mbined as follows:aheadache, tension headache, sinus headache, cervicogenic headache, drug withdrawal headache, and procedural headache.
bhypertension, blood pressure increased, blood pressure systolic increased, essential hypertension, blood pressure diastolic increased.
c
alanine aminotransferase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, aspartate aminotransferase increased, bloodalkaline phosphatase increased, liver function test increased, hepatic function abnormal, liver function test abnormal, transaminases increased.
d
edema peripheral, joint swelling, fluid retention, swelling face.
ebradycardia, sinus bradycardia, heart rate decreased.
fpain in extremity and limb discomfort.
The following adverse reactions have occurred in less than 5% of MAYZENT-treated patients but at a rate at least 1%higher than in patients receiving placebo: herpes zoster, lymphopenia, seizure, tremor, macular edema, AV block (1st and2nd degree), asthenia, and pulmonary function test decreased [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)].
Seizures
In Study 1, cases of seizures were reported in 1.7% of MAYZENT-treated patients, compared to 0.4% in patientsreceiving placebo. It is not known whether these events were related to the effects of MS, to MAYZENT, or to acombination of both.
Respiratory Effects
Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) were observed in patients treated withMAYZENT [see Warnings and Precautions (5.4)].
Vascular Events
Vascular events, including ischemic strokes, pulmonary embolisms, and myocardial infarctions, were reported in 3.0% ofMAYZENT-treated patients compared to 2.6% of patients receiving placebo. Some of these events were fatal. Physiciansand patients should remain alert for the development of vascular events throughout treatment, even in the absence ofprevious vascular symptoms. Patients should be informed about the symptoms of cardiac or cerebral ischemia caused byvascular events and the steps to take if they occur.
Malignancies
Malignancies such as malignant melanoma in situ and seminoma were reported in MAYZENT-treated patients in Study 1.An increased risk of cutaneous malignancies has been reported in association with another S1P modulator.
7 DRUG INTERACTIONS
7.1 Anti-Neoplastic, Immune-Modulating, or Immunosuppressive Therapies
MAYZENT has not been studied in combination with anti-neoplastic, immune-modulating, or immunosuppressivetherapies. Caution should be used during concomitant administration because of the risk of additive immune effectsduring such therapy and in the weeks following administration [see Warnings and Precautions (5.1)].
When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must beconsidered in order to avoid unintended additive immunosuppressive effects [see Warnings and Precautions (5.9)].
Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with
MAYZENT after alemtuzumab is not recommended.
MAYZENT can generally be started immediately after discontinuation of beta interferon or glatiramer acetate.
7.2 Anti-Arrhythmic Drugs, QT Prolonging Drugs, Drugs That May Decrease Heart Rate
MAYZENT has not been studied in patients taking QT prolonging drugs.
Class Ia (e.g., quinidine, procainamide |
