Cosibelimab

Cosibelimab is a prescription medication indicated for metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) in adults who are not candidates for curative surgery or curative radiation.

• Cosibelimab is available under the following different brand names: Unloxcyt, cosibelimab-ipdl.

Common side effects of Cosibelimab include:

• tiredness or weakness
• muscle or bone pain
• rash
• diarrhea
• low thyroid hormone levels (hypothyroidism)
• constipation 
• nausea
• headache 
• itchy skin 
• swelling 
• localized infection
• urinary tract infection

Serious side effects of Cosibelimab include:

• lung problems such as cough, chest pain, shortness of breath
• intestinal problems such as diarrhea (loose stools) or more frequent bowel movements than usual,
• stools that are black, tarry, sticky, or have blood or mucus, severe stomach-area (abdomen) pain or tenderness
• liver problems such as yellowing of your skin or the whites of the eyes, dark urine (tea-colored), severe nausea or vomiting, bleeding or bruising more easily than normal, and pain on the right side of the abdomen
• hormone gland problems such as headaches that will not go away or unusual headaches, urinating more often than usual, eye sensitivity to light, hair loss, eye problems, feeling cold, rapid heartbeat, constipation, increased sweating, your voice gets deeper, extreme tiredness, dizziness or fainting, weight gain or weight loss, changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness, feeling more hungry or thirsty than usual
• kidney problems such as a decrease in the amount of urine, swelling of the ankles, blood in the urine, loss of appetite
• skin problems such as rash, painful sores or ulcers in mouth or nose itching throat, or genital area, fever or flu-like symptoms, swollen lymph nodes, skin blistering or peeling
• other organs and tissue side effects such as chest pain, irregular heartbeat, shortness of breath, or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, bruising
• infusion reaction symptoms such as nausea, dizziness, chills or shaking, feeling like passing out, itching or rash, fever, flushing, back or neck pain, shortness of breath, or wheezing
• rejection of a transplanted organ

Rare side effects of Cosibelimab include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection solution

• 300 mg/5 mL (60 mg/mL) single-dose vial

CSCC

Adult dosage

• 1200 mg IV every 3 weeks until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Cosibelimab has no noted severe interactions with any other drugs
• Cosibelimab has no noted serious interactions with any other drugs
• Cosibelimab has no noted moderate interactions with any other drugs
• Cosibelimab has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cosibelimab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cosibelimab?”

Cautions

• Immune-mediated adverse reactions
  • May cause severe or fatal immune-mediated reactions
  • May occur in any organ system or tissue and at any time after starting therapy including after discontinuation
  • For suspected reactions, initiate appropriate workup to exclude alternative etiologies (e.g., infection)
  • Institute medical management promptly; consult specialists as appropriate
  • Hold or permanently discontinue based on the severity
• Administer systemic corticosteroids (e.g., 1-2 mg/kg/day prednisone or equivalent) until improvement to Grade of 1and less, then taper corticosteroids over at least 1 month
• Other systemic immunosuppressants may be required if reactions are not controlled with corticosteroids
• Immune-mediated pneumonitis
  • Incidence of pneumonitis may be higher following prior thoracic radiation
• Immune-mediated colitis
  • May present as diarrhea, abdominal pain, and lower gastrointestinal bleeding
  • Cytomegalovirus (CMV) infection/reactivation reported with corticosteroid-refractory immune-mediated colitis
  • For corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies
• Immune-mediated hepatitis
  • Evaluate liver enzymes before initiating and periodically during therapy
• Immune-mediated endocrinopathies
  • Can cause immune-mediated adrenal insufficiency, thyroid disorders (eg, thyroiditis, hyperthyroidism, hypothyroidism), and type 1 diabetes mellitus that may present as diabetic ketoacidosis
  • Hypophysitis can cause hypopituitarism
  • Hypothyroidism can follow hyperthyroidism
• Initiate symptomatic treatment (e.g., hormone replacement, insulin) as clinically indicated
• Evaluate thyroid function before initiation and periodically during therapy
• Monitor for hyperglycemia and other signs of diabetes
• Immune-mediated nephritis
  • May occur with renal dysfunction
  • Evaluate renal function before initiation and periodically during therapy
• Immune-mediated dermatologic reactions
  • Bullous and exfoliative dermatitis may occur (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms)
  • Treat mild to moderate non-exfoliative rashes with topical emollients and/or topical corticosteroids
  • Hold or permanently discontinue depending on the  severity
• Infusion-related reactions (IRR)
  • May cause severe or life-threatening IRRs
  • Consider premedication with antipyretic and/or antihistamine in patients with a history of systemic reactions to infusions of therapeutic proteins
  • Monitor for signs and symptoms of IRR
  • Interrupt, reduce rate, or permanently discontinue based on severity
• 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
  • Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause)
  • These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT
  • Follow patients closely for evidence of transplant-related complications and intervene promptly
  • Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after an allogeneic HSCT
• Embryo-fetal toxicity
  • Fetal harm may occur if used during pregnancy
  • Advise pregnant patients of potential risk to the fetus
  • Effective contraception is recommended during and after therapy in females of reproductive potential

Pregnancy and Lactation

• Fetal harm may occur if administered during pregnancy, based on the mechanism of action
• Fetal exposure may increase the risk of developing immune-mediated disorders or altering the normal immune response
• There are no data on the use of this drug in pregnant patients or animals
• Verify pregnancy status of females of reproductive potential before starting treatment
• Animal studies demonstrated that PD-1/PD-L1 pathway inhibition can lead to an increased risk of immune-mediated rejection of the developing fetus, resulting in fetal death
• Human IgG1 immunoglobulins (IgG1) are known to cross the placenta; therefore, the transmission may potentially occur from mother to developing fetus
• Advise pregnant patients of potential fetal risk
• Contraception
  • Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose
• Lactation
  • There are no data on the presence of cosibelimab in human milk, its effects on breastfed children, or milk production
  • Due to the potential for adverse reactions in breastfed children, advise against breastfeeding during therapy and for 4 months after the last dose