Prescribing Information Med Guide Healthcare Professional Site

Medication Guide Prescribing Information Healthcare Professional Site

Hero about Loqtorzi

What is LOQTORZI™?

LOQTORZI™ is a prescription medicine used to treat adults with a kind of cancer called NPC. Your healthcare provider will prescribe LOQTORZI™ with chemotherapy* or on its own, depending on your disease and treatment history.

LOQTORZI™ + chemotherapy*

LOQTORZI™ may be used in combination with chemotherapy* as your first treatment when your NPC:

Has spread to other parts of your body (metastatic) or
Has returned (recurrent) in nearby tissues (locally advanced)

LOQTORZI™ may be continued chemo free after completing up to 6 cycles with chemotherapy^†

*Chemotherapy is cisplatin and gemcitabine.

^†In the clinical study, cisplatin and gemcitabine were given every 3 weeks for the first 6 treatment cycles, followed by LOQTORZI™ given alone.

LOQTORZI™ alone

LOQTORZI™ may be used alone to treat your NPC when it:

Has returned (recurrent) and cannot be removed with surgery or
Has spread (metastatic), and
You received chemotherapy that contains platinum, and it did not work or is no longer working

It is not known if LOQTORZI™ is safe and effective in children.

How does it work?

LOQTORZI™ is a type of medicine called an immunotherapy. Unlike chemotherapy or radiotherapy, immunotherapy works by helping to boost your immune system’s ability to fight cancer.

LOQTORZI™ enhances your immune system's ability to detect and destroy cancer cells

Your immune system makes T cells, a type of immune cell that detects and destroys germs and cells that could make you sick—including cancer cells.

Cancer cells can hide from T cells in your immune system, allowing cancer to grow and spread undetected.

LOQTORZI™ is a medicine to treat nasopharyngeal cancer by working with your immune system. 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.

Get more educational tools and resources to help support you on your treatment journey.

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INDICATIONS

LOQTORZI (toripalimab-tpzi) is a prescription medicine used to treat adults with a kind of cancer called nasopharyngeal carcinoma (NPC).

LOQTORZI may be used in combination with the chemotherapy medicines cisplatin and gemcitabine, as your first treatment when your NPC has spread to other parts of your body (metastatic) or has returned (recurrent) in nearby tissues (locally advanced).
LOQTORZI may be used alone to treat your NPC when it:
- has returned (recurrent) and cannot be removed with surgery or
- has spread (metastatic), and
- you received chemotherapy that contains platinum, and it did not work or is no longer working.

It is not known if LOQTORZI is safe and effective in children.

Important Safety Information

What is the most important information I should know about LOQTORZI^®?

LOQTORZI is a medicine to treat nasopharyngeal cancer by working with your immune system. 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.

INDICATIONS

LOQTORZI (toripalimab-tpzi) is a prescription medicine used to treat adults with a kind of cancer called nasopharyngeal carcinoma (NPC).

LOQTORZI may be used in combination with the chemotherapy medicines cisplatin and gemcitabine, as your first treatment when your NPC has spread to other parts of your body (metastatic) or has returned (recurrent) in nearby tissues (locally advanced).
LOQTORZI may be used alone to treat your NPC when it:
- has returned (recurrent) and cannot be removed with surgery or
- has spread (metastatic), and
- you received chemotherapy that contains platinum, and it did not work or is no longer working.

It is not known if LOQTORZI is safe and effective in children.

Important Safety Information

What is the most important information I should know about LOQTORZI^®?

LOQTORZI is a medicine to treat nasopharyngeal cancer by working with your immune system. 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.

Call or see your health care provider right away if you develop any signs or symptoms of the following problems or if they get worse, including:

Lung problems: cough, shortness of breath, or chest pain.
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.
Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); or bleeding or bruising more easily than normal.
Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; change in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
Kidney problems: decrease in your amount of urine; blood in your urine; swelling of your ankles; loss of appetite.
Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or in your nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes.
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LOQTORZI. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: 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.
Infusion reactions that can sometimes be severe or life-threatening. Signs or symptoms of infusion reactions may include: chills or shaking; itching or rash; flushing; shortness of breath or wheezing; dizziness; feeling like passing out; fever; back pain.
Rejection of a transplanted organ. Your healthcare provider 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 provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious.
Your healthcare provider will check you for these problems during treatment with LOQTORZI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LOQTORZI if you have severe side effects.

Before you receive LOQTORZI, tell your health care provider about all of your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant or have received or plan to receive a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic)
have received radiation treatment in your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. LOQTORZI can harm your unborn baby. If you are able to become pregnant, your healthcare provider should do a pregnancy test before you start treatment with LOQTORZI. Use effective birth control during treatment and for at least 4 months after your final dose of LOQTORZI. Tell your health care provider right away if you think you may be pregnant or you become pregnant during treatment with LOQTORZI
are breastfeeding or plan to breastfeed. It is not known if LOQTORZI passes into your breast milk. Do not breastfeed during treatment with LOQTORZI and for 4 months after your final dose of LOQTORZI

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of LOQTORZI?

The most common side effects of LOQTORZI when used with cisplatin and gemcitabine include: nausea; vomiting; decreased appetite; constipation; low levels of thyroid hormone; rash; fever; diarrhea; burning or feeling of pins and needles in feet and toes; cough; muscle and bone pain; upper respiratory infection; sleep problems; dizziness; and feeling generally unwell.
The most common side effects of LOQTORZI when used alone include: tiredness; low levels of thyroid hormone; muscle and bone pain.

These are not all the possible side effects of LOQTORZI. Talk to your health care provider for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

LOQTORZI^® Injection: 240 mg/6 mL (40 mg/mL) solution in a single-dose vial.

Please read the Medication Guide and Prescribing Information for LOQTORZI.