Teplizumab-mzwv
Generic Name: teplizumab-mzwv
Brand Names:
Tzield
11 DESCRIPTION Teplizumab-mzwv is a CD3-directed monoclonal antibody (humanized IgG1 kappa) that has a molecular weight of approximately 150 kilodalton (kDa) and is expressed from a recombinant Chinese hamster ovary (CHO) cell line. TZIELD (teplizumab-mzwv) injection is supplied as a sterile, preservative-free, clear and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use.
Overview
11 DESCRIPTION Teplizumab-mzwv is a CD3-directed monoclonal antibody (humanized IgG1 kappa) that has a molecular weight of approximately 150 kilodalton (kDa) and is expressed from a recombinant Chinese hamster ovary (CHO) cell line. TZIELD (teplizumab-mzwv) injection is supplied as a sterile, preservative-free, clear and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use.
Uses
1 INDICATIONS AND USAGE TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes [see Dosage and Administration ( 2.1 )] . TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION Confirm Stage 2 T1D by documenting at least two positive pancreatic islet autoantibodies in those who have dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT) or alternative method if appropriate and OGTT is not available ( 2.1 ). In patients who meet criteria for a diagnosis of Stage 2 type 1 diabetes, ensure the clinical history of the patient does not suggest type 2 diabetes ( 2.1 ). Prior to initiating TZIELD, obtain a complete blood count and liver enzyme tests. Use of TZIELD is not recommended in patients with certain laboratory abnormalities ( 2.2 ). Must dilute TZIELD in 0.9% Sodium Chloride Injection, USP. See full prescribing information for detailed preparation and administration instructions ( 2.3 , 2.4 , 2.5 ).
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the Prescribing Information: Cytokine Release Syndrome [see Warnings and Precautions ( 5.1 )] Serious Infections [see Warnings and Precautions ( 5.2 )] Lymphopenia [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia and headache ( 6.1 ).
Warnings
5 WARNINGS AND PRECAUTIONS Cytokine Release Syndrome (CRS): Premedicate, monitor liver enzymes, discontinue in those that develop elevated ALT or AST more than 5 times the upper limit of normal, and if severe CRS develops consider temporarily pausing dosing ( 5.1 ). Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection. Monitor for signs and symptoms of infection during and after TZIELD treatment. If a serious infection develops, discontinue TZIELD ( 5.2 ). Lymphopenia: Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia (<500 cells per mcL lasting 1 week or longer) develops, discontinue TZIELD ( 5.3 ). 4 CONTRAINDICATIONS None. None. ( 4 ).
Pregnancy
8.1 Pregnancy Risk Summary Available case reports from clinical trials with TZIELD are insufficient to identify a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on teplizumab-mzwv, monoclonal antibodies can be actively transported across the placenta, and TZIELD may cause immunosuppression in the utero- exposed infant (see Clinical Considerations ). To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days (6 half-lives) prior to planned pregnancy.
Storage
16 HOW SUPPLIED / STORAGE AND HANDLING TZIELD (teplizumab-mzwv) injection is a clear and colorless solution (2 mg/2 mL (1 mg/mL)) supplied in a single-dose vial as follows: Carton Contents NDC 1 single dose vial NDC 73650-316-01 10 single dose vials NDC 73650-316-10 14 single dose vials NDC 73650-316-14 Refrigerate TZIELD vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from li...
Frequently Asked Questions
What is Teplizumab-mzwv used for?▼
1 INDICATIONS AND USAGE TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes [see Dosage and Administration ( 2.1 )] . TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D ( 1 ).
What are the side effects of Teplizumab-mzwv?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the Prescribing Information: Cytokine Release Syndrome [see Warnings and Precautions ( 5.1 )] Serious Infections [see Warnings and Precautions ( 5.2 )] Lymphopenia [see Warnings and Precautions ( 5.3 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia and headache ( 6.1 ).
Can I take Teplizumab-mzwv during pregnancy?▼
8.1 Pregnancy Risk Summary Available case reports from clinical trials with TZIELD are insufficient to identify a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on teplizumab-mzwv, monoclonal antibodies can be actively transported across the placenta, and TZIELD may cause immunosuppression in the utero- exposed infant (see Clinical Considerations ). To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days (6 half-lives) prior to planned pregnancy.
What are the important warnings for Teplizumab-mzwv?▼
5 WARNINGS AND PRECAUTIONS Cytokine Release Syndrome (CRS): Premedicate, monitor liver enzymes, discontinue in those that develop elevated ALT or AST more than 5 times the upper limit of normal, and if severe CRS develops consider temporarily pausing dosing ( 5.1 ). Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection. Monitor for signs and symptoms of infection during and after TZIELD treatment. If a serious infection develops, discontinue TZIELD ( 5.2 ). Lymphopenia: Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia (<500 cells per mcL lasting 1 week or longer) develops, discontinue TZIELD ( 5.3 ). 4 CONTRAINDICATIONS None. None. ( 4 ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.