Terms of Use

PLEASE READ THESE TERMS OF USE CAREFULLY BEFORE USING THIS WEBSITE OPERATED BY GENBIOPRO, INC .

Effective: May 2019

The following Terms of Use (as defined below) apply to all users of www.genbiopro.com (the “Site”). The following Terms of Use, together with any documents they expressly incorporate by reference (collectively, the “Agreement” or the “Terms”) is an agreement between you, an individual user (“You”), and GENBIOPRO, INC (“GENBIOPRO”) regarding Your use of the Site. You and GENBIOPRO are referred to herein individually as a “Party” or collectively as the “Parties”.

BEFORE USING THE SITE, PLEASE READ THE FOLLOWING TERMS CAREFULLY. BY ACCESSING, BROWSING, OR USING THE SITE, YOU ACKNOWLEDGE THAT YOU HAVE READ, UNDERSTOOD, AND AGREE TO BE BOUND BY THIS TERMS AND ANY FUTURE MODIFICATIONS. IF AT ANY TIME YOU DO NOT AGREE TO THE TERMS, PLEASE IMMEDIATELY TERMINATE YOUR USE OF THE SITE.

1. Eligibility.
In order to use the Site, You must be the age of majority in Your jurisdiction and fully able and competent to enter into the terms, conditions, obligations, affirmations, representations and warranties set forth in the Terms and to abide by and comply with the Terms. You represent that You meet the eligibility requirements in this Section and that You are over the age of 13, as the Site is not intended for children under 13.

2. Privacy Notice.
Your privacy is important to GENBIOPRO. GENBIOPRO’s Privacy Policy is hereby incorporated into the Terms by reference. All information GENBIOPRO collects on this Site is subject to our Privacy Policy located at https://www.genbiopro.com/privacypolicy]. Please read it carefully for information relating to GENBIOPRO’s collection, use, and disclosure of Your personal information.

3. Modification of the Terms.
From time to time, GENBIOPRO may change, remove, add to (including without limitation by way of additional terms) or otherwise modify the Terms, and reserves the right to do so in its discretion. In that case, GENBIOPRO will post the updated Terms, as relevant, to the Site and indicate the date of revision. GENBIOPRO encourages You to periodically review the Terms. Your continued use of the Site after new and/or revised Terms have been posted indicates that You have read, understood and agreed to the current version of the Terms that were in effect at the time you used the Site.

4. Medical Information.
You agree and understand that www.genbiopro.com may contain general information relating to GENBIOPRO products and to various medical conditions. Such information is provided for informational purposes only and is not meant to be a substitute for advice provided by a doctor or other qualified health care professional. Patients should not use the information contained herein for diagnosing a health or fitness problem or disease. PATIENTS SHOULD ALWAYS CONSULT WITH A DOCTOR OR OTHER HEALTH CARE PROFESSIONAL FOR MEDICAL ADVICE OR INFORMATION ABOUT DIAGNOSIS AND TREATMENT BEFORE USING ANY PRODUCT DESCRIBED OR DISCUSSED WITHIN THIS, OR WITHIN ANY OTHER WEBSITE.

5. Site Access.
GENBIOPRO grants You permission to use the Site, as set forth in the Terms, provided that, and for so long as (i) You use the Site solely to obtain information available on the Site to the general public regarding GENBIOPRO and its products and services; (ii) except as expressly permitted in the Terms, You do not download, reproduce, redistribute, retransmit, publish, resell, distribute, publicly display or otherwise exploit any portion of the Site in any medium without GENBIOPRO’s prior written authorization; (iii) You do not alter or modify any part of the Site; (iv) You do not engage in any of the prohibited uses described below; and (v) You otherwise fully comply with the Terms. The Site is controlled and offered by GENBIOPRO from its facilities in the United States of America. GENBIOPRO makes no representations that the Site is appropriate or available for use in other locations. If You are accessing or using the Site from other jurisdictions, You do so at Your own risk and You are responsible for compliance with local laws.

