Denileukin Diftitox-cxdl
Generic Name: denileukin diftitox-cxdl
Brand Names:
Lymphir
11 DESCRIPTION Denileukin diftitox-cxdl, an IL2-receptor-directed cytotoxin, is a recombinant DNA-derived fusion protein composed of the amino acid sequences for diphtheria toxin fragments A and B (Met 1 -Thr 387 )-His and the sequence for human interleukin-2 (IL-2; Ala 1 -Thr 133 ). It is produced in an E. coli expression system and has a molecular weight of 58 kD. Neomycin is used in the fermentation process but is undetectable in the final product.
Overview
11 DESCRIPTION Denileukin diftitox-cxdl, an IL2-receptor-directed cytotoxin, is a recombinant DNA-derived fusion protein composed of the amino acid sequences for diphtheria toxin fragments A and B (Met 1 -Thr 387 )-His and the sequence for human interleukin-2 (IL-2; Ala 1 -Thr 133 ). It is produced in an E. coli expression system and has a molecular weight of 58 kD. Neomycin is used in the fermentation process but is undetectable in the final product.
Uses
1 INDICATIONS AND USAGE LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Delay start of treatment cycle if serum albumin level is below 3 g/dL. ( 2.1 ) The recommended dosage of LYMPHIR is 9 mcg/kg/day actual body weight administered as an intravenous infusion on Days 1 through 5 of a 21-day cycle. ( 2.2 ) Administer premedication as recommended. ( 2.3 ) See full prescribing information for preparation and administration instructions. ( 2.5 ) 2.1 Important Dosing Instructions Prior to starting each treatment cycle, assess hepatic and renal function. If serum albumin is less than 3 g/dL, delay administration of LYMPHIR until serum albumin is greater than or equal to 3 g/dL [see Warnings and Precautions ( 5.1 )] .
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Capillary Leak Syndrome [see Warnings and Precautions ( 5.1 )] Visual Impairment [see Warnings and Precautions ( 5.2 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Citius Oncology, Inc. at 1-844-459-6744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
WARNING: CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity [see Dosage and Administration ( 2.1 , 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS Visual Impairment: Monitor and evaluate for visual impairment throughout treatment. Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity. ( 5.2 ) Infusion-Related Reactions: Monitor patients closely during infusions. Interrupt or discontinue for infusion-related reactions based on severity. ( 5.3 ) Hepatotoxicity: Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. ( 5.4 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Capillary Leak Syndrome LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox. Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LYMPHIR (denileukin diftitox-cxdl) for injection is supplied as a sterile, white, lyophilized cake for reconstitution in a single-dose vial containing 300 mcg denileukin diftitox-cxdl.
Frequently Asked Questions
What is Denileukin Diftitox-cxdl used for?▼
1 INDICATIONS AND USAGE LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. ( 1 )
What are the side effects of Denileukin Diftitox-cxdl?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Capillary Leak Syndrome [see Warnings and Precautions ( 5.1 )] Visual Impairment [see Warnings and Precautions ( 5.2 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Citius Oncology, Inc. at 1-844-459-6744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Can I take Denileukin Diftitox-cxdl during pregnancy?▼
8.1 Pregnancy Risk Summary Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology ( 12.1 )]. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox. Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.
What are the important warnings for Denileukin Diftitox-cxdl?▼
WARNING: CAPILLARY LEAK SYNDROME Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity [see Dosage and Administration ( 2.1 , 2.4 ) and Warnings and Precautions ( 5.1 )] . WARNING: CAPILLARY LEAK SYNDROME See full prescribing information for complete boxed warning. 5 WARNINGS AND PRECAUTIONS Visual Impairment: Monitor and evaluate for visual impairment throughout treatment. Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity. ( 5.2 ) Infusion-Related Reactions: Monitor patients closely during infusions. Interrupt or discontinue for infusion-related reactions based on severity. ( 5.3 ) Hepatotoxicity: Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. ( 5.4 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Capillary Leak Syndrome LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. 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.