Momentum - Summer 2013

GILENYA may cause serious side effects such as:
•;Slow;heart;rate,;especially;after;your;first;dose.;An;ECG;will;be
performed;before;and;6;hours;after;your;first;dose.;Your;pulse
and;blood;pressure;should;be;checked;every;hour;while;you
stay;in;a;medical;facility;during;this;time.;If;your;heart;rate
slows;down;too;much,;you;might;feel;dizzy;or;tired,;or;feel;like
your;heart;is;beating;slowly;or;skipping;beats.;Symptoms;can
happen;up;to;24;hours;after;your;first;dose.;After;6;hours,;if
your;ECG;shows;any;heart;problems;or;if;your;heart;rate;is;still
too;low;or;continues;to;decrease,;you;will;continue;to;be
watched;by;a;health;care;professional.;If;you;have;any;serious
side;effects;after;your;first;dose,;especially;those;that;require
treatment;with;other;medicines,;you;will;stay;in;a;medical
facility;to;be;watched;overnight;and;for;at;least;6;hours;after
your;second;dose;of;GILEN YA;the;next;day.;If;you;have;certain
types;of;heart;problems,;or;if;you;are;taking;certain;types;of
medicines;that;can;affect;your;heart,;you;will;be;watched
overnight;after;you;take;your;first;dose.;If;you;experience;slow
heart;rate,;it;will;usually;return;to;normal;within;1;month.;Call
your;doctor;or;go;to;the;nearest;emergency;room;right;away;if
you;have;any;symptoms;of;a;slow;heart;rate.;If;you;stop;taking
GILENYA;for;more;than;14;days;after;your;first;month;of
treatment,;you;will;need;to;repeat;this;observation.

•;Increased;risk;of;serious;infections.;GILENYA;lowers;the number;of;white;blood;cells;(lymphocytes);in;your;blood. This;will;usually;go;back;to;normal;within;2;months;of;stopping GILENYA.;Your;doctor;may;do;a;blood;test;before;you;start GILENYA.;Increased;risk;of;infection;was;seen;with;doses higher;than;the;approved;dose;(0.5;mg).;Two;patients;died;who took;higher-dose;GILENYA;(1.25;mg);combined;with;high-dose steroids.;Call;your;doctor;right;away;if;you;have;fever, tiredness,;body;aches,;chills,;nausea,;or;vomiting.

•;Macular;edema,;a;vision;problem;that;can;cause;some;of;the same;vision;symptoms;as;an;MS;attack;(optic;neuritis),;or;no symptoms.;Macular;edema;usually;starts;in;the;first;3;to;4 months;after;starting;GILEN YA.;Your;doctor;should;test;your vision;before;you;start;GILENYA;;3;to;4;months;after;you;start GILENYA;;and;any;time;you;notice;vision;changes.;Vision problems;may;continue;after;macular;edema;has;gone;away. Your;risk;of;macular;edema;may;be;higher;if;you;have;diabetes or;have;had;an;inflammation;of;your;eye;(uveitis).;Call;your doctor;right;away;if;you;have;blurriness,;shadows,;or;a;blind spot;in;the;center;of;your;vision;;sensitivity;to;light;;or unusually;colored;vision.

•;Breathing;problems.;Some;patients;have;shortness;of;breath. Call;your;doctor;right;away;if;you;have;trouble;breathing.

•;Liver;problems.;Your;doctor;should;do;blood;tests;to;check;your liver;before;you;start;GILENYA.;Call;your;doctor;right;away;if you;have;nausea,;vomiting,;stomach;pain,;loss;of;appetite, tiredness,;dark;urine,;or;if;your;skin;or;the;whites;of;your;eyes turn;yellow.

•;Increases;in;blood;pressure;(BP).;BP;should;be;monitored during;treatment.

GILENYA;may;harm;your;unborn;baby.;Talk;to;your;doctor;if;you are;pregnant;or;planning;to;become;pregnant.;Women;who;can become;pregnant;should;use;effective;birth;control;while;on

Important Safety Information

GILEN YA,;and;for;at;least;2;months;after;stopping.;If;you;become pregnant;while;taking;GILENYA,;or;within;2;months;after stopping,;tell;your;doctor;right;away.;Women;who;take;GILEN YA should;not;breastfeed,;as;it;is;not;known;if;GILEN YA;passes;into breast;milk.;A;pregnancy;registry;is;available;for;women;who become;pregnant;during;GILENYA;treatment.;Call;1-877-598-7237 or;visit;www.gilenyapregnancyregistry.com;for;more;information. Tell;your;doctor;about;all;your;medical;conditions,;including;if you;had;or;now;have;an;irregular;or;abnormal;heartbeat;;history of;stroke;or;warning;stroke;;heart;problems;;a;history;of repeated;fainting;;a;fever;or;infection,;or;if;you;are;unable;to fight;infections;;eye;problems;;diabetes;;breathing;or;liver problems;;or;high;blood;pressure.;Also;tell;your;doctor;if;you have;had;chicken;pox;or;have;received;the;vaccine;for;chicken pox.;Your;doctor;may;do;a;test;for;the;chicken;pox;virus,;and;you may;need;to;get;the;vaccine;for;chicken;pox;and;wait;1;month before;starting;GILENYA. Tell;your;doctor;about;all;the;medicines;you;take,;including medicines;for;heart;problems;or;high;blood;pressure;or;other medicines;that;may;lower;your;heart;rate;or;change;your;heart rhythm;;medicines;that;could;increase;your;chance;of;infections, such;as;medicines;to;treat;cancer;or;control;your;immune system;;or;ketoconazole;(an;antifungal);by;mouth.;If;taken;with GILEN YA,;serious;side;effects;may;occur.;You;should;not;get certain;vaccines;while;taking;GILENYA,;and;for;at;least;2;months after;stopping. The;most;common;side;effects;with;GILEN YA;were;headache, flu,;diarrhea,;back;pain,;abnormal;liver;tests,;and;cough. You;are;encouraged;to;report;negative;side;effects;of prescription;drugs;to;the;FDA.;Visit;www.fda.gov/medwatch, or;call;1-800-FDA-1088.