DIANE-35
Used for Acne
NowPatient helps you obtain your DIANE-35 prescription for free or at low-cost. Drug savings programs are suitable for individuals who are insured, don't have insurance or are underinsured and can't afford your medicine.
Manufactured by Bayer Healthcare
*You can pay as little as $0 per fill using Drug Coupons or Patient Assistance Programs. Subject to applicability & eligibility requirements.
This content is intended for US audiences only
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DIANE-35 key facts
What is DIANE-35?
DIANE-35 is the brand name for ethinylestradiol/cyproterone acetate oral tablets.
What dosages is DIANE-35 available in?
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.
What is DIANE-35 used for?
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.
How does DIANE-35 work?
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.
How do I take DIANE-35?
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.
Is it safe for me to take DIANE-35?
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
DIANE-35 Common Side Effects
Common side effects of DIANE-35:
- Nausea
- Abdominal pain
- Increased weight
- Headache
- Depression or mood changes
- Brest pain
- Breast tenderness
DIANE-35 Serious Side Effects
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
Effects of other drugs, drug classes and over-the-counter products on DIANE-35
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
Who makes DIANE-35?
Bayer Healthcare
Is DIANE-35 safe in pregnancy?
DIANE-35 should not be used during pregnancy. Inform your doctor immediately if you become pregnant while taking DIANE-35.
The FDA's medical product safety reporting program for health professionals, patients and consumers.
Learn more about reporting side effects in the USDrug Savings Guide
A practical guide to saving money and receiving support with prescription costs
How can NowPatient help me to lower the cost of my DIANE-35 prescription?
After you create a FREE account with NowPatient, you will have access to 4 programs that can help lower the cost of your DIANE-35 prescription
Applicability to each program will be dependent on your insurance status.
How do the NowPatient DIANE-35 savings programs work?
After you have created your FREE account with NowPatient, you can access the various programs from your account dashboard. Each program has clear instructions on how to check your eligibility. You can see how the process works by clicking on the feature link below and seeing the ‘How it works’ steps.
Drug Coupon and Patient Assistance Programs require an eligibility quiz to be completed.
Are the NowPatient DIANE-35 savings programs suitable for everyone, regardless of insurance status?
No. Each program has its own eligibility and applicability requirements. The table below shows if a program is available to you, based on your insurance status.
| Rx Advantage Card* for DIANE-35 | Canadian Prescription Savings* for DIANE-35 | DIANE-35 Drug Coupon* | DIANE-35 Patient Assistance Program* | |
| Insured (federal, state or government) | Available | Available | Not Available | Available If Offered by Pharmaceutical Company |
| Insured (Commercial or Private) | Available | Available | Available If Offered by Pharmaceutical Company | Available If Offered by Pharmaceutical Company |
| Uninsured | Available | Available | Not Available | Available If Offered by Pharmaceutical Company |
| Insured but without pharmacy benefit or drug coverage | Available | Available | Not Available | Available If Offered by Pharmaceutical Company |
*This is not insurance.
Are the NowPatient drug savings programs suitable for brand and generic versions of DIANE-35?
No. Each program has applicability requirements. Please see below
| Rx Advantage Card* for DIANE-35 | Canadian Prescription Savings* for DIANE-35 | DIANE-35 Drug Coupon* | DIANE-35 Patient Assistance Program* | |
| Brand | Yes | Yes | Yes, If Offered by Pharmaceutical Company | Yes, If Offered by Pharmaceutical Company |
| Generic | Yes | Yes | No | No |
*This is not insurance.
If you have Medicare Part D or Medicare Advantage and none of the DIANE-35 savings options are applicable or affordable for me, what can you do?
If you are insured with Medicare and the DIANE-35 drug savings options are not applicable to you and still remain unaffordable, then you can check Medicaid eligibility in your state by following the instructions at HealthCare.gov.
The government site is easy to use and after you have selected your state, it will navigate you to the appropriate contact point to make the application. State Medicaid programs may cover the full cost of your medication.
People who qualify for both Medicare and Medicaid are called ‘dual eligibles’.
If you are denied Medicaid for DIANE-35, and you are still unable to afford your copay or co-insurance element (for example if you are in the coverage gap or Donut Hole) then you may be eligible for a federal support program like Low Income Subsidy. To be eligible for Low Income Subsidy, you need to be a resident in one of the 50 States or the District of Columbia. You can check eligibility online at SSA Medicare D Extra Help. You can also call Social Security at 1-800-772-1213 (TTY 1-800-325-0778).
