DRUG UPDATE
MARCH 2018
SYMDEKOTM (tezacaftor/ivacaftor)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information
needed to use SYMDEKO safely and effectively. See full prescribing information
for SYMDEKO.
SYMDEKO™ (tezacaftor/ivacaftor) tablets; (ivacaftor)
tablets, for oral use Initial U.S. Approval: 2018
INDICATIONS
AND USAGE
SYMDEKO is a combination of tezacaftor and ivacaftor,
indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years
and older who are homozygous for the F508del
mutation or who have at least one
mutation in the
cystic fibrosis transmembrane conductance regulator (CFTR)
gene that is responsive to tezacaftor/ivacaftor based on in vitro data
and/or clinical evidence. (12.1, 14)
If the patient’s genotype is unknown, an FDA-cleared CF
mutation test should be used to detect the presence of a CFTR mutation followed
by verification with bi-directional sequencing when recommended by the mutation
test instructions for use.
DOSAGE
AND ADMINISTRATION
Adults and pediatric patients ages 12 years and older: one
tablet (containing tezacaftor 100 mg/ivacaftor 150 mg) in the morning and one
tablet (containing ivacaftor 150 mg) in the evening, approximately 12 hours
apart. SYMDEKO
should be taken with fat-containing food. (2.1, 12.3)
Reduce dose in patients with moderate and severe hepatic
impairment. (2.2, 8.6, 12.3)
Reduce dose when co-administered with drugs that are
moderate or strong CYP3A inhibitors. (2.3, 7.2, 12.3)
DOSAGE
FORMS AND STRENGTHS
Tablets:
SYMDEKO is co-packaged as tezacaftor 100 mg/ivacaftor 150 mg
fixed dose combination tablets and ivacaftor 150 mg tablets. (3)
CONTRAINDICATIONS
None.
(4)
WARNINGS
AND PRECAUTIONS
Elevated transaminases (ALT or AST): Transaminases (ALT and
AST) should be assessed prior to initiating SYMDEKO, every 3 months during the
first year of treatment, and annually thereafter. In patients with a history of
transaminase elevations, more frequent monitoring should be considered. Dosing
should be interrupted in patients with significant
elevations of transaminases, e.g., patients with ALT or AST
>5 x upper limit of normal (ULN), or ALT or AST >3 x ULN with bilirubin
>2 x ULN. Following resolution of transaminase elevations, consider the benefits
and risks of resuming treatment. (5.1, 6)
Use with CYP3A inducers: Concomitant use with strong CYP3A
inducers (e.g., rifampin, St. John’s wort) substantially decrease exposure of ivacaftor
and may decrease the exposure of tezacaftor, which may reduce therapeutic
effectiveness. Therefore, co-administration is not recommended. (5.2, 7.1,
12.3)
Cataracts: Non-congenital lens opacities/cataracts have been
reported in pediatric patients treated with SYMDEKO. Baseline and follow-up examinations
are recommended in pediatric patients initiating SYMDEKO treatment. (5.3, 8.4)
ADVERSE
REACTIONS
The most common adverse drug reactions to
SYMDEKO (occurring in ≥3% of patients) were headache, nausea, sinus congestion,
and dizziness. (6.1)
To report SUSPECTED ADVERSE REACTIONS,
contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG
INTERACTIONS
CYP3A inhibitors: Reduce SYMDEKO dose when co-administered
with strong (e.g., ketoconazole) or moderate (e.g., fluconazole) CYP3A
inhibitors.
Avoid food containing grapefruit or Seville oranges. (2.3,
7.2, 12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved
patient labeling.
This Patient
Information has been approved by the U.S. Food and Drug Administration.
Manufactured for: Vertex Pharmaceuticals Incorporated; 50 Northern
Avenue, Boston, MA 02210 VERTEX and the VERTEX triangle logo are registered
trademarks and SYMDEKO is a trademark of Vertex Pharmaceuticals Incorporated.
All other trademarks referenced herein are the property of their
respective owners.
©2018 Vertex Pharmaceuticals Incorporated
For more
information, go to www.symdeko.com or call 1-877-752-5933.
For Detailed Product Information CLICK HERE to download in
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