Summary
Commonly reported side effects of lomitapide include: increased serum alanine aminotransferase, increased serum aspartate aminotransferase, abdominal distention, abdominal distress, abdominal pain, constipation, diarrhea, dyspepsia, fever, nausea, vomiting, and flatulence. Continue reading for a comprehensive list of adverse effects.
Applies to lomitapide: oral capsule.
Warning
Oral route (Capsule)
Lomitapide mesylate can cause elevations in transaminases. Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended. During treatment, adjust the dose of lomitapide mesylate if the ALT or AST is 3 times the ULN or greater. Discontinue lomitapide mesylate for clinically significant liver toxicity. Lomitapide mesylate increases hepatic fat (hepatic steatosis) with or without concomitant increases in transaminases. Hepatic steatosis associated with lomitapide mesylate may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis. Because of the risk of hepatotoxicity, lomitapide mesylate is available only through a restricted program called the Juxtapid® REMS Program. Prescribe lomitapide mesylate only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH). The safety and effectiveness of lomitapide mesylate have not been established in patients with hypercholesterolemia who do not have HoFH.
Serious side effects of Lomitapide
Along with its needed effects, lomitapide 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 while taking lomitapide:
More common
- Arm, back, or jaw pain
- chest pain or discomfort
- chest tightness or heaviness
- dark urine
- fast, irregular, pounding, or racing heartbeat or pulse
- fever
- light-colored stools
- loss of appetite
- nausea and vomiting
- sweating
- trouble breathing
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- yellow eyes and skin
Other side effects of Lomitapide
Some side effects of lomitapide 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
- diarrhea
- dizziness
- excess air or gas in the stomach or intestines
- frequent urge to defecate
- full or bloated feeling
- general feeling of discomfort or illness
- headache
- heartburn
- indigestion
- joint pain
- muscle aches and pains
- passing gas
- pressure in the stomach
- shivering
- sore throat
- stomach discomfort, upset, or pain
- straining while passing stool
- stuffy or runny nose
- sweating
- swelling of the abdominal or stomach area
- trouble sleeping
- weakness
Incidence not known
- Hair loss or thinning of the hair
For Healthcare Professionals
Applies to lomitapide: oral capsule.
Cardiovascular
Very common (10% or more): Chest pain (24%), angina pectoris (10%), palpitations (10%)[Ref]
Gastrointestinal
Very common (10% or more): Diarrhea (79%), nausea (65%), dyspepsia (38%), vomiting (34%), abdominal pain (34%), abdominal discomfort (21%), abdominal distention (21%), constipation (21%), flatulence (21%), gastroesophageal reflux disease (10%), defecation urgency ((10%), rectal tenesmus (10%), gastroenteritis (14%)[Ref]
Hepatic
Very common (10% or more): Increased ALT (17%), at least one elevation in ALT and/or AST greater than or equal to 3 times ULN (29%), hepatic steatosis: of 23 patients in a study for 78 weeks, 18 (78%) exhibited an increase in hepatic fat greater than 5% and 3 (13%) exhibited an increase greater than 20%[Ref]
Immunologic
Very common (10% or more): Influenza (21%)[Ref]
Metabolic
Very common (10% or more): Weight loss (24%)[Ref]
Nervous system
Very common (10% or more): Fatigue (17%), fever (10%), headache (10%), dizziness (10%)[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (17%), pharyngolaryngeal pain (14%), nasal congestion (10%)[Ref]
Dermatologic
Common (1% to 10%): Ecchymosis, papule, rash erythematous, xanthoma[Ref]
