Tebentafusp

Tebentafusp is a prescription medication used for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. 

• Tebentafusp is available under the following different brand names: Kimmtrak, tebentafusp-tebn

Common side effects of tebentafusp include:

• cytokine release syndrome (low blood pressure, low oxygen, fever, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache)
• skin reactions (rash, itching, swelling)
• fever
• fatigue
• nausea
• chills
• abdominal pain
• fluid retention (edema)
• low blood pressure (hypotension)
• dry skin
• headache
• vomiting
• decreased lymphocyte count
• increased creatinine
• increased glucose
• increased aspartate aminotransferase
• increased alanine aminotransferase
• decreased hemoglobin
• decreased phosphate

Serious side effects of tebentafusp include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• low blood pressure
• low oxygen levels in the blood
• chills
• nausea
• vomiting
• rash
• elevated transaminases
• fatigue
• headache

Rare side effects of tebentafusp include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 100 mcg/0.5 mL (single-dose vial)

Uveal melanoma

Adult dosage

• Day 1: 20 mcg IV
• Day 8: 30 mcg IV
• Day 15 and weekly thereafter: 68 mcg IV
• Continue until unacceptable toxicity or disease progression occurs

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tebentafusp has no noted severe interactions with any other drugs
• Tebentafusp has no noted serious interactions with any other drugs
• Tebentafusp has no noted moderate interactions with any other drugs
• Tebentafusp has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tebentafusp?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tebentafusp?”

Cautions

• Increases in AST/ALT were observed; in most patients experiencing elevated ALT/AST, which occurred within the first 3 infusions; monitor AST, ALT, and total blood bilirubin before initiating and during treatment; withheld according to severity
• May cause fetal harm when administered to pregnant women
• CRS
  • CRS occurred
  • May manifest as fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache
  • Ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS
  • Ensure patients are euvolemic before initiating
  • Closely monitor for signs or symptoms of CRS following infusions
  • Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy
  • Withhold or discontinue, depending on the persistence and severity of CRS
• Skin reactions
  • Skin reactions (eg, rash, pruritus, cutaneous edema) reported
  • Median time to onset was 1 day; the median time to improvement to a grade lower than 1 was approximately 6 days
• Monitor skin reactions
  • If skin reactions occur, treat with antihistamine and topical or systemic steroids, based on the persistence and severity of symptoms
  • Withhold or permanently discontinue, depending on the severity of skin reactions
• Drug interaction overview
  • Elevation of certain proinflammatory cytokines may suppress CYP450 enzyme activities

Pregnancy and Lactation

• Based on the mechanism of action, fetal harm may occur when administered to pregnant women
• No data are available data on pregnant women
• Molecules of similar molecular weight can cross the placenta, resulting in fetal exposure; advise women of potential risks to the fetus
• Verify pregnancy status in women of reproductive potential before initiating
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for 1 week following the last dose
• Lactation
  • No data are available on the presence of tebentafusp in human milk, its effects on breastfed infants, or on milk production
  • Advise patients not to breastfeed during treatment and for at least 1 week after the last dose