kaftrio(Trikafta)的副作用:严重不良反应,常见副作用,副作用管理

kaftrio (Trikafta) is a fixed-dose combination medicine used to treat cystic fibrosis. In 2019, the U.S. Food and Drug Administration (FDA) approved its marketing for the first time, and has since continued to expand its indications.

Serious side effects of kaftrio (Trikafta)

If the following side effects occur while taking kaftrio (Trikafta), please seek medical attention in time:

Chest tightness, cough, dark urine, difficulty swallowing, dizziness, heartbeat Speeding up, headache, hives, itching, rash, large, wheal-like swelling of the face, eyelids, lips, tongue, throat, hands, legs, feet, or sexual organs, light-colored stools, nausea and vomiting, swelling of the eyelids or around the eyes, face, lips, or tongue, stomach pain or bloating, trouble breathing, yellowing of the eyes or skin, unusual tiredness, or weakness.

Common side effects of kaftrio (Trikafta)

Some side effects may occur while taking it and usually do not require medical attention. These side effects may go away during treatment as the patient's body adjusts to the medicine:

More Common Side Effects

Body aches or pains, chills, diarrhea, ear congestion, fever, loss of voice, sneezing, sore throat, stuffy or runny nose.

Less common side effects

Anxiety, bladder pain, skin blemishes, bloating, bloody or cloudy urine, blurred vision, burning, dry or itchy eyes, cold sweats, coma, confusion, cold skin, paleness, cramps, depression, difficulty urinating, burning or pain, increased discharge, Excessive tearing, flatulence, rapid heartbeat, frequent need to urinate, feeling full, heavy bleeding, increased hunger, lower back or side pain, nervousness, nightmares, aches, flatulence, pimples, redness of the eyes, eyelids or lining of the eyelids, pain, swelling, seizures, tremors, rash (crusting, scaling, drainage), slurred speech.

The side effects of kaftrio (Trikafta) for medical personnel to refer to

General adverse events

Taking kaftrio (Trikafta), 5% or more of the patients Among patients, the most commonly reported adverse reactions include headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, increased alanine aminotransferase, nasal congestion, increased blood creatine phosphokinase, increased aspartate aminotransferase, rhinorrhea, rhinitis, influenza, sinusitis, and increased blood bilirubin. The safety profile was generally consistent between pediatric and adult patients.

Cardiovascular system

Common (1% to 10%): elevated blood pressure.

Cutaneous system

Common (1% to 10%): rash, acne, eczema, itching.

Skin rashes include generalized rash, erythematous rash, maculopapular rash and pruritic rash.

Gastrointestinal system

Very common (10% and above): upper abdominal, lower abdominal and general abdominal pain (up to 14%), diarrhea (up to 13%).

Common (1% to 10%): flatulence, abdominal distension.

Genitourinary system

Common (1% to 10%): dysmenorrhea, urinary tract infection.

Liver system

Very common (10% and above): Elevated alanine aminotransferase (ALT) (up to 10%).

Common (1% to 10%): elevated aspartate aminotransferase (AST) and elevated bilirubin levels.

Post-marketing reports: Hepatic failure leading to transplantation, liver injury characterized by simultaneous elevations of transaminases and total bilirubin.

Anaphylaxis

Post-marketing reports: Anaphylaxis (angioedema and anaphylactic shock).

Metabolic system

Common (1% to 10%): hypoglycemia.