Ctrl

K

Cosibelimab

Class
Targeted therapy
Subclass
Anti-PD-L1 monoclonal antibodies
Substance name
Cosibelimab, cosibelimab-ipdl
Brand names
Unloxcyt®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment of cutaneous SCCMetastatic or locally advanced, ineligible for curative surgery or radiation
1,200 mg IV q3 weeks, administered over 60 minutes, until disease progression or unacceptable toxicity
Indications for use
Labeled indications
Adults
Treatment of cutaneous SCC (metastatic or locally advanced, ineligible for curative surgery or radiation)
Safety risks
Warnings and precautions
GvHD, hepatic veno-occlusive disease
Maintain a high level of suspicion, as serious and fatal complications can occur in patients undergoing allogeneic HSCT before or after being treated with a PD-1/PD-L1-blocking antibody, including hyperacute, acute, or chronic GvHD, hepatic veno-occlusive disease after reduced intensity conditioning, and corticosteroid-requiring febrile syndrome.
Immune-mediated adverse reactions
Maintain a high level of suspicion, as cosibelimab has been associated with an increased risk of severe and fatal immune-mediated adverse reactions, including but not limited to pneumonitis, colitis, hepatitis, adrenal insufficiency, hypophysitis, hypothyroidism, hyperthyroidism, T1DM, nephritis, and dermatitis. Assess liver enzymes, creatinine, and thyroid function tests at baseline and periodically during treatment. Interrupt treatment in case of grade 2 adverse reactions until resolution to grade ≤ 1. Permanently discontinue cosibelimab in case of grade 3 or 4 reactions.
Infusion-related reactions
Maintain a high level of suspicion, as cosibelimab can cause severe or life-threatening infusion-related reactions.
Specific populations
Renal impairment
CrCl ≥ 15 mL/min
Use acceptable. No dose adjustment required.
CrCl < 15 mL/min
No guidance available.
Renal replacement therapy
Any modality
No guidance available.
Hepatic impairment
Child-Pugh A (mild)
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
Do not use. Evidence of fetal harm in animals. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise using effective contraception during treatment and for 4 months after the last dose.
Breastfeeding
Do not use during breastfeeding.
Advise females not to breastfeed for 4 months after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
Anemia, ↓ blood lymphocyte count, ↓ platelet count, ↑ serum calcium, ↓ serum sodium, edema, hypothyroidism, diarrhea, ↑ serum ALP, ↑ serum AST, infusion-related reactions, fatigue, headache, itching, musculoskeletal pain, ↑ serum ALT, ↑ serum lipase, nausea, constipation, skin rash, ↑ serum potassium
Common 1-10%
↓ WBC count, hyperthyroidism, pneumonitis, urinary tract infections
Uncommon < 1%
Adrenal insufficiency, colitis, myocarditis, pericarditis, vasculitis, meningitis, encephalitis, myelitis, myasthenia gravis, Guillain-Barré syndrome, uveitis, iritis, acute pancreatitis, gastritis, myositis, polymyositis, rhabdomyolysis, hypoparathyroidism, aplastic anemia, hemolytic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis, sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, exfoliative dermatitis, bullous pemphigoid, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, visual disturbances, vision loss
Unknown frequency
Hepatitis, hypophysitis, diabetes mellitus type 1, nephritis, renal dysfunction
Interactions
Drug(s)
Check Interactions
Reset

What did you think about this content?

Create free account

Sign up for free to access the full drug resource