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GILENYA- fingolimod hcl capsule


Patient Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Tell patients not to discontinue GILENYA without first discussing this with the prescribing physician. Advise patients to contact their physician if they accidently take more GILENYA than prescribed.

Cardiac Effects

Advise patients that initiation of GILENYA treatment results in a transient decrease in heart rate. Inform patients that they will need to be observed in the doctor's office or other facility for at least 6 hours after the first dose, after reinitiation if treatment is interrupted or discontinued for certain periods, and after the dosage is increased[see Dosage and Administration (2.4), Warnings and Precautions (5.1)].

Risk of Infections

Inform patients that they may have an increased risk of infections, some of which could be life-threatening, when taking GILENYA, and that they should contact their physician if they develop symptoms of infection. Advise patients that the use of some vaccines should be avoided during treatment with GILENYA and for 2 months after discontinuation. Recommend to patients that they delay treatment with GILENYA until after VZV vaccination if they have not had chickenpox or a previous VZV vaccination. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection[see Warnings and Precautions (5.2)].

Progressive Multifocal Leukoencephalopathy

Inform patients that cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients who received GILENYA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes[see Warnings and Precautions (5.3)].

Macular Edema

Advise patients that GILENYA may cause macular edema, and that they should contact their physician if they experience any changes in their vision. Inform patients with diabetes mellitus or a history of uveitis that their risk of macular edema is increased[see Warnings and Precautions (5.4)].

Hepatic Effects

Inform patients that GILENYA may cause liver injury. Advise patients that they should contact their physician if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine[see Warnings and Precautions (5.5)].

Posterior Reversible Encephalopathy Syndrome

Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological sequelae[see Warnings and Precautions (5.6)].

Respiratory Effects

Advise patients that they should contact their physician if they experience new onset or worsening of dyspnea[see Warnings and Precautions (5.7)].

Fetal Risk

Inform patients that, based on animal studies, GILENYA may cause fetal harm. Discuss with women of childbearing age whether they are pregnant, might be pregnant or are trying to become pregnant. Advise women of childbearing age of the need for effective contraception during GILENYA treatment and for 2 months after stopping GILENYA. Advise the patient that if she should nevertheless become pregnant, she should immediately inform her physician[see Warnings and Precautions (5.8)].

Severe Increase in Disability After Stopping GILENYA

Inform patients that severe increase in disability has been reported after discontinuation of GILENYA. Advise patients to contact their physician if they develop worsening symptoms of MS following discontinuation of GILENYA[see Warnings and Precautions (5.9)].

Malignancies

Advise patients that basal cell carcinoma and melanoma are associated with use of GILENYA. Advise patients that any suspicious skin lesions should be promptly evaluated. Advise patients to limit exposure to sunlight and ultraviolet light by wearing protective clothing and using a sunscreen with a high protection factor. Inform patients that lymphoma has also occurred in patients receiving GILENYA[see Warnings and Precautions (5.11)].

Persistence of GILENYA Effects After Drug Discontinuation

Advise patients that GILENYA remains in the blood and continues to have effects, including decreased blood lymphocyte counts, for up to 2 months following the last dose[see Warnings and Precautions (5.12)].

Hypersensitivity Reactions

Advise patients that GILENYA may cause hypersensitivity reactions including rash, urticaria, and angioedema. Advise patients to contact their physician if they have any symptoms associated with hypersensitivity[see Warnings and Precautions (5.13)].

Pregnancy and Pregnancy Registry

Instruct patients that if they are pregnant or plan to become pregnant while taking GILENYA they should inform their physician. Encourage patients to enroll in the GILENYA Pregnancy Registry if they become pregnant while taking GILENYA[see Use in Specific Populations (8.1)].


T2019-92



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