For all patients:
Isotretinoin must not be taken by patients who are pregnant or who may become pregnant. There is a high risk that isotretinoin will cause loss of the pregnancy, or will cause the baby to be born too early, to die shortly after birth, or to be born with birth defects (physical problems that are present at birth).
A program called iPLEDGE has been set up to make sure that pregnant women do not take isotretinoin and that women do not become pregnant while taking isotretinoin. All patients, including women who cannot become pregnant and men, can get isotretinoin only if they are registered with iPLEDGE, have a prescription from a doctor who is registered with iPLEDGE and fill the prescription at a pharmacy that is registered with iPLEDGE. Do not buy isotretinoin over the internet.
You will receive information about the risks of taking isotretinoin and must sign an informed consent sheet stating that you understand this information before you can receive the medication. You will need to see your doctor every month during your treatment to talk about your condition and the side effects you are experiencing. At each visit, your doctor may give you a prescription for up to a 30-day supply of medication with no refills. If you are a woman who can become pregnant, you will also need to have a pregnancy test in an approved lab each month and have your prescription filled and picked up within 7 days of your pregnancy test. If you are a man or if you are a woman who cannot become pregnant, you must have this prescription filled and picked up within 30 days of your doctor visit. Your pharmacist cannot dispense your medication if you come to pick it up after the allowed time period has passed.
Tell your doctor if you do not understand everything you were told about isotretinoin and the iPLEDGE program or if you do not think you will be able to keep appointments or fill your prescription on schedule every month.
Your doctor will give you an identification number and card when you start your treatment. You will need this number to fill your prescriptions and to get information from the iPLEDGE website and phone line. Keep the card in a safe place where it will not get lost. If you do lose your card, you can ask for a replacement through the website or phone line.
Do not donate blood while you are taking isotretinoin and for 1 month after your treatment.
Do not share isotretinoin with anyone else, even someone who has the same symptoms that you have.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with isotretinoin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (//www.fda.gov/Drugs), the manufacturer's website, or the iPLEDGE program website (//www.ipledgeprogram.com) to obtain the Medication Guide.
Talk to your doctor about the risks of taking isotretinoin.
For female patients:
If you can become pregnant, you will need to meet certain requirements during your treatment with isotretinoin. You need to meet these requirements even if you have not started menstruating (having monthly periods) or have had a tubal ligation ('tubes tied'; surgery to prevent pregnancy). You may be excused from meeting these requirements only if you have not menstruated for 12 months in a row and your doctor says you have passed menopause (change of life) or you have had surgery to remove your uterus and/or both ovaries. If none of these are true for you, then you must meet the requirements below.
You must use two acceptable forms of birth control for 1 month before you begin to take isotretinoin, during your treatment and for 1 month after your treatment. Your doctor will tell you which forms of birth control are acceptable and will give you written information about birth control. You can also have a free visit with a doctor or family planning expert to talk about birth control that is right for you. You must use these two forms of birth control at all times unless you can promise that you will not have any sexual contact with a male for 1 month before your treatment, during your treatment, and for 1 month after your treatment.
If you choose to take isotretinoin, it is your responsibility to avoid pregnancy for 1 month before, during, and for 1 month after your treatment. You must understand that any form of birth control can fail. Therefore, it is very important to decrease the risk of accidental pregnancy by using two forms of birth control at all times. Tell your doctor if you do not understand everything you were told about birth control or you do not think that you will be able to use two forms of birth control at all times.
If you plan to use oral contraceptives (birth control pills) while taking isotretinoin, tell your doctor the name of the pill you will use. Isotretinoin interferes with the action of micro-dosed progestin ('minipill') oral contraceptives (Ovrette, Micronor, Nor-QD). Do not use this type of birth control while taking isotretinoin.
