Diane 35 (Cyproterone acetate and ethinylestradiol)

Diane 35 (Cyproterone Acetate and Ethinylestradiol): Patient-Friendly Information for Australian Patients

Basic Product Information

Mechanism of Action

Diane 35 combines two active ingredients: cyproterone acetate (a progestogen with anti-androgen properties) and ethinylestradiol (a synthetic estrogen). These work together to regulate hormone levels in your body. In simple terms, cyproterone acetate reduces the effects of male hormones (androgens), while ethinylestradiol balances female hormones. This synergy helps treat conditions related to androgen excess, such as acne and hirsutism.

For specialists: Cyproterone acetate competitively inhibits androgen receptors, blocking the action of endogenous androgens at target tissues. It also decreases LH secretion from the pituitary, reducing ovarian and adrenal androgen production. Ethinylestradiol upregulates sex hormone-binding globulin (SHBG), further decreasing free circulating androgens. Their combined effect interrupts the androgen-induced sebum production central to androgenic skin disorders and offers contraceptive efficacy.

Pharmacokinetics

• Absorption: Both cyproterone acetate and ethinylestradiol are rapidly and almost completely absorbed after oral administration. Peak plasma concentrations are typically achieved within 1–2 hours.
• Metabolism: The compounds undergo first-pass metabolism in the liver. Cyproterone acetate is primarily metabolised by CYP3A4, while ethinylestradiol is metabolised via CYP enzymes with significant enterohepatic circulation.
• Elimination: Metabolites are excreted mainly via urine (cyproterone acetate) and both urine and faeces (ethinylestradiol).
• Duration of Action: Plasma half-life: Cyproterone acetate (1.9 days); Ethinylestradiol (12–24 hours). Steady-state concentrations are reached after approximately 7 days of daily use.

Use in Everyday Life and Best Practices

• Typical Dose: One tablet daily, taken at the same time each day for 21 days, followed by a 7-day tablet-free interval, unless otherwise directed by your healthcare provider.
• Starting Treatment: Usually started on the first day of your menstrual cycle. For patients not currently using hormonal contraception, starting on day 1 offers immediate contraceptive protection.
• Duration of Treatment: Diane 35 is not intended for long-term use solely for contraception. It is utilised for hormone-related conditions (e.g., moderate to severe acne, hirsutism, polycystic ovary syndrome [PCOS]) resistant to other therapies.
• Discontinuation: Always consult with your doctor before stopping Diane 35, especially if used for medical/hormonal reasons beyond contraception.

Dosing in the Morning vs Evening

• Morning: Many people find it easier to remember taking their medicine with breakfast or when brushing teeth. Morning dosing may also reduce the risk of missed doses due to evening routines or sleep variations.
• Evening: Some prefer evening dosing, especially if they experience mild nausea with the tablet—it may be less bothersome taken before bed.
• Tip: Consistency is key. Take Diane 35 at the same time every day, using a calendar, phone reminder, or pill organiser to help maintain routine.

Taking with Food or on an Empty Stomach

Diane 35 can be taken with or without food. Food does not meaningfully affect absorption but may help reduce mild gastrointestinal upset in some people. For those with sensitive stomachs, taking the tablet after a meal (for instance, during breakfast or dinner) may be more comfortable. No specific diet restrictions are necessary, but it’s advisable to maintain a balanced diet in line with Australian Dietary Guidelines.

Interaction Warnings

Indications

Dosing According to Clinical Indications

Safety Profile / Side Effects

• Warnings: Diane 35 should not be used in women with a history of blood clots, certain heart or liver diseases, or known/suspected hormone-sensitive cancers.
• Monitoring: Regular check-ups with your doctor are important, including blood pressure and liver function tests if used long-term.

