-marketing reports.
Most cases presented with progressive dyspnea associated with lung infiltrations. The time of onset ranges from 1 week to several years after initiating anagrelide. 5 Post- Market Adverse Reactions). Sensitivity/Resistance Due to the presence of lactose, patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption or the Lapp lactase deficiency should […]
1 Special Populations ................................................................................................... 1 Pregnant Women ......................................................................................................
2 Breast-feeding ........................................................................................................... 3 Pediatrics ...................................................................................................................
4 Geriatrics ................................................................................................................... 11 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 pms-ANAGRELIDE (anagrelide hydrochloride) Page 3 of 37 Quantitative Data Clinical Trial Findings .....................................................................
5 Post-Market Adverse Reactions ................................................................................ 14 9 DRUG INTERACTIONS.......................................................................................................
2 Drug Interactions Overview ....................................................................................... 4 Drug-Drug Interactions .............................................................................................
5 Drug-Food Interactions ............................................................................................. 6 Drug-Herb Interactions .............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 16 10 CLINICAL PHARMACOLOGY ..............................................................................................
1 Mechanism of Action ................................................................................................ 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 18 11 STORAGE, STABILITY AND DISPOSAL ................................................................................
20 PART II: SCIENTIFIC INFORMATION ........................................................................................ 21 13 PHARMACEUTICAL INFORMATION ..................................................................................
21 14 CLINICAL TRIALS ............................................................................................................... 1 Trial Design and Study Demographics .......................................................................
2 Study Results ............................................................................................................. 3 Comparative Bioavailability Studies ..........................................................................
4 Immunogenicity......................................................................................................... 25 15 MICROBIOLOGY ...............................................................................................................
25 16 NON-CLINICAL TOXICOLOGY............................................................................................. 25 17 SUPPORTING PRODUCT […]