Cosibelimab-ipdl
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Nehal Eid
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Overview
Cosibelimab-ipdl is a programmed death ligand-1 (PD-L1) blocking antibody that is FDA approved for the treatment of It is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.. Common adverse reactions include The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dosage is 1,200 mg as an intravenous infusion over 60 minutes every 3 weeks.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cosibelimab-ipdl in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cosibelimab-ipdl in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Cosibelimab-ipdl FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cosibelimab-ipdl in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cosibelimab-ipdl in pediatric patients.
Contraindications
None.
Warnings
• Immune-Mediated Adverse Reactions o Immune-mediated adverse reactions can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immunemediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
o Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
o Withhold or permanently discontinue UNLOXCYT based on the severity of reaction.
• Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction.
• Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD L1 blocking antibody.
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Adverse Reactions
Clinical Trials Experience
The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation, nausea, headache, pruritus, edema, localized infection, and urinary tract infection.
Postmarketing Experience
There is limited information regarding Cosibelimab-ipdl Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Cosibelimab-ipdl Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Based on its mechanism of action, It can cause fetal harm when administered to a pregnant woman. There are no available data on the use in pregnant women. Animal studies have demonstrated that inhibition of the PD1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see Data). Human IgG1 immunoglobulins (IgG1) are known to cross the placental barrier; therefore, cosibelimab-ipdl has the potential to be transmitted from the mother to the developing fetus.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cosibelimab-ipdl in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cosibelimab-ipdl during labor and delivery.
Nursing Mothers
There is no information regarding the presence of cosibelimab-ipdl in human milk or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 4 months after the last dose.
Pediatric Use
The safety and effectiveness have not been established in pediatric patients.
Geriatic Use
Of the 141 patients treated with Cosibelimab-ipdl as a single agent, 21% (29) were younger than 65 years, 31% (44) were aged 65 through 75 years, and 48% (68) were 75 years or older. No overall differences in safety or effectiveness were observed between these patients and younger patients.
Gender
There is no FDA guidance on the use of Cosibelimab-ipdl with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cosibelimab-ipdl with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cosibelimab-ipdl in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cosibelimab-ipdl in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cosibelimab-ipdl in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cosibelimab-ipdl in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Cosibelimab-ipdl Administration in the drug label.
Monitoring
There is limited information regarding Cosibelimab-ipdl Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Cosibelimab-ipdl and IV administrations.
Overdosage
There is limited information regarding Cosibelimab-ipdl overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Cosibelimab-ipdl Pharmacology in the drug label.
Mechanism of Action
PD-L1 may be expressed on tumor cells and tumor-infiltrating immune cells and can contribute to the inhibition of the anti-tumor immune response in the tumor microenvironment. Binding of PD-L1 to the PD-1 and B7.1 receptors found on T cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation, and cytokine production. Cosibelimab-ipdl binds PD-L1 and blocks the interaction between PD-L1 and its receptors PD-1 and B7.1. This interaction releases the inhibitory effects of PD-L1 on the anti-tumor immune response. Cosibelimab-ipdl has also been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.
Structure
There is limited information regarding Cosibelimab-ipdl Structure in the drug label.
Pharmacodynamics
Cosibelimab-ipdl exposure-response relationships and the time course of pharmacodynamic responses have not been fully characterized.
Pharmacokinetics
Cosibelimab-ipdl pharmacokinetic parameters are presented as geometric mean (coefficient of variation) unless otherwise stated. At the recommended dosage, the cosibelimab-ipdl steady-state maximum plasma concentration (Cmax) is 492 µg/mL (24.3%) and area under curve (AUC) is 112000 µg*h/mL (39.6%). Cosibelimab-ipdl Cmax and AUC increased proportionally over the dose range of 800 mg to 1,200 mg following single dosing. Steady-state concentrations of cosibelimab-ipdl are reached by 12 weeks. At 1,200 mg every 3 weeks, the mean cosibelimab-ipdl concentrations (coefficient of variation, CV%) at steady-state ranged between a minimum concentration of 120 µg/L (46.3%) and a maximum concentration of 453 µg/L (22.2%). Steady-state exposure was achieved after 84 days of treatment. In patients with CSCC, cosibelimab-ipdl steady-state exposure at 1,200 mg every 3 weeks (the recommended dosage) was comparable to the exposure at 800 mg every 2 weeks.
Nonclinical Toxicology
There is limited information regarding Cosibelimab-ipdl Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Cosibelimab-ipdl Clinical Studies in the drug label.
How Supplied
There is limited information regarding Cosibelimab-ipdl How Supplied in the drug label.
Storage
There is limited information regarding Cosibelimab-ipdl Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Cosibelimab-ipdl Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Cosibelimab-ipdl interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Cosibelimab-ipdl Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Cosibelimab-ipdl Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.