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This Consumer Health Data Privacy Policy (“Policy”) describes how Exeltis USA, Inc. as part of Exeltis Pharmaceuticals Holding, S.L. and all its subsidiaries located in Spain, EU or third countries (hereinafter, jointly referred to as “Exeltis”, “we,” “us” or “our”) processes “Consumer Health Data,” as that term is defined under applicable state privacy law, about consumers who reside in the states of Nevada, Washington and any other applicable U.S. jurisdiction in connection with the website https://twirla.com (hereinafter, the “Website”), owned by Insud Pharma, S.L.U. Please carefully read this Policy as it contains important information concerning your Consumer Health Data and how we use it.

This Policy relates only to Consumer Health Data. It does not describe how Exeltis processes your personal data. For more information about Exeltis’ information practices with respect to personal data, please refer to our Privacy Policy.

Categories. We collect the following categories of Consumer Health Data:

  • Individual health conditions, treatment, diseases, or diagnosis that you share with our nurse professionals;
  • Information that could identify your attempt to seek health care services, including our prescription products;
  • Use or purchase of prescribed medication, including our prescription products
  • Bodily functions, vital signs, symptoms, or measurements that you share with our nurse professionals;
  • Reproductive or sexual health information; and
  • Any inferences of the above categories of consumer health data derived or extrapolated from non-health information, such as cookies and other tracking technologies on our websites and mobile apps if you provide your express permission for our collection.

Sources of Collection. We collect Consumer Health Data from the following categories of sources:

  • Directly from you when you share it with us and from your interactions with our products and services, including our patient savings or similar programs that we may offer and information provided to us via chat or other interactions with our nurse professionals;
  • With your permission, we and our third-party providers and business partners may collect your health data over time and across different internet websites or online services when you use any internet website or online service of the regulated entity; and
  • From third parties and business partners, including our nurse professionals and those involved with the patient savings or similar programs that we may offer.

Purposes of Collection. We collect, processes, and disclose Consumer Health Data for the following business purposes:

  • To provide, operate, maintain and protect our Website;
  • To provide our products and services, including the patient savings and related discount, reimbursement, education or support programs;
  • To analyze and improve our Website, including developing new products, functionalities or services;
  • To communicate with you, respond to your inquiries, fulfil your orders and to send you information by email, postal mail, telephone, text message, notifications or other means about our products and services;
  • To promote, conduct or distribute educational or promotional content or events, including events that may be in person and to support our marketing and advertising activities, including delivering personalized advertising;
  • To enhance and help us better understand your browsing experience, needs and preferences and provide consistent, personalized services and experiences across our Website;
  • To protect the security or integrity of the Website, including to perform security analyses to verify that the Website are working properly and have not been compromised based on our legitimate interests;
  • To protect us, our users and the public, and comply with applicable law, regulation or legal process, including to validate user information for fraud and risk detection purposes, resolve disputes and protect the rights of users and third parties, respond to claims and legal process (such as subpoenas and court orders), fulfill our reporting obligations, monitor and enforce compliance with our contracts and otherwise detect, prevent or stop any activity that may be illegal, unethical or legally actionable; and
  • To evaluate or conduct a merger, divestiture, restructuring, reorganization, dissolution or other sale or transfer of some or all of our assets, whether as a going concern or as part of bankruptcy, liquidation or similar proceeding, in which personal data held by us about Users is among the assets transferred.
  • Disclosures. We disclose some or all of the above categories of Consumer Health Data for the purposes described above with the following third parties and affiliates:
  • To our affiliate and parent companies listed in the beginning of this Policy, primarily due to the use of shared computer systems, which may be located in the European Economic Area (EEA) or in third countries;
  • As legally required in relevant legal proceedings and otherwise to the extent required or explicitly authorized by applicable law;
  • To other companies we collaborate with for research and development activities related to products and services jointly offered or developed by us and that company; and
  • To data analytics and advertising and marketing providers.

Your Privacy Rights

Depending on your place of residency, you may have the right to submit some or all of the following requests regarding your Consumer Health Data, subject to applicable law and certain exceptions:

  • Right to confirm and access your Consumer Health Data, including a list of all third parties and affiliates with whom we have shared the Consumer Health Data. You may request that we provide you with a copy of the Consumer Health Data that we maintain about you.
  • Right to correct your Consumer Health Data. If your Consumer Health Data we maintain is inaccurate and you would like us to rectify it, you may request that we make changes to it.
  • Right to withdraw consent from collection or sharing of your Consumer Health Data at any time.
  • Right to delete your Consumer Health Data.
  • Right to appeal a decision by us regarding your request to exercise any of the above rights.