6. Ownership; Intellectual Property Right and Proprietary Rights.
As between the Parties, the Site and its entire contents, features and functionality, including but not limited to all information, content, visual interfaces, interactive features, information, graphics, design, compilation, computer code, products, software, services, and all other elements of the Site that are provided by GENBIOPRO (“GENBIOPRO Materials”) are owned and/or licensed by GENBIOPRO. This Terms permits you to use the Site for your personal, non-commercial use only. Except as expressly authorized by GENBIOPRO, You agree not to reproduce, sell, license, distribute, copy, modify, publicly perform or display, transmit, publish, edit, adapt, create derivative works from, or otherwise make unauthorized use of the Site or the GENBIOPRO Materials. GENBIOPRO reserves all rights not expressly granted in the Terms. You shall not acquire any right, title, or interest to the GENBIOPRO Materials, except for the limited rights set forth in the Terms.

7. Prohibited Uses of the Site.
(a) As a condition of Your use of the Site, You hereby represent and warrant that You will not use the Site for any purpose that is unlawful or prohibited by the Terms including, without limitation, the prohibitions in this Section.
(b) Any use by You of any of the GENBIOPRO Materials and the Site, other than to obtain information available on the Site regarding GENBIOPRO and its products and services, is prohibited. You agree not to reproduce, duplicate, copy, sell, trade, resell, distribute, or exploit any portion of the Site, use of the Site, or access to the Site.
(c) You agree not to use the Site if You do not meet the eligibility requirements described in Section 1 above.
(d) You agree not to intentionally interfere with or damage, impair or disable the operation of the Site or any user’s enjoyment of it, by any means, including uploading or otherwise disseminating viruses, worms, spyware, adware, or other malicious code.
(e) You agree not to remove, circumvent, disable, damage or otherwise interfere with any security-related features of the Site, features that prevent or restrict the use or copying of any part of the Site, or features that enforce limitations on the use of the Site.
(f) You agree not to attempt to gain unauthorized access to the Site, or any part of it, or other computer systems or networks connected to the Site, through hacking, password mining or any other means or interfere or attempt to interfere with the proper working of the Site or any activities conducted through the Site.
(g) You agree not to obtain or attempt to obtain any materials or information through any means not intentionally made available through the Site. You agree neither to modify the Site in any manner or form, nor to use modified versions of the Site, including (without limitation) for the purpose of obtaining unauthorized access to the Site, or any portion thereof.
(h) You agree not to use any robot, spider, scraper, or other automated means to access the Site for any purpose without express written permission or bypass robot exclusion headers or other measures that prevent or restrict access to the Site, or any portion thereof.
(i) You agree that GENBIOPRO, the terms, trademarks and all related names, logos, products and service names, designs and slogans are trademarks of GENBIOPRO or its affiliates or licensors. You agree (1) not to utilize framing techniques to enclose any trademark, logo, or other GENBIOPRO Materials without our express written consent (2) not to use any meta tags or any other “hidden text” utilizing GENBIOPRO’s name or trademarks without GENBIOPRO’s express written consent (3) not to use any GENBIOPRO logos, graphics, or trademarks as part of the link without GENBIOPRO’s express written consent.
(j) You agree not to deep-link to the Site and will promptly remove any links to the Site that GENBIOPRO finds objectionable in its sole discretion.
(k) You agree not to reverse engineer, decompile, disassemble or otherwise attempt to discover the source code of the Site or any part thereof.
(l) You agree not to modify, adapt, translate, or create derivative works based upon the Site or any part thereof.
(m) You agree not to impersonate another person or entity, or falsely state or otherwise misrepresent Your affiliation with a person or entity.
(n) You agree not to encourage or facilitate any of the above or otherwise attempt to interfere with the proper working of the Site.

8. Links and Third Party Websites.
GENBIOPRO or third parties may provide links on the Site to other sites including the content therein (“Reference Sites”). GENBIOPRO has no control over such Reference Sites or their content and therefore makes no claim or representation regarding, and expressly disclaims responsibility for, the accuracy, quality, legality, nature, availability, or reliability of Reference Sites or content linked to by the Site. GENBIOPRO provides links to You only as a convenience, and the inclusion of any link on the Site does not imply our affiliation, endorsement, or adoption of the linked site or any information therein. ACCESS AND USE OF REFERENCE SITES, INCLUDING THE INFORMATION, MATERIAL, PRODUCTS, AND SERVICES ON REFERENCE SITES OR AVAILABLE THROUGH REFERENCE SITES, IS SOLELY AT YOUR OWN RISK. The Terms do not govern Your use of any site other than the Site. You should review applicable terms and policies, including the privacy and data gathering practices, of any Reference Sites.
If you wish to link your website to this Site, you may only link to the homepage. You may link to any other pages within this Site only with GENBIOPRO’s prior consent.

