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FEMYSO is a brand name for Mifepristone, supplied as a kit. 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 Prior to prescribing Femyso, 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 Femyso, including bleeding, infection and incomplete abortion; • Obtain the patient’s informed consent to take the drug. Femyso should be prescribed by health professionals with adequate knowledge of medical abortion and/or who have completed a Femyso education program.
Before starting Femyso, 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 Femyso administration and reliable contraceptive methods should be started as early as possible. • Failure of Femyso may require surgical termination of pregnancy (see CLINICAL TRIALS).
• Signs and symptoms they may experience. Femyso (mifepristone tablets and misoprostol tablets kit) Page 6 of 45 • How to access emergency medical care by telephone or local access. Each patient should be provided with a printed copy of the Femyso Patient Medication Information and a Patient Information Card.
The Patient Information Card should be completed by the health professional. ca or by phone at 1-844-587-4623. The Femyso Patient Medication Information and the Patient Information Card are also included in the box. Hepatic impairment Mifepristone and its metabolites showed a decrease in both overall peak and exposure in patients with moderate hepatic impairment compared to healthy-matched participants.
3 Pharmacokinetics , Special Populations and Conditions, Hepatic Insufficiency). 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.
4 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.
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).
1 Adverse Reaction Overview The most frequent undesirable effects which were observed during treatment with mifepristone tablet/misoprostol tabletswere: Femyso (mifepristone tablets and misoprostol tablets kit) Page 13 of 45 • 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 diarrhea) 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 mifepristone tablet/misoprostol tablets, 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. Mifepristone tablet/misoprostol tablets was studied in three open-label multi-center prospective studies.
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 Femyso. 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 Femyso, so that the health professional will be aware that the patient is undergoing a medical abortion.
Rhesus alloimmunisation The use of Femyso requires measures to prevent rhesus alloimmunisation. Carcinogenesis and Genotoxicity See Section NON-CLINICAL TOXICOLOGY for the carcinogenesis and mutagenesis on animals. Cardiovascular Rare serious cardiovascular accidents (cardiac arrest, myocardial infarction and/or spasm of the coronary arteries and severe hypotension) have been reported following administration of prostaglandins including misoprostol.
Femyso 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. Femyso (mifepristone tablets and misoprostol tablets kit) Page 9 of 45 Endocrine and Metabolism Patients with suspected acute adrenal failure were excluded from trials and therefore should be treated with caution.
If treatment with Femyso is required, therapy should be adjusted. The safety and efficacy have not been studied in women suffering from malnutrition. Treatment with Femyso is therefore not recommended. Genitourinary Gestational age should be confirmed by an appropriate method.
Femyso 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 Femyso.
For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING.
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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5 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.
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 Femyso (mifepristone tablets and misoprostol tablets kit) Page 7 of 45 Patient Information Card, clinical trial data indicates that health professionals can instruct patients to take the Misoprostol tablets (Step 2) right away.
5 Overdose Mifepristone No cases of overdose have been reported. In the event of massive ingestion of mifepristone signs of adrenal failure may occur. Signs of acute intoxication may require specialist treatment including the administration of dexamethasone.
Misoprostol Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort reported. Possible symptoms of an overdose are sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhea, fever, palpitations, hypotension or bradycardia.
Hypertension and tachycardia have also been reported. There is no specific antidote. Treatment should be symptomatic and supportive. Consider administration of activated charcoal in the event of a potentially toxic ingestion. Activated charcoal may reduce absorption of misoprostol if given within one or two hours after ingestion.
In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected. For the most recent information in the management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1- 844-764-7669).
In these studies, a total of 1,596 women were included in the safety analysis. 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 mifepristone tablet/misoprostol tablets use.
Skin and subcutaneous tissue disorders:
Skin rash/pruritus and acute generalized exanthematous pustulosis.
Ultrasound imaging is recommended before prescribing Femyso 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 Femyso. 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, diarrhea and weakness with or without abdominal pain or fever.
Strong consideration should be given to obtaining a complete blood count in these patients. Significant 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 Femyso 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 Femyso 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 mifepristone tablet/misoprostol tablets, including angioedema occurring within an hour of misoprostol intake.
Angioedema associated with upper […]