The only once-weekly transdermal contraceptive patch 1
Evra ® ( norelgestromin / ethinyl estradiol ) transdermal system :
• Delivers efficacy and cycle control which is comparable with oral contraceptives 2
• Has a safety profile which is similar to the combined oral pill 3
• Offers a higher compliance rate vs . oral contraceptives 4
If you would like to register to receive further information on Evra , please scan the QR code or go to : https :// www . janssenmedicalcloud . co . uk / stay-in-touch
EVRA ® 203 micrograms / 24 hours + 33.9 micrograms / 24 hours TRANSDERMAL PATCH PRESCRIBING INFORMATION ACTIVE INGREDIENT ( S ): norelgestromin and ethinyl estradiol . Please refer to Summary of Product Characteristics ( SmPC ) before prescribing . INDICATION ( S ): Female contraception . Safety / efficacy established in women aged 18-45 years . DOSAGE & ADMINISTRATION : Adults : Transdermal use . One patch for 7 days , for 3 weeks followed by 1 week patch free . No data in women > 45 years of age . Contraceptive efficacy in women ≥ 90kg may be reduced . Children : Not recommended < 18 years of age Renal impairment : Not studied but supervision required . Hepatic impairment : Not studied – see contraindications . CONTRAINDICATIONS : Hypersensitivity . Presence or risk of venous or arterial thromboembolism ( VTE / ATE ), ( refer to SmPC ): Current VTE requiring anticoagulant therapy , history of deep vein thrombosis ( DVT ), or pulmonary embolism . Known hereditary or acquired risk of VTE or known thrombogenic mutations . Major surgery with prolonged immobilisation . History of myocardial infarction , angina pectoris . Presence of one serious risk factor for ATE : diabetes with vascular symptoms , severe hypertension , severe dyslipoproteinaemia . Cerebrovascular disease , current / history stroke , transient ischaemic attacks . Known hereditary or acquired predisposition for ATE . History of migraine with focal neurological symptoms . Known or suspected carcinoma breast , endometrium or other oestrogen-dependent neoplasia . Hepatic adenomas or carcinoma . Abnormal liver function related to acute or chronic hepatocellular disease . Undiagnosed abnormal genital bleeding . Drug combinations with paritaprevir / ritonavir , ombitasvir , and / or dasabuvir . SPECIAL WARNINGS & PRECAUTIONS : Exclude likelihood of pregnancy before starting treatment . Prior to initiation ( and at regular intervals ) assess personal and family medical history , measure blood pressure and perform physical examination . Discuss associated risk of VTE / ATE , known personal risk factors and symptoms of VTE and ATE . Increased risk of VTE in 6 week period of puerperium . Instruct to read leaflet carefully . Advise hormonal contraceptives do not protect against HIV infections or sexually transmitted disease . Discontinue : appearance of any contraindication ; high blood pressure not responding to treatment ; recurrence of cholestaticrelated pruritus . Consider discontinuing : aggravation / new risk factors for VTE / ATE ; acute / chronic liver function disturbances . As with all combined hormonal contraceptives : increased risk of cervical & breast cancer , worsening depression and risk of suicidal behaviour / suicide ( women advised to contact physician in case of mood changes ), epilepsy , Crohn ’ s disease , ulcerative colitis . Following may occur or deteriorate : jaundice and / or pruritus related to cholestasis , gallbladder disease including cholecystitis and cholelithiasis , porphyria , SLE , haemolytic uraemic syndrome , Sydenham ’ s chorea , herpes gestationis , otosclerosis-related hearing loss , chloasma . Hepatic tumours reported rarely . Possible increased risk of pancreatitis with hypertriglyceridaemia ( including family history ). Observe diabetic women carefully . Irregular spotting or