I am uninsured or underinsured and none of the DIANE-35 prescription saving options are applicable or affordable for me, what can I do?
If you are uninsured or underinsured (for example, DIANE-35 is not covered by your plan) and the drug savings options are not applicable or still unaffordable, then you can check Medicaid eligibility in your state by following the instructions at HealthCare.gov.
The government site is easy to use and you can select your state and it will navigate you to the appropriate contact point to make the application. State Medicaid programs may cover the full cost of your medication.
If you are denied and all else fails, and if you have been prescribed DIANE-35 for an FDA-approved indication, you can call the pharmaceutical company to see if they have any other assistance programs.
I am commercially or privately insured and none of the DIANE-35 prescription saving options are applicable or affordable for me, what can I do?
If your medication is not covered by your plan, you can you can appeal your insurance company’s decision. Sometimes, a formal appeal can result in the drug being covered if it is deemed medically necessary.
If you cannot afford your copay, then you can check Medicaid eligibility in your state by following the instructions at HealthCare.gov.
However, being privately insured might complicate your eligibility for Medicaid, as having private insurance may be considered in the financial eligibility assessment.
The government site is easy to use and you can select your state and it will navigate you to the appropriate contact point to make the application. If you qualify, state Medicaid may cover the full cost of your medication.
If I have federal, state or commercial insurance and none of the DIANE-35 prescription saving options are applicable or affordable for me, are there any other support organisations that can help me with my co-insurance or copay?
If you have already tried Medicaid and received a denial letter or if you are insured with Medicare and have been denied Low-Income Subsidy, then you can try one of the following organizational support programs:
1. Patient Access Network Foundation (PAN) assistance for DIANE-35
If you are having trouble paying for your DIANE-35 medication due to unaffordable copays or deductibles, the Patient Access Network Foundation (PAN), may be able to assist you. To qualify for PAN assistance for DIANE-35 you will need to meet one or all of the following criteria:
- Your income is below 400% of the federal poverty level
- DIANE-35 is prescribed for an approved FDA indication
- You live in and receive treatment in the United States or U.S. territories, even if you do not have U.S. citizenship
- You have Medicare insurance coverage that covers DIANE-35
- If DIANE-35 is listed on PAN’s list of covered medications
You can check the Patient Access Network Foundation Website for more information.
2. HealthWell Foundation Copay Program for DIANE-35
If you are having trouble paying for your DIANE-35 medication due to unaffordable copays or deductibles, the HealthWell Foundation Copay Program may be able to assist you. To qualify for assistance for DIANE-35 you will need to meet the following criteria:
- You live in and are being treated in the United States
- You are insured and your plan covers DIANE-35
- If DIANE-35 is listed on the HealthWell Foundation’s list of covered medications
You can check the HealthWell Foundation Website for more information.
3. Patient Advocate Foundation Co-Pay Relief Program for DIANE-35
Patient Advocate Foundation’s Co-Pay Relief program exists to help reduce the financial distress you or your family may face when paying for your DIANE-35 treatment. If you qualify and can demonstrate the need, the foundation will provide you with direct payment covering co-pays, co-insurance, and deductibles. To qualify for assistance for DIANE-35 you will need to meet the following criteria:
- You must be currently insured and have coverage for DIANE-35
- You must have a confirmed diagnosis and treatment plan
- You must reside and receive treatment in the United States
- Your Income must fall at or below 300% or 400% of the Federal Poverty Guideline (FPG) with consideration for the Cost of Living Index (COLI) and number in the household
- Applications can also be completed by contacting the program sponsor, toll-free at 866-512-3861.
You can check the Patient Advocate Foundation Website for more information.
Medical Disclaimer
NowPatient has taken all reasonable steps to ensure that all material is factually accurate, complete, and current. However, the knowledge and experience of a qualified healthcare professional should always be sought after instead of using the information on this page. Before taking any drug, you should always speak to your doctor or another qualified healthcare provider.
The information provided here about medications is subject to change and is not meant to include all uses, precautions, warnings, directions, drug interactions, allergic reactions, or negative effects. The absence of warnings or other information for a particular medication does not imply that the medication or medication combination is appropriate for all patients or for all possible purposes.
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