Toripalimab

Toripalimab is a prescription medication indicated in combination with cisplatin and gemcitabine for first-line treatment of metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). Toripalimab is also indicated as a monotherapy for the treatment of recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

• Toripalimab is available under the following different brand names: Loqtorzi, toripalimab-tpzi

Common side effects of Toripalimab include:

• nausea
• vomiting 
• decreased appetite 
• constipation
• low thyroid levels 
• rash
• fever 
• diarrhea 
• peripheral neuropathy 
• cough
• muscle and joint pain 
• upper respiratory infection 
• trouble sleeping
• dizziness, and malaise
• tiredness
• low levels of thyroid hormone
• muscle and bone pain

Serious side effects of Toripalimab include:

• allergic reaction such as rash, hives, itching, and red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat
• lung or breathing problems such as shortness of breath or other trouble breathing, cough, or fever
• signs of bowel problems (such as colitis) such as black, tarry, or bloody stools; fever; mucus in the stools; throwing up blood or throw up that looks like coffee grounds; or severe stomach pain, constipation, or diarrhea
• nervous system problems such as change in balance, change in mood or behavior, feeling confused or sleepy, fever, memory problems, severe muscle weakness, numbness or tingling in the arms or legs, seizures, stiff neck, or bright lights bothering your eyes
• heart problems such as chest pain; fast, slow, or abnormal heartbeat; shortness of breath; a big weight gain; or swelling in the arms or legs
• signs of electrolyte problems such as mood changes; confusion; muscle pain, cramps, or spasms; weakness; shakiness; change in balance; an abnormal heartbeat; seizures; loss of appetite; or severe upset stomach or throwing up
• high blood pressure such as very bad headache or dizziness, passing out, or change in eyesight
• liver problems such as dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes
• fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak
• severe muscle pain, tenderness, or weakness (with or without fever)
• muscle cramps

Rare side effects of Toripalimab 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

• 40 mg/mL (6-mL single-dose vial)

NPC

Adult dosage

• Combination therapy
  • 240 mg IV every 3 weeks
  • continue until disease progression, unacceptable toxicity, or up to 24 months
• Monotherapy
  • 3 mg/kg IV every 2 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, healthcare provider, or pharmacist first.

• Toripalimab has severe interactions with no other drugs
• Toripalimab has serious interactions with the following drug:
  • etrasimod
• Toripalimab has moderate interactions with no other drugs
• Toripalimab has minor interactions with no 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 Toripalimab?”

Long-Term Effects

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

Cautions

• Severe infusion-related reactions can occur; discontinue in patients with severe or life-threatening infusion reactions
• May cause fetal harm when administered to pregnant women
• In clinical trials in multiple myeloma patients, adding a PD-1 blocking antibody to a thalidomide analog plus dexamethasone resulted in increased mortality
• Cytomegalovirus infection/reactivation reported in patients with corticosteroid-refractory immune-mediated colitis; in cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologiesComplications of allogeneic hematopoietic stem cell transplantation (HSCT)
• Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after treatment 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 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
• Monitor closely for evidence of transplant-related complications and intervene promptly
• Assess the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody before or after an allogeneic HSCTImmune-mediated adverse reactions
• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and include immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, and dermatologic adverse reactions; evaluate liver enzymes and thyroid function at baseline and periodically during treatment
• Immune-mediated encephalitis can occur; withhold therapy in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out infectious or other causes of those findings
• When combined with cisplatin and gemcitabine, immune-mediated nephritis may occur; reactions may be severe or fatal; monitor for early identification and management; evaluate creatinine at baseline and periodically during treatment
• Other clinically significant and potentially fatal immune-mediated adverse reactions
• (eg, myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis) can occur after discontinuation
• Immune-mediated endocrinopathies
• Immune-mediated hypophysitis reported; monitor
  • Immune-mediated hypothyroidism and hyperthyroidism reported; monitor for changes in thyroid function and initiate thyroid hormone replacement as needed; administer hormone-replacement therapy for hypothyroidism; initiate medical management for control of hyperthyroidism
  • Adrenal insufficiency may occur; monitor for signs and symptoms of adrenal insufficiency during and after treatment
  • May cause type 1 diabetes mellitus; monitor for hyperglycemia
• Immune-mediated skin reactions
  • May cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN); if symptoms or signs of SJS or TEN develop, withhold therapy and refer the patient for specialized care for assessment and treatment
  • Immune-mediated rash reported in combination with ipilimumab; withhold for severe rash and permanently discontinue for life-threatening rash
• Immune-mediated colitis
  • Therapy can cause immune-mediated colitis, defined as requiring the use of corticosteroids and having no clear alternative etiology; a common sign in the definition of colitis reported to be diarrhea

Pregnancy and Lactation

• Based on its mechanism of action, fetal harm may occur when administered to pregnant women
• No data are available on the use of toripalimab in pregnant women
• Human IgG4 immunoglobulins are known to cross the placenta; therefore, they can potentially be transmitted from mother to developing fetus
• Advise women of the potential risk to a fetus
• Contraception
  • Verify pregnancy status before initiating in women of reproductive potential
  • Use effective contraception during treatment and for at least 4 months following the last dose
• Lactation
  • No data are available on the presence of toripalimab in human milk or its effects on breastfed children or milk production
  • Maternal IgG is known to be present in human milk
  • Effects of local gastrointestinal exposure and limited systemic exposure in breastfed children to toripalimab are unknown
  • Advise lactating women not to breastfeed during treatment and for 4 months after the last dose