Tevimbra

Pronunciation: TEV-im-bra
Generic name: tislelizumab-jsgr
Dosage form: injection for intravenous infusion

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 16, 2024.

What is Tevimbra?

Tevimbra (tislelizumab-jsgr) is a programmed death receptor-1 (PD-1) blocking antibody that is given intravenously (into a vein) and may be used to treat adults with esophageal squamous cell carcinoma that has spread to other parts of the body (metastatic) or cannot be surgically removed.

Tevimbra is given after prior treatments that did not include a PD-L 1 inhibitor.

Tevimbra (tislelizumab-jsgr) belongs to the class of medicines known as checkpoint inhibitors and works by blocking the PD-1 pathway to help prevent cancer cells from hiding from the immune system, boosting the immune system's response against cancer. Tevimbra is highly specific for PD-1.

Tevimbra was FDA-approved on 13 March 2024.

What are the side effects of Tevimbra?

Tevimbra can cause serious side effects, including:

Serious, life-threatening immune system and other reactions (see warnings below)
Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of Tevimbra:

chills or shaking
dizziness
itching or rash
feeling like you might pass out
flushing
fever
shortness of breath or wheezing
back or neck pain.

Get emergency medical help if you have signs of an allergic reaction to Tevimbra (such as hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;
eye pain, vision changes, sensitivity to light;
severe muscle pain or weakness;
confusion, memory problems, neck stiffness, drowsiness, balance problems;
numbness or tingling in your arms or legs;
kidney problems - little or no urination, swelling in your feet or ankles, blood in your urine;
liver problems - severe nausea or vomiting, right-sided upper stomach pain, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
lung problems - new or worsening cough, chest pain, feeling short of breath;
skin problems - rash, itching, redness, swelling, pain, sores, blisters, sores in your mouth or nose or on your genitals;
signs of a hormonal disorder - frequent or unusual headaches, vision problems, fast heartbeats, dizziness, fainting, tiredness, mood or behavior changes, hunger, increased thirst or urination, constipation, hair loss, hoarse or deepened voice, sweating, feeling cold, weight gain or loss; or
(if you have had a stem cell transplant) feeling sick or uneasy, with pain or swelling near your transplanted organ.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Tevimbra side effects affecting 20% of more people may include:

laboratory abnormalities, such as increased glucose levels and liver function tests and decreased hemoglobin, lymphocytes, sodium, and albumin
anemia
fatigue/tiredness
pain in the muscles and bones
weight loss
cough.

Other side effects include:

decreased appetite
pneumonia
nausea, vomiting, stomach pain, diarrhea, constipation
difficulty swallowing
low thyroid levels
rash
bleeding.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings and serious effects

Tevimbra can cause immune-mediated reactions, which are serious, sometimes life-threatening, side effects in many different parts of your body. Some of these may need to be treated with other medicines, and your cancer treatments may be delayed.

Call your doctor at once if you have a cough, shortness of breath or other lung problems, vision changes, muscle pain or weakness, stomach pain, diarrhea, blood in your stools, little or no urinating, bruising or bleeding, dark urine (tea colored), yellowing of your skin or eyes, severe nausea or vomiting, frequent headaches, dizziness, confusion, increased thirst or urination, skin problems, numbness or tingling, feeling cold, changes in mood or behavior, decreased sex drive, increased sweating, sensitivity to light or other eye problems, skin problems, bruising, or weight gain or loss.

Problems can also happen in other organs and tissues. These are not all signs and symptoms of immune system problems that can happen with Tevimbra. Your healthcare provider will conduct regular laboratory tests throughout your treatment.

Tevimbra can cause severe infusion-related reactions. Tell your healthcare provider right away if you experience chest tightness, wheezing, shortness of breath, facial flushing, itching, hives, swelling, or any other allergic reaction.

Life-threatening and other serious complications can occur in people who have received an allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody, such as Tevimbra.

May cause harm to an unborn baby. Females who can get pregnant should use an adequate form of contraception while being treated with Tevimbra.

Before taking this medicine

To make sure Tevimbra is safe for you, tell your doctor if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have liver or kidney disease
have thyroid disease
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area in the past and have received other medicines that are similar to Tevimbra
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed.

Pregnancy

Tevimbra may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while receiving Tevimbra and for at least 4 months after your last dose. Tell your doctor right away if you become pregnant.

Breastfeeding

It is not known if Tevimbra passes into your breast milk. Do not breastfeed while using this medicine, and for at least 4 months after your last dose.

How is Tevimbra administered?

Tevimbra is administered as a slow intravenous infusion into your vein once every 3 weeks

The recommended dose is 200mg.
The infusion is given over 60 minutes initially, but subsequent infusions can be given over 30 minutes if they are well tolerated.
You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Tevimbra.
The dosage and administration of Tevimbra may need to be withheld if immune-mediated adverse reactions occur.

What happens if I miss a dose?

Call your doctor for instructions if you miss a chemotherapy appointment.

What should I avoid while receiving Tevimbra?

Follow your doctor's instructions about restricting food, beverages, or activity.

What other drugs will affect Tevimbra?

Other drugs may interact with Tevimbra, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.