If you plan to use hormonal contraceptives (birth control pills, patches, implants, injections, rings, or intrauterine devices), be sure to tell your doctor about all the medications, vitamins, and herbal supplements you are taking. Many medications interfere with the action of hormonal contraceptives. Do not take St. John's wort if you are using any type of hormonal contraceptive.
You must have two negative pregnancy tests before you can begin to take isotretinoin. Your doctor will tell you when and where to have these tests. You will also need to be tested for pregnancy in a laboratory each month during your treatment, when you take your last dose and 30 days after you take your last dose.
You will need to contact the iPLEDGE system by phone or the internet every month to confirm the two forms of birth control you are using and to answer two questions about the iPLEDGE program. You will only be able to continue to get isotretinoin if you have done this, if you have visited your doctor to talk about how you are feeling and how you are using your birth control and if you have had a negative pregnancy test within the past 7 days.
Stop taking isotretinoin and call your doctor right away if you think you are pregnant, you miss a menstrual period, or you have sex without using two forms of birth control. If you become pregnant during your treatment or within 30 days after your treatment, your doctor will contact the iPLEDGE program, the manufacturer of isotretinoin, and the Food and Drug Administration (FDA). You will also talk with a doctor who specializes in problems during pregnancy who can help you make choices that are best for you and your baby. Information about your health and your baby's health will be used to help doctors learn more about the effects of isotretinoin on unborn babies.
For male patients:
A very small amount of isotretinoin will probably be present in your semen when you take prescribed doses of this medication. It is not known if this small amount of isotretinoin may harm the fetus if your partner is or becomes pregnant. Tell your doctor if your partner is pregnant, plans to become pregnant, or becomes pregnant during your treatment with isotretinoin.
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May or may not be due to the method.
- Problems with side effects affect women’s satisfaction and use of COCs. They deserve the provider’s attention. If the client reports side effects or problems, listen to her concerns, give her advice, and support, and, if appropriate, treat. Make sure she understands the advice and agrees.
- Encourage her to keep taking a pill every day even if she has side effects. Missing pills can risk pregnancy and may make some side effects worse.
- Many side effects will subside after a few months of use. For a woman whose side effects persist, give her a different COC formulation, if available, for at least 3 months.
- Offer to help the client choose another method—now, if she wishes, or if problems cannot be overcome.
Missed pills
- See Managing Missed Pills.
Irregular bleeding (bleeding at unexpected times that bothers the client)
- Reassure her that many women using COCs experience irregular bleeding. It is not harmful and usually becomes less or stops after the first few months of use.
- Other possible causes of irregular bleeding include:
- To reduce irregular bleeding:
- Urge her to take a pill each day and at the same time each day.
- Teach her to make up for missed pills properly, including after vomiting or diarrhea (see Managing Missed Pills).
- For modest short-term relief, she can try 800 mg ibuprofen 3 times daily after meals for 5 days or other nonsteroidal anti-inflammatory drug (NSAID), beginning when irregular bleeding starts. NSAIDs provide some relief of irregular bleeding for implants, progestin-only injectables, and IUDs, and they may also help for COCs.
- If she has been taking the pills for more than a few months and NSAIDs do not help, give her a different COC formulation, if available. Ask her to try the new pills for at least 3 months.
- If irregular bleeding continues or starts after several months of normal or no monthly bleeding, or you suspect that something may be wrong for other reasons, consider underlying conditions unrelated to method use (see Unexplained vaginal bleeding).
No monthly bleeding
- Ask if she is having any bleeding at all. (She may have just a small stain on her underclothing and not recognize it as monthly bleeding.) If she is, reassure her.
- Reassure her that some women using COCs stop having monthly bleeding, and this is not harmful.There is no need to lose blood every month. It is similar to not having monthly bleeding during pregnancy. She is not pregnant or infertile. Blood is not building up inside her. (Some women are happy to be free from monthly bleeding, and for some women this may help prevent anemia.)
- Ask if she has been taking a pill every day. If so, reassure her that she is not likely to be pregnant. She can continue taking her COCs as before.
