DIANE-35

DIANE-35 is the brand name for ethinylestradiol/cyproterone acetate oral tablets.

DIANE-35 is available as an oral tablet that contains ethinylestradiol 0.035 mg and cyproterone acetate 2 mg. It also comes with 7 placebo tablets.

DIANE-35 is an antiandrogen and an estrogen that is used for:
Moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism in women of reproductive age. The prevention of pregnancy.

DIANE-35 is an antiandrogen and estrogen combination. These medicines work by blocking the effects of a class of hormones called androgens. Cyproterone also supresses ovulation and therefore has a contraceptive effect.

DIANE-35 comes as a pre-packaged course (28 days) of medication. There are 21 active tablets and 7 placebo tablets and they don’t contain any active medication. The typical dose is to take 1 active tablet by mouth daily for 21 days, followed by 1 placebo tablet daily for the remaining 7 days. The tablets must be taken in order as shown on the medication packaging.

DIANE-35 is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following.

• Hypersensitivity to the active substances or to any of the excipients.
• Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism).
• Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g.
  angina pectoris and transient ischaemic attack).
• Presence or history of cerebrovascular accident
• History of migraine with focal neurological symptoms
• The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis such as, diabetes mellitus with vascular symptoms, severe hypertension, or severe dyslipoproteinaemia
• Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)
• Severe hepatic disease as long as liver function values have not returned to normal
• Use of direct-acting antiviral (DAA) medicinal products containing ombitasvir, paritaprevir, or dasabuvir, and combinations of these.
• Presence or history of liver tumours (benign or malignant)
• Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
  Undiagnosed vaginal bleeding
• Concomitant use with another hormonal contraceptive.
  Known or suspected pregnancy
• Lactation

Common side effects of DIANE-35:

• Nausea
• Abdominal pain
• Increased weight
• Headache
• Depression or mood changes
• Brest pain
• Breast tenderness

Serious side effects are rare with DIANE-35. Contact your healthcare provider immediately if you experience any of the following.

• Heart attack: chest pain, stomach discomfort, sweating, nausea, dizziness
• Stroke: sudden numbness or weakness in the arm, leg, or face, confusion, trouble seeing, headache, difficulty walking
• Deep vein thrombosis (blood clot in the leg): leg cramp, swelling, pain, muscle tightness
• Pulmonary embolism (blood clot in the lung): cough, chest pain, trouble breathing, racing heart
• Liver problems: yellowing of the skin or the whites of the eyes, tiredness, stomach pain

The following medications may interact with DIANE-35:

• Substances increasing the clearance of DIANE-35 (diminished efficacy by enzyme-induction), e.g.: Phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine topiramate, felbamate, griseofulvin, and products containing St. John’s wort
• Substances with variable effects on the clearance of DIANE-35, e.g.: When co-administered with combined oral contraceptives, many HIV/HCV protease inhibitors and nonnucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of estrogen or progestin. These changes may be clinically relevant in some cases
• Substances decreasing the clearance of DIANE-35 (enzyme inhibitors)
• Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. itraconazole, voriconazole fluconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the estrogen or the progestin or both

Bayer Healthcare

DIANE-35 should not be used during pregnancy. Inform your doctor immediately if you become pregnant while taking DIANE-35.

• ethinyl estradiol/cyproterone acetate