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Suggested Prescriber/Counselling Checklist for DIANE-35 (cyproterone acetate/ethinylestradiol) and its generics

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DIANE-35 (cyproterone acetate and ethinyl estradiol) is indicated for the treatment of women with severe acne, unresponsive to oral antibiotic and other available treatments, with associated symptoms of androgenization, including seborrhea and mild hirsutism.

Note: DIANE-35 is NOT indicated for the purposes of contraception.

This suggested checklist can assist you when prescribing DIANE-35 (cyproterone acetate/ethinylestradiol) and its generics. Please see the Next link will take you to another Web site Canadian Product Monograph (PM) for full prescribing information on indications, warnings and precautions, and adverse events.

If any of the criteria below is checked YES, DO NOT prescribe DIANE-35:
Medical conditions/medications YES NO
Concomitant use with another hormonal contraceptive    
History of or actual thrombophlebitis or thromboembolic disorders    
History of or actual cerebrovascular disorders    
History of or actual myocardial infarction or coronary arterial disease    
History of cholestatic jaundice, previous or existing liver tumours or active liver disease    
Smoker AND age > 35 years    
Known or suspected carcinoma of the breast or estrogen-dependent neoplasia    
Pregnancy is suspected or diagnosed    
Any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields    
Severe diabetes with vascular changes    
History of migraine with aura    
Very high blood pressure e.g., systolic > 160 or diastolic > 100 mmHg    
Very high blood lipids    

The following potential additional risk factors have been discussed with the patient:

  • Smoking
  • Age over 35 years
  • Hypertension
  • Diabetes
  • Migraine
  • Obesity BMI > 30 kg/m2
  • Major surgery or a period of prolonged immobilization

Patient has been counselled TO SEEK MEDICAL ATTENTION if the following symptoms occur:

  • Sudden unexplained breathlessness or rapid breathing; severe pain in the chest which may increase with deep breathing; sudden cough without an obvious cause (which may bring up blood) - indicating potential pulmonary embolism.
  • Severe pain or swelling in either leg that may be accompanied by tenderness, warmth or changes in the skin colour such as turning pale, red or blue which may indicate a deep vein thrombosis.
  • Chest pain, often acute, but may include just discomfort, pressure, heaviness, upper body discomfort, radiating to back, jaw, throat, or arm together with feelings of indigestion or choking, sweating, nausea, vomiting or dizziness. These symptoms could indicate a heart attack.
  • Face, arm or leg weakness or numbness, especially on one side of the body; trouble speaking or understanding; sudden confusion; sudden loss of vision or blurred vision; severe headache/migraine that is worse than normal. This may indicate a stroke.