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TIBELLA is a brand name for Tibolone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tibella (tibolone) is indicated for short-term treatment of vasomotor symptoms due to estrogen deficiency in postmenopausal women, more than one year after menopause. For all women the decision to prescribe Tibella should be based on an assessment of the individual patient’s overall risks and, particularly in the over…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Starting Tibella Any irregular/unscheduled vaginal bleeding, either on or off Hormone Replacement Therapy (HRT), should be investigated to exclude malignancy before starting Tibella. (see WARNINGS AND PRECAUTIONS) Women experiencing a natural menopause should commence treatment with Tibella at least 12 months after their last natural bleed.
In case of a surgical menopause, treatment with Tibella may commence immediately. Women being treated with gonadotrophin Serious Warnings and Precautions Tibella may increase the risk of stroke, breast cancer and, in women with an intact uterus, endometrial cancer and can be dependent on individual risk factors (See Clinical Trial Adverse Reactions).
A complete personal and family medical history should be taken before starting treatment with Tibella. Periodic check-ups are recommended while on the treatment. The Women’s Health Initiative (WHI) trial examined the health benefits and risks of oral combined estrogen plus progestin therapy (n=16,608) and oral estrogen -alone therapy (n=10,739) in postmenopausal women aged 50 to 79 years.
2 years compared to those receiving placebo. 8 years compared to those receiving placebo. Therefore, the following should be given serious consideration at the time of prescribing: Estrogens with or without progestins should not be prescribed for primary or secondary prevention of cardiovascular diseases.
Estrogens with or without progestins should be prescribed at the lowest effective dose for the approved indication. Estrogens with or without progestins should be prescribed for the shortest period possible for the approved indication.
TIBELLA (tibolone) Page 6 of 40 releasing hormone (GnRH) analogues, for example, for endometriosis, may commence treatment with Tibella immediately. Switching from a sequential or continuous combined HRT preparation If changing from a sequential HRT preparation, treatment with Tibella should start the day following completion of the prior regimen.
If changing from a continuo us combined HRT preparation, treatment can start at any time. 5 mg) per day. 5 mg. The tablets should be swallowed whole with some water or other drink, preferably at the same time every day. When a pack is complete, patients should start a new pack the next day without missing any days on the drug.
1 Adverse Reaction Overview See WARNING AND PRECATIONS regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives. The following adverse reactions have been reported with estrogen/progestin combination in general: Blood and lymphatic system disorders Altered coagulation tests (see Warnings and Precautions, Drug-Laboratory Tests Interactions).
Cardiac disorders Palpitations; increase in blood pressure (see Warnings and Precautions); coronary thrombosis. Endocrine disorders Increased blood sugar levels; decreased glucose tolerance. , retinal thrombosis, optic neuritis); visual disturbances; steepening of the corneal curvature; intolerance to contact lenses.
TIBELLA (tibolone) Page 16 of 40 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 multif orme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism and acne. Vascular disorders Isolated cases of: thrombophlebitis; thromboembolic disorders.
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. General For the treatment of postmenopausal symptoms, Tibella should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and Tibella should only be continued as long as the benefit outweighs the risk.
The risks of stroke, breast cancer and, in women with an intact uterus, endometrial cancer for each woman should be carefully assessed, in the light of her individual risk factors and bearing in mind the frequency and characteristics of both cancers and stroke, in terms of their respon se to treatment, morbidity and mortality.
Evidence regarding the risks associated with HRT or tibolone in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favorable than in older women.
Tibella is not intended for contraceptive use. Conditions which need supervision If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
g. g. 5 mg Ascorbyl palmitate, lactose monohydrate, magnesium stearate, mannitol, and potato starch. TIBELLA (tibolone) Page 8 of 40 Systemic lupus erythematosus A history of endometrial hyperplasia (see below) Epilepsy Asthma Otosclerosis Reasons for immediate withdrawal of therapy: Therapy should be discontinued in case a contra-indication is discovered and in the following situations: Jaundice or deterioration in liver function Significant increase in blood pressure New onset of migraine-type headache Pregnancy Carcinogenesis and Mutagenesis (also see ADVERSE REACTIONS) Endometrial hyperplasia and carcinoma The available data from randomised controlled trials are conflicting, however, observational studies have consistently shown that women who are prescribed Tibella in normal clinical practice are at an increased risk of having endometrial cancer diagnosed.
g. g. protein C, protein S, or antithrombin deficiency) TIBELLA (tibolone) Page 5 of 40 Partial or complete loss of vision due to ophthalmic vascular diseases Porphyria Hypersensitivity 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 DOSAGE FORMS, COMPOSITION AND PACKAGING.
