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Zinbryta
Overview
What is Zinbryta?
Daclizumab is a humanized monoclonal antibody that binds to the alpha subunit of the interleukin-2 receptor (IL-2Rα, CD25). Daclizumab is composed of two humanized gamma-1 heavy chains and two humanized kappa light chains and has a molecular weight of approximately 144 kilodaltons (kDa).
ZINBRYTA injection is supplied as a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution for subcutaneous use in a single-dose prefilled autoinjector and syringe. Each 1 mL prefilled autoinjector and syringe contains 150 mg daclizumab; polysorbate 80, USP (0.3 mg); sodium chloride (5.84 mg); sodium succinate, anhydrous (5.94 mg); succinic acid (0.35 mg); and Water for Injection, USP. The pH is 6.0.
What does Zinbryta look like?
What are the available doses of Zinbryta?
Injection: 150 mg/mL solution in a single-dose prefilled autoinjector.
Injection: 150 mg/mL solution in a single-dose prefilled syringe.
ZINBRYTA is a sterile, preservative-free, colorless to slightly yellow, clear to slightly opalescent solution.
What should I talk to my health care provider before I take Zinbryta?
How should I use Zinbryta?
ZINBRYTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
The recommended dosage of ZINBRYTA is 150 milligrams injected subcutaneously once monthly .
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.
What interacts with Zinbryta?
Sorry No Records found
What are the warnings of Zinbryta?
Sorry No Records found
What are the precautions of Zinbryta?
Sorry No Records found
What are the side effects of Zinbryta?
Sorry No records found
What should I look out for while using Zinbryta?
ZINBRYTA is contraindicated in patients with:
Some patients required systemic corticosteroids or other immunosuppressant treatment for autoimmune hepatitis or other immune-mediated disorders and continued this treatment after the last dose of ZINBRYTA
[see Warnings and Precautions (, )]
Because of the risks of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders, ZINBRYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZINBRYTA REMS Program
[see Warnings and Precautions ()]
What might happen if I take too much Zinbryta?
Sorry No Records found
How should I store and handle Zinbryta?
Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or expose to temperatures above 30°C (86°F). Discard if frozen. If refrigeration is unavailable, ZINBRYTA may be stored protected from light up to 30°C (86°F) for a period up to 30 days. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature. Discard after 30 days without refrigeration. Store in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or expose to temperatures above 30°C (86°F). Discard if frozen. If refrigeration is unavailable, ZINBRYTA may be stored protected from light up to 30°C (86°F) for a period up to 30 days. Do not place ZINBRYTA back into the refrigerator after allowing it to warm to room temperature. Discard after 30 days without refrigeration. Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).Capsules: 0.25 mcg calcitriol in soft gelatin, light orange, oval capsules, imprinted with R25; bottles of 30 (NDC 63304-239-30), and bottles of 100 (63304-239-01).Capsules: 0.5 mcg calcitriol in soft gelatin, dark orange, oblong capsules, imprinted with R50; bottles of 100 (NDC 63304-240-01).Oral Solution: a clear, colorless to pale yellow oral solution containing 1 mcg/mL of calcitriol; each amber glass bottle of 15 mL of oral solution supplied with 20 single-use, graduated oral dispensers (NDC 63304-241-59).Calcitriol Capsules and Oral Solution should be protected from light.Store at 59° to 86°F (15° to 30°C).
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism by which daclizumab exerts therapeutic effects in multiple sclerosis is unknown but is presumed to involve modulation of IL-2 mediated activation of lymphocytes through binding to CD25, a subunit of the high-affinity IL-2 receptor.
Non-Clinical Toxicology
ZINBRYTA is contraindicated in patients with:Some patients required systemic corticosteroids or other immunosuppressant treatment for autoimmune hepatitis or other immune-mediated disorders and continued this treatment after the last dose of ZINBRYTA
[see Warnings and Precautions (, )]
Because of the risks of hepatic injury, including autoimmune hepatitis, and other immune-mediated disorders, ZINBRYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ZINBRYTA REMS Program
[see Warnings and Precautions ()]
Cholestyramine
Cholestyramine has been reported to reduce intestinal absorption of fat-soluble vitamins; as such it may impair intestinal absorption of calcitriol (see and
Phenytoin/Phenobarbital
The coadministration of phenytoin or phenobarbital will not affect plasma concentrations of calcitriol, but may reduce endogenous plasma levels of 25(OH)D by accelerating metabolism. Since blood level of calcitriol will be reduced, higher doses of calcitriol may be necessary if these drugs are administered simultaneously.
Thiazides
Thiazides are known to induce hypercalcemia by the reduction of calcium excretion in urine. Some reports have shown that the concomitant administration of thiazides with calcitriol causes hypercalcemia. Therefore, precaution should be taken when coadministration is necessary.
Digitalis
Calcitriol dosage must be determined with care in patients undergoing treatment with digitalis, as hypercalcemia in such patients may precipitate cardiac arrhythmias (see ).
Ketoconazole
Ketoconazole may inhibit both synthetic and catabolic enzymes of calcitriol. Reductions in serum endogenous calcitriol concentrations have been observed following the administration of 300 mg/day to 1200 mg/day ketoconazole for a week to healthy men. However, in vivo drug interaction studies of ketoconazole with calcitriol have not been investigated.
Corticosteroids
A relationship of functional antagonism exists between vitamin D analogues, which promote calcium absorption, and corticosteroids, which inhibit calcium absorption.
Phosphate-Binding Agents
Since calcitriol also has an effect on phosphate transport in the intestine, kidneys and bones, the dosage of phosphate-binding agents must be adjusted in accordance with the serum phosphate concentration.
Vitamin D
Since calcitriol is the most potent active metabolite of vitamin D, pharmacological doses of vitamin D and its derivatives should be withheld during treatment with calcitriol to avoid possible additive effects and hypercalcemia (see ).
Calcium Supplements
Uncontrolled intake of additional calcium-containing preparations should be avoided (see ).
Magnesium
Magnesium-containing preparations (eg, antacids) may cause hypermagnesemia and should therefore not be taken during therapy with calcitriol by patients on chronic renal dialysis.
[see Drug Interactions ()]
The following serious adverse reactions are described elsewhere in labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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