9. Availability of Service.
GENBIOPRO may make changes to or discontinue any of the products or services described on the Site at any time, and without notice. The media, products, or services on the Site may be out of date, and GENBIOPRO makes no commitment to update the materials on the Site.
If You are dissatisfied with the Site, please let us know at info@genbiopro.com . Your input is valuable to us. Your only remedy with respect to any dissatisfaction with (i) the Site, (ii) any term of the Terms, (iii) any policy or practice of GENBIOPRO in operating the Site, or (iv) any content or information transmitted through the Site, is to discontinue Your use of any and all parts of the Site.

10. Terms Violations; Termination.
You agree that GENBIOPRO in its sole discretion and for any or no reason, may terminate availability of the Site (or any part thereof). You agree that Your access to the Site, or portion thereof, may be terminated without prior notice and You agree that GENBIOPRO shall not be liable to You or any third-party for any such termination. These remedies are in addition to any other remedies GENBIOPRO may have at law or in equity.

11. INDEMNIFICATION.
YOU AGREE TO INDEMNIFY AND HOLD HARMLESS GENBIOPRO AND ITS SUBSIDIARIES, AFFILIATES OR ANY RELATED COMPANIES (INCLUDING THOSE WHICH SHARE SUBSTANTIALLY COMMON OWNERSHIP), AND THE OFFICERS, DIRECTORS, STOCKHOLDERS, EMPLOYEES, AGENTS AND REPRESENTATIVES OF ANY OF THEM FROM ANY AND ALL CLAIMS, LOSSES, OBLIGATIONS, DAMAGES, LIABILITIES, COSTS, DEBT, AND EXPENSES (INCLUDING ATTORNEY’S FEES) ARISING OUT OF (I) YOUR USE OR MISUSE OF THE SITE; (II) YOUR VIOLATION OF THE TERMS; (III) YOUR VIOLATION OF THE RIGHTS OF ANY OTHER PERSON OR ENTITY USING THE SITE; AND (IV) YOUR BREACH OF THE FOREGOING REPRESENTATIONS, WARRANTIES, AND COVENANTS. GENBIOPRO RESERVES THE RIGHT, AT YOUR EXPENSE, TO ASSUME THE EXCLUSIVE DEFENSE AND CONTROL OF ANY MATTER FOR WHICH YOU ARE REQUIRED TO INDEMNIFY US AND YOU AGREE TO COOPERATE WITH OUR DEFENSE OF THESE CLAIMS. YOU AGREE NOT TO SETTLE ANY MATTER WITHOUT THE PRIOR WRITTEN CONSENT OF GENBIOPRO. GENBIOPRO WILL USE REASONABLE EFFORTS TO NOTIFY YOU OF ANY SUCH CLAIM, ACTION, OR PROCEEDING UPON BECOMING AWARE OF IT.

