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How do the warnings differ between Symdeko and Orkambi?

Medically reviewed by Judith Stewart, BPharm. Last updated on May 13, 2021.

Official answer

by Drugs.com

Orkambi (lumacaftor/ivacaftor) and Symdeko (ivacaftor/tezacaftor and ivacaftor) are prescription medicines used in the treatment of cystic fibrosis. Both drugs carry warnings for elevated liver enzymes and cataracts. Orkambi carries additional warnings for worsening of liver function, breathing problems, and high blood pressure.

What is Orkambi?

Orkambi is a combination of lumacaftor and ivacaftor.

  • It is used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene.
  • Orkambi is available as tablets and oral granules.

What is Symdeko?

Symdeko is a co-packaged combination of tezacaftor/ivacaftor and ivacaftor.

  • It is used for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with Symdeko.
  • Symdeko is available as tablets.

Comparison of Side Effects and Warnings

Orkambi Symdeko
Worsening of Liver Function Orkambi may cause worsening of liver function in people with severe liver disease. The worsening of liver function can be serious or cause death. People with liver disease may require the dose of Orkambi to be adjusted.
High Liver Enzymes in the Blood High liver enzymes in the blood can be a sign of liver injury in people receiving Orkambi. Blood tests to check the liver are required before starting Orkambi, then every 3 months during the first year of taking Orkambi, then every year while taking Orkambi. High liver enzymes in the blood can be a sign of liver injury in people receiving Symdeko. Blood tests to check the liver are required before starting Symdeko, then every 3 months during the first year of taking Symdeko, then every year while Symdeko.
Breathing Problems Breathing problems such as shortness of breath or chest tightness may occur in patients when starting Orkambi, especially in patients who have poor lung function. Patients with poor lung function may need to be monitored more closely when starting Orkambi.
Blood Pressure An increase in blood pressure may occur in some patients receiving Orkambi. Blood pressure should be monitored during treatment with Orkambi.
Cataracts Abnormality of the eye lens (cataract) may occur in some children and adolescents receiving Orkambi. Eye examinations should be performed before and during treatment with Orkambi to look for cataracts. Abnormality of the eye lens (cataract) may occur in some children and adolescents receiving Symdeko. Eye examinations should be performed before and during treatment with Symdeko to look for cataracts.
Common Side Effects The most common side effects of Orkambi include:
  • breathing problems such as shortness of breath and chest tightness
  • nausea
  • diarrhea
  • fatigue
  • increase in a certain blood enzyme called creatine phosphokinase
  • rash
  • gas
  • common cold, including sore throat, stuffy or runny nose
  • flu or flu-like symptoms
  • irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding

The most common side effects of Symdeko include:

  • headache
  • sinus congestion
  • nausea
  • dizziness

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