- Did she skip the 7-day break between packs (21-day packs) or skip the 7 nonhormonal pills (28-day pack)? If so, reassure her that she is not pregnant. She can continue using COCs.
- If she has missed hormonal pills or started a new pack late:
- She can continue using COCs.
- Tell a woman who has missed 3 or more pills or started a new pack 3 or more days late to return if she has signs and symptoms of early pregnancy.
- See instructions on how to make up for missed pills.
Ordinary headaches (nonmigrainous)
- Try the following (one at a time):
- Suggest aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever.
- Some women get headaches during the hormone-free week (the 7 days a woman does not take hormonal pills). Consider extended use (see Extended and Continuous Use of Combined Oral Contraceptives).
- Any headaches that get worse or occur more often during COC use should be evaluated.
Nausea or dizziness
- For nausea, suggest taking COCs at bedtime or with food.
If symptoms continue:
Breast tenderness
- Recommend that she wear a supportive bra (including during strenuous activity and sleep).
- Try hot or cold compresses.
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Suggest aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever.
- Consider locally available remedies.
Weight change
- Review diet and counsel as needed.
Mood changes or changes in sex drive
- Some women have changes in mood during the hormone-free week (the 7 days when a woman does not take hormonal pills). Consider extended use (see Extended and Continuous Use of Combined Oral Contraceptives).
- Ask about changes in her life that could affect her mood or sex drive, including changes in her relationship with her partner. Give her support as appropriate.
- Clients who have serious mood changes such as major depression should be referred for care.
- Consider locally available remedies.
Acne
- Acne usually improves with COC use. It may worsen for a few women.
- If she has been taking pills for more than a few months and acne persists, give her a different COC formulation, if available. Ask her to try the new pills for at least 3 months.
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Consider locally available remedies.
New Problems That May Require Switching Methods
May or may not be due to the method.
Unexplained vaginal bleeding (that suggests a medical condition not related to the method) or heavy or prolonged bleeding
- Refer or evaluate by history and pelvic examination. Diagnose and treat as appropriate.
- She can continue using COCs while her condition is being evaluated.
-
If bleeding is caused by sexually transmitted infection or pelvic inflammatory disease, she can continue using COCs during treatment.
Starting treatment with anticonvulsants, rifampicin, or rifabutin
- Barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, and rifabutin may make COCs, patch, and combined vaginal ring less effective. Combined hormonal methods, including combined pills and monthly injectables, may make lamotrigine less effective. If using these medications long-term, she may want a different method, such as a progestin-only injectable, implant, a copper-bearing IUD, or an LNG-IUD.
- If using these medications short-term, she can use a backup method along with COCs for greater protection from pregnancy.
Migraine headaches (see Identifying Migraine Headaches and Auras)
- Regardless of her age, a woman who develops migraine headaches, with or without aura, or whose migraine headaches become worse while using COCs should stop using COCs.
- Help her choose a method without estrogen.
Circumstances that will keep her from walking for one week or more
- If she is having major surgery, or her leg is in a cast, or for other reasons she will be unable to move about for several weeks, she should:
- Tell her doctors that she is using COCs.
- Stop taking COCs and use a backup method during this period.
- Restart COCs 2 weeks after she can move about again.
Certain serious health conditions (suspected heart or serious liver disease, high blood pressure, blood clots in deep veins of legs or lungs, stroke, breast cancer, damage to arteries, vision, kidneys, or nervous system caused by diabetes, or gallbladder disease). See Signs and Symptoms of Serious Health Conditions.
- Tell her to stop taking COCs.
- Give her a backup method to use until the condition is evaluated.
- Refer for diagnosis and care if not already under care.
Suspected pregnancy
- Assess for pregnancy.
- Tell her to stop taking COCs if pregnancy is confirmed.
- There are no known risks to a fetus conceived while a woman is taking COCs (see Question 5).