12. Disclaimers; No Warranties.
(a) Acknowledgement. YOU EXPRESSLY ACKNOWLEDGE THAT AS USED IN THIS SECTION 12, THE TERM GENBIOPRO INCLUDES GENBIOPRO’S OFFICERS, DIRECTORS, EMPLOYEES, STOCKHOLDERS, AGENTS, AFFILIATES, AND SUBCONTRACTORS.
(b) No warranties. TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, GENBIOPRO DISCLAIMS ALL WARRANTIES, STATUTORY, EXPRESS, OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NON-INFRINGEMENT OF PROPRIETARY RIGHTS. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM GENBIOPRO OR THROUGH THE SITE, WILL CREATE ANY WARRANTY NOT EXPRESSLY STATED HEREIN.
(c) “As is” and “As available” and “With All Faults.” YOU EXPRESSLY AGREE THAT THE USE OF THE SITE IS AT YOUR SOLE RISK. THE SITE IS PROVIDED ON AN “AS IS” AND “AS AVAILABLE”, “WITH ALL FAULTS” BASIS AND WITHOUT WARRANTIES OR REPRESENTATIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED.
(d) Website Operation. GENBIOPRO DOES NOT WARRANT THAT THE MATERIALS AVAILABLE ON THIS SITE WILL BE UNINTERRUPTED OR FREE OF ERRORS, VIRUSES, OR OTHER HARMFUL COMPONENTS AND DOES NOT WARRANT THAT ANY OF THE FOREGOING WILL BE CORRECTED.
(e) Harm to Your Computer. YOU UNDERSTAND AND AGREE THAT YOUR USE, ACCESS, DOWNLOAD, OR OTHERWISE OBTAINING INFORMATION, MATERIALS, OR DATA THROUGH THE SITE IS AT YOUR OWN DISCRETION AND RISK AND THAT YOU WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO YOUR PROPERTY (INCLUDING YOUR COMPUTER SYSTEM) OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OR USE OF SUCH MATERIAL OR DATA.
(f) Accuracy. GENBIOPRO DOES NOT WARRANT OR MAKE ANY REPRESENTATIONS REGARDING THE USE OR THE RESULTS OF THE USE OF THE SITE OR ANY REFERENCE SITES IN TERMS OF CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE.
FOR AVOIDANCE OF DOUBT, YOU AGREE THAT GENBIOPRO WILL NOT BE LIABLE FOR DECISIONS YOU MAKE ABOUT YOUR DIAGNOSIS AND TREATMENT IN RELIANCE WITH ANY INFORMATION ON THE SITE, RELATED TO OUR PRODUCTS OR TO ASSOCIATED MEDICAL CONDITIONS. ANY OPINION OR INFORMATION PRESENTED ON THE SITE IS INTENDED FOR PURPOSES OF GENERAL INFORMATION ONLY AND WILL NOT CREATE ANY WARRANTY NOT EXPRESSLY STATED IN THESE TERMS.

13. Limitation of Liability and Damages.
(a) Limitation of Liability. UNDER NO CIRCUMSTANCES, AND UNDER NO LEGAL THEORY, INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE, SHALL GENBIOPRO OR ITS AFFILIATES, CONTRACTORS, EMPLOYEES, AGENTS, OR THIRD PARTY PARTNERS OR SUPPLIERS, BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, OR EXEMPLARY DAMAGES (INCLUDING WITHOUT LIMITATION, LOSS OF PROFITS, DATA OR USE OR COST OF COVER) ARISING OUT OF OR RELATING TO THE TERMS OR THAT RESULT FROM YOUR USE OR THE INABILITY TO USE THE SITE MATERIALS, THE SITE ITSELF, OR ANY OTHER INTERACTIONS WITH GENBIOPRO EVEN IF GENBIOPRO OR A GENBIOPRO AUTHORIZED REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
(b) Limitation of Damages. IN NO EVENT SHALL GENBIOPRO OR ITS AFFILIATES, CONTRACTORS, EMPLOYEES, AGENTS, OR THIRD PARTY PARTNERS, LICENSORS OR SUPPLIERS’ TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION ARISING OUT OF OR RELATING TO THE TERMS OR YOUR USE OF THE SITE (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), WARRANTY, OR OTHERWISE) EXCEED TWENTY-FIVE DOLLARS ($25 USD).

