Description
Tezacaftor/ivacaftor and ivacaftor combination is used to treat cystic fibrosis (CF) in patients 6 years of age and older. It is only used for patients who have two copies of F508del mutation, or who have at least one mutation in their CF transmembrane conductance regulator (CFTR) gene. Your doctor will use a test to check for the mutation before you receive the medicine.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tezacaftor/ivacaftor and ivacaftor combination in children younger than 6 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies on the relationship of age to the effects of tezacaftor/ivacaftor and ivacaftor combination have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Levoketoconazole
- Lonafarnib
- Nirmatrelvir
- Ritonavir
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Adagrasib
- Alfentanil
- Alpelisib
- Alprazolam
- Amiodarone
- Amprenavir
- Apalutamide
- Aprepitant
- Atazanavir
- Avacopan
- Bedaquiline
- Belumosudil
- Bentazepam
- Benzhydrocodone
- Berotralstat
- Bictegravir
- Boceprevir
- Bosentan
- Bromazepam
- Budesonide
- Buprenorphine
- Carbamazepine
- Cenobamate
- Ceritinib
- Chlordiazepoxide
- Ciprofloxacin
- Clarithromycin
- Clobazam
- Clofazimine
- Clonazepam
- Clorazepate
- Cloxazolam
- Clozapine
- Cobicistat
- Codeine
- Colchicine
- Conivaptan
- Crizotinib
- Cyclosporine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Apalutamide
- Mavacamten
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Exposure to radiation���Use with caution. May increase risk of developing cataracts.
- Kidney disease, severe or
- Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
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.
- For cystic fibrosis:
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.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects.
Do not use this medicine together with carbamazepine (Carbatrol®, Equetro®, Tegretol®), rifabutin (Mycobutin®), rifampin (Rifamate®, Rifater®), phenobarbital (Luminal®), phenytoin (Dilantin®), or St John’s wort.
This medicine may cause serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have 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.
Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by 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.
Side Effects
Along with its needed effects, a medicine 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:
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 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
- Headache
Less common
- Stuffy nose
Other side effects not listed may also occur 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.
CON-XXXXXXXX
