Tislelizumab

Tislelizumab is a prescription medication indicated for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) in patients previously treated with systemic chemotherapy that did not include a PD-(L) 1 inhibitor.

• Tislelizumab is available under the following different brand names: Tevimbra, tislelizumab-jsgr.

Common side effects of Tislelizumab include:

• anemia (low red blood cell counts)
• hypothyroidism (an underactive thyroid gland) 
• cough
• rash
• itching
• tiredness 
• decreased appetite
• musculoskeletal pain
• decreased weight
• increased glucose
• decreased lymphocytes
• decreased sodium
• decreased albumin
• increased alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine transaminase (ALT)

Serious side effects of Tislelizumab include:

• anemia 
• pneumonia (infection of the lungs)
• dysphagia
• hemorrhage
• esophageal obstruction

Rare side effects of Tislelizumab 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

Injectable solution

• 10 mg/mL (10 mL single-dose vial)

Esophageal cancer

Adult dosage

• 200 mg IV every 3 weeks
• Continue 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.

• Tislelizumab has no noted severe interactions with any other drugs
• Tislelizumab has no noted serious interactions with any other drugs
• Tislelizumab has no noted moderate interactions with any other drugs
• Tislelizumab 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 Tislelizumab?”

Long-Term Effects

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

Cautions

• May cause severe or life-threatening infusion-related reactions; monitor for signs and symptoms of infusion-related reactions
• Can cause fetal harm; advise women of reproductive potential of potential risk to a fetus and use of effective contraception
• Immune-related reactions
  • Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue
  • Immune-mediated adverse reactions can occur at any time after starting treatment with a PD-1/PD-L1 blocking antibody
  • While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies
  • Institute medical management promptly, including specialty consultation as appropriate; withhold or permanently discontinue therapy depending on severity; in general, if therapy requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less
  • Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month; consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy
  • Immune-mediated pneumonitis or interstitial lung disease occurred; monitor for signs and symptoms of pneumonitis; incidence of pneumonitis is higher in patients who have received thoracic radiation
  • Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions
  • Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment
  • Immune-mediated pneumonitis or interstitial lung disease occurred; monitor for signs and symptoms of pneumonitis; incidence of pneumonitis is higher in patients who have received thoracic radiation
  • May cause immune-mediated hepatitis, which can be fatal
• Immune-mediated endocrinopathies
• Adrenal insufficiency may occur; monitor for clinical signs and symptoms of adrenal insufficiency
• Type 1 diabetes mellitus reported; monitor for hyperglycemia or other signs and symptoms of diabetes; initiate insulin therapy as clinically indicated; interrupt treatment based on severity
• Myositis/polymyositis, rhabdomyolysis, and associated sequelae including kidney failure, arthritis, polymyalgia, and rheumatic reported
• Hypophysitis/hypopituitarism may occur; hypophysitis can present as acute symptoms associated with mass effects, such as headache, photophobia, or visual field cuts; hypophysitis can cause hypopituitarism; withhold or permanently discontinue therapy depending on severity; for Grade 2 or higher hypophysitis, initiate prednisone 1-2 mg/kg/day or equivalents, followed by a taper and hormone replacement therapy as clinically indicated
• Thyroid disorders may occur; thyroiditis can present with or without endocrinopathy; not reported to lead to permanent discontinuation; hypothyroidism can follow hyperthyroidism; monitor thyroid function before and periodically during treatment; initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated; continue therapy for hypothyroidism and interrupt for hyperthyroidism or permanently discontinue therapy based on severity
• Other immune-mediated adverse reactions
  • Immune-mediated adverse reactions (ie, myositis, myocarditis, arthritis, polymyalgia rheumatica, pericarditis), which may be severe or fatal, can occur in any organ system or tissue; reactions can occur at any time after starting a PD1/PD-L1 blocking antibody
• 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 benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after an allogeneic HSCT
• Colitis
  • Drug can cause immune-mediated colitis that can present as diarrhea, abdominal pain, and lower gastrointestinal (GI) bleeding
  • Cytomegalovirus (CMV) infection/ reactivation reported in patients with corticosteroid-refractory immune-mediated colitis
  • In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies

Pregnancy and Lactation

• Based on its mechanism of action, it can cause fetal harm when administered during pregnancy
• No data are available on use in pregnant women
• Verify pregnancy status in women of reproductive potential before initiating
• Contraception
  • Advise women of reproductive potential to use effective contraception during treatment and for at least 4 months following the last dose
• Lactation
  • There is no information regarding the presence of Tislelizumab-jsgr in human milk or its effects on breastfed children or on milk production
  • Advise lactating women not to breastfeed during treatment and for at least 4 months after the last dose