Instruction for Evra
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Evra is a combined contraceptive.
Release form and composition
Active substances in the composition of the patch:
norelgestromin (HE) - 6 mg;
ethinylestradiol (EE) - 0.6 mg.
Within 24 hours, one patch releases 0.203 mg HE and 0.0339 mg EE.
The transdermal patch consists of the following layers:
auxiliary components: adhesive mixture of polyisobutylene and polybutylene (221.4 mg), lauryl lactate (12 mg), crospovidone (60 mg);
polyester nonwoven fabric (34 mg);
supporting film (110.7 mg);
protective film (208.95 mg).
The contraceptive effect of Evra is due to inhibition of the gonadotropic function of the pituitary gland, suppression of follicle development and an obstacle to the ovulation process. Also, the drug increases the viscosity of the cervical secretion and reduces the susceptibility of the endometrium to the blastocyst, thereby enhancing the contraceptive effect.
The Pearl index, reflecting the frequency of pregnancy in 100 women within 1 year of using the selected method of contraception, is 0.9. At the same time, the frequency of pregnancy does not depend on the race and age of the woman, but increases with a body weight of more than 90 kg.
After the application of TTS, the concentration of active substances in the blood plasma reaches steady-state values after 48 hours and is 0.8 ng / ml HE and 50 pg / ml EE.
With long-term use of this contraceptive, the equilibrium concentration (Css) and the area under the concentration-time curve (AUC) slightly increase.
Under physical exertion and various temperature conditions, significant changes in Css of ethinyl estradiol, Css and AUC of norelgestromin are absent, and the AUC of ethinyl estradiol slightly increases during exercise.
The target values of the equilibrium concentration of HE and EE are maintained for 10 days of using the patch, that is, the contraceptive effect of Evra is maintained even if the woman changes the patch 2 days later than the 7-day period.
Norelgestromin and its serum metabolite norgestrel are characterized by a high degree of binding to plasma proteins (> 97%). Norelgestromin binds to albumin, norgestrel - mainly to globulins that bind sex hormones. Ethinylestradiol has a high degree of binding to blood plasma albumin.
It is NOT metabolized in the liver to form norgestrel, various conjugated and hydroxylated metabolites. EE is metabolized to various hydroxylated compounds, their sulfate and glucuronide conjugates.
In human liver microsomes, progestogens and estrogens inhibit many enzymes of the cytochrome P450 system (including CYP3A4 and CYP2C19).
The half-life is NOT on average 28 hours, EE - 17 hours. Their metabolites are excreted through the intestines and by the kidneys.
The Css and AUC values of Evra's active substances decrease slightly with increasing age, surface area or body weight.
Indications for use
Evra is a drug used for contraception (prevention of unwanted pregnancy).
known or suspected pregnancy;
postpartum period (4 weeks);
migraine with focal neurological symptoms;
diagnosed (including history) or suspected estrogen-dependent malignant tumors (for example, endometrial cancer);
confirmed or suspected breast cancer;
bleeding from the vagina of unexplained etiology;
cholestatic jaundice during a previous pregnancy or jaundice with previous use of hormonal contraceptives;
benign or malignant liver tumors;
acute or chronic liver disease with impaired liver function;
diabetes mellitus with vascular lesions;
conditions preceding thrombosis (including transient ischemic attacks and angina pectoris), including a history of;
thrombosis (arterial and venous) and thromboembolism (including thrombosis, deep vein thrombophlebitis, cerebrovascular disorders, pulmonary embolism, stroke, myocardial infarction) at present or in history;
severe or multiple risk factors for venous or arterial thrombosis, including smoking over the age of 35, uncontrolled arterial hypertension, hereditary dyslipoproteinemia, cerebrovascular or coronary artery disease, complicated valvular heart disease, atrial fibrillation, subacute bacterial endocarditis, obesity [mass index bodies over 30 kg / m2 - the ratio of body weight (in kilograms) to the square of growth (in meters)], extensive surgical intervention with prolonged immobilization;
hereditary predisposition to venous or arterial thrombosis, including the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant), antithrombin III deficiency, protein S deficiency, activated protein C resistance, hyperhomocysteinemia, and protein C deficiency;
age under 18;
hypersensitivity to the components of the drug.