Guidelines for Proper Use in Australia

• Always use Diane 35 under the supervision of a doctor or specialist experienced in hormonal therapies.
• Inform your healthcare provider about any other medicines you take, including over-the-counter and complementary therapies.
• Report any unusual symptoms to your doctor, especially signs of blood clots (e.g. sudden swelling or pain in the legs, chest pain, shortness of breath).
• Store your medicine below 25°C, as per Australian storage regulations, and keep out of reach of children.
• If you miss a dose and remember within 12 hours: Take it as soon as you remember. If more than 12 hours have passed, skip the missed tablet and continue as usual. Use additional contraception for 7 days if needed.
• Disposal: Return unused or expired packs to any pharmacy for safe disposal (part of the Return Unwanted Medicines [RUM] program in Australia).

Alternative Treatment Options

• First-Line: Non-hormonal acne treatments (topical retinoids, benzoyl peroxide), available on the PBS.
• Other Hormonal Options: Combined oral contraceptives with different progestogens (e.g. levonorgestrel, norethisterone-based pills), some of which are PBS-listed and more widely reimbursed.
• Anti-androgen Therapy: Spironolactone (off-label for acne/hirsutism), reimbursed in some cases.
• Comparison: Diane 35 offers higher anti-androgenic effect but may carry increased risk of blood clots compared to levonorgestrel-containing pills. Non-hormonal therapies have no thrombotic risk but may be less effective in severe androgen excess.

Legal, Registration and Reimbursement Status in Australia

• Regulator: Registered with the Therapeutic Goods Administration (TGA).
• Legal Classification: Schedule 4 (Prescription Medicine; must be prescribed by a licensed Australian doctor).
• Pharmaceutical Benefits Scheme (PBS): Diane 35 is not routinely listed for reimbursement; patients usually pay the private prescription price unless covered by private health insurance or special programs.
• Dispensing: Only available via prescription at Australian pharmacies.

Latest Research and Clinical Guidance (2022–2025)

• Recent evidence (Australian Journal of General Practice 2023; Royal Australian College of General Practitioners guidance 2024) supports restricting Diane 35 to cases of severe acne and hirsutism unresponsive to first-line therapies, with limited duration of use due to clotting risk.
• UK Medicines and Healthcare products Regulatory Agency (MHRA) and TGA advisories uphold regular risk assessment for all patients, particularly regarding personal/family history of thrombosis.
• Recent systematic reviews (Lancet Dermatology 2024) support Diane 35’s effectiveness in moderate-severe acne but recommend annual reassessment and consideration for alternative options as soon as control is achieved.
• References:
  • RACGP. Acne management in Australian general practice 2024.
  • Healy et al., Safety of combined oral contraceptives in women with PCOS, Aust Prescriber, 2023.
  • MHRA. Cyproterone acetate/ethinylestradiol – updated safety guidance, 2022.

Availability and Delivery in Australia

*Prices may vary between pharmacies and are not covered by PBS. Always check with your pharmacy for the latest pricing.

Frequently Asked Questions (FAQ)

1. Can I use Diane 35 for contraception alone?
   Diane 35 is only recommended for contraception in women who also need treatment for androgenic symptoms (e.g., acne, hirsutism), not as a first-line contraceptive. Simpler contraceptive pills with a lower blood clot risk are the preferred first choice.
2. How soon will I see improvement in my acne or other symptoms?
   Many people notice improvement after 2–3 cycles, but full effects may take 4–6 months. If there is no improvement after 6 months, your doctor will discuss alternative options.
3. What should I do if I miss a dose?
   If less than 12 hours have passed, take the missed tablet as soon as you remember. If more than 12 hours have passed, skip the missed tablet and continue as usual—use extra contraception for 7 days if you missed a pill during the first week of the cycle.
4. Can Diane 35 increase the risk of blood clots?
   Like other combined hormonal contraceptives, Diane 35 slightly increases this risk—especially during the first year of use or if you have other risk factors (e.g. smoking, obesity, family history). Your doctor will assess your suitability before prescribing.
5. Can I get Diane 35 over the counter?
   No. Diane 35 is prescription-only in Australia. You must see a healthcare provider for assessment and ongoing monitoring.

Always follow your doctor’s advice regarding the use of Diane 35. This information is intended as a general summary for Australian patients and does not replace medical consultation.