14. Limitations by Applicable Law; Basis of the Bargain.
(a) Limitations by Applicable Law. CERTAIN JURISDICTIONS DO NOT ALLOW LIMITATIONS ON IMPLIED WARRANTIES OR THE EXCLUSION OR LIMITATION OF CERTAIN DAMAGES. IF YOU RESIDE IN SUCH A JURISDICTION, SOME OR ALL OF THE ABOVE DISCLAIMERS, EXCLUSIONS, OR LIMITATIONS MAY NOT APPLY TO YOU, AND YOU MAY HAVE ADDITIONAL RIGHTS. THE LIMITATIONS OR EXCLUSIONS OF WARRANTIES, REMEDIES, OR LIABILITY CONTAINED IN THE TERMS APPLY TO YOU TO THE FULLEST EXTENT SUCH LIMITATIONS OR EXCLUSIONS ARE PERMITTED UNDER THE LAWS OF THE JURISDICTION IN WHICH YOU ARE LOCATED.
(b) Basis of the Bargain. YOU ACKNOWLEDGE AND AGREE THAT GENBIOPRO HAS PERMITTED YOU TO ACCESS THE SITE IN RELIANCE UPON THE WARRANTY DISCLAIMERS AND THE LIMITATIONS OF LIABILITY SET FORTH HEREIN, THAT THE WARRANTY DISCLAIMERS AND THE LIMITATIONS OF LIABILITY SET FORTH HEREIN REFLECT A REASONABLE AND FAIR ALLOCATION OF RISK BETWEEN YOU AND GENBIOPRO, AND THAT THE WARRANTY DISCLAIMERS AND THE LIMITATIONS OF LIABILITY SET FORTH HEREIN FORM AN ESSENTIAL BASIS OF THE BARGAIN BETWEEN YOU AND GENBIOPRO. YOU ACKNOWLEDGE AND AGREE THAT GENBIOPRO WOULD NOT BE ABLE TO PROVIDE THE SITE TO YOU ON AN ECONOMICALLY REASONABLE BASIS WITHOUT THESE LIMITATIONS.

15. Digital Millennium Copyright Act Compliance.
If You are a copyright owner or an agent thereof, and believe that any third party content on the Site infringes upon Your copyrights, You may submit a notification pursuant to the Digital Millennium Copyright Act (“DMCA”) by providing our Copyright Agent with the following information in writing (see 17 U.S.C § 512(c)(3) for further detail).
(i) A physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed;
(ii) Identification of the copyrighted work claimed to have been infringed, or, if multiple copyrighted works on the Site are covered by a single notification, a representative list of such works from the Site;
(iii) Identification of the material that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled, and information reasonably sufficient to permit GENBIOPRO to locate the material;
(iv) Information reasonably sufficient to permit GENBIOPRO to contact the complaining party, such as an address, telephone number, and, if available, an electronic mail address at which the complaining party may be contacted;
(v) A statement that the complaining party has a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law; and
(vi) A statement that the information in the notification is accurate, and under penalty of perjury, that the complaining party is authorized to act on behalf of the owner of an exclusive right that is allegedly infringed.
GENBIOPRO’s designated Copyright Agent to receive notifications of claimed infringement is:

GenBioPro, Inc.
PO Box 32011
Las Vegas, NV 89103
Email: info@genbiopro.com
Telephone: 1-866-611-4716
Fax: 1-877-239-8036

16. Miscellaneous.
(a) Notice. GENBIOPRO may provide You with notices, including those regarding changes to the Terms, by means of electronic emails or by a general notice on the Site. You may give notice to GENBIOPRO at any time, by letter delivered by first-class postage prepaid U.S mail or overnight courier to the following address:

GenBioPro, Inc.
PO Box 32011
Las Vegas, NV 89103
Email: info@genbiopro.com
Telephone: 1-866-611-4716
Fax: 1-877-239-8036

(b) Governing Law. The Terms shall be governed by and construed in accordance with the laws of the State of Nevada, U.S.A., without giving effect to any principles of conflicts of law.
(c) Jurisdiction. You agree that any action at law or in equity arising out of or relating to the Terms or the Site shall be filed only in the state or federal courts in and for Clark County, Nevada and You hereby consent and submit to the personal and exclusive jurisdiction and venue of such courts for the purposes of litigating any such action.
(d) Waiver. A provision of the Terms may be waived only by a written instrument executed by the party entitled to the benefit of such provision. The failure of GENBIOPRO to exercise or enforce any right or provision of the Terms will not constitute a waiver of such right or provision.
(e) Severability. If any provision of the Terms shall be unlawful, void, or for any reason unenforceable, then that provision shall be deemed severable from the Terms and shall not affect the validity and enforceability of any remaining provisions.
(f) Headings. The heading references herein are for convenience purposes only, do not constitute a part of the Terms, and shall not be deemed to limit or affect any of the provisions hereof.
(g) Claims. YOU AGREE THAT ANY CAUSE OF ACTION BROUGHT BY YOU ARISING OUT OF OR RELATED TO THE SITE MUST COMMENCE WITHIN ONE (1) YEAR AFTER THE CAUSE OF ACTION ACCRUES. OTHERWISE, SUCH CAUSE OF ACTION IS PERMANENTLY BARRED.
(h) The Terms constitutes the sole and entire agreement between you and GENBIOPRO with respect to the Site and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to the Site.
(i) Disclosures. The services and products hereunder are offered by GENBIOPRO , located at PO Box 32011, Las Vegas, NV 89103, email: info@genbiopro.com, Telephone: 1-866-611-4716. If you are a California resident, you may have this same information emailed to you by sending a letter to the foregoing address with your email address and a request for this information.