Relative (for the following diseases / conditions, Evra can be used only after a careful assessment of the expected benefits and possible risks):
herpes during a previous pregnancy;
hemolytic uremic syndrome;
systemic lupus erythematosus;
family history of cholestatic jaundice (eg, Rotor, Dubin-Johnson syndromes);
chronic idiopathic jaundice;
diabetes mellitus without vascular complications;
thrombophlebitis of superficial veins and varicose veins;
venous or arterial thromboembolism in close relatives (parents, brothers, sisters) at a relatively young age;
breast cancer in first-line relatives;
severe depression, including a history of
gallstone disease, including a history of;
uterine fibroids and endometriosis;
controlled arterial hypertension;
acute liver dysfunction during a previous pregnancy or previous use of sex hormones;
severe migraine without focal neurological symptoms.
Instructions for the use of Evra: method and dosage
To achieve the maximum contraceptive effect, Evra must be used in strict accordance with the recommendations described below.
One patch is designed for 7 days of use, after this period it should be immediately replaced with a new one, on the same day of the week - that is, on the 8th and 15th day of the drug use cycle (the so-called replacement days). From the 22nd to the 28th day of the cycle - a break, during which menstrual-like bleeding of withdrawal is noted. After that, a new contraceptive cycle begins, even if the withdrawal bleeding has not ended by this time.
Under no circumstances should a break in wearing the patch be exceeded for more than 7 days, since the risk of a decrease in the effectiveness of the drug and, as a consequence, pregnancy, increases. If the break was exceeded, it is necessary to additionally use barrier contraceptives within 7 days, since with each expired day, the likelihood of ovulation increases.
Mode of application
Transdermal patch Evra must be glued, tightly pressing, on healthy, clean, dry, intact skin of the outer surface of the upper shoulder, abdomen, buttocks, upper body with minimal hair growth - in areas where it will not come into contact with tight-fitting clothing. To avoid possible irritation, it is recommended to stick each new patch on a different area of the skin, including within the same anatomical region. It is categorically impossible to apply TTS on the area of the mammary glands. To avoid reducing the adhesive properties of the patch, do not apply powder, cream, lotion or any other local remedy to the skin where it will be glued.
Every day, a woman should inspect the patch to be sure of the strength of its attachment.
The used plasters still contain a significant amount of the active substances of the drug, so they should be disposed of correctly: from the outside of the bag, separate a special adhesive film, place the TTS, turning its sticky side to the painted area on the bag and lightly pressing it to seal it, and then throw it into the trash bucket. Do not throw it down the drain or toilet.
Starting a transdermal patch
If in the previous menstrual cycle the woman did not use a hormonal contraceptive, it is necessary to stick the Evra on the first day of menstruation. Exactly after 7 and 14 days - on days 8 and 15 of the cycle, respectively - the patch is replaced with a new one. On the 22nd day of the TTS cycle, it is necessary to remove and take a break until the 28th day of the cycle. Day 29 - the first day of a new contraceptive cycle, etc.
In cases where a woman does not start using the patch on the first day of the cycle, an additional barrier method of contraception should be used over the next 7 days.
When switching to Evra from a combined oral contraceptive (COC), it is necessary to stick the patch on the first day of menstrual bleeding that occurs after stopping the COC. If this recommendation is followed, the pronounced effect of the drug remains, otherwise, within 7 days, it is necessary to additionally use a barrier method of contraception. However, with a break of more than 7 days, ovulation is possible, therefore, before using a transdermal patch, a woman should consult a doctor. Sexual contact during this time can lead to pregnancy. If withdrawal bleeding does not begin within 5 days after taking the last active oral contraceptive pill, pregnancy should also be excluded before starting to use Evra.
When switching to Evra from drugs containing only progestogen, you can start using the patch on the day the implant is removed or the day when the next injection is to be made, however, during the first 7 days, you should additionally use a barrier method of contraception.
After giving birth, non-breastfeeding women can start using the transdermal patch 4 weeks after delivery. If later, within 7 days it is necessary to use an additional barrier method. Women who had sexual intercourse during this period should first exclude pregnancy or wait for the first menstruation.
After an abortion or miscarriage before the 20th week of pregnancy, you can start using Evra immediately, then additional contraception is not required.
After an abortion or miscarriage at the 20th week of pregnancy or later, you can start using the drug on day 21 or on the first day of the first menstruation (whichever comes first).
In cases where the patch is partially or completely peeled off, an insufficient amount of active contraceptive substances enters the bloodstream.
If less than 24 hours have passed after peeling off the TTS (even partial), it is necessary to re-stick the plaster in the same place or immediately replace it with a new one and continue to adhere to the usual mode of application of Evra. Additional contraceptive protection is not required.