For the exercise of any of the abovementioned rights, you or your authorized agent, may contact Exeltis by email, addressing the request to dataprotection@insudpharma.com, indicating as reference: “EXERCISE OF RIGHTS” and identifying the right to be exercised. In order to process your request, we may ask you to verify your identity by confirming your name, e-mail address, phone number, or other identifiable information that we have in our records, such as most recent interaction with us, if applicable.

Policy Updates

Exeltis reserves the right, in our sole discretion, to modify or replace this Policy. Your continued use of the Website after any such changes constitutes your acceptance of the new Policy.

Please review this Policy every so often in order to acknowledge any possible modifications. If you do not accept this Policy, partially or as a whole, or any subsequent modification, please discontinue any use of the Website immediately.

Contact

If you have any further questions about the use of your personal data or about our Privacy Policy, you can contact Insud Pharma Group’s Data Protection Officer by email through dataprotection@insudpharma.com.

Effective date of the Policy: July the 22nd, 2025

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 KG/M2

Cigarette Smoking and Serious Cardiovascular Events

Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.

Contraindicated in Women with a BMI ≥30 kg/m2

TWIRLA is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events (VTEs).

CONTRAINDICATIONS

TWIRLA is contraindicated and should not be used in women who have or develop the following conditions:

  • At high risk of arterial or venous thromboembolic events, including smoke (if over age 35); have current or history of deep vein thrombosis or pulmonary embolism; have cerebrovascular disease; have coronary artery disease; have thrombogenic valvular or thrombogenic rhythm diseases of the heart; have inherited or acquired hypercoagulopathies; have uncontrolled hypertension with vascular disease; have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration
  • Headaches with focal neurological symptoms, migraine with aura
  • Women over 35 years of age with any migraine headache
  • BMI ≥30 kg/m2
  • Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis, or liver disease
  • Undiagnosed abnormal uterine bleeding
  • Pregnancy
  • Current or history of breast cancer
  • Hypersensitivity to any components of TWIRLA
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. 

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders and Other Vascular Conditions: Women are at increased risk for a venous thromboembolic event (VTE) when using TWIRLA.

  • Stop TWIRLA if an arterial or VTE occurs.
  • Stop TWIRLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
  • Discontinue TWIRLA during prolonged immobilization and, if feasible, stop TWIRLA at least 4 weeks before and through 2 weeks after major surgery.
  • Start TWIRLA no earlier than 4 weeks after delivery in women who are not breast-feeding.
  • Before starting TWIRLA, evaluate any past medical history or family history of thromboembolism or thromboembolic disorders and consider whether history suggests inherited or acquired hypercoagulopathy.

Arterial Events: CHCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke, particularly among older women (>35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity.
Venous Events: The use of CHCs increase the risk of VTEs. Risk factors include, smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs.

Liver Disease:

  • Elevated Liver Enzymes: Discontinue TWIRLA if jaundice develops. Acute liver test abnormalities may necessitate the discontinuation of CHC use until the liver tests return to normal and CHC causation has been excluded.
  • Liver Tumors: CHCs increase the risk of hepatic adenomas. Rupture of hepatic adenomas may cause death from abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) CHC users.

Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment: Discontinue TWIRLA prior to starting therapy with the hepatitis C combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. TWIRLA can be restarted approximately 2 weeks following completion of treatment with that combination drug regimen.

Hypertension: For all women, monitor blood pressure at routine visits and stop TWIRLA if blood pressure rises significantly. An increase in blood pressure has been reported in women using CHCs, and this increase is more likely in older women with extended duration of use.

Gallbladder Disease: Studies suggest CHCs increase the risk of developing gallbladder disease and may also worsen existing gallbladder disease.

Adverse Carbohydrate and Lipid Metabolic Effects:

  • Hyperglycemia: TWIRLA may decrease glucose tolerance. Carefully monitor prediabetic and diabetic women who are using TWIRLA.
  • Dyslipidemia: Consider alternative contraception for women with uncontrolled dyslipidemia. TWIRLA may cause adverse lipid changes. Women with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using TWIRLA, which may increase the risk of pancreatitis.

