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Orkambi Side Effects

Generic Name: ivacaftor / lumacaftor

Note: This document contains side effect information about ivacaftor / lumacaftor. Some of the dosage forms listed on this page may not apply to the brand name Orkambi.

In Summary

Common side effects of Orkambi include: upper respiratory tract infection, dyspnea, chest discomfort, nausea, and skin rash. Other side effects include: influenza, and flatulence. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ivacaftor / lumacaftor: oral tablet

Along with its needed effects, ivacaftor/lumacaftor 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 ivacaftor / lumacaftor:

More common

  • Difficult or labored breathing
  • tightness in the chest
  • upper abdominal or stomach pain

Incidence not known

  • Blurred vision
  • dark urine
  • discomfort in the upper right stomach area
  • dizziness
  • general feeling of tiredness or weakness
  • headache
  • light-colored stools
  • loss of appetite
  • nausea
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • stomach pain, continuing
  • unusual tiredness
  • vomiting
  • yellow eyes or skin

Some side effects of ivacaftor / lumacaftor 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

  • Absent, missed, or irregular menstrual periods
  • bloated feeling
  • body aches or pain
  • chills
  • cough
  • cough producing mucus
  • cramps
  • diarrhea
  • ear congestion
  • excess air or gas in the stomach or bowels
  • feeling of fullness
  • fever
  • heavy bleeding
  • increased sputum production
  • longer or heavier menstrual periods
  • loss of voice
  • muscle aches
  • passing gas
  • rash
  • sneezing
  • sore throat
  • stopping of menstrual bleeding
  • stuffy or runny nose
  • unusual weakness

For Healthcare Professionals

Applies to ivacaftor / lumacaftor: oral tablet

General

The most frequently reported side effects were dyspnea, nasopharyngitis, nausea, diarrhea, upper respiratory tract infection, fatigue, respiration abnormal, blood creatine phosphokinase increased, rash, flatulence, rhinorrhea, and influenza.[Ref]

Respiratory

Very common (10% or more): Infective pulmonary exacerbation of cystic fibrosis (37.5%), cough (30.5%), sputum increased (14.8 %), dyspnea (up to 14%), hemoptysis (13.8%), nasopharyngitis (up to 13%), upper respiratory tract infection (up to 10%)
Common (1% to 10%): Rhinitis, pharyngeal erythema, sinus congestion, respiration abnormal, rhinorrhea, nasal congestion

Ivacaftor:
Very common (10% or more): Nasopharyngitis, nasal congestion
Common (1% to 10%): Sinus congestion, pharyngeal erythema[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 13%), diarrhea (up to 12%), abdominal pain
Common (1% to 10%): Flatulence, oropharyngeal pain, vomiting

Ivacaftor:
Very common (10% or more): Abdominal pain[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

Nervous system

Very common (10% or more): Headache (up to 15.7%), dizziness

Ivacaftor:
Very common (10% or more): Dizziness, headache[Ref]

Other

Very common (10% or more): Bacteria in sputum
Common (1% to 10%): Blood creatine phosphokinase increased, fatigue, influenza, ear discomfort, ear pain, tinnitus, tympanic membrane hyperemia, vestibular disorder, chest discomfort
Uncommon (0.1% to 1%): Ear congestion

Ivacaftor:
Very common (10% or more): Bacteria in sputum
Common (1% to 10%): Ear discomfort, ear pain, tinnitus, tympanic membrane hyperemia, vestibular disorder
Uncommon (0.1% to 1%): Ear congestion[Ref]

Endocrine

Very common (10% or more): Breast mass
Uncommon (0.1% to 1%): Breast inflammation, gynecomastia, nipple disorder, nipple pain

Ivacaftor:
Common (1% to 10%): Breast mass
Uncommon (0.1% to 1%): Breast inflammation, gynecomastia, nipple disorder, nipple pain[Ref]

Cardiovascular

Common (1% to 10%): Blood pressure increased/hypertension[Ref]

Hepatic

Common (1% to 10%): AST increased, ALT increased
Uncommon (0.1% to 1%): Hepatic encephalopathy, cholestatic hepatitis
Frequency not reported: Total bilirubin increased
Postmarketing reports: Liver failure leading to death, liver function decompensation[Ref]

Genitourinary

Common (1% to 10%): Menstruation abnormal/irregular, dysmenorrhea, metrorrhagia, amenorrhea, menorrhagia
Uncommon (0.1% to 1%): Oligomenorrhea, polymenorrhea[Ref]

Ocular

Frequency not reported: Non-congenital lens opacities[Ref]

References

1. "Product Information. Orkambi (ivacaftor-lumacaftor)." Vertex Pharmaceuticals, Cambridge, MA.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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