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Amivantamab Dosage

Medically reviewed by Drugs.com. Last updated on Jun 25, 2021.

Applies to the following strengths: vmjw 50 mg/mL

Usual Adult Dose for Non-Small Cell Lung Cancer

Body weight at baseline (NOTE: dose adjustments are not required for subsequent body weight changes after baseline measurement):

  • Less than 80 kg: 1050 mg IV once a week for 4 weeks (with the initial dose as a split infusion in Week 1 on Day 1 and Day 2) then every 2 weeks thereafter until disease progression or unacceptable toxicity
  • Greater than or equal to 80 kg: 1400 mg IV once a week for 4 weeks (with the initial dose as a split infusion in Week 1 on Day 1 and Day 2) then every 2 weeks thereafter until disease progression or unacceptable toxicity

INFUSION RATES FOR THE 1050 MG DOSE:
WEEK 1 (split dose infusion):
  • Week 1 Day 1: 350 mg IV at 50 mL/hr initially; increase the initial rate to the subsequent rate of 75 mL/hr after 2 hours in the absence of infusion-related reactions
  • Week 1 Day 2: 700 mg IV at 50 mL/hr initially; increase the initial rate to the subsequent rate of 75 mL/hr after 2 hours in the absence of infusion-related reactions
WEEK 2: 1050 mg IV at 85 mL/hr both initially and subsequently
WEEK 3: 1050 mg IV at 125 mL/hr both initially and subsequently
WEEK 4: 1050 mg IV at 125 mL/hr both initially and subsequently
SUBSEQUENT WEEKS (after Week 4 patients are dosed every 2 weeks): 1050 mg IV at 125 mL/hr

INFUSION RATES FOR THE 1400 MG DOSE:
WEEK 1 (split dose infusion):
  • Week 1 Day 1: 350 mg IV at 50 mL/hr initially; increase the initial rate to the subsequent rate of 75 mL/hr after 2 hours in the absence of infusion-related reactions
  • Week 1 Day 2: 1050 mg IV at 35 mL/hr initially; increase the initial rate to the subsequent rate of 50 mL/hr after 2 hours in the absence of infusion-related reactions
WEEK 2: 1400 mg IV at 65 mL/hr both initially and subsequently
WEEK 3: 1400 mg IV at 85 mL/hr both initially and subsequently
WEEK 4: 1400 mg IV at 125 mL/hr both initially and subsequently
SUBSEQUENT WEEKS (after Week 4 patients are dosed every 2 weeks): 1400 mg IV at 125 mL/hr

PREMEDICATION:
Prior to initial infusion of this drug (Week 1, Days 1 and 2), administer premedication to reduce the risk of infusion-related reactions:
ANTIHISTAMINE (required at all doses):
Diphenhydramine (25 to 50 mg) or equivalent:
  • IV: Administer 15 to 30 minutes before administering this drug.
  • Oral: Administer 30 to 60 minutes before administering this drug.
ANTIPYRETIC (required at all doses):
Acetaminophen (650 to 1000 mg):
  • IV: Administer 15 to 30 minutes before administering this drug.
  • Oral: Administer 30 to 60 minutes before administering this drug.
GLUCOCORTICOID (required at initial dose [Week 1, Days 1 and 2]; optional for subsequent doses):
Dexamethasone (10 mg) or methylprednisolone (40 mg) or equivalent:
  • IV: Administer 45 to 60 minutes before administering this drug.
NOTE: Administer both antihistamine and antipyretic prior to all infusions. Glucocorticoid administration required for Week 1, Days 1 and 2 doses only and as necessary for subsequent infusions.

Use: For 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, whose disease has progressed on or after platinum-based chemotherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

DOSE ADJUSTMENTS FOR ADVERSE REACTIONS:
Body weight less than 80 kg at baseline:

  • Initial dose: 1050 mg
  • First dose reduction: 700 mg
  • Second dose reduction: 350 mg
  • Third dose reduction: Discontinue therapy.
Body weight 80 kg or greater at baseline:
  • Initial dose: 1400 mg
  • First dose reduction: 1050 mg
  • Second dose reduction: 700 mg
  • Third dose reduction: Discontinue therapy.

INFUSION-RELATED REACTIONS (IRRs):
  • Grade 1 or 2: Interrupt the infusion if IRR is suspected until resolved; resume at 50% of the infusion rate at which the reaction occurred; if no additional symptoms after 30 minutes, the infusion rate may be escalated as described in the adult dosing section; include corticosteroid with premedications for subsequent dose as described in the adult dosing section.
  • Grade 3: Interrupt the infusion and administer supportive care medications; monitor until resolved; resume the infusion at 50% of the infusion rate at which the reaction occurred; if no additional symptoms after 30 minutes, the infusion rate may be escalated as described in the adult dosing section.
INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS:
  • Any Grade: Withhold therapy if ILD/pneumonitis is suspected; permanently discontinue therapy if ILD/pneumonitis is confirmed.
DERMATOLOGIC ADVERSE REACTIONS (e.g., dermatitis acneiform, pruritus, dry skin):
  • Grade 2: Initiate supportive care; reassess after 2 weeks; if rash does not improve, consider dose reduction.
  • Grade 3 (e.g., severe bullous, blistering, or exfoliating skin conditions [i.e., toxic epidermal necrolysis]): Withhold therapy and initiate supportive care; upon recovery to Grade 2 or less, resume at reduced dose; if no improvement within 2 weeks, permanently discontinue therapy.
  • Grade 4: Permanently discontinue therapy.
OTHER ADVERSE REACTIONS:
  • Grade 3: Withhold therapy until recovery to Grade 1 or less or baseline; resume at the same dose if recovery occurs within 1 week; resume at reduced dose if recovery occurs after 1 week but within 4 weeks; permanently discontinue therapy if recovery does not occur within 4 weeks.
  • Grade 4: Withhold therapy until recovery to Grade 1 or less or baseline; resume at reduced dose if recovery occurs within 4 weeks; permanently discontinue therapy if recovery does not occur within 4 weeks or for recurrent Grade 4 reactions.

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:

  • Select patients for treatment with this drug based on the presence of EGFR exon 20 insertion mutations.
  • The diluted solution should be administered within 10 hours (including infusion time) at room temperature 59F to 77F (15C to 25C).
  • Administer by IV infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.2 micrometer) primed with diluent only.
  • Administration sets should be made of either polyurethane (PU), polybutadiene (PBD) PVC, PP, or PE.
  • Administer this drug via a peripheral line on Week 1 and Week 2 due to the high incidence of infusion-related reactions during initial treatment; it may be administered via central line for subsequent weeks.
  • Do not infuse this drug concomitantly in the same IV line with other agents.

Storage requirements:
  • Store unopened vials in a refrigerator at 2C to 8C (36F to 46F) in original carton to protect from light. Do not freeze.

Reconstitution/preparation techniques:
  • Dilute and prepare this drug for IV infusion before administration.
  • Verify that the solution is colorless to pale yellow.
  • Do not use if discoloration or visible particles are present.
  • For the initial infusion, prepare this drug as close to administration time as possible to allow for the possibility of extended infusion time in the event of an infusion-related reaction.
  • The manufacturer product information should be consulted.

IV compatibility:
  • This drug is compatible with 5% dextrose solution or 0.9% sodium chloride solution.

Frequently asked questions

Further information

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