Symdeko: Uses, Side Effects and Dosage

What is SYMDEKO used for?

SYMDEKO is used for the treatment of cystic fibrosis (CF) in patients 12 years of age and older who:

• are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or
• are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, D110H, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.

It is not known if SYMDEKO is safe and effective in children under 12 years of age.

How does SYMDEKO work?

• The CFTR gene provides instructions to your cells to make the CFTR protein. This protein helps take chloride ions in and out of the cells in many organs of your body.
• People with CF have a lower amount of the CFTR protein and/or reduced function of the CFTR protein.

• SYMDEKO contains two ingredients:

  • Tezacaftor. This is a CFTR Corrector. It increases the amount of the CFTR protein at the surface of the cell.
  • Ivacaftor. This is a CFTR Potentiator. It makes the CFTR protein at the cell surface work better in allowing more chloride ions to pass through.

What are the ingredients in SYMDEKO?

Medicinal ingredients: tezacaftor and ivacaftor

Non-medicinal ingredients:

Tezacaftor/Ivacaftor tablet

Tablet core: Croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

Tablet film coat: HPMC/hypromellose 2910, hydroxypropyl cellulose, iron oxide yellow, talc, and titanium dioxide.

Ivacaftor tablet

Tablet core: Colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

Tablet film coat: Carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide.

Printing ink: Ammonium hydroxide, iron oxide black, propylene glycol, and shellac.

SYMDEKO comes in the following dosage forms:

Tablet: tezacaftor 100 mg / ivacaftor 150 mg and ivacaftor 150 mg

Do not use SYMDEKO if:

• You are allergic (hypersensitive) to:

  • tezacaftor
  • ivacaftor
  • any of the non-medicinal ingredients or any of the ingredients in the component of the container

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SYMDEKO. Talk about any health conditions or problems you may have, including if you:

• Have liver disease. Your doctor may need to adjust your dose of SYMDEKO.
• Have kidney disease.

• Are pregnant or plan to become pregnant. It is not known if SYMDEKO will harm your unborn baby.

  You and your doctor should decide if you will take SYMDEKO while you are pregnant.

• Are breastfeeding or planning to breastfeed. It is not known if SYMDEKO can pass into your breast milk. You and your doctor should decide if you should take SYMDEKO while you are breastfeeding.

Other warnings you should know about:

Cataracts

Cloudiness of the eye lens (cataract) without any effect on vision has been seen in some children and adolescents while taking SYMDEKO. Your doctor may perform eye exams before you start taking SYMDEKO and during treatment with SYMDEKO to look for cataracts.

Abnormal test results

Abnormal blood tests of the liver have been seen in some people taking SYMDEKO. Your doctor will order some blood tests to check your liver:

• before you take SYMDEKO,
• every 3 months of the first year while you are taking SYMDEKO, and
• every year while you are taking SYMDEKO.

If you have had abnormal blood tests of the liver in the past, your doctor may order blood tests to check your liver more often.

Tell your doctor right away if you have any of these symptoms, which may be a sign of liver problems:

• pain or discomfort in the upper right stomach (abdominal) area
• yellowing of your skin or the white part of your eyes
• loss of appetite
• nausea or vomiting
• dark urine
• pale stools
• itchy skin

Children

SYMDEKO is not for use in children under 12 years of age. It is not known if SYMDEKO is safe and effective in children under 12 years of age.

Driving and using machines

You may get dizzy when you take SYMDEKO. Wait to see how you feel after taking SYMDEKO before you drive or use machines. For children: you or your child’s caregiver should supervise your child when they take SYMDEKO. Wait to see if your child is dizzy after taking it before they ride their bikes or do anything else that needs their full attention.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with SYMDEKO:

• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole and fluconazole).
• Medicines used to treat bacterial infections (such as clarithromycin, erythromycin, rifampicin and rifabutin). You should not take SYMDEKO with rifampicin and rifabutin.
• Medicines used to treat seizures (such as phenobarbital, carbamazepine and phenytoin). You should not take SYMDEKO with these medicines.
• Warfarin (a medicine used to prevent blood clots from forming or growing larger).
• Medicines used to treat diabetes (such as glimepiride and glipizide).
• Digoxin (a medicine used to treat congestive heart failure or a heart rhythm problem called atrial fibrillation).
• Medicines used after an organ transplant (such as cyclosporine, tacrolimus and sirolimus).
• Everolimus (used to treat certain types of cancer).
• St. John’s wort (Hypericum perforatum). You should not take SYMDEKO with this medicine.
• Food or drinks containing grapefruit or Seville oranges. You should avoid eating and drinking these.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How to take SYMDEKO:

• In order to get the right amount of medicine in your body, SYMDEKO should always be taken with fat-containing food. Meals and snacks recommended in CF guidelines contain acceptable amounts of fat. Examples of meals that contain fat are:

  • meals that have been prepared with butter or oils.
  • meals that have eggs, nuts, whole-milk dairy products (such as whole-milk, cheese, and yogurt) or meats.
• Take SYMDEKO exactly how your doctor tells you to take it, even if you feel well.
• Check with your doctor if you are not sure about how to take SYMDEKO.

Usual dose:

To remove the tablet, push it through the blister strip.

Morning dose: Take 1 yellow tablet (tezacaftor 100 mg / ivacaftor 150 mg). Swallow it whole with fat-containing food.

Evening dose: Take 1 light blue tablet (ivacaftor 150 mg) 12 hours after your morning dose. Swallow it whole with fat-containing food.

• Do not change the dose or stop taking SYMDEKO without first talking to your doctor.
• Your doctor may need to adjust your dose if you have liver disease or if you are taking medications that may interact with SYMDEKO.

Refilling your prescription:

Remember to get a new prescription from your doctor or a refill from your pharmacy 7-10 days before taking your last dose of SYMDEKO.

Overdose:

If you think you have taken too much SYMDEKO, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss your dose of SYMDEKO and:

• it is 6 hours or less from the time you usually take it, you should take the missed dose as soon as possible with fat-containing food.
• it has been more than 6 hours from the time you usually take it, do not take the missed dose. Wait until it is time for your next dose and take it at the usual time.
• Do not take 2 doses at the same time to make up for your missed dose.

What are possible side effects from using SYMDEKO?

These are not all the possible side effects you may feel when taking SYMDEKO. If you experience any side effects not listed here, contact your healthcare professional.

Side effects include:

• Headache
• Common cold
• Nausea
• Stuffy nose
• Dizziness

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Do not use this medicine after the expiry date that is stated on the package after EXP. The expiry date refers to the last day of that month.

Store at or below 30°C.

Keep out of reach and sight of children.

You may need to read this leaflet again. Do not throw this away.

If you want more information about SYMDEKO:

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes this

  Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada.html); the manufacturer’s website http://www.vrtx.ca; or by calling 1-877-634-8789.

© 2020 Vertex Pharmaceuticals Incorporated

SYMDEKO is a registered trademark of Vertex Pharmaceuticals Incorporated.

Last Revised: August 21, 2020