What is isotretinoin?

Isotretinoin is a form of vitamin A that is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Isotretinoin is available only from a certified pharmacy under a special program called iPLEDGE.

Isotretinoin may also be used for purposes not listed in this medication guide.

Isotretinoin side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Isotretinoin may cause serious side effects. Stop using isotretinoin and call your doctor at once if you have:

• problems with your vision or hearing;
• muscle or joint pain, bone pain, back pain;
• increased thirst, increased urination;
• hallucinations, (see or hearing things that are not real);
• symptoms of depression–unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
• signs of liver or pancreas problems–loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
• severe stomach problems–severe stomach or chest pain, pain when swallowing, heartburn, diarrhea, rectal bleeding, bloody or tarry stools; or
• increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects of isotretinoin may include:

• dryness of your skin, lips, eyes, or nose (you may have nosebleeds);
• vision problems;
• headache, back pain, joint pain, muscle problems;
• skin reactions; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Isotretinoin in just a single dose can cause severe birth defects or death of a baby. Never use isotretinoin if you are pregnant or able to become pregnant.

You must have a negative pregnancy test before taking isotretinoin. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using isotretinoin and call your doctor at once if you think you might be pregnant.

Before taking this medicine

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 or able to become 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 able to get pregnant. You must have 2 negative pregnancy tests before you start taking isotretinoin, 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.

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.

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

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

Tell your doctor if you have ever had:

• 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;
• a food or drug allergy; or
• an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.

Do not breastfeed.

Not approved for use by anyone younger than 12 years old.

How should I take isotretinoin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Each prescription of isotretinoin must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.

Always take isotretinoin with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.

Follow all directions about taking isotretinoin with or without food.

Use isotretinoin for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.

You may need frequent blood tests.

Never share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

Isotretinoin dosing information

Usual Adult Dose for Acne:

Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
Maximum dose: Up to 2 mg/kg/day
Duration of therapy: Up to 20 weeks

Comments:
-Patients should take some formulations of this drug with food.
-Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).
-Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.
-Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.
-The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.

Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

Usual Pediatric Dose for Acne:

12 years or older:
-Maintenance dose: 0.25 to 0.5 mg/kg orally 2 times a day
-Maximum dose: 2 mg/kg/day
-Duration of therapy: Up to 20 weeks

Comments:
-Patients should take some formulations of this drug with food.
-Prior to increasing the dose, patients should be asked about their compliance with treatment (e.g., taking this drug with food).
-Patients with very severe acne, scarring, or primary manifestations on the trunk may require 2 mg/kg/day dosing.
-Any patient requesting refills requires a new prescription and a new authorization from the iPLEDGE program.
-The safety and efficacy of once a day dosing has not been established; thus, once a day dosing is not recommended.

Use: Treatment of severe recalcitrant nodular acne in patients who are unresponsive to conventional therapy, including systemic antibiotics

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.

What should I avoid while taking isotretinoin?

Do not take a vitamin or mineral supplement that contains vitamin A, unless your doctor tells you to.

Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it. Donated blood that is later given to a pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.

While you are taking isotretinoin and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. Scarring may result.

Isotretinoin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid driving or hazardous activity until you know how isotretinoin will affect you. Isotretinoin may impair your vision, especially at night.

What other drugs will affect isotretinoin?

Tell your doctor about all your other medicines, especially:

• phenytoin;
• St. John’s wort (may make birth control pills less effective);
• vitamin or mineral supplements;
• progestin-only birth control pills (mini-pills, may not work as well when taken with isotretinoin);
• steroid medicine; or
• a tetracycline antibiotic, including doxycycline or minocycline.

What is risdiplam?

Risdiplam is used to treat a genetic condition called spinal muscular atrophy in children and adults.

Risdiplam may also be used for purposes not listed in this medication guide.

Risdiplam side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Serious side effects may be more likely, or you may have none at all.

Common side effects of risdiplam may include:

• fever, cough, or lung infection;
• vomiting, diarrhea, constipation;
• rash; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of risdiplam on the baby.

May harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control while using risdiplam and for at least 1 month after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.

It may be harder for you to get a woman pregnant while you are using risdiplam.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take risdiplam?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Doses are based on age and weight. Your dose may change if you gain or lose weight.

You may take risdiplam with or without food, but take it the same time each day.

Swallow the tablet whole with water and do not crush, chew, or break it.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

To make sure you swallow the entire dose of liquid medicine, drink a glass of water after taking the medicine.

Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

If you are breastfeeding a child using liquid medicine, give this medicine to a child before or after feeding. Do not mix risdiplam liquid with infant formula or milk.

If the entire dose is not swallowed or if you vomit shortly after taking risdiplam, do not take another dose. Take your next dose as scheduled.

If you are unable to swallow table whole, read and carefully follow the instructions provided to you on how to prepare and take risdiplam. Risdiplam liquid may also be given through a feeding tube. Ask a doctor or pharmacist if you do not understand these instructions.

Do not change your dose or stop using a medicine without your doctor’s advice.

Do not use liquid medicine in powder form. If you receive the medicine as a powder, ask your pharmacist to mix the medicine for you.

Store the tablet in the original container tightly closed at room temperature, away from moisture and heat. Ask your pharmacist how to properly store the liquid medicine and the reusable oral syringes.

Risdiplam dosing information

Usual Adult Dose for Spinal Muscular Atrophy:

5 mg orally once a day

Comments:
-See Other Comments or Administration Advice for important information on dose preparation and administration.

Use: For the treatment of spinal muscular atrophy

Usual Pediatric Dose for Spinal Muscular Atrophy:

Less than 2 months: 0.15 mg/kg orally once a day

2 months to less than 2 years: 0.2 mg/kg orally once a day

2 years and older:
-Weight less than 20 kg: 0.25 mg/kg orally once a day
-Weight 20 kg or more: 5 mg orally once a day

Comments:
-See Other Comments or Administration Advice for important information on dose preparation and administration.

Use: For the treatment of spinal muscular atrophy

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking risdiplam?

Avoid getting risdiplam in your eyes or on your skin. If this happens, wash your skin with soap and water or rinse your eyes with water.

What other drugs will affect risdiplam?

Other drugs may affect risdiplam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.