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FDA Approves SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor)

 

February 12, 2018

The U.S. Food and Drug Administration (FDA) approved SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) to treat cystic fibrosis (CF) in people ages 12 years and older who have two copies of the F508del mutation or one mutation that is responsive to SYMDEKO. SYMDEKO is Vertex’s third CF medicine and offers an important option for many patients, including those eligible who may be interested in a different treatment.

At Vertex, we understand that medicines can only help patients who can get them, and we have an in-house team of employees dedicated to helping patients and their caregivers navigate their insurance and access needs. More information is available by visiting www.VertexGPS.com or by calling 1-877-752-5933.

Read The Press Release

Our Leadership Discusses Approval

Reshma Kewalramani, M.D.

Senior Vice President, Clinical Development and Medical Affairs

Click for SYMDEKO full Prescribing Information, including Patient Information

Andy Partridge

Senior Vice President, North America Commercial Region

Click for SYMDEKO full Prescribing Information, including Patient Information

Paul Negulescu, Ph.D.

Senior Vice President and Site Head, San Diego Research

Click for SYMDEKO full Prescribing Information, including Patient Information

 


INDICATION AND IMPORTANT SAFETY INFORMATION FOR SYMDEKO™ (tezacaftor 100mg/ivacaftor 150 mg and ivacaftor 150 mg) tablets
SYMDEKO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have two copies of the F508del mutation, or who have at least one mutation in the CF gene that is responsive to treatment with SYMDEKO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if SYMDEKO is safe and effective in children under 12 years of age.

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

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

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

SYMDEKO may cause dizziness in some people who take it. Patients should not drive a car, use machinery, or do anything that requires alertness until they know how SYMDEKO affects them.

Patients should avoid food or drink that contains grapefruit or Seville oranges while they are taking SYMDEKO.

SYMDEKO can cause serious side effects, including:
High liver enzymes in the blood, which have been reported in people treated with SYMDEKO or treated with ivacaftor alone. The patient’s doctor will do blood tests to check their liver before they start SYMDEKO, every 3 months during the first year of taking SYMDEKO, and every year while taking SYMDEKO. 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 the skin or the white part of the eyes; loss of appetite; nausea or vomiting; dark, amber-colored urine.

Abnormality of the eye lens (cataract) in some children and adolescents treated with SYMDEKO or with ivacaftor alone. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with SYMDEKO to look for cataracts.

The most common side effects of SYMDEKO include headache, nausea, sinus congestion, and dizziness.

These are not all the possible side effects of SYMDEKO. Please click here to see the full Prescribing Information for SYMDEKO