givers
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original container. Do not freeze. TEGSEDI can be kept at room temperature (up to 30°C [86°F]) in the original container for up to 6 weeks; if not used within the 6 weeks, discard TEGSEDI.
Remove from refrigerated storage (2°C to 8°C [36°F to 46°F]) at least 30 minutes before use. [TEGSEDI] prefilled syringe should be allowed to reach room temperature prior to injection.
Avoid exposure to temperatures above 30°C (86°F).
17 PATIENT COUNSELING INFORMATION
Advise the patient and caregiver to read the FDA-approved patient labeling (MEDICATION GUIDE and INSTRUCTIONS FOR USE).
Thrombocytopenia
Inform patients that TEGSEDI can cause reductions in platelet count that may result in thrombocytopenia. Instruct patients to notify a healthcare provider immediately if they show symptoms of thrombocytopenia (e.g., unusual or prolonged bleeding, neck stiffness, or atypical severe headache). Advise patients of the importance of monitoring during treatment with TEGSEDI [see Warnings and Precautions (5.1)]. Also instruct patients to notify their healthcare provider of all medications, including over-the-counter, that they are taking [see Drug Interactions (7.1)].
Glomerulonephritis and Renal Toxicity
Inform patients that glomerulonephritis has occurred in patients treated with TEGSEDI. Advise patients of the importance of monitoring of urine protein to creatinine ratio (UPCR during treatment with TEGSEDI [see Warnings and Precautions (5.2)].
TEGSEDI REMS Program
TEGSEDI is available only through a restricted program called the TEGSEDI REMS Program [see Warnings and Precautions (5.3)]. Inform the patient of the following notable requirements:
Patients must enroll in the program and comply with ongoing monitoring requirements.
TEGSEDI is available only from certified pharmacies participating in the program. Therefore, provide patients with the telephone number and website for information on how to obtain the product.
Stroke and Cervicocephalic Arterial Dissection
Educate patient on symptoms of stroke and central nervous system arterial dissection and instruct them to seek help as soon as possible if symptoms of these or other serious neurologic adverse reactions occur [see Warnings and Precautions (5.4)].
Liver Effects
Instruct patients to inform a healthcare professional of symptoms suggestive of hepatic dysfunction that occur after administration of TEGSEDI [see Warnings and Precautions (5.6)].
Hypersensitivity
Instruct patients to inform a healthcare professional of symptoms suggestive of hypersensitivity that occur after administration of TEGSEDI [see Warnings and Precautions (5.7)].
Recommended Vitamin A Supplementation
Inform patients that TEGSEDI treatment leads to a decrease in vitamin A levels measured in the serum. Instruct patients to take the recommended daily allowance of vitamin A. Advise patients to contact their healthcare provider if they experience ocular symptoms suggestive of vitamin A deficiency (e.g., night blindness) and refer them to an ophthalmologist if they develop these symptoms [see Warnings and Precautions (5.9)].
Administration Instructions
Train patients and caregivers on proper subcutaneous administration technique and how to use the single-dose prefilled syringe. Instruct patients and/or caregivers to read and follow the Instructions for Use each time t |
