Loqtorzi 240mg/6ml Inj, 6ml

Toripalimab is a humanized IgG4 monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2 ligands. This blockade releases PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. Binding of PD-1 to its ligands (PD-L1 and PD-L2) inhibits T-cell proliferation and cytokine production. In some tumors, upregulation of PD-L1 and PD-L2 can occur, and binding to PD-1 on T cells can inhibit anti-tumor T-cell immunity. Toripalimab's blockade of PD-1/PD-L1 and PD-1/PD-L2 interactions enhances T-cell function, including anti-tumor activity.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Allergic reactions: Rash, hives, itching, 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: Shortness of breath, trouble breathing, cough, or fever.
Nervous system problems: Burning, numbness, or tingling sensation, change in balance, confusion, dizziness, hallucinations, memory problems or loss, new or worsening behavior or mood changes (such as anxiety, depression, or thoughts of suicide), trouble focusing, trouble sleeping, or trouble thinking or speaking.
Heart problems: Chest pain, fast, slow, or abnormal heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs.
Electrolyte problems: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe nausea or vomiting.
High blood pressure: Severe headache or dizziness, passing out, or changes in eyesight.
Liver problems: Dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Thyroid, pituitary, or adrenal gland problems: Changes in mood or behavior, changes in weight or taste, constipation, deeper voice, dizziness, fainting, feeling cold, feeling very tired, hair loss, severe or long-lasting headache, changes in sex interest, eye problems, fast heartbeat, increased sweating, fast or deep breathing, sweet-smelling breath, changes in the smell of urine or sweat, or frequent urination.
Kidney problems: Inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes.
Pancreas problems (pancreatitis): Severe stomach pain, severe back pain, or severe nausea or vomiting.
Other symptoms: Fever, chills, or sore throat, unexplained bruising or bleeding, or feeling very tired or weak.
Severe muscle problems: Severe or long-lasting muscle pain, tenderness, or weakness (with or without fever).

Infusion-Related Side Effects

Some people may experience side effects during the infusion, which can be severe or life-threatening. Inform your doctor if you experience:

Back or neck pain
Chills
Shaking
Dizziness
Passing out
Fever
Flushing
Itching
Rash
Shortness of breath
Swelling of the face
Wheezing

Common Side Effects

This medication can cause diarrhea, which may be a sign of a bowel problem (colitis). If you experience any of the following symptoms, contact your doctor immediately:

Bloody stools
Dark, tarry, or sticky stools
Diarrhea
Severe stomach pain

Other Side Effects

Inform your doctor if you experience any of the following side effects, which can be a sign of other conditions:

Signs of high or low blood sugar, such as:
+ Breath that smells like fruit
+ Dizziness
+ Fast breathing
+ Fast heartbeat
+ Feeling confused
+ Feeling sleepy
+ Feeling weak
+ Flushing
+ Headache
+ Unusual thirst or hunger
+ Frequent urination
+ Shaking
+ Sweating
Eye problems, such as changes in vision, eye pain, or severe eye irritation
Constipation
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Back, bone, joint, muscle, or neck pain
Signs of a common cold
Trouble sleeping
Feeling dizzy, tired, or weak
Mouth irritation or mouth sores
Weight loss

Reporting Side Effects

If you experience any side effects, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
If you are breastfeeding, as you should not breastfeed while taking this medication or for 4 months after your last dose.

To ensure safe use, tell your doctor and pharmacist about:

All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Any health problems you have, as this medication may interact with other drugs or health conditions.

Before starting, stopping, or changing the dose of any medication, consult with your doctor to confirm it is safe to do so in conjunction with this medication.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your health.

If you experience gastrointestinal side effects such as stomach upset, vomiting, diarrhea, or decreased appetite, consult your doctor, as they may be able to suggest ways to minimize these symptoms.

This medication can cause an increase in blood sugar levels, potentially leading to new-onset diabetes or worsening of existing diabetes. Therefore, it is vital to monitor your blood sugar levels as advised by your doctor.

Additionally, this medication can cause high blood pressure. Regular blood pressure checks, as recommended by your doctor, are necessary to ensure your blood pressure remains within a healthy range.

In rare cases, this medication can cause severe health problems in various organs, including the bowels, lungs, liver, thyroid, pituitary, and adrenal glands, pancreas, kidneys, and other parts of the body. Nerve problems, muscle problems, or severe skin reactions may also occur, and in some instances, these problems can be life-threatening. These complications can arise at any time during treatment or even after treatment has ended. If you have any concerns or questions, discuss them with your doctor.

If you have undergone an organ transplant or a cornea transplant, it is crucial to inform your doctor, as you will need to monitor for signs of organ or cornea graft rejection. Furthermore, if you have received a stem cell transplant from a donor (allogeneic), consult your doctor, as this medication has been associated with severe complications in people who have undergone such transplants, which can be life-threatening.

This medication can harm an unborn baby. A pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant. If you are of childbearing potential, it is essential to use effective birth control while taking this medication and for four months after the last dose. If you become pregnant, notify your doctor immediately.

• Live or live-attenuated vaccines (due to potential for infection or reduced vaccine efficacy)

• Corticosteroids (systemic) or other immunosuppressants (prior to or concurrently with treatment, except for managing immune-related adverse reactions, as they may interfere with toripalimab's pharmacodynamic activity)

• New or worsening cough
• Shortness of breath
• Chest pain
• Diarrhea (especially severe or persistent)
• Abdominal pain
• Blood or mucus in stool
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Severe fatigue
• Headache
• Changes in vision
• Dizziness
• Increased thirst or urination
• Unexplained weight changes
• Hair loss
• Skin rash (new or worsening)
• Itching
• Muscle weakness or pain
• Joint pain
• Numbness or tingling
• Fever
• Chills

Loqtorzi can cause fetal harm when administered to a pregnant woman. Based on its mechanism of action, toripalimab can cross the placenta and may cause immune-mediated adverse reactions in the developing fetus, including increased rates of abortion and stillbirth. Advise pregnant women of the potential risk to a fetus.

It is not known whether toripalimab is excreted in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Loqtorzi and for 4 months after the last dose.

The safety and effectiveness of Loqtorzi in pediatric patients have not been established. Its use is not recommended in this population.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients (<65 years). No dose adjustment is required for geriatric patients. However, older patients may be more susceptible to immune-related adverse events.

• Loqtorzi is the first and only FDA-approved treatment for nasopharyngeal carcinoma (NPC), specifically for recurrent, unresectable, or metastatic NPC in combination with gemcitabine and cisplatin as first-line treatment, and as monotherapy for recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
• Immune-related adverse events (irAEs) can occur in any organ system and at any time during or after treatment. Early recognition and management are crucial.
• Patients should be educated on the signs and symptoms of irAEs and instructed to report them immediately.
• Management of irAEs often involves corticosteroids and/or withholding/discontinuing toripalimab.
• Endocrinopathies (e.g., thyroid disorders, adrenal insufficiency, diabetes) may require long-term hormone replacement therapy.

• Chemotherapy (e.g., gemcitabine/cisplatin, platinum-based regimens)
• Radiation therapy
• Targeted therapies (if applicable for specific mutations)
• Other investigational agents for NPC.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which can be a safe and environmentally friendly way to dispose of unwanted medications.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information about its safe and effective use. It is crucial to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will help healthcare professionals provide appropriate treatment.