Headache: If a woman using TWIRLA develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue TWIRLA as indicated. Consider discontinuation of TWIRLA if there is any increased frequency or severity of migraines during CHC use (which may be prodromal of a cerebrovascular event).

Bleeding Irregularities and Amenorrhea: 

  • Unscheduled and Scheduled Bleeding and Spotting: Women using TWIRLA may experience unscheduled bleeding and spotting, especially during the first 3 months of use. If bleeding persists or occurs after previously regular cycles on TWIRLA, evaluate for causes such as pregnancy or malignancy.
  • Amenorrhea and Oligomenorrhea: Women using TWIRLA may experience absence of scheduled bleeding, even if they are not pregnant. If scheduled bleeding does not occur, consider the possibility of pregnancy.

Other Warnings and Precautions include age-related considerations, depression, breast cancer, cervical cancer, effect on binding globulins, hereditary angioedema, and chloasma.

ADVERSE REACTIONS

The following serious adverse reactions occurred in <1% of women who received TWIRLA: cholelithiasis, cholecystitis, major depression, suicidal ideation, appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis. A total of 4 VTEs in TWIRLA-treated patients were identified in the phase 3 clinical trial. The most common adverse reactions (≥2%) in clinical trials for TWIRLA are application site disorders, nausea, headache, dysmenorrhea, and increased weight.

Patients should be counseled that TWIRLA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

DRUG INTERACTIONS

Drugs or herbal products that induce certain enzyme inducers, including CYP3A4, may decrease the effectiveness of TWIRLA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with TWIRLA.

USE IN SPECIFIC POPULATIONS

  • CHCs can reduce milk production in breastfeeding women. Advise the nursing woman to use another method of contraception while breastfeeding.
  • Twirla is not indicated in females before menarche or postmenopausal women.

To report SUSPECTED ADVERSE REACTIONS, call Exeltis at 1‑877‑324‑9349 or FDA at www.fda.gov/medwatch or 1‑800‑FDA‑1088.

Please see here for full Prescribing Information, including BOXED WARNING, for additional Important Safety Information.

INDICATION AND USAGE

TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Limitations of Use: Consider the reduced effectiveness of TWIRLA in women with a BMI ≥25 to <30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥30 kg/m2.


References

  1. Twirla Prescribing Information.
  2. US Census Bureau; 2024.
  3. Nelson AL, et al. Contraception. 2021;103:137-143.
  4. Data on file

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥30 KG/M2

Cigarette Smoking and Serious Cardiovascular Events

Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including TWIRLA, are contraindicated in women who are over 35 years of age and smoke.

Contraindicated in Women with a BMI ≥30 kg/m2

TWIRLA is contraindicated in women with a BMI ≥30 kg/m2. Compared to women with a lower BMI, women with a BMI ≥30 kg/m2 had reduced effectiveness and may have a higher risk for venous thromboembolic events (VTEs).

CONTRAINDICATIONS

TWIRLA is contraindicated and should not be used in women who have or develop the following conditions:

  • At high risk of arterial or venous thromboembolic events, including smoke (if over age 35); have current or history of deep vein thrombosis or pulmonary embolism; have cerebrovascular disease; have coronary artery disease; have thrombogenic valvular or thrombogenic rhythm diseases of the heart; have inherited or acquired hypercoagulopathies; have uncontrolled hypertension with vascular disease; have diabetes mellitus and are over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration
  • Headaches with focal neurological symptoms, migraine with aura
  • Women over 35 years of age with any migraine headache
  • BMI ≥30 kg/m2
  • Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis, or liver disease
  • Undiagnosed abnormal uterine bleeding
  • Pregnancy
  • Current or history of breast cancer
  • Hypersensitivity to any components of TWIRLA
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. 

WARNINGS AND PRECAUTIONS

Thromboembolic Disorders and Other Vascular Conditions: Women are at increased risk for a venous thromboembolic event (VTE) when using TWIRLA.

  • Stop TWIRLA if an arterial or VTE occurs.
  • Stop TWIRLA if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
  • Discontinue TWIRLA during prolonged immobilization and, if feasible, stop TWIRLA at least 4 weeks before and through 2 weeks after major surgery.
  • Start TWIRLA no earlier than 4 weeks after delivery in women who are not breast-feeding.
  • Before starting TWIRLA, evaluate any past medical history or family history of thromboembolism or thromboembolic disorders and consider whether history suggests inherited or acquired hypercoagulopathy.

