Amivantamab

Amivantamab is a prescription medication used:

• in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test. 
• as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy
• Amivantamab is available under the following different brand names: Rybrevant, and amivantamab-vmjw.

Common side effects of Amivantamab include:

• Infection around the fingernails,
• Muscle or joint pain, 
• Nausea, 
• Vomiting, 
• Shortness of breath, 
• Cough, 
• Swelling, 
• Sores in the mouth or throat, 
• Fatigue, 
• Constipation, 
• Diarrhea, 
• Dizziness, 
• Headache, and
• Abnormal blood test results (high blood sugar, low level of albumin, high levels of liver enzymes, low levels of electrolytes (sodium and potassium))

Serious side effects of Amivantamab include:

• Hives, 
• Difficulty breathing, 
• Swelling of the face, lips, tongue, or throat, 
• Eye pain or itching, 
• Redness of the eye, 
• Dry or watery eyes, 
• Blurred vision, 
• Increased sensitivity to light, 
• Rash, and
• Infusion-related reactions

Rare side effects of Amivantamab 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, loss of coordination, feeling 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

• 350 mg/7mL (50 mg/mL) single-dose vial

Non–Small Cell Lung Cancer

Adult dosage

• Below 80 kg
  • Week 1, Day 1: 350 mg Intravenous for 1 dose
  • Week 1, Day 2: 700 mg Intravenous for1 dose
  • Weeks 2-4: 1050 mg Intravenous weekly
  • Week 5 and thereafter: 1050 mg Intravenous every 2 weeks
  • Continue until disease progression or unacceptable toxicity.
• Above 80 kg
  • Week 1, Day 1: 350 mg Intravenous for 1 dose
  • Week 1, Day 2: 1050 mg Intravenous for 1 dose
  • Weeks 2-4: 1400 mg Intravenous for weekly
  • Week 5 and thereafter: 1400 mg Intravenous every 2 weeks
  • Continue until disease progression or unacceptable toxicity.

First-line treatment

Adult dosage

• Combination regimen
• Each cycle is 21 days
  • Pemetrexed 500 mg/m2 IV on Day 1
  • Carboplatin AUC 5 IV on Day for up to 12 weeks, PLUS
  • Amivantamab on Day 1 (except for Week 1 when the dose is split)
  • Continue pemetrexed and amivantamab only until disease progression or unacceptable toxicity, PLUS
• Below 80 kg
  • Week 1, Day 1: 350 mg IV for 1 dose
  • Week 1, Day 2: 1050 mg IV for 1 dose
  • Weeks 2-4: 1400 mg IV weekly
  • Weeks 5 and 6: No dose
  • Week 7 and thereafter: 1750 mg IV every 3 weeks
  • Continue until disease progression or unacceptable toxicity.
• Above 80 kg
  • Week 1, Day 1: 350 mg IV for 1 dose
  • Week 1, Day 2: 1400 mg IV for 1 dose
  • Weeks 2-4: 1750 mg IV weekly
  • Weeks 5 and 6: No dose
  • Week 7 and thereafter: 2100 mg IV every 3 weeks
  • Continue until disease progression or unacceptable toxicity

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.

• Amivantamab has no noted severe interactions with any other drugs.
• Amivantamab has no noted serious interactions with any other drugs.
• Amivantamab has no noted moderate interactions with any other drugs.
• Amivantamab 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 your products. 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 Amivantamab?”

Long-Term Effects

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

Cautions

• ILD/pneumonitis reported; monitor for new or worsening symptoms indicative of ILD/pneumonitis (.g, dyspnea, cough, fever)
• May cause ocular toxicity (. g, keratitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, uveitis); promptly refer patients with eye symptoms to an ophthalmologist.
• Based on the mechanism of action and findings from animal models, fetal harm may occur when administered to pregnant females
• IRRs
  • IRRs occurred.
  • Signs and symptoms of IRRs include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting.
  • Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse as recommended.
  • Monitor any signs and symptoms of infusion reactions during infusion in a setting where cardiopulmonary resuscitation medication and equipment are available.
• Dermatologic adverse reactions
  • TEN, rash (including dermatitis acneiform), pruritus, and dry skin were reported.
  • Instruct patient to limit sun exposure during and for 2 months after treatment.
  • Advise patients to wear protective clothing and use broad-spectrum UVA/UVB sunscreen.
  • For dry skin, recommend alcohol-free emollient cream.
  • If skin reactions develop, start topical corticosteroids and topical and/or oral antibiotics.
  • For Grade 3 reactions, add oral steroids and consider dermatologist consultation.
  • Promptly refer to a dermatologist if patients do not improve within 2 weeks or present with severe rash or atypical appearance or distribution.

Pregnancy and Lactation

• Based on the mechanism of actions and findings in animal models, fetal harm may occur when administered to pregnant females
• No data on use in pregnant females or animal data to assess drug risk in pregnancy are available.
• Verify the pregnancy status of females of reproductive potential before initiating therapy.
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 3 months after the final dose
• Lactation
  • There are no data on drug presence in human milk or milk production or its effects on breastfed children.
  • Advise females not to breastfeed during treatment and for 3 months after the final dose.