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IMVEXXY is a brand name for Estradiol (also known as Oestradiol), supplied as a insert. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: IMVEXXY ® (17 β-estradiol) is indicated for: • the treatment of postmenopausal moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy. IMVEXXY clinical effectiveness is supported by safety and efficacy data based on a 12-week study. The safety and efficacy of longer-term use of IMVEXXY have not been…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
(See 7 WARNINGS AND PRECAUTIONS) IMVEXXY may be used in women with or without an intact uterus. During treatment with IMVEXXY, even during the first 2 weeks, there was minimal systemic absorption and average plasma estradiol levels did not exceed postmenopausal levels.
IMVEXXY clinical effectiveness is supported by safety and efficacy data based on a 12-week study. The safety and efficacy of longer term use of IMVEXXY have not been established (see CLINICAL TRIALS). 2 Recommended Dose and Dosage Adjustment Generally, women should be started at the 4 mcg dosage strength.
Dosage adjustment should be guided by the clinical response. IMVEXXY ® (estradiol vaginal inserts) – Product Monograph Page 6 of 37 Unclassified / Non classifié Treatment may be started on any convenient day. Initial dose: 1 vaginal insert daily at approximately the same time for 2 weeks Maintenance dose: 1 vaginal insert twice weekly, every three to four days (for example, Monday and Thursday) Pediatrics (<18 years of age): IMVEXXY is not indicated for use in the pediatric population.
4 Administration IMVEXXY should be administered intravaginally by manual placement (without an applicator), by inserting the smaller end up for a depth of about two inches into the vaginal canal. 5 Missed Dose If a patient misses a dose, it should be administered as soon as possible.
If it is close to the patient’s next scheduled dose, the missed dose should be skipped, and the patient should continue with her normal schedule. The patient should not insert two doses at the same time.
1 Adverse Reaction Overview See 7 WARNINGS AND PRECAUTIONS regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives. 7 Drug-Laboratory Test Interactions). Cardiac disorders Palpitations; increase in blood pressure (see 7 WARNINGS AND PRECAUTIONS); coronary thrombosis.
Endocrine disorders Increased blood sugar levels; decreased glucose tolerance. g. retinal thrombosis, optic neuritis); visual disturbances; steepening of the corneal curvature; intolerance to contact lenses. Gastrointestinal disorders Nausea; vomiting; abdominal discomfort (cramps, pressure, pain, bloating).
General disorders and administration site conditions Fatigue; changes in appetite; changes in body weight; change in libido. Hepatobiliary disorders Gallbladder disorder; asymptomatic impaired liver function; cholestatic jaundice. Musculoskeletal and connective tissue disorders Musculoskeletal pain including leg pain not related to thromboembolic disease (usually transient, lasting 3-6 weeks) may occur.
Nervous system disorders Aggravation of migraine episodes; headaches; dizziness; neuritis. Psychiatric disorders Mental depression; nervousness; irritability. Renal and urinary disorders Cystitis; dysuria; sodium retention; edema. Reproductive system and breast disorders Breakthrough bleeding; spotting; change in menstrual flow; dysmenorrhea; vaginal itching/discharge; dyspareunia; endometrial hyperplasia; pre-menstrual-like syndrome; reactivation of endometriosis; changes in cervical erosion and amount of cervical secretion; breast swelling and tenderness.
Skin and subcutaneous tissue disorders Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; haemorrhagic eruption; loss of scalp hair; hirsutism and acne. Vascular disorders Isolated cases of: thrombophlebitis; thromboembolic disorders.
, Carcinogenesis and Mutagenesis [11/2024] TABLE OF CONTENTS 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................................................................................
1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration .......................................................................................................
5 Missed Dose ........................................................................................................... 6 5 OVERDOSAGE............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 6 7 WARNINGS AND PRECAUTIONS ................................................................................. 1 Special Populations ..............................................................................................
IMVEXXY is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSTION AND PACKAGING.
g. g. stroke, myocardial infarction, coronary heart disease) • Active or past history of confirmed venous thromboembolism (such as deep vein thrombosis or pulmonary embolism) or active thrombophlebitis • Partial or complete loss of vision due to ophthalmic vascular disease.
• Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders IMVEXXY ® (estradiol vaginal inserts) – Product Monograph Page 5 of 37 Unclassified / Non classifié
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Estradiol in Canada.
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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.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 1 Clinical Trial Adverse Reactions – Pediatrics No data available. IMVEXXY is not indicated for pediatric patients.
3 Less Common Clinical Trial Adverse Reactions Cardiac disorders: palpitations. Gastrointestinal disorders: abdominal distension, abdominal pain lower, abdominal pain upper, dyspepsia, gastroesophageal reflux disease. General disorders and administration site conditions: fatigue, hyperhidrosis, oedema peripheral.
Infections and infestations: vulvovaginal candidiasis, vulvovaginal mycotic infection. Injury, poisoning and procedural complications: vulvar laceration. Investigations: blood alkaline phosphate increased, blood bilirubin increased, blood glucose increased, blood iron decreased, blood pressure increased, electrocardiogram change.
IMVEXXY ® (estradiol vaginal inserts) – Product Monograph Page 16 of 37 Unclassified / Non classifié Metabolism and nutrition disorders: hypercholesterolaemia. Nervous system disorders: cluster headache, dizziness, migraine. Psychiatric disorders: anxiety.
Renal and urinary disorders: dysuria, haematuria. Reproductive system and breast disorders: breast tenderness, cervical dysplasia, hot flush, perineal ulceration, vaginal dysplasia, vulvovaginal burning sensation, vulvovaginal erythema, vulvovaginal pain, vulvovaginal pruritus.
Respiratory, thoracic and mediastinal disorders: cough. Skin and subcutaneous tissue disorders: acne, blister, bromhidrosis, chloasma, pruritus, rash. Vascular disorders: hypertension. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data There were no clinically meaningful changes in the mean hematology values, mean blood chemistry values, or any urinalysis parameters, between Baseline and Week 12 (Follow-up) in women treated with IMVEXXY 4 or 10 mcg, or with placebo.
5 Post-Market Adverse Reactions No data available. If adverse symptoms persist, the prescription of HRT should be re-considered.
1 Pregnant Women ................................................................................................. 2 Breast-feeding ......................................................................................................
3 Pediatrics.............................................................................................................. 4 Geriatrics ..............................................................................................................
13 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................
1 Clinical Trial Adverse Reactions – Pediatrics........................................................ 3 Less Common Clinical Trial Adverse Reactions .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other IMVEXXY ® (estradiol vaginal inserts) – Product Monograph Page 3 of 37 Unclassified / Non classifié Quantitative Data.............................................................................................................
5 Post-Market Adverse Reactions........................................................................... 16 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview .................................................................................
3 Drug-Behavioural Interactions ............................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 17 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 20 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 20 PART II: SCIENTIFIC INFORMATION .....................................................................................
21 13 PHARMACEUTICAL INFORMATION .......................................................................... 21 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication .................................................................................. 22 Postmenopausal Moderate to Severe Dyspareunia ........................................................ 22 15 MICROBIOLOGY ......................................................................................................
24 16 NON-CLINICAL TOXICOLOGY .................................................................................... 24 PATIENT MEDICATION INFORMATION ................................................................................ 26 […]