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FREYA is a brand name for Desogestrel, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FREYA (desogestrel/ethinyl estradiol tablets, USP) is indicated for: • Conception control 1.1 Pediatrics Pediatrics: The safety and efficacy of desogestrel/ethinyl estradiol tablets has not been established in women under the age of 18 years. Use of this product before menarche is not indicated. 1.2 Geriatrics…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Patients should be instructed to read the package insert prior to starting FREYA and any time they are unsure of administration. In the case of FREYA 28, patients should be instructed to read the package insert and the day label strip.
If they have additional questions, they should call their doctor or clinic. FREYA (desogestrel and ethinyl estradiol) Page 6 of 67 Protected B / Protégé B FREYA tablets may be prescribed as a 21-day or a 28-day regimen. FREYA tablets must be taken at approximately the same time every day until the pack is empty.
, the first day of menstrual flow) or on the first Sunday after her period begins. If the patient’s period starts on Sunday, she should start that same day. 2 Recommended Dose and Dosage Adjustment FREYA 21 (21-Day Regimen): One white tablet is to be taken for 21 consecutive days (three weeks).
Tablets are then discontinued for one week. The patient must not be off the pill for more than seven consecutive days. A new pack will be started on the eighth day. ) FREYA 28 (28-Day Regimen): One white tablet is to be taken for 21 consecutive days (three weeks), followed by a green tablet for seven consecutive days (one week).
A new pack (white tablet) will be started on the eighth day, following the completion of the green tablets. The patient will have a period while they are on the green tablet. On this regimen the patient must not go a day without taking a pill.
4 Administration It is recommended that FREYA be taken at the same time each day. The patient should be counselled to associate taking the pill with some regular activity like eating a meal or going to bed. , latex condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use.
This will provide a back-up in case pills are forgotten while they are getting used to taking them. If spotting, light bleeding, or feeling sick to their stomach occurs during the first three months the women should be counselled to not stop taking the pill.
The problem will usually go away. If it does not subside, the patient should consult her doctor or clinic. , the pill should not be stopped) even if the women does not have sex very often. When receiving any medical treatment, patients should tell their doctor that they are using birth control pills.
, retinal thrombosis) • pulmonary embolism • thrombophlebitis The following other adverse reactions also have been reported in patients receiving combination hormonal contraceptives: nausea and vomiting, usually the most common adverse reaction, occurs in approximately 10% or fewer of patients during the first cycle.
The following other reactions, as a general rule, are seen less frequently or only occasionally: • abdominal pain • amenorrhea during and after treatment • angioedema (exogenous estrogens may induce or exacerbate symptoms of angioedema in women with hereditary and acquired angioedema)a • auditory disturbances • breakthrough bleeding • breast changes (tenderness, enlargement, and secretion) • cataracts • changes in appetite • change in corneal curvature (steepening) • changes in glucose tolerance or effect on peripheral insulin resistance • changes in libido • change in menstrual flow • change in weight (increase or decrease) • chloasma or melasma which may persist • cholestatic jaundice • chorea FREYA (desogestrel and ethinyl estradiol) Page 20 of 67 Protected B / Protégé B • Crohn’s disease • cystitis-like syndrome • diarrhea • dizziness • dysmenorrhea • edema • endocervical hyperplasia • erythema multiforme • erythema nodosum • gallstone formationa • gastrointestinal symptoms (such as abdominal cramps and bloating) • headache • hemolytic uremic syndrome • hemorrhagic eruption • herpes gestationisa • hirsutism • hypersensitivity • hypertensiona • hypertriglyceridemia (increased risk of pancreatitis when using COCs) • impaired renal function • increase in size of uterine leiomyomata • intolerance to contact lenses • jaundice related to cholestasisa • liver function disturbances • loss of scalp hair • mental depression • migraine • nervousness • optic neuritis • otosclerosis-related hearing lossa • pancreatitis • porphyria • possible diminution in lactation when given immediately postpartum • premenstrual-like syndrome • pruritus related to cholestasisa • rash (allergic) • Raynaud's phenomenon • reduced tolerance to carbohydrates • retinal thrombosis • rhinitis • spotting • Sydenham’s choreaa FREYA (desogestrel and ethinyl estradiol) Page 21 of 67 Protected B / Protégé B • Systemic lupus erythematosusa • temporary infertility after discontinuation of treatment • ulcerative colitis • urticaria • vaginal candidiasis • vaginal discharge • vaginitis a Occurrence or deterioration of conditions for which association with COC use is not conclusive.
, Hepatitis C 08/2023 7 WARNINGS AND PRECAUTIONS, Immune 08/2023 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................................................................................ 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ......................................................................................................... 5 Missed Dose .............................................................................................................
7 5 OVERDOSAGE............................................................................................................ 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 9 7 WARNINGS AND PRECAUTIONS ...............................................................................
