MIFEPRISTONE MEDICATION ABORTION: PATIENT INFORMATION & AGREEMENT

This is the exact language that is in the Danco Laboratories written materials.

Medication Guide

MIFEPREX® (MIF-eh-prex)
(mifepristone)

Read this information carefully before taking Mifeprex* and misoprostol. It will help you understand how the treatment works. This MEDICATION GUIDE does not take the place of talking with your health care provider (provider).


What is Mifeprex?

Mifeprex is used to end an early pregnancy. It blocks a hormone needed for your pregnancy to continue. It is not approved for ending later pregnancies. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period began. When you use Mifeprex (Day 1), you also need to take another medicine misoprostol, 2 days after you take Mifeprex (Day 3), to end your pregnancy. But, about 5-8 out of 100 women taking Mifeprex will need a surgical procedure to end the pregnancy or to stop too much bleeding.


What is the most important information I should know about Mifeprex?

What symptoms should I be concerned with? Although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth. Prompt medical attention is needed in these circumstances. Serious infection has resulted in death in a very small number of cases in which misoprostol was used in the vagina. There is no information that vaginal use of misoprostol caused these deaths. If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your provider. Your provider’s telephone number is ________________.

Be sure to contact your provider promptly if you have any of the following:

Heavy Bleeding. Contact your provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (surgical abortion/D&C) to stop it.

Abdominal Pain or “Feeling Sick”. If you have abdominal pain or discomfort, or you are “feeling sick”, including weakness, nausea, vomiting, or diarrhea, with or without fever, more than 24 hours after taking misoprostol, you should contact your provider without delay. These symptoms may be a sign of a serious infection or another problem (including an ectopic pregnancy, a pregnancy outside the womb.)

Fever. In the days after treatment, if you have a fever of 100.4°F or higher that lasts for more than 4 hours, you should contact your provider right away. Severe abdominal pain or fever may be a symptom of a serious infection or another problem (including an ectopic pregnancy.).

Take this MEDICATION GUIDE with you. When you visit an emergency room or a provider who did not give you your Mifeprex, you should give them your MEDICATION GUIDE so that they understand that you are having a medical abortion with Mifeprex.

What to do if you are still pregnant after Mifeprex with misoprostol treatment. If you are still pregnant, your provider will talk with you about the other choices you have, including a surgical procedure to end your pregnancy. There is a chance that there may be birth defects if the pregnancy is not ended.

Talk with your provider. Before you take Mifeprex, you should read this MEDICATION GUIDE and sign a statement (PATIENT AGREEMENT). You and your provider should discuss the benefits and risks of your using Mifeprex.


Who should not take Mifeprex?

Some women should not take Mifeprex. Do not take it if:

  • It has been more than 49 days (7 weeks) since your last menstrual period began.
  • You have an IUD. It must be taken out before you take Mifeprex.
  • Your provider has told you that you have a pregnancy outside the uterus (ectopic pregnancy).
  • You have problems with your adrenal glands (chronic adrenal failure).
  • You take a medicine to thin your blood.
  • You have a bleeding problem.
  • You take certain steroid medicines.
  • You cannot return for the next 2 visits.
  • You cannot easily get emergency medical help in the 2 weeks after you take Mifeprex.
  • You are allergic to mifepristone, misoprostol, or medicines that contain misoprostol, such as Cytotec or Arthrotec.

Tell your provider about all your medical conditions to find out if you can take Mifeprex. Also, tell your provider if you smoke at least 10 cigarettes a day.


How should I take Mifeprex?

Day 1 at your provider’s office:

  • Read this MEDICATION GUIDE.
  • Discuss the benefits and risks of using Mifeprex to end your pregnancy.
  • If you decide Mifeprex is right for you, sign the PATIENT AGREEMENT.
  • After getting a physical exam, swallow 3 tablets of Mifeprex.

Day 3 at your provider’s office:

  • If you are still pregnant, take 2 misoprostol tablets.
  • Misoprostol may cause cramps, nausea, diarrhea, and other symptoms.
  • Your provider may send you home with medicines for these symptoms.