If after peeling off the TTS (even partial) more than 24 hours have passed, or the woman does not know exactly when the patch came off, it is necessary to immediately start a new cycle, i.e. stick a new patch and then consider this day as the first day of the contraceptive cycle. In the first 7 days, it is recommended to additionally use a barrier method of contraception.
Do not try to re-glue a patch that has lost its adhesive properties. In this case, you must use a new one. Do not use sticky tapes or bandages to hold the TTS in place.
Missed days of changing the patch
After a 7-day break from using the patch, you need to glue a new one. In cases where a woman forgets to do this, the recommendations described below should be followed.
If this happened at the beginning of the contraceptive cycle (first week / first day), it is necessary to stick the patch as soon as the woman remembers this, and consider this day the first day of the contraceptive cycle, respectively, the replacement day will also shift. For 7 days, you additionally need to use a barrier method of contraception. In the case of sexual intercourse during this extended period, conception is possible.
If this happened in the middle of the cycle (second week / eighth day or third week / fifteenth day), while:
no more than 48 hours have passed since the day of replacement (the day when it was necessary to replace the TTS), it is necessary to immediately glue a new plaster, and the next one - on the usual day of replacement. For women who used the previous TTS correctly within 7 days preceding the first missed day of attaching a new patch, additional contraception is not required;
more than 48 hours have passed since the day of replacement, you must immediately glue a new patch, consider this day the first day of the new contraceptive cycle and count the new days of replacement from it. For 7 days, you should additionally use a barrier method of contraception.
In cases where a woman forgot to remove the patch on the 22nd day of the cycle, it should be removed as soon as possible, the next cycle should be started on the usual replacement day (29th day of the cycle). Additional methods of contraception are not required.
Change day of replacement
To move your period by one cycle, you must apply a new patch on day 22 of the cycle, thereby skipping the standard 7-day cancellation period. However, it should be borne in mind that in this case, the appearance of spotting discharge or intermenstrual bleeding is possible. After 6 weeks of consecutive use of Evra, it is imperative to take a break in the use of the drug, and then resume its regular use.
Women who wish to postpone the replacement day should complete the current contraceptive cycle, i.e. remove the third patch, and, choosing a new replacement day, stick the first patch of the next contraceptive cycle. It is important to take into account that the period of interruption in the use of Evra should not exceed 7 days. You should also be aware that the shorter this period, the higher the likelihood of the absence of the next menstrual bleeding, and during the next contraceptive cycle, the occurrence of scant or abundant acyclic bleeding is possible.
According to clinical trials, the most common adverse reactions of Evra are: discomfort in the mammary glands, local reactions, headache, nausea.
The frequency of side effects is classified as follows: very often - ≥ 1/10, often - from ≥ 1/100 to <1/10, infrequently - from ≥ 1/1000 to <1/100, rarely - from ≥1 / 10,000 to <1/1000, very rarely - <1/10 000, including individual messages.
Possible side effects:
local reactions: often - reactions on the skin at the site of application of the patch, such as peeling, dryness, burning, swelling, bruising, crusting, induration, inflammation, atrophy, discharge, infection, formation of nodules and pustules, scarring, loss of sensitivity, unpleasant odor , erosion, ulcer, excoriation, eczema, abscess, bleeding, paresthesia, photosensitivity, tumor growth; infrequently - irritation;
general disorders: often - malaise, fatigue; infrequently - peripheral edema, hypersensitivity reactions;
on the part of the cardiovascular system: infrequently - arterial hypertension; rarely - thrombophlebitis of the veins of the extremities, venous thrombosis; very rarely - arterial thrombosis and thromboembolism, myocardial infarction, hypertensive crisis;
from the gastrointestinal tract: very often - nausea; often - bloating, abdominal pain, diarrhea, vomiting; very rarely - colitis;
on the part of metabolism and nutrition: often - an increase in body weight; very rarely - increased appetite, hyperglycemia, insulin resistance;
from the musculoskeletal system: often - muscle cramps;
from the central and peripheral nervous system: very often - headache; often - migraine, dizziness; very rarely - subarachnoid hemorrhage, migraine with focal neurological symptoms, dysgeusia, cerebrovascular accidents (including transient cerebrovascular accidents, occlusions and stenosis of cerebral vessels, ischemic and hemorrhagic strokes);
on the part of the psyche: often - aggressiveness, tearfulness, affect, anxiety, emotional instability, depression; infrequently - insomnia, change in libido; very rarely - frustration, anger;
from the hepatobiliary system: infrequently - cholecystitis, cholelithiasis; very rarely - liver damage, cholestasis, cholestatic jaundice;
