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NEXTSTELLIS is a brand name for Drospirenone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Pregnant women: NEXTSTELLIS should not be used in women who are pregnant.
Hepatic impairment:
No clinical studies have been performed with NEXTSTELLIS in patients with hepatic insufficiency. NEXTSTELLIS is contraindicated in women with moderate to severe hepatic diseases.
Renal impairment:
NEXTSTELLIS has not been specifically studied in patients with renal impairment. As drospirenone has anti-mineralocorticoid activity there is a potential for Product Monograph Page 6 of 57 Nextstellis (Estetrol monohydrate and Drospirenone Tablets) Unclassified / Non classifié hyperkalemia in high-risk patients, NEXTSTELLIS is contraindicated in women with moderate to severe renal insufficiency.
Concomitant medications:
Please see DRUG-DRUG INTERACTION section. 2 Recommended Dose and Dosage Adjustment Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly. It is recommended that NEXTSTELLIS tablets should be taken every day at about the same time regardless of mealtimes and as directed on the package.
Stickers marked with the 7 days of the week are provided, and the relevant weekday sticker should be stuck on the tablet blister as an indicator of when the first tablet has been taken. 4 Administration Each pack starts with 24 pink active tablets, followed by 4 white inert tablets.
One hormone- containing pink tablet is taken each day for 24 consecutive days, followed by one hormone-free white tablet for 4 days. Tablets should be taken at about the same time every day. The next pack is started immediately after finishing the previous one on the same day of the week that the first course was started, without a break and irrespective of the presence or absence of withdrawal bleeding.
, when taking the second, third or fourth white tablet, and may not have finished before the next pack is started. , the first day of menstrual flow) or on the first Sunday after her period begins. NEXTSTELLIS is effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle.
If the first NEXTSTELLIS tablet is taken later than Day 1 of the menstrual cycle, an additional barrier method of birth control, such as a condom, is recommended for the first 7 days of use. Changing from another Combined Oral contraceptives (COCs) NEXTSTELLIS should be started on the day when the new pack of the previous COC would have started.
Changing from a progestogen-only-method (minipill, implant, injectable) or from a hormonal intrauterine system (IUS) Changing to NEXTSTELLIS can be done at any time by stopping the minipill and starting NEXTSTELLIS the next day. An implant or IUS can be removed on any day, and NEXTSTELLIS should be started that same day.
1 Adverse Reaction Overview An increased risk of the following serious adverse reactions has been observed in women using COCs (see WARNINGS AND PRECAUTIONS): • arterial thromboembolism; • myocardial infarction; • pulmonary embolism; • stroke; • transient ischemic attacks; • venous thrombosis; • liver disease.
The most commonly reported adverse reactions related to NEXTSTELLIS are metrorrhagia, menorrhagia, dysmenorrhoea, headache, acne, and breast pain/tenderness. 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 for identifying and approximating rates of adverse drug reactions in real-world use.
Product Monograph Page 21 of 57 Nextstellis (Estetrol monohydrate and Drospirenone Tablets) Unclassified / Non classifié Adverse Drug Reactions To assess the safety of NEXTSTELLIS for the proposed indication, data were pooled from two Phase 3 (C301 and C302) and three Phase 2 (C201, C202 and ES-C02) studies.
These studies were conducted in healthy pre-menopausal women between 16 to 50 years of age with a duration of study at least three 28-day cycles, and included the dosage and regimen of NEXTSTELLIS (E4/DRSP 15/3 mg, 24/4). The safety analysis included safety data from 3,790 subjects, of which a total of 3,575 subjects was confirmed treated.
A total of 2,212 subjects completed 13 cycles of treatment in the two Phase 3 studies. Treated subjects contributed a total of 2,735 woman-years (WY) or 35,677 cycles of exposure. Within the treated population, 3,181 women aged 16 to 35 years contributed 31,412 cycles, while 394 women aged 36 to 50 years contributed 4,266 cycles.
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General The information contained in this section is, in principle, from studies carried out in women who used combination oral contraceptives with higher strengths of estrogens and progestins than those in common use today.
The effect of long-term use of combination oral contraceptives (COCs) with lower doses of both estrogen and progestin administered orally remains to be determined. The use of COCs has been associated with increased risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity and mortality is small in healthy women without underlying risk factors.
The risk of morbidity and mortality increases significantly if associated with the presence of other risk factors such as hypertension, hyperlipidemias, obesity, and diabetes. Other medical conditions which have been associated with adverse circulatory events include systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease, (Crohn’s disease or ulcerative colitis), sickle cell disease, valvular heart disease, and atrial fibrillation.
The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, although a direct association with COCs has not been firmly established: porphyria, Product Monograph Page 11 of 57 Nextstellis (Estetrol monohydrate and Drospirenone Tablets) Unclassified / Non classifié systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham’s chorea, herpes gestationis, and otosclerosis-related hearing loss.
Patients should discontinue the medication at the earliest manifestation of:
A. Thromboembolic and cardiovascular disorders, such as thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis, proptosis and retinal thrombosis. B. , immobilization after accidents or confinement to bed during long-term illness).
NEXTSTELLIS 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 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
, transient ischaemic attack, angina pectoris); • active liver disease, or history of or actual benign or malignant liver tumours; • known or suspected carcinoma of the breast; • carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; • undiagnosed abnormal vaginal bleeding; • steroid-dependent jaundice, cholestatic jaundice, history of jaundice of pregnancy; • any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields; • known or suspected pregnancy; • current or history of migraine with focal aura; • history of or actual pancreatitis if associated with severe hypertriglyceridaemia; • renal insufficiency; • hepatic dysfunction; • adrenal insufficiency.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Drospirenone in Canada.
