Generic name: Daclizumab 150mg in 1mL
Dosage form: injection, solution
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Instruct patients to inject a missed dose as soon as possible but no more than two weeks late. After two weeks, skip the missed dose and take the next dose on schedule. Administer only one dose at a time.
Important Administration Instructions
ZINBRYTA is for subcutaneous use only.
Train patients in the proper technique for self-administering subcutaneous injections using the prefilled syringe.
Thirty minutes prior to injection, remove ZINBRYTA from the refrigerator to allow the drug to warm to room temperature. Do not use external heat sources such as hot water to warm ZINBRYTA. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature [see How Supplied/Storage and Handling (16.2)].
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ZINBRYTA is a colorless to slightly yellow, clear to slightly opalescent solution. Do not use ZINBRYTA if it is cloudy or there are visible particles.
Sites for injection include the thigh, abdomen, and back of the upper arm.
Use each prefilled syringe one time and then place in a sharps disposal container for disposal according to community guidelines [see How Supplied/Storage and Handling (16.3)].
Assessment Prior to Initiating ZINBRYTA
Prior to initiating ZINBRYTA, obtain and evaluate the following:
- Serum transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) and total bilirubin levels. Initiation of ZINBRYTA is contraindicated in patients with pre-existing hepatic disease or hepatic impairment including ALT or AST at least 2 times the ULN [see Contraindications (4) and Warnings and Precautions (5.1)].
Assessment for Tuberculosis and Other Infections
- Evaluate patients at high risk for tuberculosis infection prior to initiating treatment with ZINBRYTA [see Warnings and Precautions (5.5)]. For patients testing positive for tuberculosis, treat tuberculosis by standard medical practice prior to therapy with ZINBRYTA.
- Avoid initiating ZINBRYTA in patients with tuberculosis or other severe active infection [see Warnings and Precautions (5.5)].
- Prior to initiation of ZINBRYTA, screen patients for Hepatitis B and C. ZINBRYTA is contraindicated in patients with pre-existing hepatic disease [see Contraindications (4)].
Because vaccination with live vaccines is not recommended during treatment and up to 4 months after discontinuation of treatment, consider any necessary immunization with live vaccines prior to treatment with ZINBRYTA [see Warnings and Precautions (5.5)].
Laboratory Testing and Monitoring to Assess Safety after Initiating ZINBRYTA
Conduct the following laboratory tests at periodic intervals to monitor for early signs of potentially serious adverse effects:
Test transaminase levels and total bilirubin monthly and assess before the next dose of ZINBRYTA. Follow transaminase levels and total bilirubin monthly for 6 months after the last dose of ZINBRYTA. As shown in Table 1, interruption or discontinuation of ZINBRYTA therapy is recommended for management of certain liver test abnormalities [see Warnings and Precautions (5.1)].
|Elevated Transaminases and/or Total Bilirubin
[see Warnings and Precautions (5.1)]
|ALT or AST greater than 5 times ULN
Total bilirubin greater than 2 times ULN
ALT or AST greater than or equal to 3 but less than 5 times ULN and total bilirubin greater than 1.5 but less than 2 times ULN
In clinical trials, permanent discontinuation of therapy was required if the patient had liver test abnormalities resulting in suspension of study treatment for at least 8 consecutive weeks.
ULN = upper limit of normal
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