Loqtorzi

Generic name: Toripalimab-tpzi
Dosage form: injection single-dose vial (240 mg/6 mL)

Usage of Loqtorzi

Loqtorzi (toripalimab-tpzi) is a PD-1 inhibitor used for the treatment of advanced nasopharyngeal carcinoma (NPC). Loqtorzi is a next-generation, programmed death receptor-1 (PD-1) monoclonal antibody that blocks PD-L1 and PD-L2, which allows the immune system to activate and kill the tumor. Loqtorzi works by blocking the PD-1 receptor on tumor cells so the immune system is more able to attack and kill tumor cells.

Loqtorzi is given as an intravenous infusion every two or three weeks, depending on your treatment regime.

Loqtorzi received FDA approval on October 27, 2023, based on positive results from the Phase II clinical study POLARIS-02 and the Phase 3 clinical trial JUPITER-02. Loqtorzi is FDA-approved to treat adults as:

as a first treatment when NPC has spread to other parts of the body (metastatic) or has returned (recurrent) in nearby tissues (locally advanced), when used together with gemcitabine and cisplatin

you have received chemotherapy that contains platinum, and it did not work or is no longer working, and NPC has returned and cannot be removed with surgery or has spread (metastatic).

Loqtorzi side effects

The most common Loqtorzi side effects when used as a single therapy are fatigue, hypothyroidism, and musculoskeletal pain these occurred in 20% or more of patients.

The most common Loqtorzi side effects when used in combination with cisplatin and gemcitabine are 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, these side effects affected 20% or more of patients.

Also see the warning section below for serious side effects.

These are not all the possible side effects of Loqtorzi. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Loqtorzi

Tell your healthcare 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

have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)

have received radiation treatment to your chest area

have had a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.

Pregnancy

Loqtorzi can harm your unborn baby.

Tell you healhcare providers if you are pregnant or plan to become pregnant.

Females who are able to become pregnant should have a negative pregnancy test before you start treatment with Loqtorzi. You should use an effective method of birth control during your treatment and for 4 months after your last dose of this medicine. Talk to your healthcare provider about the best birth control methods that you can use during this time. Tell your healthcare provider right away if you think you may be pregnant or if you become pregnant during treatment with Loqtorzi.

Breastfeeding

Do not breastfeed during treatment and for 4 months after the last dose of Loqtorzi.

Tell you healhcare providers if you are breastfeeding or plan to breastfeed. It is not known if Loqtorzi passes into your breast milk.

How to use Loqtorzi

Recommended adult Loqtorzi dose for First-line Treatment of Metastatic or Recurrent, Locally Advanced NPC with Cisplatin and Gemcitabine: 240 mg every three weeks.

Recommended adult Loqtorzi dose Previously Treated Unresectable or Metastatic NPC: 3 mg/kg every two weeks.

Warnings

Loqtorzi treats nasopharyngeal cancer by working with your immune system, so it may 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 your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

cough

shortness of breath

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 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)

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

Kidney problems

decrease in your amount of urine

swelling of your ankles

blood in your urine

loss of appetite

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

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 this medicine. 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.

Infusion reactions that can sometimes be severe or life-threatening. Signs or symptoms of infusion reactions may include:

chills or shaking

dizziness

itching or rash

feeling like passing out

Flushing

Fever

shortness of breath or wheezing

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.

What other drugs will affect Loqtorzi

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Not all possible interactions are listed here.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.