scored, round biconvex film-coated tablet with beveled edges, debossed with on one side
and ‘T’ on other side.
Starter Pack* – blister card of twelve 0.25 mg tablets in a calendarized blister wallet...............NDC 0078-0979-12
*This starter pack is only intended for patients who will receive the 2 mg maintenance dosage.
Bottle of 28 tablets........................................................................................................................NDC 0078-0979-50
2 mg tablet: Pale yellow, unscored, round biconvex film-coated tablet with beveled edges, debossed with on one side
and ‘II’ on other side.
Bottle of 30 tablets.........................................................................................................................NDC 0078-0986-15
16.2 Storage and Handling
Unopened Containers
Store unopened containers of MAYZENT 0.25 mg and 2 mg film-coated tablets in a refrigerator between 2°C to 8°C
(36°F to 46°F).
Opened Containers
Store opened containers of MAYZENT as follows:
Starter Pack/Blister Card
MAYZENT 0.25 mg film-coated tablets in the Starter Pack may be stored at 20°C to 25°C (68°F to 77°F) [see USPControlled Room Temperature] for up to 1 week after opening the blister. Store in original container.
Bottles
MAYZENT 0.25 mg and 2 mg film-coated tablets in bottles may be stored at 20°C to 25°C (68°F to 77°F) [see USPControlled Room Temperature] for up to 1 month after opening the bottles.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Tell patients not to discontinue MAYZENT without first discussing this with the prescribing physician. Advise patients tocontact their physician if they accidently take more MAYZENT than prescribed.
Risk of Infections
Inform patients that they may have an increased risk of infections, some of which could be life-threatening, when takingMAYZENT, and that they should contact their physician if they develop symptoms of infection [see Warnings andPrecautions (5.1)]. Advise patients that the use of some vaccines containing live virus (live attenuated vaccines) should beavoided during treatment with MAYZENT and MAYZENT should be paused 1 week prior and until 4 weeks after aplanned vaccination. Recommend that patients postpone treatment with MAYZENT for at least 1 month after VZVvaccination. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the riskof infection.
Macular Edema
Advise patients that MAYZENT may cause macular edema, and that they should contact their physician if theyexperience any changes in their vision while taking MAYZENT [see Warnings and Precautions (5.2)]. Inform patientswith diabetes mellitus or a history of uveitis that their risk of macular edema is increased.
Cardiac Effects
Advise patients that initiation of MAYZENT treatment results in transient decrease in heart rate [see Warnings andPrecautions (5.3)]. Inform patients that to reduce this effect, dosage titration is required. Advise patients that dosagetitration is also required if a dose is missed for more than 24 hours during the titration or if 4 or more consecutive dailymaintenance doses are missed [see Dosage and Administration (2.2, 2.3, 2.5) and Warnings and Precautions (5.3)].
Inform certa |
