Tezacaftor/ivacaftor and ivacaftor (Oral)

Tezacaftor/ivacaftor and ivacaftor combination is used to treat cystic fibrosis (CF) in patients 6 years of age and older. It is only for patients who have two copies of the F508del mutation, or who have at least one mutation in their CF transmembrane conductance regulator (CFTR) gene. Your doctor will perform a test to check for the mutation before you receive the medicine.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your or your child's progress at regular visits to ensure that this medicine is working properly. Blood tests will be needed to monitor for unwanted effects.

Do not use this medicine with carbamazepine (Carbatrol®, Equetro®, Tegretol®), rifabutin (Mycobutin®), rifampin (Rifamate®, Rifater®), phenobarbital (Luminal®), phenytoin (Dilantin®), or St John’s wort.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Contact your doctor right away if you experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

This medicine may cause dizziness. Do not drive or do anything else that could be dangerous unless you know how this medicine affects you.

Contact your doctor right away if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, it's important to weigh the risks of taking it against the benefits it may provide. This is a decision you will make together with your doctor. For this medicine, keep the following points in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how tezacaftor/ivacaftor and ivacaftor combination affects children younger than 6 years of age. Safety and effectiveness have not been established for this age group.

Geriatric

Studies on how tezacaftor/ivacaftor and ivacaftor combination affects older adults have not been performed. However, no specific problems related to older adults have been documented so far.

Breast Feeding

There are no adequate studies in women to assess the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. If you are taking this medicine, it's especially important for your healthcare professional to know about any of the medicines listed below. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may adjust your other medications.

• Levoketoconazole
• Nirmatrelvir
• Ritonavir

Using this medicine with any of the following medicines is generally not recommended, but might be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Abametapir
• Adagrasib
• Alfentanil
• Alprazolam
• Amiodarone
• Amprenavir
• Apalutamide
• Aprepitant
• Atazanavir
• Belzutifan
• Bentazepam
• Benzhydrocodone
• Boceprevir
• Bromazepam
• Buprenorphine
• Carbamazepine
• Ceritinib
• Chlordiazepoxide
• Cimetidine
• Ciprofloxacin
• Clarithromycin
• Clobazam
• Clofazimine
• Clonazepam
• Clorazepate
• Cloxazolam
• Clozapine
• Cobicistat
• Codeine
• Conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Darunavir
• Delorazepam
• Diazepam
• Digoxin
• Dihydrocodeine
• Dihydroergotamine
• Diltiazem
• Dofetilide
• Dronedarone
• Duvelisib
• Eliglustat
• Enzalutamide
• Ergotamine
• Erythromycin
• Estazolam
• Everolimus
• Fedratinib
• Fentanyl
• Fexinidazole
• Finerenone
• Flibanserin
• Fluconazole
• Flunitrazepam
• Flurazepam
• Fluvoxamine
• Fosamprenavir
• Fosnetupitant
• Fosphenytoin
• Glimepiride
• Glipizide
• Halazepam
• Hydrocodone
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ivosidenib
• Josamycin
• Ketazolam
• Ketoconazole
• Larotrectinib
• Lefamulin
• Lemborexant
• Lenacapavir
• Letermovir
• Lonafarnib
• Lopinavir
• Loprazolam
• Lorazepam
• Lorlatinib
• Lormetazepam
• Lumacaftor
• Mavacamten
• Medazepam
• Meperidine
• Metaclazepam
• Methadone
• Mibefradil
• Midazolam
• Mifepristone
• Mitotane
• Morphine
• Morphine Sulfate Liposome
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Nitrazepam
• Nordazepam
• Olutasidenib
• Omaveloxolone
• Oxazepam
• Oxycodone
• Pacritinib
• Pentazocine
• Phenobarbital
• Phenytoin
• Pimavanserin
• Pimozide
• Pinazepam
• Pirtobrutinib
• Posaconazole
• Prazepam
• Primidone
• Quazepam
• Quinidine
• Remimazolam
• Ribociclib
• Rifabutin
• Rifampin
• Rifapentine
• Ritlecitinib
• Ritonavir
• Saquinavir
• Schisandra sphenanthera
• Sirolimus
• Sirolimus Protein-Bound
• St John's Wort
• Sufentanil
• Tacrolimus
• Telaprevir
• Telithromycin
• Temazepam
• Temsirolimus
• Tetrazepam
• Tocilizumab
• Tramadol
• Treosulfan
• Triazolam
• Trofinetide
• Troleandomycin
• Tucatinib
• Ubrogepant
• Verapamil
• Voriconazole
• Voxelotor
• Warfarin
• Zolpidem

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also cause interactions. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following is generally not recommended, but may be unavoidable in some situations. If used together, your doctor may adjust the dose or frequency of this medicine, or provide specific instructions regarding food, alcohol, or tobacco use.

• Grapefruit Juice

Other Medical Problems

Having other medical conditions may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, especially:

• Exposure to radiation—Use with caution. May increase the risk of developing cataracts.

• Kidney disease, severe or
• Liver disease, moderate to severe—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

Along with its necessary effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they might need medical attention.

Check with your doctor right away if any of the following side effects occur:

Rare

• Nausea
• severe constipation
• stomach pain
• vomiting

Incidence not known

• Blindness
• blurred vision
• chest tightness
• cough
• dark urine
• decreased vision
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• light-colored stools
• loss of appetite
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing
• yellow skin or eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Headache

Less common

• Stuffy nose

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Available Dosage Forms:

• Tablet

Therapeutic Class: Respiratory Agent

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablets whole. Do not crush, break, or chew them.

Take this medicine with fat-containing foods, including food prepared with butter or oils, cheese, eggs, meat, nuts, or whole milk.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For cystic fibrosis: Adults and children 12 years of age and older—One yellow tablet (tezacaftor 100 milligrams [mg]/ivacaftor 150 mg) taken in the morning and 1 light blue tablet (ivacaftor 150 mg) taken in the evening, about 12 hours apart. Children 6 to 11 years of age weighing 30 kilograms (kg) or more—One yellow tablet (tezacaftor 100 milligrams [mg]/ivacaftor 150 mg) taken in the morning and 1 light blue tablet (ivacaftor 150 mg) taken in the evening, about 12 hours apart. Children 6 to 11 years of age weighing less than 30 kg—One white tablet (tezacaftor 50 milligrams [mg]/ivacaftor 75 mg) taken in the morning and 1 light blue tablet (ivacaftor 75 mg) taken in the evening, about 12 hours apart. Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is 6 hours or less from the time you normally take your medicine, take a dose as soon as you can. If it is more than 6 hours, wait until then to use the medicine and skip the missed dose. Do not take extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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