Telisotuzumab vedotin

Telisotuzumab vedotin is a prescription medication indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [50% or more of tumor cells with strong (3+) staining] who have received a prior systemic therapy

• Telisotuzumab vedotin is available under the following different brand names: Emrelis, telisotuzumab vedotin-tllv.

Common side effects of Telisotuzumab vedotin include:

• tiredness
• decreased appetite
• swelling in the feet, ankles, legs, or hands
• decreased white blood cell counts
• increased glucose levels
• increased liver enzyme levels
• decreased phosphorus levels
• decreased sodium levels
• decreased red blood cell counts
• decreased calcium levels

Serious side effects of Telisotuzumab vedotin include:

• symptoms of peripheral neuropathy may include numbness, tingling, burning sensations, pain or discomfort, muscle weakness, difficulty walking
• lung problems may cause symptoms like cough, trouble breathing or shortness of breath, fever, and wheezing 
• eye problems may cause symptoms like blurred vision, dry eyes, sensitivity to light, eye pain or swelling, eye redness
• symptoms of infusion-related reactions may include itching or rash, shortness of breath or wheezing, flushing, chest discomfort, fever, back pain, chills, headache, nausea or vomiting, fainting

Rare side effects of Telisotuzumab vedotin 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

Injection, lyophilized powder for reconstitution

• 20 mg
• 100 mg

Non-Small Cell Lung Cancer (NSCLC)

Adult dosage

• 1.9 mg/kg IV every 2 weeks until disease progression or unacceptable toxicity
• Do not exceed 190 mg/dose in patients weighing 100 kg or more

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your doctor has directed you to use this medication, 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.

Drug interaction overview

Monomethyl auristatin E (MMAE) is a CYP3A4 substrate

• Strong CYP3A4 inhibitors
  • If coadministered, monitor for telisotuzumab vedotin adverse reactions
  • Concomitant use may increase unconjugated MMAE exposure, which may increase the risk of adverse reactions

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

Peripheral neuropathy

• Can cause peripheral sensory and motor neuropathy
• Median time to peripheral neuropathy onset: 105 days (range, 1-472)
• Monitor for signs and symptoms of new or worsening peripheral neuropathy (e.g., hypoesthesia, hyperesthesia, paresthesia, burning sensation, neuropathic pain, muscle weakness)
• Hold, reduce dose, or permanently discontinue based on severity

Interstitial lung disease (ILD)/pneumonitis

• Can cause severe, life-threatening, or fatal ILD/pneumonitis
• Median time to ILD/pneumonitis onset: 48 days (range, 23-85)
• Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms
• Monitor for signs and symptoms of ILD/pneumonitis
• Hold or permanently discontinue based on severity

Ocular surface disorders

• Can cause ocular surface disorders (e.g., blurred vision, visual impairment, keratitis, dry eye)
• Median time to onset of ocular surface disorders: 47 days (range, 1-319)
• Monitor for ocular surface disorders during therapy
• Hold therapy and refer patients to an eye care professional for ophthalmic examination and treatment if Grade 2 or more ocular toxicity develops
• Hold or permanently discontinue based on severity

Infusion-related reactions (IRR)

• Can cause IRR; signs and symptoms include dyspnea, flushing, chills, nausea, chest discomfort, and hypotension
• Median time to IRR onset: 28 days (range, 1-43)
• Monitor for signs and symptoms of IRR during the infusion
• Hold, reduce infusion rate, or permanently discontinue based on severity
• Give premedications before subsequent infusions in patients who experience IRR (see Administration)

Embryo-fetal toxicity

• May cause fetal harm when administered during pregnancy
• Advise pregnant patients of potential fetal risk
• Effective contraception is recommended during and after therapy in females of reproductive potential and male patients with female partners of reproductive potential

Pregnancy and Lactation

• May cause fetal harm when administered during pregnancy, based on its mechanism of action and data from animal studies
• Advise pregnant patients of potential fetal risk
• Perform pregnancy testing before starting therapy in females of reproductive potential

Contraception requirements

• Females of reproductive potential: Use effective contraception during and for 2 months after the last dose
• Male patients with female partners of reproductive potential: Use effective contraception during and for 4 months after the last dose

Infertility

Females

• MMAE-containing antibody-drug conjugates may impair women's fertility, based on findings from animal studies
• The effect on fertility was reversible in animals

Males

• May impair male fertility, based on findings from animal studies
• Reversibility of this effect is unknown

Lactation

• No data on the presence of telisotuzumab vedotin or MMAE in human milk or on effects in breastfed children, or milk production
• Avoid breastfeeding during therapy and for 1 month after the last dose due to the potential for serious adverse reactions in breastfed children