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MIFISO is a brand name for Mifepristone, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Mifiso (mifepristone tablet/misoprostol tablets) is indicated for: medical termination of a developing intra-uterine pregnancy with a gestational age up to 63 days as measured from the first day of the Last Menstrual Period (LMP) in a presumed 28-day cycle. Mifiso is not intended for routine use as a contraceptive.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Prior to prescribing Mifiso, health professionals must: Ensure that patients have access to emergency medical care in the 14 days following administration of mifepristone; Schedule follow-up 7 to 14 days after patients take mifepristone to confirm complete pregnancy termination; Exclude ectopic pregnancy and confirm gestational age by an appropriate method.
Counsel each patient on the risks and benefits of Mifiso, including bleeding, infection and incomplete abortion; Obtain the patient’s informed consent to take the drug. Mifiso should be prescribed by health professionals with adequate knowledge of medical abortion and/or who have completed a Mifiso education program.
Mifiso (mifepristone tablets and misoprostol tablets kit) Page 6 of 39 Before starting Mifiso, patients must be informed of the following: Mifepristone and misoprostol must be taken in sequence according to instructions. Follow-up within 7 to 14 days after intake of mifepristone to confirm pregnancy termination and complete abortion is required.
Return to fertility is expected immediately after Mifiso administration and reliable contraceptive methods should be started as early as possible. Failure of Mifiso may require surgical termination of pregnancy (see CLINICAL TRIALS).
Signs and symptoms they may experience. How to access emergency medical care by telephone or local access. Mifiso should be prescribed by health professionals with adequate knowledge of medical abortion and/or who have completed a Mifiso education program Each patient should be provided with a printed copy of the Mifiso Patient Medication Information and a Patient Information Card.
The Patient Information Card should be completed by the health professional. ca or by phone at 1-877-230-4227. The Mifiso Patient Medication Information and the Patient Information Card are also included in the box. 2 Recommended Dose and Dosage Adjustment 200 mg of mifepristone (1 tablet) 800 mcg of misoprostol (4 tablets, each tablet containing 200 mcg) There are no data available on the effect of food intake on the absorption of mifepristone or misoprostol.
3 Administration Step 1 Mifepristone: 200 mg of mifepristone (1 tablet) should be taken orally, followed 24 to 48 hours (1 to 2 days) later by the administration of misoprostol. Mifepristone should be administered as directed by the prescribing health professional.
1 Adverse Reaction Overview The most frequent undesirable effects which were observed during treatment with Mifiso were: Reproductive system disorders: vaginal bleeding, sometimes heavy and prolonged uterine cramping (see WARNINGS AND PRECAUTIONS, Genitourinary).
Gastrointestinal disorders: nausea, vomiting, diarrhea and abdominal pain. General disorders: headache, dizziness, chills and fever. Bleeding was occasionally observed after mifepristone alone. Misoprostol administration resulted in vaginal bleeding, abdominal pain and cramping.
In some patients, persistent or heavy vaginal bleeding required treatment with intravenous fluids or blood transfusion. 2 days. Infectious complications, including sometimes fatal sepsis, have been observed. Patients typically presented with abdominal pain or discomfort, fever or general malaise (including weakness, nausea, vomiting or diarrhoea) more than 24 hours after taking misoprostol.
Clostridium sordellii infection was observed in some women without abdominal pain or fever, that progressed rapidly to multi-organ failure and death. The adverse events reported with Mifiso, classified according to frequency and system organ class, are summarized as shown in Table 2.
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. Mifiso was studied in three open-label multi-center prospective studies. In these studies, a total of 1,596 women were included in the safety analysis.
General Please see SERIOUS WARNINGS AND PRECAUTIONS BOX. A patient’s ability to comply with the requirements of the regimen, especially the need for a follow-up visit, should be considered prior to administering Mifiso. Patients should be advised to take their Patient Information Card with them if they visit an emergency room or another health professional who did not prescribe Mifiso, so that the health professional will be aware that the patient is undergoing a medical abortion.
Rhesus alloimmunisation The use of Mifiso requires measures to prevent rhesus alloimmunisation. Carcinogenesis and Mutagenesis See Section NON-CLINICAL TOXICOLOGY for the carcinogenesis and mutagenesis on animals. Cardiovascular Rare serious cardiovascular accidents have been reported following administration of prostaglandins including misoprostol.
Mifiso has not been studied, and is therefore not recommended, in women with cardiovascular disease. Women with risk factors for cardiovascular disease (hypertension, diabetes or who are over the age of 35 and are heavy smokers) should be treated with caution.
Driving and Operating Machinery Caution is warranted when driving or operating a vehicle or potentially dangerous machinery. Dizziness, fatigue, headache, and fainting can occur. The side effects diminish after Day 3 and are gone by Day 14.
The patient must rest 3 hours after taking the misoprostol tablets. Mifiso (mifepristone tablets and misoprostol tablets kit) Page 9 of 39 Endocrine and Metabolism Patients with suspected acute adrenal failure were excluded from trials and therefore should be treated with caution.
If treatment with Mifiso is required, therapy should be adjusted. The safety and efficacy have not been studied in women suffering from malnutrition. Treatment with Mifiso is therefore not recommended. Genitourinary Gestational age should be confirmed by an appropriate method.
