Diane-35 (Cyproterone Acetate + Ethinyl Estradiol)

Diane-35 Description Diane-35 contains two types of sex hormones, a progestogen called Cyproterone acetate and an estrogen called Ethinylestradiol. It is used in women of reproductive age who suffer from conditions due to an increased sensitivity to androgens in the body. Androgens are hormones in the body that make one display more male characteristics. Women who are more sensitive to androgen may have conditions such as acne, very oily skin or excessive hair growth in certain areas of the face or body. The medication also provides effective oral contraception in women being treated for the above conditions. If you are taking Diane-35 for any of the conditions above, you must not take any other hormonal contraceptive at the same time. Ordering Diane-35 In the US: Diane-35 is not FDA-approved in the United States but is approved in Canada, the EU, and most of the world. US patients with a valid prescription from a licensed physician (US or international) may legally import a personal supply of up to 90 days under the FDA’s Personal Importation Policy. We’ve shipped to US patients since 2005. Shipping from Israel is $35 — most patients order 2–3 months at once to make the shipping math work. Can’t get a prescription for Diane 35 in the US? Diane-35 is not FDA-approved in the United States, so most US-licensed physicians will not prescribe it. For androgen-related skin symptoms (acne, hirsutism, oily skin) and contraception, US physicians commonly prescribe Yaz or Yasmin (drospirenone + ethinyl estradiol) — both are FDA-approved, have mild anti-androgenic activity, and are available in the US with a standard US prescription. We stock and ship both internationally if you prefer to source from us. See the You may also like section below for our most-ordered birth control options. Why patients order Diane-35 from IVFPharmacy ✓ Trusted by US patients since 2005. Over 20 years shipping fertility and women’s-health medications internationally. ✓ Authentic Bayer Diane-35. Manufactured in Germany, sourced through our licensed supply chain in Israel. ✓ Delivery guarantee. Most orders arrive in around a week. If your order does not arrive within 2 weeks, we will refund or reship your order. ✓ Pharmacist support. Questions about your order, prescription, or usage? Contact us — a licensed pharmacist will reply within one business day. ✓ Prescription verification. We verify every prescription before dispatch. Your medication safety is the standard, not the exception. Diane-35 Uses and Side Effects Diane 35 Uses & Indications: Diane-35 is a combined oral medication containing cyproterone acetate 2 mg (an anti-androgen progestin) and ethinyl estradiol 0.035 mg (an estrogen). It is prescribed in women of reproductive age for the treatment of androgen-dependent conditions, including:  – Severe acne (with seborrhea / oily skin) that has not responded adequately to topical therapy or antibiotics  – Mild to moderate hirsutism — excessive facial or body hair growth in androgen-sensitive areas  – Androgenic alopecia — female-pattern hair thinning linked to androgen sensitivity While treating these conditions, Diane-35 also provides reliable hormonal contraception. Per Bayer’s product monograph and European Medicines Agency guidance, Diane-35 is not indicated for use solely as a contraceptive — it is intended for women who need treatment for an androgen-related condition and want contraception at the same time. Diane-35 is also commonly prescribed in international practice to manage the androgenic symptoms of polycystic ovary syndrome (PCOS), such as acne and hirsutism. PCOS itself is not listed as an indication in the monograph; the prescribing rationale relates to the underlying symptoms. How Diane-35 Works Cyproterone acetate blocks the action of androgens (male hormones) at the receptor level and suppresses the body’s own androgen production. Ethinyl estradiol stabilizes the menstrual cycle and provides contraceptive cover. Together, these effects reduce the dermatological symptoms of androgen excess — typically over 3–6 cycles of consistent use. Diane 35 Side Effects: Common side effects Most common side effects are mild and tend to improve over the first 2–3 cycles as the body adjusts:  – Nausea, breast tenderness, headache  – Mood changes, fatigue, irritability  – Weight changes, fluid retention  – Breakthrough bleeding or spotting between periods  – Decreased libido  – Skin pigmentation changes (chloasma) — typically mild Serious risks and warnings  – Blood clots (VTE): Diane-35 increases the risk of venous thromboembolism — deep vein thrombosis (DVT) and pulmonary embolism (PE). The VTE risk with Diane-35 is higher than with combined oral contraceptives containing levonorgestrel.  – Cardiovascular events: Increased risk of heart attack and stroke, particularly in women who smoke, are over 35, have high blood pressure, or have migraine with aura.  – Liver effects: Rare benign and malignant liver tumors; elevated liver enzymes.  – Mood: Depression and mood disturbance have been reported. Do not take Diane-35 if you have:  – A current or past history of blood clots (DVT, PE), heart attack, or stroke  – A known thrombophilia (such as Factor V Leiden)  – Migraine with aura  – Severe hypertension or severe diabetes with vascular complications  – Severe liver disease, including active liver tumors  – Known or suspected breast cancer or other hormone-sensitive cancer  – Undiagnosed abnormal vaginal bleeding  – A current or planned pregnancy, or are breastfeeding Smoking and Diane-35 Smoking significantly increases the risk of serious cardiovascular side effects from all combined hormonal contraceptives, including Diane-35. Women who smoke and use Diane-35 should be aware of the increased risk, particularly women over the age of 35. Most international prescribing guidelines recommend that women over 35 who smoke not use combined oral contraceptives. This summary is drawn from Bayer’s Diane-35 product monograph. It is intended for general patient information and does not replace the patient information leaflet supplied with your medication, or advice from your prescribing physician. Read the full patient information leaflet before starting Diane-35, and discuss any side effects or concerns with your physician or pharmacist. Source: Diane-35 Product Monograph, Bayer Canada. Frequently Asked Questions about Diane-35 Q: Is Diane-35 available in the US? A: Diane-35 is not FDA-approved in the United States. The combination of cyproterone acetate (2 mg) and ethinyl estradiol (0.035 mg) was never granted US approval. Diane-35 is fully approved in Canada, the European Union, the UK, and most of the world, where it is prescribed for androgen-related skin conditions in women who also need contraception. US patients with a valid prescription can order internationally through IVFPharmacy. Q: Can I legally import Diane-35 to the US? A: The FDA’s Personal Importation Policy provides enforcement discretion for individuals importing up to a 90-day supply of medication not approved in the US, under specific conditions including a serious condition and physician oversight. Because FDA-approved alternatives exist for Diane-35’s indications, importation is reviewed case-by-case. We recommend speaking with your prescribing physician about your specific situation before ordering. We’ve shipped to US patients under this framework since 2005. Q: How much Diane-35 should I order at once? A: Most US patients order a 2- or 3-month supply at once. Our international shipping is a flat $35 regardless of order size, so ordering multiple packs together spreads the shipping cost across more medication. The FDA permits personal importation of up to a 90-day supply per shipment. Please order at least two weeks in advance to allow time for prescription verification and international delivery. Q: What are FDA-approved alternatives for acne and hirsutism in women? A: For androgen-driven acne and hirsutism in women who also want contraception, US physicians commonly prescribe Yaz or Yasmin (drospirenone + ethinyl estradiol), which carry mild anti-androgenic activity. Spironolactone is another option, often combined with a standard combined oral contraceptive. Speak with your physician about which option fits your medical history. We ship both Yaz and Yasmin internationally if you choose to source from us. Q: How long does shipping to the US take and what does it cost? A: Shipping from Israel to the US is a flat $35 and typically arrives in 5–7 business days after dispatch. Orders ship after we receive and verify your prescription. IVFPharmacy has shipped to US patients since 2005 and offers a delivery guarantee. See our shipping page for full details and tracking information.