Amnesteem

Name: Amnesteem

Amnesteem Overview

Amnesteem is a prescription medication used to treat the most severe form of acne called nodular acne. Amnesteem belongs to a group of drugs called retinoids. It is thought to work by preventing oil production in glands under the skin.

This medication comes in capsule form and is usually taken twice daily, with food. Amnesteem may be taken for four or five months. A longer periods of use is not recommended.

Common side effects of Amnesteem include dry skin, chapped lips, dry eyes, or dry nose causing nosebleeds. Amnesteem can also cause birth defects, miscarriages, or premature births.

Because Amnesteem can cause birth defects, patients, doctors, and pharmacies must be registered with a special distribution program called the iPLEDGE program.

Side Effects of Amnesteem

Serious side effects have been reported with Amnesteem. See “Amnesteem Precautions” section.

Common side effects of Amnesteem may include the following:

  • dry skin
  • chapped lips
  • dry eyes
  • dry nose that may lead to nosebleeds

Call your doctor if you get any side effect that bothers you or that does not go away.

Amnesteem Interactions

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Amnesteem and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:

  • Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Amnesteem. Taking both together may increase your chance of getting side effects.
  • tetracycline antibiotics such as doxycycline, tetracycline, or minocycline (Minocin)
  • progestin-only birth control pills (mini-pills) such as Camilla, and Norethindrone
  • Dilantin (phenytoin)
  • corticosteroids such as dexamethasone, hydrocortisone, or fludrocortisone (Florinef)
  • St. John’s wort

These medicines should not be used with Amnesteem unless your doctor tells you it is okay.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.

Inform MD

Tell your doctor if you have any of the following health conditions:

  • mental problems
  • asthma
  • liver disease
  • diabetes
  • heart disease
  • bone loss (osteoporosis) or weak bones
  • an eating problem called anorexia nervosa (where people eat too little)
  • food or medicine allergies

Tell your doctor if you are pregnant or breastfeeding. Amnesteem must not be used by women who are pregnant or breastfeeding.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Amnesteem and certain other medicines can interact with each other, sometimes causing serious side effects.

Amnesteem Usage

Take Amnesteem exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Amnesteem, your doctor will:

  • explain the iPLEDGE program to you
  • have you sign the Patient Information/Informed Consent form (for all patients). Female patients who can get pregnant must also sign another consent form.

You will not be prescribed Amnesteem if you cannot agree to or follow all the instructions of the iPLEDGE program.

  • You will get no more than a 30 day supply of Amnesteem at a time. This is to make sure you are following the iPLEDGE program. You should talk with your doctor each month about side effects.
  • The amount of Amnesteem you take has been specially chosen for you. It is based on your body weight, and may change during treatment.
  • Take Amnesteem 2 times a day with a meal, unless your doctor tells you otherwise. Swallow your Amnesteem capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Amnesteem can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole.
  • If you miss a dose, just skip that dose. Do not take two doses at the same time.
  • If you take too much Amnesteem or overdose, call your doctor or poison control center right away.
  • Your acne may get worse when you first start taking Amnesteem. This should last only a short while. Talk with your doctor if this is a problem for you.
  • You must return to your doctor as directed to make sure you don’t have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Amnesteem. Female patients who can get pregnant will get a pregnancy test each month.
  • Female patients who can get pregnant must agree to use two separate forms of effective birth control at the same time one month before, while taking and for one month after taking Amnesteem. You must access the iPLEDGE system to answer questions about the program requirements and to enter your two chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654.

You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Amnesteem.

If you have sex at any time without using two forms of effective birth control, get pregnant or miss your expected period, stop using Amnesteem and call your doctor right away.

What you should avoid while taking Amnesteem:

  • Do not get pregnant while taking Amnesteem and for one month after stopping Amnesteem. See “Amnesteem Precautions" section.
  • Do not breastfeed while taking Amnesteem and for one month after stopping Amnesteem. It is not known if Amnesteem can pass through your milk and harm the baby.
  • Do not give blood while you take Amnesteem and for one month after stopping Amnesteem. If someone who is pregnant gets your donated blood, her baby may be exposed to Amnesteem and may be born with birth defects.
  • Do not take other medicines or herbal products with Amnesteem unless you talk to your doctor.
  • Do not drive at night until you know if Amnesteem has affected your vision. Amnesteem may decrease your ability to see in the dark.
  • Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Amnesteem and for at least 6 months after you stop. Amnesteem can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
  • Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Amnesteem may make your skin more sensitive to light.
  • Do not share Amnesteem with other people. It can cause birth defects and other serious health problems.

Amnesteem FDA Warning

CONTRAINDICATIONS AND WARNINGS

Amnesteem must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Amnesteem in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.

Birth defects which have been documented following Amnesteem exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion and premature births have been reported.

Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.

If pregnancy does occur during treatment of a female patient who is taking Amnesteem, Amnesteem must be discontinued immediately and she should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.

Special Prescribing Requirements

Because of Amnesteem’s teratogenicity and to minimize fetal exposure, Amnesteem is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE™. Amnesteem must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Amnesteem must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE 

What should I discuss with my healthcare provider before taking Amnesteem (isotretinoin)?

Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.

For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. You must have a negative pregnancy test before you start taking isotretinoin. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

  • tubal ligation (tubes tied);

  • vasectomy of the male sexual partner;

  • an IUD (intrauterine device);

  • estrogen-containing birth control pills (not mini-pills); and

  • hormonal birth control patches, implants, injections, or vaginal ring.

Secondary forms of birth control include:

  • a male latex condom with or without spermicide;

  • a diaphragm plus a spermicide;

  • a cervical cap plus a spermicide; and

  • a vaginal sponge containing a spermicide.

Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.

Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.

You should not use isotretinoin if you are allergic to it.

To make sure isotretinoin is safe for you, tell your doctor if you have:

  • a history of depression or mental illness;

  • asthma;

  • liver disease;

  • diabetes;

  • heart disease or high cholesterol;

  • osteoporosis or low bone mineral density;

  • an eating disorder such as anorexia;

  • an intestinal disorder such as inflammatory bowel disease, ulcerative colitis, or Crohn's disease; or

  • a food or drug allergy.

It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States. The sale and distribution of isotretinoin outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.

It is not known whether isotretinoin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Isotretinoin is not approved for use by anyone younger than 12 years old.

Commonly used brand name(s)

In the U.S.

  • Absorica
  • Accutane
  • Amnesteem
  • Claravis
  • Myorisan
  • Sotret
  • Zenatane

Available Dosage Forms:

  • Capsule
  • Capsule, Liquid Filled

Therapeutic Class: Antiacne

Chemical Class: Retinoid

Overdosage

The oral LD50 of isotretinoin is greater than 4000 mg/kg in rats and mice (> 600 times the recommended clinical dose of 1 mg/kg/day after normalization of the rat dose for total body surface area and > 300 times the recommended clinical dose of 1 mg/kg/day after normalization of the mouse dose for total body surface area) and is approximately 1960 mg/kg in rabbits (653 times the recommended clinical dose of 1 mg/kg/day after normalization for total body surface area). In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness and ataxia. These symptoms quickly resolve without apparent residual effects.

Amnesteem causes serious birth defects at any dosage (see Boxed CONTRAINDICATIONS AND WARNINGS). Females of reproductive potential who present with isotretinoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus, as described in the Boxed CONTRAINDICATIONS AND WARNINGS. Non-pregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling as described in PRECAUTIONS. Educational materials for such patients can be obtained by calling the manufacturer. Because an overdose would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for one month after the overdose. All patients with isotretinoin overdose should not donate blood for at least one month.

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