Arterial Events: CHCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke, particularly among older women (>35 years of age), smokers, and women with hypertension, dyslipidemia, diabetes, or obesity.
Venous Events: The use of CHCs increase the risk of VTEs. Risk factors include, smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs.

Liver Disease:

  • Elevated Liver Enzymes: Discontinue TWIRLA if jaundice develops. Acute liver test abnormalities may necessitate the discontinuation of CHC use until the liver tests return to normal and CHC causation has been excluded.
  • Liver Tumors: CHCs increase the risk of hepatic adenomas. Rupture of hepatic adenomas may cause death from abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) CHC users.

Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment: Discontinue TWIRLA prior to starting therapy with the hepatitis C combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. TWIRLA can be restarted approximately 2 weeks following completion of treatment with that combination drug regimen.

Hypertension: For all women, monitor blood pressure at routine visits and stop TWIRLA if blood pressure rises significantly. An increase in blood pressure has been reported in women using CHCs, and this increase is more likely in older women with extended duration of use.

Gallbladder Disease: Studies suggest CHCs increase the risk of developing gallbladder disease and may also worsen existing gallbladder disease.

Adverse Carbohydrate and Lipid Metabolic Effects:

  • Hyperglycemia: TWIRLA may decrease glucose tolerance. Carefully monitor prediabetic and diabetic women who are using TWIRLA.
  • Dyslipidemia: Consider alternative contraception for women with uncontrolled dyslipidemia. TWIRLA may cause adverse lipid changes. Women with hypertriglyceridemia, or a family history thereof, may have an increase in serum triglyceride concentrations when using TWIRLA, which may increase the risk of pancreatitis.

Headache: If a woman using TWIRLA develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue TWIRLA as indicated. Consider discontinuation of TWIRLA if there is any increased frequency or severity of migraines during CHC use (which may be prodromal of a cerebrovascular event).

Bleeding Irregularities and Amenorrhea: 

  • Unscheduled and Scheduled Bleeding and Spotting: Women using TWIRLA may experience unscheduled bleeding and spotting, especially during the first 3 months of use. If bleeding persists or occurs after previously regular cycles on TWIRLA, evaluate for causes such as pregnancy or malignancy.
  • Amenorrhea and Oligomenorrhea: Women using TWIRLA may experience absence of scheduled bleeding, even if they are not pregnant. If scheduled bleeding does not occur, consider the possibility of pregnancy.

Other Warnings and Precautions include age-related considerations, depression, breast cancer, cervical cancer, effect on binding globulins, hereditary angioedema, and chloasma.

ADVERSE REACTIONS

The following serious adverse reactions occurred in <1% of women who received TWIRLA: cholelithiasis, cholecystitis, major depression, suicidal ideation, appendicitis, ectopic pregnancy, pneumonia, and gastroenteritis. A total of 4 VTEs in TWIRLA-treated patients were identified in the phase 3 clinical trial. The most common adverse reactions (≥2%) in clinical trials for TWIRLA are application site disorders, nausea, headache, dysmenorrhea, and increased weight.

Patients should be counseled that TWIRLA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

DRUG INTERACTIONS

Drugs or herbal products that induce certain enzyme inducers, including CYP3A4, may decrease the effectiveness of TWIRLA or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with TWIRLA.

USE IN SPECIFIC POPULATIONS

  • CHCs can reduce milk production in breastfeeding women. Advise the nursing woman to use another method of contraception while breastfeeding.
  • Twirla is not indicated in females before menarche or postmenopausal women.

To report SUSPECTED ADVERSE REACTIONS, call Exeltis at 1‑877‑324‑9349 or FDA at www.fda.gov/medwatch or 1‑800‑FDA‑1088.

Please see here for full Prescribing Information, including BOXED WARNING, for additional Important Safety Information.

INDICATION AND USAGE

TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI <30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Limitations of Use: Consider the reduced effectiveness of TWIRLA in women with a BMI ≥25 to <30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥30 kg/m2.


References

  1. Twirla Prescribing Information.
  2. US Census Bureau; 2024.
  3. Nelson AL, et al. Contraception. 2021;103:137-143.
  4. Data on file