Description
Lomitapide is used together with a low-fat diet, exercise, and other cholesterol-lowering medicines to reduce low-density lipoprotein cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).
This medicine is available only under a restricted distribution program called Juxtapid® REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Capsule
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of lomitapide in children younger than 2 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lomitapide in the elderly. However, elderly patients are more likely to have age-related heart, kidney, or liver problems, which may require caution and an adjustment in the dose for patients receiving lomitapide.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Amprenavir
- Aprepitant
- Atazanavir
- Berotralstat
- Boceprevir
- Ceritinib
- Ciprofloxacin
- Clarithromycin
- Clofazimine
- Cobicistat
- Conivaptan
- Crizotinib
- Darunavir
- Diltiazem
- Dronedarone
- Duvelisib
- Erythromycin
- Fluconazole
- Fosamprenavir
- Fosaprepitant
- Fosnetupitant
- Idelalisib
- Imatinib
- Indinavir
- Isavuconazole
- Isavuconazonium
- Itraconazole
- Ketoconazole
- Letermovir
- Levoketoconazole
- Lonafarnib
- Lopinavir
- Mifepristone
- Nefazodone
- Nelfinavir
- Netupitant
- Nirmatrelvir
- Paritaprevir
- Posaconazole
- Ribociclib
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Alfentanil
- Alprazolam
- Amiodarone
- Apalutamide
- Asciminib
- Avacopan
- Bedaquiline
- Belzutifan
- Benzhydrocodone
- Budesonide
- Buprenorphine
- Carbamazepine
- Clozapine
- Codeine
- Colchicine
- Dabrafenib
- Daridorexant
- Dihydrocodeine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Eliglustat
- Elinzanetant
- Enasidenib
- Encorafenib
- Enzalutamide
- Fedratinib
- Fentanyl
- Fexinidazole
- Finerenone
- Gepotidacin
- Givinostat
- Haloperidol
- Hydrocodone
- Ivosidenib
- Lanreotide
- Larotrectinib
- Lazertinib
- Lefamulin
- Lemborexant
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Kratom
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol use disorder, history of—Use with caution. May cause side effects to become worse.
- Galactose intolerance (a rare genetic disorder) or
- Glucose-galactose malabsorption (a rare genetic disorder) or
- Lapp lactase deficiency (a rare genetic disorder) or
- Liver disease, active or
- Liver disease, moderate or severe—Should not be used in patients with these conditions.
- Kidney disease or
- Liver disease, mild—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Pancreatitis (inflammation or swelling of the pancreas) or
- Stomach or bowel problems—Use with caution. May increase risk for nutrient deficiencies.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
It is very important that you understand the requirements of the Juxtapid® REMS program, and become familiar with the Juxtapid® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
Take this medicine without food, at least 2 hours after your evening meal.
Swallow the capsule whole with a glass of water. If you are unable to swallow the capsule, you may open it and sprinkle the contents onto 1 tablespoon of applesauce or mashed banana. If you or your child need a smaller spoon, you may use a teaspoon to take the mixture.
In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's orders about any special diet.
Your doctor may also want you to take supplements (eg, vitamin E, essential fatty acids) while you are using this medicine.
If you are also using bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol), take it at least 4 hours after or 4 hours before you take this medicine.
Do not drink more than 1 alcohol-containing drink per day. Drinking large amounts of alcohol may increase your risk of having liver problems.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For lowering cholesterol in patients with homozygous familial hypercholesterolemia (HoFH):
- Adults and children 18 years of age and older—At first, 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 60 mg per day.
- Children 16 to 17 years of age—At first, 5 mg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 40 mg per day.
- Children 11 to 15 years of age—At first, 2 mg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 40 mg per day.
- Children 2 to 10 years of age—At first, 2 mg once a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 20 mg per day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For lowering cholesterol in patients with homozygous familial hypercholesterolemia (HoFH):
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you stop taking this medicine for more than a week, call your doctor right away before restarting treatment.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your bad cholesterol levels and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, you must have a negative pregnancy test before starting treatment with this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
If you are using this medicine together with birth control pills and have diarrhea and vomiting, use other forms of effective birth control for 7 days after your symptoms improve.
Do not use this medicine if you are also taking aprepitant (Emend®), boceprevir (Victrelis®), conivaptan (Vaprisol®), crizotinib (Xalkori®), diltiazem (Cardizem®), imatinib (Gleevec®), mibefradil (Posicor®), nefazodone (Serzone®), telaprevir (Incivek®), verapamil (Calan®), medicine to treat infections (including ciprofloxacin, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or medicine to treat HIV/AIDS (including amprenavir, atazanavir, darunavir/ritonavir, fosamprenavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir, tipranavir/ritonavir, Crixivan®, Kaletra®, Norvir®, Reyataz®). Using these medicines together can cause serious side effects.
Check with your doctor right away if you have bloating, constipation, decreased urine output, diarrhea, excess air or gas in the stomach or intestines, full feeling, lightheadedness, nausea, passing gas, stomach pain, or vomiting. These may be symptoms of serious stomach or bowel problems.
Using this medicine together with simvastatin and lovastatin may cause serious muscle problems called rhabdomyolysis and myopathy. Check with your doctor right away if you have dark urine, fever, muscle cramps or spasms, muscular pain, stiffness, tenderness, wasting or weakness, or unusual tiredness or weakness.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem (including fatty liver).
Do not change your dose or stop taking this medicine without first talking with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Arm, back, or jaw pain
- bloating
- chest pain or discomfort
- chest tightness or heaviness
- dark urine
- diarrhea
- excess air or gas in the stomach or intestines
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- full feeling
- headache
- light-colored stools
- loss of appetite
- nausea and vomiting
- passing gas
- sore throat
- stuffy or runny nose
- sweating
- trouble breathing
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Acid or sour stomach
- back pain
- belching
- chills
- constipation
- cough
- decreased weight
- dizziness
- frequent urge to defecate
- general feeling of discomfort or illness
- heartburn
- indigestion
- joint pain
- muscle aches and pains
- pressure in the stomach
- shivering
- stomach discomfort, upset, or pain
- straining while passing stool
- sweating
- swelling of the abdominal or stomach area
- trouble sleeping
- weakness
Incidence not known
- Hair loss or thinning of the hair
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20060682