About Day 14 at your provider’s office:

  • This follow-up visit is very important. You must return to the provider about 14 days after you have taken Mifeprex to be sure you are well and that you are not pregnant.
  • Your provider will check whether your pregnancy has completely ended. If it has not ended, there is a chance that there may be birth defects. If you are still pregnant, your provider will talk with you about the other choices you have, including a surgical procedure to end your pregnancy.

What should I avoid while taking Mifeprex and misoprostol?

Do not take any other prescription or non-prescription medicines (including herbal medicine or supplements) at any time during the treatment period without first asking your provider about them because they may interfere with the treatment. Ask your provider about what medicines you can take for pain.

If you are breastfeeding at the time you take Mifeprex and misoprostol, discuss with your provider if you should stop breastfeeding for a few days.


What are the possible and reasonably likely side effects of Mifeprex?

Cramping and bleeding are expected with this treatment. Usually, these symptoms mean that the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about Day 14. See “How should I take Mifeprex?” for more information on when to return to your provider. If you are not already bleeding after taking Mifeprex, you probably will begin to bleed once you take misoprostol, the medicine you take on Day 3. Bleeding or spotting can be expected for an average of 9-16 days and may last for up to 30 days. Your bleeding may be similar to, or greater than, a normal heavy period. You may see blood clots and tissue. This is an expected part of ending the pregnancy.

Other common symptoms of treatment include diarrhea, nausea, vomiting, headache, dizziness, back pain, and tiredness. These side effects lessen after Day 3 and are usually gone by Day 14. Your provider will tell you how to manage any pain or other side effects.


When should I begin birth control?

You can become pregnant again right after your pregnancy ends. If you do not want to become pregnant again, start using birth control as soon as your pregnancy ends or before you start having sexual intercourse again.


Medicines are sometimes prescribed for purposes other than those listed in a MEDICATION GUIDE. For more information, ask your provider for the information about Mifeprex that is written for health care professionals. Ask your provider if you have any questions.

This MEDICATION GUIDE has been approved by the U.S. Food and Drug Administration. Revised 7/19/05

PATIENT AGREEMENT

Mifeprex (mifepristone) Tablets

  1. I have read the attached MEDICATION GUIDE for using Mifeprex and misoprostol to end my pregnancy.
  2. I discussed the information with my health care provider (provider).
  3. My provider answered all my questions and told me about the risks and benefits of using Mifeprex and misoprostol to end my pregnancy.
  4. I believe I am no more than 49 days (7 weeks) pregnant.
  5. I understand that I will take Mifeprex in my provider’s office (Day 1).
  6. I understand that I will take misoprostol in my provider’s office two days after I take Mifeprex (Day 3).
  7. My provider gave me advice on what to do if I develop heavy bleeding or need emergency care due to the treatment.
  8. Bleeding and cramping do not mean that my pregnancy has ended. Therefore, I must return to my provider’s office in about 2 weeks (about Day 14) after I take Mifeprex to be sure that my pregnancy has ended and that I am well.
  9. I know that in some cases, the treatment will not work. This happens in about 5 to 8 women out of 100 who use this treatment.
  10. I understand that if my pregnancy continues after any part of the treatment, there is a chance that there may be birth defects. If my pregnancy continues after treatment with Mifeprex and misoprostol, I will talk with my provider about my choices, which may include a surgical procedure to end my pregnancy.
  11. I understand that if the medicines I take do not end my pregnancy and I decide to have a surgical procedure to end my pregnancy, or if I need a surgical procedure to stop bleeding, my provider will do the procedure or refer me to another provider who will. I have that provider’s name, address and phone number.
  12. I have my provider’s name, address and phone number and know that I can call if I have any questions or concerns.
  13. I have decided to take Mifeprex and misoprostol to end my pregnancy and will follow my provider’s advice about when to take each drug and what to do in an emergency.
  14. I will do the following:
  • contact my provider right away if in the days after treatment I have a fever of 100.4°F or higher that lasts for more than 4 hours or severe abdominal pain.
  • contact my provider right away if I have heavy bleeding (soaking through two thick full-size sanitary pads per hour for two consecutive hours).
  • contact my provider right away if I have abdominal pain or discomfort, or am “feeling sick”, including weakness, nausea, vomiting, or diarrhea, more than 24 hours after taking misoprostol
  • take the MEDICATION GUIDE with me when I visit an emergency room or a provider who did not give me Mifeprex, so that they will understand that I have a medical abortion with Mifeprex.
  • return to my provider’s office in 2 days (Day 3) to check if my pregnancy has ended. My provider will give me misoprostol if I am still pregnant.
  • return to my provider’s office about 14 days after beginning treatment to be sure that my pregnancy has ended and that I am well.


