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Italian CF Program Update

More children & adults with CF in Italy now have access to KALYDECO® (ivacaftor).

March 2017

The Italian Medicines Agency (Agenzia Italiana del Farmaco, or AIFA) has extended reimbursement for KALYDECO® (ivacaftor) to include children with cystic fibrosis (CF) ages 2 years and older and weighing less than 25kg who have one of nine approved gating mutations (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D) and people with CF ages 18 and older with an R117H mutation and a 5T variant in the Poly-T tract. 

“The Italian authorities recognize the importance of people with cystic fibrosis treating the underlying cause of their disease as early as possible through access to transformative medicines,” said Simon Bedson, Senior Vice President and International General Manager at Vertex. “We’re delighted to reach this agreement as it moves us another step closer to our goal of providing medicines to all people with cystic fibrosis.” 

The Italian Official Gazette published the expanded agreement, known as the Registration Decree, today (March 31, 2017). KALYDECO will be available to children who are eligible on the Italian National Health service tomorrow. Elsewhere in Europe, KALYDECO is currently available to people with CF ages 2 and older with gating mutations in Austria, Belgium, Denmark, England, France, Germany, the Netherlands, Norway, Scotland, Sweden, Switzerland and Wales and for people with CF and an R117H mutation ages 18 or older in Austria, Denmark, Germany, the Netherlands, Norway, Sweden and Spain. Vertex remains actively engaged with governments around the world to make our medicines available to all people who are eligible for them.

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INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO® (ivacaftor) IN THE UNITED STATES

KALYDECO (ivacaftor) is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 2 years and older who have one of the following mutations in their CF gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H. KALYDECO is not for use in people with CF due to other mutations in the CF gene. KALYDECO is not effective in patients with CF with two copies of the F508del mutation (F508del/F508del) in the CF gene. It is not known if KALYDECO is safe and effective in children under 2 years of age.

Patients should not take KALYDECO if they are taking certain medicines or herbal supplements such as: the antibiotics rifampin or rifabutin; seizure medications such as phenobarbital, carbamazepine, or phenytoin; or St. John's wort.

Before taking KALYDECO, patients should tell their doctor if they: have liver or kidney problems; drink grapefruit juice, or eat grapefruit or Seville oranges; are pregnant or plan to become pregnant because it is not known if KALYDECO will harm an unborn baby; and are breastfeeding or planning to breastfeed because is not known if KALYDECO passes into breast milk.

KALYDECO may affect the way other medicines work, and other medicines may affect how KALYDECO works. Therefore the dose of KALYDECO may need to be adjusted when taken with certain medications. Patients should especially tell their doctor if they take antifungal medications such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin.

KALYDECO can cause dizziness in some people who take it. Patients should not drive a car, use machinery, or do anything that needs them to be alert until they know how KALYDECO affects them. Patients should avoid food containing grapefruit or Seville oranges while taking KALYDECO.

KALYDECO can cause serious side effects including:

High liver enzymes in the blood have been reported in patients receiving KALYDECO. The patient's doctor will do blood tests to check their liver before starting KALYDECO, every 3 months during the first year of taking KALYDECO, and every year while taking KALYDECO. For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often.

Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of their skin or the white part of their eyes; loss of appetite; nausea or vomiting; or dark, amber-colored urine.

Abnormality of the eye lens (cataract) has been noted in some children and adolescents receiving KALYDECO. The patient's doctor should perform eye examinations prior to and during treatment with KALYDECO to look for cataracts. The most common side effects include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.

These are not all the possible side effects of KALYDECO. Please click here to see the full U.S. Prescribing Information for KALYDECO (ivacaftor).