infections and invasions: often - fungal infections of the vagina; very rarely - pustular rash;
on the part of the organs of vision: very rarely - intolerance to contact lenses;
on the part of the skin and subcutaneous tissues: often - skin reactions, itching, acne; infrequently - allergic dermatitis, urticaria, eczema, erythema, photosensitivity reactions, alopecia, chloasma; rarely - itchy rash, erythematous rash, generalized itching; very rarely - nodular, erythema polyform, seborrheic dermatitis, exfoliative rash, angioedema;
benign, malignant and undetermined etiology of the neoplasm: rarely - uterine leiomyoma; very rarely - breast fibroadenoma, cervical cancer, breast cancer, liver neoplasms, liver adenoma;
on the part of the reproductive system and mammary glands: very often - fibrocystic changes in the mammary glands, pain, swelling, swelling, discomfort, increased sensitivity and enlargement of the mammary gland; often - vaginal discharge, uterine spasm, painful menstrual bleeding; infrequently - discharge from the genital tract, dryness of the mucous membrane of the vagina and vulva, galactorrhea, breast tumors; rarely - rare menstrual bleeding or their absence; very rarely - acyclic, scanty or profuse bleeding, cervical dysplasia, suppression of lactation;
laboratory indicators: very rarely - an increase in the concentration of low-density lipoproteins, a change in the concentration of glucose in the blood, a change in the concentration of cholesterol in the blood.
In case of an overdose, the following symptoms are noted: bleeding from the vagina, nausea, vomiting. In this case, the TTS should be removed as soon as possible and symptomatic therapy should be carried out. There is no specific antidote.
You can use the Evra patch only after consulting a doctor, who must exclude pregnancy and assess the appropriateness of using the drug by collecting a detailed history of the patient and her immediate family, including data on heredity. It also requires a gynecological and general examination (including examination of the mammary glands, mammography, blood pressure measurement). If you suspect a hereditary predisposition to venous thromboembolism (for example, if the parents, sister or brother have this disease), the woman is referred for additional consultation with the appropriate specialist.
Evra does not protect against sexually transmitted infections. Every woman should be warned about this when prescribing the drug.
If any symptoms appear during the use of Evra, which may indicate the occurrence of thromboembolic complications, it is necessary to immediately stop using TTS. The risk of vascular complications is increased with obesity, varicose veins and thrombophlebitis of the superficial veins.
Also, the risk of developing venous thromboembolic complications increases with prolonged immobilization and surgical interventions on the lower extremities. For this reason, 4 weeks before a planned operation, within 2 weeks after an emergency surgery, during and after prolonged immobilization, the use of hormonal contraceptives is not recommended.
According to some epidemiological studies, long-term use of combined hormonal contraceptives at a young age (before the first pregnancy) increases the risk of developing breast cancer. Some studies have shown that taking hormonal contraception is associated with an increased risk of cervical tumors, including cancer.
Due to the risk of benign hepatic adenomas in case of severe pain in the upper abdomen, symptoms of intra-abdominal bleeding or enlarged liver, you should consult a doctor for differential diagnosis and exclusion of liver tumors.
In case of pharmacologically uncontrolled arterial hypertension, the drug should be discontinued. The application can be resumed only after the pressure has returned to normal.
According to the instructions, Evra can affect some indicators of functional tests. In particular, while using a transdermal patch:
reduced glucose tolerance;
increases the concentration of prothrombin and coagulation factors VII, VIII, IX and X;
platelet aggregation increases;
decreased protein S levels;
the concentration of triglycerides, total cholesterol, high-density lipoprotein cholesterol (HDL-X) and low-density lipoprotein cholesterol (LDL-X) increases, while the ratio of LDL-C / HDL-C can remain unchanged;
decreased levels of antithrombin III;
the content of thyroxine-binding globulin increases, as a result of which the concentration of total thyroid hormone increases. The binding of free triiodothyronine (TZ) by ion exchange resin decreases, as evidenced by an increase in the concentration of thyroxine-binding globulin. The concentration of free thyroxine (T4) does not change. It is also possible to increase the concentration of other binding proteins;
the concentration of serum folate decreases, which is why there is a risk of clinically significant consequences in case of pregnancy soon after the abolition of the contraceptive (currently, in the early stages of pregnancy, it is recommended to take folic acid for all women with its deficiency);
the concentration of globulins that bind sex hormones increases, as a result of which the concentrations of general circulating endogenous sex hormones increase. At the same time, the concentrations of biologically active or free sex hormones decrease or remain unchanged.