Alternative Treatment Plans for Mifeprex (Mifepristone)

This document can be used if the patient is choosing the alternative regimen of mifepristone/misoprostol. The patient signs the patient agreement and alternative treatment plan. One copy is given to the patient and one copy is put in the chart

I understand that I am required to sign this form if I want Mifeprex. I also understand that the [Your Health Center Name Here]uses an alternative approach to medical abortion that is supported by research. This alternative approach allows women up to 8 weeks pregnant to participate. The medication doses and way misoprostol is given (put in the cheek to dissolve rather than swallowed) are different and the follow-up visit after misoprostol is sooner.

In research studies, other ways of using mifepristone and misoprostol for medical abortion have been shown to be equally safe and effective (or more effective.) We offer the following alternative regimen for using Mifeprex:

A.    Medication Dosing Changes:

  1. A lower dose of 200 mg of Mifeprex (one pill) will be used instead of the 600 mg (three pills) dose recommended on the package. The lower dose has been shown to be equally effective, have less side effects, and is less expensive.
  2. The dose of misoprostol will be 800 mcg (four pills) instead of two pills and they are put inside the cheek to dissolve (called “buccal”) instead of swallowed. The combination of 200 mg of Mifeprex (mifepristone) by mouth and 800 mcg of buccal misoprostol has been shown to:
    Cause less nausea and vomiting.
    Be equally effective at ending early pregnancy.
    Be acceptable to women
    Be effective up to 8 weeks pregnant
    Be effective when used as early as 24 hours after taking the mifepristone

B.    Choosing to take the Second Medication (misoprostol) at Home

Studies have shown that women can use the second drug (misoprostol) at home without a health care provider being present. Misoprostol at home has been found to be safe, effective and acceptable to women. Most women abort within 2 to 24 hours (average is 4 hours) after taking the second drug, misoprostol. Women in studies preferred to take their misoprostol at home because of privacy, convenience, control, and comfort, among other reasons. Most women reported that the bleeding and cramping following misoprostol were managed at home more comfortably and conveniently. We offer Ibuprofen 800 mg and Acetaminophen/hydrocodone 500mg/5mg for pain relief.

C.    Follow-Up Care

Using this alternative regimen above, patients can return sooner for confirmation that the pregnancy has been successfully terminated. If you choose this alternative method, you do not need to come to the office on day 3; you can return between Day 4 and 14 for your follow-up visit.


I request the following alternative treatment plan for my medical abortion..

Alternative Treatment Plan
Please initial

____ My medication will be a 200 mg dose of Mifeprex (mifepristone) by mouth and 800 mcg of misoprostol buccally. I will use the misoprostol at home myself on the date specified on my information sheet. I will return from 1 to 2 weeks after using mifepristone.
I have been given information about different methods of taking Mifeprex and misoprostol to end my pregnancy. I have read and understood the treatment plan described in the Medication Guide and Patient Agreement above provided in the Mifeprex (mifepristone) labeling approved by the FDA. I understand the alternative options for taking Mifeprex (mifepristone) using the alternative treatment plan above. These alternative methods have been studied extensively and found to be as safe and effective as the method approved by the FDA. My provider has answered all of my questions about the different methods of taking Mifeprex and misoprostol.

Based on this information, I have chosen the method that is the best choice for me. I have indicated that choice by my initials in the box above. I understand that my choice is a change from the method approved by the FDA as stated in the Patient Agreement required by the FDA. By signing below, I consent to the treatment plan I have initialed above.

Patient Signature:_______________________________________________

Patient Name (print):_____________________________________________

Date:__________________________

The patient signed the PATIENT AGREEMENT in my presence after I counseled her and answered all her questions. I have given her the MEDICATION GUIDE for mifepristone, and a patient instruction sheet.