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When changing from an injectable contraceptive, NEXTSTELLIS should be started on the day the next injection would have been due. In all of these cases, it is advisable to additionally use a reliable barrier method such as a condom until 7 consecutive days of pink active tablet-taking are completed.
Product Monograph Page 7 of 57 Nextstellis (Estetrol monohydrate and Drospirenone Tablets) Unclassified / Non classifié Following first-trimester abortion NEXTSTELLIS can be started immediately and no additional contraceptive measures are necessary.
Following delivery or second-trimester abortion It is advisable to start NEXTSTELLIS between Days 21 and 28 after delivery or second- trimester abortion. If starting later, it is advisable to additionally use a reliable barrier method such as a condom until 7 consecutive days of pink active tablet-taking are completed.
However, if intercourse has already occurred without contraception, a further pregnancy should be excluded or the next menstrual period should begin before NEXTSTELLIS is started. When the tablets are administered in the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.
For breastfeeding women see WARNINGS AND PRECAUTIONS section. If spotting or breakthrough bleeding occurs Breakthrough bleeding or spotting may occur in women taking COCs, especially during the first 3 months of use. The patient is instructed to continue on the same regimen.
This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her healthcare provider. If withdrawal bleeding does not occur Although pregnancy is unlikely if NEXTSTELLIS is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered.
If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. Hormonal contraceptives should be discontinued if pregnancy is confirmed. g. vomiting or diarrhoea), absorption of the active substances may not be complete and additional contraceptive measures should be taken.
If vomiting occurs within 4 hours after pink tablet-taking, the tablet should be considered as missed and a new tablet should be taken as soon as possible. The new tablet should be taken within 24 hours of the usual time of tablet-taking if possible.
The next tablets should then be taken daily at the usual time. If more than 24 hours elapsed since the last tablet taken, the advice […]
The safety population (n=3,790) also included 215 subjects who were dispensed study medication, but for whom the actual intake of study medication was not confirmed. Approximately 50% of the subjects reported a Treatment-Emergent Adverse Event (TEAE), of which approximately half was judged to be related to NEXTSTELLIS.
Less than 10% of TEAEs resulted in premature discontinuation. 3%). In subjects aged ≥16 to ≤35 years, relative distributions of TEAEs were similar to that observed in the all-subjects population. Table 3 below presents the treatment-emergent adverse events (TEAE) that occurred in at least 1% of the subjects from the safety analysis, and suspected to have a causal relationship to NEXTSTELLIS.
3 n = number of subjects; TEAE = Treatment Emergent Adverse Event. 1%) included in the safety population. These include 9 cases of spontaneous abortion, 2 cases of ectopic pregnancy, 7 cases of psychiatric disorders, 2 cases of depression, and one case of vascular disorder and one case of venous thrombosis.
8%). 03%). 2%). 2%). 3 Less Common Clinical Trial Adverse Reactions (< 1%) Ear and labyrinth disorders: Vertigo Eye disorders: Dry eye, Vision blurred, Visual impairment Gastrointestinal disorders: Abdominal distension, Colitis, Constipation, Diarrhoea, Dry mouth, Dyspepsia, Flatulence, Gastrointestinal motility disorder, Gastro-oesophageal reflux disease, Lip swelling, Vomiting General disorders and administration site conditions: Abdominal pain, Chest pain, Fatigue, Feeling abnormal, […]
Other non-hormonal methods of contraception should be used until regular activities are resumed. For use of oral contraceptives when surgery is contemplated, see Perioperative Considerations, below. C. Visual defects- partial or complete D.
Papilledema or ophthalmic vascular lesions E. Severe headache of unknown etiology or worsening of pre-existing migraine headache F. Increase in epileptic seizures NEXTSTELLIS contains 3 mg of the progestin drospirenone (DRSP) that has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone.
, renal insufficiency, hepatic dysfunction, and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium should have their serum potassium level checked during the first treatment cycle.
Drugs that may increase serum potassium include ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, heparin, aldosterone antagonists, and NSAIDs. Consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly.
, indinavir, boceprevir), and clarithromycin (see drug-drug interaction). Carcinogenesis and Mutagenesis Breast Cancer Women who currently have or have had breast cancer should not use NEXTSTELLIS because breast cancer is a hormonally-sensitive tumour (see CONTRAINDICATIONS).
Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, nulliparity and late age at first full-term pregnancy. The identified groups of women that may be at increased risk of developing breast cancer before menopause are long-term users of oral contraceptives (more than eight years) and starters at early age.
In a few women, the use of oral contraceptives may accelerate the growth of an existing but undiagnosed breast cancer. Women receiving oral contraceptives should be instructed in self-examination of their breasts. Their physicians should be notified whenever any masses are detected.
A yearly clinical breast examination is also recommended because, if a breast cancer should develop, estrogen containing drugs may cause a rapid progression. Product Monograph Page 12 of 57 Nextstellis (Estetrol monohydrate and Drospirenone Tablets) Unclassified / Non classifié Cervical Cancer The most important risk factor for cervical cancer is persistent human papilloma virus (HPV) infection.
g. cervical screening and sexual behaviour. No epidemiological data on the risk of cervical cancer in users of NEXTSTELLIS are available. Liver Tumors Women who have a history of or actual benign or malignant liver tumours should not use NEXTSTELLIS (see CONTRAINDICATIONS).
Hepatocellular carcinoma may be associated with oral contraceptives. The risk appears to increase with duration of hormonal contraceptive use. However, the attributable risk (the excess incidence) of liver cancers in oral contraceptive users is extremely small.
A liver tumor should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur in women taking COCs. Cardiovascular Epidemiological studies have suggested an association between the […]