Hormonal contraceptives can cause retinal vascular thrombosis. In the following cases, you should immediately stop using Evra and consult a doctor for diagnostic and therapeutic measures:
unexpected transient, partial or complete loss of vision;
bouts of blurred vision;
swelling of the papilla;
violation of the integrity of the retinal vessels.
During the period of application of the transdermal patch, women are advised to avoid exposure to sunlight or artificial ultraviolet light, since there is a risk of skin hyperpigmentation, including incompletely reversible ones.
In women weighing ≥ 90 kg, contraceptive effectiveness may be reduced.
Women who smoke are at increased risk of developing cardiovascular side effects, and therefore it is strongly recommended to refrain from smoking.
During the period of application of Evra, women should regularly undergo preventive medical examinations, the volume and frequency of which should be selected individually by the doctor depending on the clinical picture, but at least once every six months.
The transdermal patch should not be cut or damaged, as this may impair its contraceptive effectiveness.
Influence on the ability to drive vehicles and complex mechanisms
Evra has no or little effect on psychomotor and cognitive functions.
Application during pregnancy and lactation
Evra is contraindicated in women during these periods of life.
The efficacy and safety of Evra have been established for women from 18 years of age to the onset of menopause, therefore, the drug is not prescribed to adolescents under the age of 18.
With impaired renal function
Evra should be used with caution in case of functional impairment of the kidneys.
For violations of liver function
Evra should be used with caution in the following cases: liver dysfunction, acute liver dysfunction during a previous pregnancy or previous use of sex hormones.
Antibiotics, some drugs and herbal medicines that induce liver microsomal enzymes (including CYP3A4) that metabolize contraceptive hormones reduce the effectiveness of Evra. In this case, during the period of taking such drugs and within 7 days after their cancellation (when taking rifampicin and St. John's wort drugs - within 28 days after cancellation), it is necessary to additionally use a barrier method of contraception. If therapy with such means is prolonged (more than 3 weeks), a new contraceptive cycle should be started without a withdrawal period. Drugs that may reduce the effectiveness of Evra include: griseofulvin, bosentan, barbiturates, modafinil, rifampicin and rifabutin, aprepitant (fosaprepitant), some of the HIV protease inhibitors or combinations thereof (eg ritonavir, nelfinavir), St. John's wort, some perforatum Non-nucleoside reverse transcriptase inhibitors (eg, nevirapine), certain antiepileptic drugs (eg, felbamate, rufinamide, eslicarbazepine acetate, phenytoin, carbamazepine, topiramate, oxcarbazepine).
The following drugs may increase plasma ethinyl estradiol levels: etoricoxib, ascorbic acid, paracetamol, HMG-CoA reductase inhibitors (including rosuvastatin and atorvastatin), CYP3A4 inhibitors (including grapefruit juice, fluconazole, some itraconazolazole, v reverse transcriptase inhibitors (eg etravirine), some HIV protease inhibitors (eg indinavir, atazanavir).
With the simultaneous use of Evra, it can increase (due to inhibition of CYP) the plasma concentrations of the following drugs: selegiline, omeprazole, tizanidine, cyclosporine, voriconazole, theophylline, prednisolone.
In the case of combined use, Evra can reduce (due to the induction of glucuronidation) the plasma concentrations of the following drugs: lamotrigine, temazepam, paracetamol, morphine, clofibrate, salicylic acid. Due to a decrease in the levels of these substances in the blood, undesirable reactions may develop, therefore, a correction of their doses is required.
Before taking any medication while using this TTS, it is recommended to consult your doctor.
Terms and conditions of storage
Store in its original packaging at temperatures up to 30 ° C out of reach of children.
Shelf life is 2 years.
Reviews about Evra
Reviews about Evra are mostly positive. Women note the high contraceptive efficacy of the drug, as well as the absence of side effects from the gastrointestinal tract, characteristic of oral combined contraceptives.
However, there are also negative reviews about Hebrew, which describe the poor adhesive properties of the patch, which is why it quickly peels off. In this case, doctors recommend that you carefully follow the recommendations for gluing TTS and find a comfortable place on the body where the patch will be fixed securely.
Terms of sell
You don't need a prescription to buy Evra.