Lomitapide may rarely cause serious (possibly fatal) liver disease. This medication increases fat in the liver, which may also increase the risk for liver disease. Careful monitoring by your doctor may decrease your risk. Lab and/or medical tests (such as liver function) should be done before starting treatment and while you are taking this medication. Keep all medical and lab appointments. Get medical help right away if you have any symptoms of liver damage, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.
To receive lomitapide in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
Before taking lomitapide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, galactose intolerance (such as Lapp lactase deficiency or glucose-galactose malabsorption).
This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Do not drink more than 1 alcoholic beverage each day while taking this medication. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication must not be used during pregnancy. It may harm an unborn baby. Your doctor may order a pregnancy test before starting this medication. Ask about reliable forms of birth control (such as condoms, birth control pills) while using this medication and for 2 weeks after the last dose. If you become pregnant or think you may be pregnant, tell your doctor right away.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.
Nausea, vomiting, diarrhea, upset stomach, gas, stomach cramping/pain, weight loss, dizziness, headache, tiredness, or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
To lessen stomach/intestinal symptoms, follow a low-fat diet as instructed by your doctor or dietician. Taking this medication at least 2 hours after the evening meal may also help lessen these side effects.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Vomiting/diarrhea that doesn't stop may result in dehydration. Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, severe dizziness, itching/swelling (especially of the face/tongue/throat), trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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