08/2023 7 WARNINGS AND PRECAUTIONS, Hepatitis C 08/2023 7 WARNINGS AND PRECAUTIONS, Immune 08/2023 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
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Advice in case of vomiting In case of severe gastro-intestinal disturbance, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet- FREYA (desogestrel and ethinyl estradiol) Page 7 of 67 Protected B / Protégé B taking, the advice concerning the Management of missed tablets is outlined below.
If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.
When to start FREYA No hormonal contraceptive use in the preceding cycle:
Tablet taking should start on Day 1 of the woman’s menstrual cycle or on the first Sunday after her period begins. Switching from another combination hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch): The woman should start FREYA preferably on the day after the last active tablet of her previous COC, but at the latest, on the day following the usual tablet-free or inactive tablet of her previous COC.
In case a vaginal ring or transdermal patch has been used, the woman should start using FREYA preferably on the day of removal, but at the latest when the next application would have been due. Switching from a progestogen-only-method (mini-pill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch from the mini-pill to FREYA on any day of her cycle.
Patients using a progestogen injection should start FREYA on the day the next injection is due. Patients using an implant or an IUS should start FREYA on the day it is removed. In all cases, the woman should be advised to use an additional barrier method for the first 7 days of FREYA use.
Following complete first-trimester abortion:
The woman may start using FREYA immediately. When doing so, she need not take additional contraceptive measures.
Following delivery or second-trimester abortion:
Women should be advised to start FREYA on Day 21 to 28 after delivery or second trimester abortion, after consulting with their physician. When starting later, the woman should be advised to use an additional barrier method for the first seven days of tablet-taking.
However, if intercourse has already occurred, pregnancy should be excluded before the actual start of use or the woman should be advised to wait for her first menstrual period prior to starting FREYA. The increased risk of venous thromboembolism (VTE) during the postpartum period should be considered when restarting FREYA (see 7 WARNINGS AND PRECAUTIONS).
For breastfeeding women, see 7 WARNINGS AND PRECAUTIONS – Breastfeeding. 5 Missed Dose The patient should be instructed to use the following chart if she misses one or more of her birth control pills. She should be told to match the number of pills missed with the appropriate starting time for her dosing regimen.
FREYA (desogestrel and ethinyl estradiol) Page 8 of 67 Protected B / Protégé B Sunday Start Day One Start Miss One Pill Miss One Pill Take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.
Take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day. Miss Two Pills in a Row Miss Two Pills in a Row First Two Weeks 1. Take 2 pills the day you remember and […]
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials 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 is useful for identifying drug-related adverse events and for approximating rates. Eighty-six per cent of the 1,195 subjects reported 1 or more adverse experiences. The majority of these (64%) were considered (by the investigators) to be unrelated to desogestrel and ethinyl estradiol tablets usage.
Of the total population, approximately 12% of the subjects discontinued due to an adverse experience. 2) a Percentages are of total patients entered. b Starter/Switcher status could not be determined in one subject. c A total of 145 patients actually had a clinical AE as the primary reason for discontinuation.
FREYA (desogestrel and ethinyl estradiol) Page 22 of 67 Protected B / Protégé B With the exception of menses-related adverse experiences, no significant changes in the incidence of adverse experiences over time were seen. No drug-related adverse effects were observed during general physical or pelvic examination.
The breast examination showed a reduction in nodularity. No changes in body mass index or blood pressure were observed. Baseline distribution of abnormalities in cervical cytology was comparable to those at last visit. No patient developed a clinically significant abnormal value for routine laboratory analytes that led to either early discontinuation or hospitalization.
Detailed ophthalmologic examinations, including slit-lamp, were performed in a subset of 28 healthy women at baseline and after 12 cycles. No patients were found to have a decrease in visual acuity. Complete ophthalmological examination failed to identify possible desogestrel and ethinyl estradiol tablets-related changes.
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1 Special Populations ................................................................................................ 1 Pregnant Women ............................................................................................. 2 Breast-feeding ..................................................................................................
3 Pediatrics.......................................................................................................... 4 Geriatrics ..........................................................................................................
18 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions .............................................................................
5 Post-Market Adverse Reactions............................................................................. 23 9 DRUG INTERACTIONS .............................................................................................. 2 Drug Interactions Overview ...................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions......................................................................... 30 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 32 11 STORAGE, STABILITY AND DISPOSAL ........................................................................
34 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 34 PART II: SCIENTIFIC INFORMATION ..................................................................................... 35 13 PHARMACEUTICAL INFORMATION ..........................................................................
35 14 CLINICAL TRIALS ...................................................................................................... 1 Clinical Trials by Indication ..............................................................................
2 Comparative Bioavailability Studies ................................................................ 41 15 MICROBIOLOGY ...................................................................................................... 42 16 NON-CLINICAL TOXICOLOGY ....................................................................................
42 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 48 PATIENT MEDICATION INFORMATION ................................................................................ 1 Pediatrics Pediatrics: The safety and efficacy of desogestrel/ethinyl estradiol tablets has not been established in […]