Elexacaftor/ivacaftor/tezacaftor

Structure of elexacaftor

What is elexacaftor/ivacaftor/tezacaftor?

Elexacaftor, tezacaftor, and ivacaftor are the drugs used in the treatment of cystic fibrosis

What are the uses of this medicine?

Elexacaftor, tezacaftor, and ivacaftor tablets is indicated for the treatment of cystic fibrosis (CF)

Ivacaftor

How does this medicine work?

• Elexacaftor and tezacaftor bind to different sites on the CFTR protein and have an additive effect in facilitating the cellular processing and trafficking of select mutant forms of CFTR (including F508del-CFTR) to increase the amount of CFTR protein delivered to the cell surface compared to either molecule alone
• Ivacaftor potentiates the channel open probability (or gating) of the CFTR protein at the cell surface.

Tezacaftor

Who Should Not Use this medicine?

Those that do not have a diagnosis of Cystic Fibrosis.

Is this medicine FDA approved?

The U.S. Food and Drug Administration has approved the use of Trikafta® (elexacaftor/tezacaftor/ivacaftor)

How should this medicine be used?

• Swallow the tablets whole.
• TRIKAFTA should be taken with fat-containing food. Examples of meals or snacks that contain fat are those prepared with butter or oils or those containing eggs, cheeses, nuts, whole milk, or meats
• Information for Missed Doses:
• If 6 hours or less have passed since the missed morning or evening dose, the patient should take the missed dose as soon as possible and continue on the original schedule.

If more than 6 hours have passed since:

• the missed morning dose, the patient should take the missed dose as soon as possible and should not take the evening dose. The next scheduled morning dose should be taken at the usual time.
• the missed evening dose, the patient should not take the missed dose. The next scheduled morning dose should be taken at the usual time.

Morning and evening doses should not be taken at the same time.

What are the dosage forms and brand names of this medicine?

• 6 to less than 12 years weighing less than 30 kgs--Two tablets, each containing elexacaftor 50 mg/tezacaftor 25 mg/ivacaftor 37.5 mg--One tablet of ivacaftor 75 mg
• 6 to less than12 years weighing 30 kgs or more-Two tablets, each containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg--One tablet of ivacaftor 150 mg
• 12 years and older-Two tablets, each containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg [One tablet of ivacaftor 150 mg]

What side effects can this medication cause?

• headache
• upper respiratory tract infections
• abdominal pain
• diarrhoea
• rash
• nasal congestion
• increased creatinine
• elevated liver enzymes
• rhinorrhoea
• sinusitis
• influenza
• raise bilirubin levels

What special precautions should I follow?

• monitor liver function tests every 3 months for one year , and then once every one year
• regular ophthalmological examinations has to be done

What to do in case of emergency/overdose?

No specific antidote is available for overdosage with TRIKAFTA. Treatment of overdosage consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.

In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

there are limited studies on the use of TRIKAFTA in pregnancy

Can this medicine be used in children?

The safety and effectiveness of TRIKAFTA in patients with CF younger than 6 years of age have not been established.

What should I know about storage and disposal of this medication?

Store at 68ºF - 77ºF (20ºC - 25ºC); excursions permitted to 59ºF - 86ºF (15ºC - 30ºC)

• Dailymed label info on Elexacaftor/ivacaftor/tezacaftor
• FDA Elexacaftor/ivacaftor/tezacaftor

Elexacaftor/ivacaftor/tezacaftor Resources
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