Mifiso should not be prescribed to patients who: have a confirmed or suspected ectopic pregnancy; have an intrauterine device (IUD) in place; have unconfirmed gestational age; have chronic adrenal failure; are on concurrent long term systemic corticosteroid therapy; have haemorrhagic disorders or using concurrent anticoagulation therapy; have inherited porphyria; have uncontrolled asthma; have known hypersensitivity to mifepristone, misoprostol, other prostaglandins, or any of the excipients used in Mifiso.
For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING. Mifiso (mifepristone tablets and misoprostol tablets kit) Page 5 of 39
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mifepristone in Canada.
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Step 2 Misoprostol: 800 mcg of misoprostol (4 tablets, each tablet containing 200 mcg) should be taken in a single intake by buccal route (kept between the cheek and the gum for 30 minutes before any remaining fragments are swallowed with water).
4 Missed Dose Step 1 Mifepristone tablet Patients should be advised to contact their health professional immediately if they delay or do not take the Mifepristone tablet at the time and date directed by the health professional. This information can be found on the completed Patient Information Card.
Mifiso (mifepristone tablets and misoprostol tablets kit) Page 7 of 39 Step 2 Misoprostol tablets Patients should be advised to contact their health professional immediately if they forget to take the Misoprostol tablets and it is more than 48 hours after they have taken the Mifepristone tablet.
If it is less than 48 hours since the patient took Step 1 but after the time and date on the Patient Information Card, clinical trial data indicates that health professionals can instruct patients to take the Misoprostol tablets (Step 2) right away.
4 years for Studies 1, 2 and 3, respectively. Treatment-emergent adverse events reported in clinical trials are reported in Table 3. Nausea and vomiting tended to increase slightly with advancing gestational age. 1 Clinical Trial Adverse Reactions – Pediatrics Study results in women less than 18 years of age Of the 1,000 women enrolled in Study 3, 67 were less than 18 years of age.
The reported frequent adverse events are detailed below. Women less than 18 years old reported vomiting more frequently than women 18 years and older. 5 Post-Market Adverse Reactions The following adverse reaction have been identified during the post-marketing experience in association with Mifiso use.
Skin and subcutaneous tissue disorders:
Skin rash/pruritus and acute generalized exanthematous pustulosis.
Ultrasound imaging is recommended before prescribing Mifiso when an ectopic pregnancy is suspected or gestational age is uncertain. Health professionals should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy, since some of the symptoms of a medical abortion may be similar to those of a ruptured ectopic pregnancy.
The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed Mifiso. 1% of cases prior to 63 days of gestation (see CLINICAL TRIALS). The rate of failure increases with advancing gestational age.
Reasons for failure requiring a surgical termination of pregnancy included persistent non-viable pregnancies, continuing pregnancies and persistent heavy vaginal bleeding. Follow-up is mandatory to ensure that the expulsion is completed.
In the event of an ongoing pregnancy, pregnancy termination should be completed by another method (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Woman). Animal studies have shown that, if a pregnancy continues after exposure to mifepristone or misoprostol, fetal abnormalities may occur (see NONCLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
Bleeding Bleeding occurs in almost all cases and is not proof of complete expulsion (see CLINICAL TRIALS). Prolonged heavy vaginal bleeding may occur and can be a sign of incomplete expulsion. Bleeding can lead to a significant decrease in hemoglobin levels and may necessitate a blood transfusion.
Persistent bleeding should be monitored closely. The patient should have access to emergency medical care until complete termination of pregnancy is confirmed at a follow-up visit. Infections Cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of mifepristone and misoprostol.
A sustained fever of 38oC or higher, severe abdominal pain or pelvic tenderness in the days after a medical abortion may be an indication of infection. g. g. Streptococcus) should be highly suspected if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol.
However, the symptoms of Clostridium sordellii infection are sometimes not the usual symptoms of sepsis. Very rarely, deaths have been reported. Therefore, the possibility of sepsis should be considered in all women who present with nausea, vomiting, diarrhoea and weakness with or without abdominal pain or fever.
Strong consideration should be given to obtaining a complete blood count in these patients. Significant Mifiso (mifepristone tablets and misoprostol tablets kit) Page 10 of 39 leukocytosis with a marked left shift and hemoconcentration may be indicative of sepsis.
Health professionals should consider immediately initiating treatment with antibiotics that include coverage of anaerobic bacteria such as Clostridium sordellii. Hematologic Heavy bleeding requiring curettage occurred in some patients in clinical trials.
Patients with anemia should be treated with caution. Patients with severe anemia were excluded from clinical trials and administration of Mifiso in these patients is not recommended. Hepatic/Biliary/Pancreatic The safety and efficacy have not been studied in women suffering from hepatic failure.
Treatment with Mifiso is therefore not recommended. Immune Cases of skin rash following misoprostol administration were reported by patients in clinical trials. Angioedema of the face, lips, tongue, and/or larynx, including cases of anaphylaxis have been reported in post-market surveillance with the use of Mifiso, including angioedema occurring within an hour of misoprostol intake.
Angioedema associated with upper airway swelling may be life threatening. If the tongue, hypopharynx, or larynx has been involved, appropriate therapy and/or measures […]