bleeding , especially in early treatment . Amenorrhoea / oligomenorrhoea after discontinuation . SIDE EFFECTS : Very common : headache , nausea , breast tenderness . Common : ( vulvo ) vaginal fungal infection , vaginal candidiasis , mood , affect / anxiety disorders , migraine , dizziness , vomiting , diarrhoea , abdominal pain / distension , acne , rash , pruritus , skin reaction / irritation , muscle spasms , dysmenorrhoea , vaginal bleeding and menstrual disorders , uterine spasm , breast disorders , vaginal discharge , malaise , fatigue , application site reactions ( erythema , irritation , pruritus , rash ), weight increased . Other side effects : hepatic neoplasm / adenoma , breast cancer , cervix carcinoma , uterine leiomyoma , fibroadenoma of breast , hypersensitivity , anaphylactic reaction , hypercholesterolaemia , hyperglycaemia / insulin resistance , cerebrovascular accident , cerebral haemorrhage , arterial thromboembolism , ( acute ) myocardial infarction , hypertension , hypertensive crisis , thrombosis ( arterial / venous / pulmonary ), venous thromboembolism , pulmonary embolism , hepatic lesion , jaundice cholestatic , cholestasis , angioedema , cervical dysplasia , lipid disorders . Refer to SmPC for other side effects . PREGNANCY : Stop immediately . LACTATION : Not recommended . INTERACTIONS : Contraindicated : drug combinations containing paritaprevir / ritonavir , ombitasvir , and / or dasabuvir . Contraceptive failure : As with other combined contraceptives may occur with hepatic enzymes inducers ; including , but not limited to : antiepileptics ,
certain antivirals ( HIV medication ritonavir , nevirapine , efavirenz ) and antifungals , antibiotics ( rifampicin ), sedatives ( barbiturates ), bosentan , modafinil and St John ’ s Wort . Combinations of HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors , including HCV inhibitors , can increase / decrease plasma concentrations of oestrogen / progestins . Etoricoxib . Evra affects plasma concentrations of lamotrigine ( reduces ) and ciclosporin ( increases ). Some endocrine , liver function and blood component tests may be affected . For further information read Evra SmPC and SmPC for co-prescribed medication ( s ). Refer to SmPC for full details of interactions . LEGAL CATEGORY : POM PRESENTATIONS , PACK SIZES , MARKETING AUTHORISATION NUMBER ( S ) & BASIC NHS COSTS
PRESENTATIONS
PACK SIZES
MARKETING AUTHORISATION NUMBER ( S )
BASIC NHS COSTS
Transdermal patch 9 patches EU 1 / 02 / 223 / 002 £ 19.51
MARKETING AUTHORISATION HOLDER : Janssen-Cilag International NV , Turnhoutseweg 30 , B-2340 Beerse , Belgium FURTHER INFORMATION IS AVAILABLE FROM : Janssen- Cilag Limited , 50-100 Holmers Farm Way , High Wycombe , Buckinghamshire HP12 4EG UK . Prescribing information last revised : May 2020
© Janssen-Cilag Limited 2020
Adverse events should be reported . Reporting forms and information can be found at www . mhra . gov . uk / yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store . Adverse events should also be reported to Janssen- Cilag Limited on 01494 567447 or at dsafety @ its . jnj . com .
References : 1 . Evra Summary of Product Characteristics , May 2020 . Available at : https :// www . medicines . org . uk / emc / product / 6794 . Accessed : October 2020 2 . Audet M , Moreau M et al . Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive . JAMA 2001 ; 285 ( 18 ): 2347-2354 3 . Sibai B , Odlind V et al . A comparative and pooled analysis of the safety and tolerability of the contraceptive patch ( Ortho Evra™ / Evra™ ). Fertil Steril 2002 ; 77 ( 2 ): 19-26 4 . Smallwood G , Meador M et al . Efficacy and safety of a transdermal contraceptive system . Obstet Gynecol 2001 ; 98 ( 5 ): 799-805 .
Item Code : CP-181764 Date of Preparation : October 2020 Promotional information from Janssen