Telisotuzumab Vedotin Dosage

Medically reviewed by Drugs.com. Last updated on Jun 23, 2025.

Usual Adult Dose for Non-Small Cell Lung Cancer

1.9 mg/kg IV every 2 weeks
Maximum dose: 190 mg/dose
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Infuse over at least 30 minutes.
• Select patients for treatment based on the presence of high c-Met protein overexpression using an approved US FDA test.
• Information on US FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.

Use: For the treatment of locally advanced or metastatic, nonsquamous non-small cell lung cancer with high c-Met protein overexpression (50% or more of tumor cells with strong [3+] staining) in patients who have received 1 prior systemic therapy

Renal Dose Adjustments

Renal dysfunction: Data not available

Liver Dose Adjustments

Mild liver dysfunction (total bilirubin up to 1 times the upper limit of normal [1 x ULN] and AST greater than ULN or total bilirubin greater than 1 to 1.5 x ULN and any AST): No adjustment recommended
Moderate or severe liver dysfunction (total bilirubin greater than 1.5 x ULN and any AST): Not recommended

Comments:

• Increased exposure to monomethyl auristatin E is likely, which may increase risk of adverse reactions, in patients with moderate or severe liver dysfunction.

Dose Adjustments

Recommended Dose Reduction Levels:

• First dose reduction: 1.6 mg/kg IV every 2 weeks
• Second dose reduction: 1.3 mg/kg IV every 2 weeks
• Third dose reduction: 1 mg/kg IV every 2 weeks
• Permanently discontinue this drug in patients unable to tolerate 1 mg/kg.

Dosage Modifications and Management for Adverse Reactions:
Peripheral Neuropathy:

• Grade 2 or 3: Withhold until resolved to grade 1 or lower.
• Restart at the next lower dose level.
• Grade 4: Permanently discontinue.

Interstitial Lung Disease (ILD) or Pneumonitis:

• Grade 1: Withhold this drug and consider corticosteroids as soon as ILD/pneumonitis is suspected.
• Restart after radiographic resolution.
• Grade 2 or higher: Permanently discontinue.

Keratitis:

• Grade 2: Withhold therapy and refer patient to an eye care professional for ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops).
• Resume therapy at the same dose at the discretion of the health care provider.
• Grade 3 or 4: Permanently discontinue.
• Refer patient to an eye care professional for ophthalmic examination and treatment (e.g., lubricating and/or steroidal eye drops).

Infusion-Related Reactions:

• Grades 1 to 3: Interrupt infusion and administer supportive treatment.
• Restart infusion at 50% rate reduction; increase infusion rate as tolerated for subsequent doses.
• In patients who have infusion-related reactions, administer premedication before all future doses.
• Grade 4: Permanently discontinue this drug and administer supportive treatment.

Peripheral Edema:

• Grade 2 or higher:
• First occurrence: Withhold therapy until resolved to grade 1 or lower. Restart at the same dose level.
• Subsequent occurrence: Withhold therapy until resolved to grade 1 or lower. Restart at the next lower dose level.

Other Adverse Reactions:

• Grade 3:
• First occurrence: Withhold therapy until resolved to grade 1 or lower. Restart at the same dose level.
• Subsequent occurrence: Withhold therapy until resolved to grade 1 or lower. Restart at the next lower dose level.
• Grade 4: Permanently discontinue this drug.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer as an IV infusion only, using a dedicated infusion line with a 0.2 or 0.22 micron in-line filter made of polyether sulfone, polyvinylidene fluoride, or polyamide.
• Inspect the reconstituted solution for particulate matter and discoloration. Discard the vial if the reconstituted solution is discolored, is cloudy, or contains visible particulates.
• If the prepared infusion solution was refrigerated, then allow the solution to reach room temperature before administration.
• Do not mix this drug with other drugs or administer other drugs through the same IV line.

Recommended Premedication for Patients Who Experience Infusion-Related Reactions for Subsequent Infusions:

• Antihistamine (e.g., IV or oral diphenhydramine [25 to 50 mg] or famotidine [20 mg]): Administer 30 to 60 minutes before each infusion.
• Antipyretic (e.g., IV or oral acetaminophen [650 to 1000 mg]): Administer 30 to 60 minutes before each infusion.
• Glucocorticoid (e.g., IV methylprednisolone [125 mg or equivalent]): Administer 30 to 60 minutes before each infusion.

Storage requirements:

• Vials: Store in a refrigerator at 2C to 8C (36F to 46F) in the original carton to protect from light; do not freeze or shake.
• Before reconstitution, allow the vial to reach room temperature.
• Reconstituted solution: If not used immediately, refrigerate the reconstituted vial at 2C to 8C (36F to 46F) for up to 24 hours from time of reconstitution; do not freeze or shake.
• Diluted solution: If not used immediately, refrigerate the diluted solution at 2C to 8C (36F to 46F) for up to 24 hours and an additional 4 hours at room temperature at 9C to 30C (48F to 86F) until the end of administration; do not freeze or shake.

Reconstitution/preparation techniques:

• Reconstitute and further dilute this drug before IV infusion.
• The manufacturer product information should be consulted.

IV compatibility:

• Compatible: Sterile Water for Injection, 0.9% Sodium Chloride Injection

General:

• This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
• This is a hazardous drug; follow applicable special handling and disposal procedures.

Monitoring:

• General: For signs or symptoms of infusion-related reactions (during infusion)
• Nervous System: For signs or symptoms of new or worsening peripheral neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, a burning sensation, neuropathic pain, or muscle weakness (during therapy)
• Ocular: For ocular surface disorders (during therapy)
• Respiratory: For signs or symptoms of ILD or pneumonitis (during therapy)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Reach out to your health care provider if you experience any of the following:
• new or worsening numbness or tingling in your hands or feet, or any muscle weakness
• new or worsening respiratory symptoms
• new or worsening ocular problems or vision changes
• Contact your health care provider immediately if signs and symptoms of infusion reactions (including fever, chills, rash, or breathing problems) develop.
• Patients of childbearing potential: Inform your health care provider of a known/suspected pregnancy; use effective contraception during therapy and for 2 months after the last dose.
• Male patients with partners of childbearing potential: Use effective contraception during therapy and for 4 months after the last dose.
• Do not breastfeed during therapy and for 1 month after the last dose.

See also:

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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