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Tibella may be administered with or without food. A separate progestogen should not be added with Tibella treatment. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effect ive dose for the shortest duration (see WARNINGS AND PRECAUTIONS) should be used.
There is no relevant use of Tibella in the pediatric population; therefore, Health Canada has not authorized an indication for pediatric use. 3 Reconstitution Not applicable. 4 Administration For oral use. 5 Missed Dose A missed dose should be taken as soon as remembered, unless it is more than 12 hours overdue.
In the latter case, the missed dose should be skipped and the next dose s hould be taken at the normal time. Missing a dose may increase the likelihood of breakthrough bleeding and spotting.
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. 5 mg) of tibolone and 3476 women receiving placebo. 5 years. Table 2 shows the undesirable effects that occurred statistically significantly more frequently during treatment with tibolone than with placebo.
TIBELLA (tibolone) Page 17 of 40 Table 2:
Common Adverse Reactions System Organ Class Common (≥1/100 to <1/10) Gastrointestinal disorders Lower abdominal pain Skin and subcutaneous tissue disorders Abnormal hair growth Reproductive system and breast disorders Vaginal discharge Endometrial thickening Breast tenderness Genital pruritus Vaginal candidiasis Vaginal hemorrhage* Pelvic pain Cervical dysplasia Genital discharge Vulvovaginitis Investigations Weight increase Abnormal cervical smear * Bleeding that happens at least 12 months after periods have stopped.
Breast cancer An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined estrogen-progestogen therapy for more than 5 years. Any increased risk in users of estrogen-only and tibolone therapies is substantially lower than seen in users of estrogen-progestogen combinations.
The level of risk is dependent on the duration of use. Results of the largest epidemiological study (Million Women Study) are presented. 3 3 (0-6) a: Taken from baseline incidence rates in developed countries b: Overall risk ratio. The risk ratio is not constant but will increase with increasing durat ion of use Endometrial cancer risk Postmenopausal women with a uterus The endometrial cancer risk is about 5 in every 1000 women with a uterus not using HRT or tibolone.
The randomised placebo-controlled trial that included women who had not been screened for endometrial abnormalities at baseline, and therefore reflected clinical practice, identified the highest risk of endometrial cancer (LIFT study, mean age 68 years).
9 years compared with 4 cases of endometrial cancer in the tibolone group (n=1,746). 8 additional case of endometrial cancer in every 1000 women who used tibolone for one year in this study. Ovarian cancer Use of estrogen-only or combined estrogen-progestogen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed.
56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 […]
In these studies, risk increased with increasing duration of use. Tibolone increases endometrial wall thickness, as measured by transvaginal ultrasound. Break-through bleeding and spotting may occur during the first months of treatment.
Women should be advised to report any break-through bleeding or spotting if it is still present after 6 months of treatment, if it starts beyond that time or if it continues after treatment has been discontinued. The woman should be referred for gynecological investigation, which is likely to include endometrial biopsy to exclude endometrial malignancy.
Breast cancer Evidence with respect to breast cancer risk in association with tibolone is inconclusive. 5 mg dose. This risk became apparent within a few years of use and increased with duration of intake, returning to baseline within a few (at most five ) years after stopping treatment (see ADVERSE REACTIONS).
These results could not be confirmed in a study using the General Practice Research Database (GPRD). HRT, especially estrogen-progestogen combined treatment, increases the density of mammographic images which may adversely affect the radiological detection of breast cancer.
Available epidemiological data indicate that the use of combined estrogen plus progestin by postmenopausal women is associated with an increased risk of invasive breast cancer. In the estrogen plus progestin arm of the WHI trial, among 10,000 women over a one -year period, there were 8 more cases of invasive breast cancer (38 on combined HRT versus 30 on placebo).
04) and were at a more advanced stage compared with those diagnosed in the placebo group. The percentage of women with abnormal mammograms TIBELLA (tibolone) Page 9 of 40 (recommendations for short-interval follow-up, a suspicious abnormality, or highly suggestive of malignancy) was significantly higher in the estrogen plus progestin group versus the placebo group.
This difference appeared at year one and persisted in each year thereafter. In the estrogen-alone arm of the WHI trial, there was no statistically significant difference in the rate of invasive breast cancer in hysterectomized women treated with conjugated equine estrogens versus women treated with placebo.
It is recommended that estrogens with or without progestins not be given to women with existing breast cancer or those with a previous history of the disease (see CONTRAINDCATIONS). There is a need for caution in prescribing estrogens with or without progestins for women with known risk factors associated with the development of breast cancer, such as strong family history of breast cancer (first degree relative) or who present a breast condition with an increased risk (abnormal mammograms and/ or atypical hyperplasia at breast biopsy).
Other known risk factors for the development of breast cancer such as nulliparity, obesity, early menarche, late age at […]