Last Updated: May 28, 2019

Important Safety Information

Mifepristone tablets, 200mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.


IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING

  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use. No causal relationship between the use of mifepristone and misoprostol and these events has been established.
    • Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.
    • Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.
  • Because of the risks of serious complications described above, mifepristone is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.
  • Before prescribing mifepristone, inform the patient about these risks. Ensure the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.
  • Advise the patient to take the Medication Guide with her if she visits an emergency room or another healthcare provider who did not prescribe mifepristone, so that provider knows that she is undergoing a medical abortion.

 

Contraindications 

  • Administration of mifepristone and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions:
    • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
    • Chronic adrenal failure (risk of acute renal insufficiency)
    • Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
    • History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
    • Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
    • Inherited porphyrias (risk of worsening or of precipitation of attacks)
  • Use of mifepristone and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, mifepristone may be used.

 

Warnings and Precautions

Infection and Sepsis

  • As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of mifepristone. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
  • A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

 

Uterine Bleeding

  • Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
  • Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days.  Up to 8% of all subjects may experience some type of bleeding for 30 days or more.  In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
  • Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in women who bleed heavily.
  • Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.

 

Mifepristone REMS Program

Mifepristone is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program, because of the risks of serious complications. Notable requirements of the mifepristone REMS Program include the following:

  • Prescribers must be certified with the program by completing the Prescriber Agreement Form.
  • Patients must sign a Patient Agreement Form.
  • Mifepristone must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

 

Ectopic Pregnancy

Mifepristone is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

 

Rhesus Immunization

The use of mifepristone is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

 

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.

 

For additional information about mifepristone, click for the Full Prescribing Information, including Boxed Warning.

 

Important Safety Information
Show More

Mifepristone tablets, 200mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING

  • Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use. No causal relationship between the use of mifepristone and misoprostol and these events has been established.
    • Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. A high index of suspicion is needed to rule out serious infection and sepsis.
    • Bleeding. Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.
  • Because of the risks of serious complications described above, mifepristone is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.
  • Before prescribing mifepristone, inform the patient about these risks. Ensure the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.
  • Advise the patient to take the Medication Guide with her if she visits an emergency room or another healthcare provider who did not prescribe mifepristone, so that provider knows that she is undergoing a medical abortion.

 

Contraindications 

  • Administration of mifepristone and misoprostol for the termination of pregnancy is contraindicated in patients with any of the following conditions:
    • Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
    • Chronic adrenal failure (risk of acute renal insufficiency)
    • Concurrent long-term corticosteroid therapy (risk of acute renal insufficiency)
    • History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
    • Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
    • Inherited porphyrias (risk of worsening or of precipitation of attacks)
  • Use of mifepristone and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, mifepristone may be used.

 

Warnings and Precautions

Infection and Sepsis

  • As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of mifepristone. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
  • A high index of suspicion is needed to rule out sepsis if a patient reports abdominal pain, discomfort, or general malaise (including weakness, nausea, vomiting or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise.

 

Uterine Bleeding

  • Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
  • Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days.  Up to 8% of all subjects may experience some type of bleeding for 30 days or more.  In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
  • Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in women who bleed heavily.
  • Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.

 

Mifepristone REMS Program

Mifepristone is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program, because of the risks of serious complications. Notable requirements of the mifepristone REMS Program include the following:

  • Prescribers must be certified with the program by completing the Prescriber Agreement Form.
  • Patients must sign a Patient Agreement Form.
  • Mifepristone must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

 

Ectopic Pregnancy

Mifepristone is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

 

Rhesus Immunization

The use of mifepristone is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.

 

Adverse Reactions

Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.

 

For additional information about mifepristone, click for the Full Prescribing Information, including Boxed Warning.