Provider’s Signature: ______________________________________________

Name of Provider (print): ___________________________________________

Date: ___________________________

After the patient and the provider sign this PATIENT AGREEMENT, give 1 copy to the patient before she leaves the office and put 1 copy in her medical record. Give a copy of the MEDICATION GUIDE to the patient.


PATIENT COPY

Alternative Treatment Plans for Mifeprex (Mifepristone)

I understand that I am required to sign this form if I want Mifeprex. I also understand that [Your Health Center Name Here]uses an alternative approach to medical abortion that is supported by research. This alternative approach allows women up to 8 weeks pregnant to participate. The medication doses and way misoprostol is given (put in the cheek to dissolve rather than swallowed) are different and the follow-up visit after misoprostol is sooner.

In research studies, other ways of using mifepristone and misoprostol for medical abortion have been shown to be equally safe and effective (or more effective.) We offer the following alternative regimen for using Mifeprex:

A.    Medication Dosing Changes:

  1. A lower dose of 200 mg of Mifeprex (one pill) will be used instead of the 600 mg (three pills) dose recommended on the package. The lower dose has been shown to be equally effective, have less side effects, and is less expensive.
  2. The dose of misoprostol will be 800 mcg (four pills) instead of two pills and they are put inside the cheek to dissolve (called “buccal”) instead of swallowed. The combination of 200 mg of Mifeprex (mifepristone) by mouth and 800 mcg of misoprostol bucally has been shown to:
    Cause less nausea and vomiting.
    Be equally effective at ending early pregnancy.
    Be acceptable to women
    Be effective up to 8 weeks pregnant.
    Be effective when used as early as 24 hours after taking the mifepristone.

B.    Choosing to take the Second Medication (misoprostol) at Home

Studies have shown that women can use the second drug (misoprostol) at home without a health care provider being present. Misoprostol at home has been found to be safe, effective and acceptable to women. Most women abort within 2 to 24 hours (average is 4 hours) after taking the second drug, misoprostol. Women in studies preferred to take their misoprostol at home because of privacy, convenience, control, and comfort, among other reasons. Most women reported that the bleeding and cramping following misoprostol were managed at home more comfortably and conveniently. We offer Ibuprofen 800 mg and Acetaminophen/hydrocodone 500mg/5mg for pain relief.

C.    Follow-Up Care

Using this alternative regimen above, patients can return sooner for confirmation that the pregnancy has been successfully terminated. If you choose this alternative method, you do not need to come to the office on day 3; you can return between Day 4 and 14 for your follow-up visit.


I request the following alternative treatment plan for my medical abortion.

Alternative Treatment Plan
Please initial

____ My medication will be a 200 mg dose of Mifeprex (mifepristone) by mouth and 800 mcg of misoprostol buccally. I will use the misoprostol at home myself on the date specified on my information sheet. I will return from 1 to 2 weeks after using mifepristone.

I have been given information about different methods of taking Mifeprex and misoprostol to end my pregnancy. I have read and understood the treatment plan described in the Medication Guide and Patient Agreement above provided in the Mifeprex (mifepristone) labeling approved by the FDA. I understand the alternative options for taking Mifeprex (mifepristone) using the alternative treatment plan above. These alternative methods have been studied extensively and found to be as safe and effective as the method approved by the FDA. My provider has answered all of my questions about the different methods of taking Mifeprex and misoprostol.

Based on this information, I have chosen the method that is the best choice for me. I have indicated that choice by my initials in the box above. I understand that my choice is a change from the method approved by the FDA as stated in the Patient Agreement required by the FDA. By signing below, I consent to the treatment plan I have initialed above.

Patient Signature:_______________________________________________

Patient Name (print):_____________________________________________

Date:__________________________

The patient signed the PATIENT AGREEMENT in my presence after I counseled her and answered all her questions. I have given her the MEDICATION GUIDE for mifepristone, and a patient instruction sheet.

Provider’s Signature: ______________________________________________

Name of Provider (print): ___________________________________________

Date: ___________________________

After the patient and the provider sign this PATIENT AGREEMENT, give 1 copy to the patient before she leaves the office and put 1 copy in her medical record. Give a copy of the MEDICATION GUIDE to the patient.