Patient Medication Information: uses, side effects, how to take - Loqtorzi
Serious warnings and precautions box
What LOQTORZI is used for:
- LOQTORZI is used to treat patients with nasopharyngeal carcinoma (NPC), a cancer of the nasopharynx (which is located behind the nose and above the back of the throat).
LOQTORZI may be used together with other medicines called cisplatin and gemcitabine, as your first treatment when your NPC has spread to other parts of your body or has returned in nearby tissues.
LOQTORZI may be used alone to treat your NPC when:
- it has returned and cannot be removed with surgery or
- it has spread (metastatic), and
- you received chemotherapy that contains platinum, and it did not work or is no longer working.
How LOQTORZI works:
LOQTORZI works by helping your immune system fight your cancer.
The ingredients in LOQTORZI are:
Medicinal ingredients: toripalimab
Non-medicinal ingredients: citric acid monohydrate, mannitol, polysorbate 80, sodium chloride, sodium citrate and Water for Injection
- LOQTORZI can cause severe or fatal reactions of the immune system attacking any organ or tissue, including the lungs, liver, kidneys, heart, skin and bowels.
- LOQTORZI can cause severe or life-threatening infusion reactions including allergic reactions and anaphylaxis.
- Fatal and other serious complications can happen in patients who have a stem cell transplant (HSCT) before or after being treated with medications similar to LOQTORZI.
LOQTORZI comes in the following dosage forms:
Concentrate for solution for intravenous infusion, 40 mg/mL
Do not use LOQTORZI if:
- You are allergic to toripalimab or to any other ingredients in LOQTORZI. Talk to your healthcare professional if you are not sure.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LOQTORZI. Talk about any health conditions or problems you may have, including if:
- You have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- You had or will have a stem cell transplant from a donor (allogeneic)
- You have received an organ transplant
- You have received radiation treatment to your chest area
- You have had a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
- You are breastfeeding
Other warnings you should know about:
Pregnancy
- You should not use LOQTORZI if you are pregnant. If you are pregnant, think you may be pregnant or are planning to have a baby, talk to your healthcare professional before taking this medicine.
- LOQTORZI can harm your unborn baby.
- If you are a woman who could become pregnant, you should use an effective method of birth control during your treatment and for at least 4 months after the last dose of LOQTORZI.
Breastfeeding
- Tell your healthcare professional if you are breastfeeding or plan to breastfeed.
- Do not breastfeed during treatment and for at least 4 months after the last dose of LOQTORZI. It is not known if LOQTORZI passes into your breastmilk.
LOQTORZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after treatment has ended.
Problems can happen in any organ or tissue. Call or see your healthcare professional right away for any new or worsening signs or symptoms, which may include, but are not limited to:
- chest pain, irregular heartbeat, shortness of breath, 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
See the table “Serious side effects and what to do about them” for more information.
Rejection of a transplanted organ. Your healthcare professional should tell you what signs and symptoms you should report and monitor, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LOQTORZI. Your healthcare professional will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare professional will check you for these problems during treatment with LOQTORZI. They may treat you with corticosteroid or hormone replacement medicines. They may also need to delay or completely stop treatment with LOQTORZI if you have severe side effects.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
We do not know if LOQTORZI can interact with other drugs, food or supplements.
How to take LOQTORZI:
- LOQTORZI will be given to you by a healthcare professional in a hospital or a clinic.
- Your healthcare professional will give you LOQTORZI into your vein through an intravenous (IV) line over 30 or 60 minutes.
- Your healthcare professional will test your blood to check for certain side effects.
Usual dose:
LOQTORZI in combination with cisplatin and gemcitabine for first-line treatment of NPC
The recommended dose is 240 mg of LOQTORZI every 3 weeks in combination with cisplatin and gemcitabine for up to 6 cycles, followed by 240 mg of LOQTORZI every 3 weeks given on its own.
LOQTORZI for treatment of NPC previously treated with platinum chemotherapy
The recommended dose is 3 mg of LOQTORZI for every kg of body weight, every 2 weeks.
Your healthcare professional will decide how many treatments you need.
Overdose:
If you think you, or a person you are caring for, have taken too much LOQTORZI, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X 91-844-764-7669) immediately, even if there are no signs or symptoms.
Missed dose:
If you miss any appointments, call your healthcare professional as soon as possible to reschedule.
Possible side effects from using LOQTORZI:
These are not all the possible side effects you may have when taking LOQTORZI. If you experience any side effects not listed here, tell your healthcare professional.
- Burning or feeling of pins and needles in feet and toes
- Constipation
- Cough
- Decreased appetite
- Diarrhea
- Diabetes
- Dizziness
- Ear problems
- Feeling generally unwell
- Fever
- Headache
- Low levels of thyroid hormone
- Muscle and bone pain
- Nausea
- Nose bleeds
- Rash
- Sleep problems
- Tiredness
- Upper or lower respiratory infection
- Weight loss
- Vomiting
Serious side effects and what to do about them
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Frequency / Side Effect / Symptom | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Common | |||
| Hormone gland problems: 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, feeling more hungry or thirsty than usual, change in mood or behavior, such as decreased sex drive, irritability, or forgetfulness | ✓ | ||
| Intestinal problems: 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 or swelling | ✓ | ||
Lung problems: Inflammation of the lungs (pneumonitis) which can cause shortness of breath, chest pain, or coughing | ✓ | ||
Skin problems: rash, itching, painful sores or ulcers in your mouth or in your nose, throat, or genital area, skin blistering or peeling, fever or flu-like symptoms, swollen lymph nodes, hair loss | ✓ | ||
| Uncommon | |||
| Cardiac (heart) problems: chest pain, irregular heartbeat, shortness of breath, swelling of ankles, high or low blood pressure, blood clots | ✓ | ||
| Eye problems: double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight | ✓ | ||
| Infusion reactions: chills or shaking, dizziness, itching or rash, feeling like passing out, flushing, fever, shortness of breath or wheezing, back pain | ✓ | ||
| Kidney problems: decrease in your amount of urine, swelling of your ankles, blood in your urine, loss of appetite | ✓ | ||
| Liver problems: yellowing of skin or the whites of your eyes, dark urine (tea colored), severe nausea or vomiting, bleeding or bruising more easily than normal, pain on the right side of your stomach-area (abdomen) | ✓ | ||
| Nervous system problems: confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, muscle weakness, tingling or numbness of the arms or legs, sudden back pain, loss of reflexes | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
LOQTORZI will be kept refrigerated (2°C to 8°C) at the hospital or clinic. You will not bring it home.
If you want more information about LOQTORZI:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (Drug Product Database: Access the database; the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.
Date of Authorization: 2025-11-03