amivantamab

High Alert

First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (in combination with carboplatin and pemetrexed).
Locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations in patients whose disease has progressed on or after platinum-based chemotherapy.
First-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations (in combination with lazertinib).
Locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations in patients whose disease has progressed on or after treatment with an EFGR tyrosine kinase inhibitor (in combination with carboplatin and pemetrexed).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: deep vein thrombosis (DVT), edema

Derm: dry skin, paronychia, pruritus, rash, TOXIC EPIDERMAL NECROLYSIS (TEN)

EENT: blepharitis, blurred vision, conjunctival redness, dry eye, keratitis, ocular itching, uveitis, vision impairment

Endo: hyperglycemia

F and E: hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia

GI: ↑liver enzymes, abdominal pain, constipation, hypoalbuminemia, nausea, stomatitis, vomiting

GU: ↑serum creatinine

Hemat: bleeding, lymphopenia

Metab: ↓appetite

MS: pain

Neuro: dizziness, fatigue, headache, peripheral neuropathy

Resp: cough, dyspnea, pneumonia, pulmonary embolism (PE), INTERSTITIAL LUNG DISEASE (ILD)/PNEUMONITIS

Misc: fever, infusion-related reactions

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

Solution for injection: 50 mg/mL

Route/Dosage ⬆ ⬇

First-Line Treatment of NSCLC with Exon 20 Insertion Mutations or Previously Treated NSCLC with Exon 19 Deletions or Exon 21 L858R Substitution Mutations

IV (Adults ≥80 kg): 1750 mg once weekly for 4 wk (on Wk 1, split infusion on Days 1 and 2; on Wk 2–4, give infusion on Day 1); then 2100 mg every 3 wk starting on Wk 7 (no dose during Wk 5 and 6). Administer after carboplatin and pemetrexed. Continue until disease progression or unacceptable toxicity.
IV (Adults <80 kg): 1400 mg once weekly for 4 wk (on Wk 1, split infusion on Days 1 and 2; on Wk 2–4, give infusion on Day 1); then 1700 mg every 3 wk starting on Wk 7 (no dose during Wk 5 and 6). Administer after carboplatin and pemetrexed. Continue until disease progression or unacceptable toxicity.

Previously Treated NSCLC with Exon 20 Insertion Mutations or First-Line Treatment of NSCLC with Exon 19 Deletions or Exon 21 L858R Substitution Mutations

IV (Adults ≥80 kg): 1400 mg once weekly for 5 wk (on Wk 1, split infusion on Days 1 and 2; on Wk 2–5, give infusion on Day 1); then 1400 mg every 2 wk starting on Wk 7 (no dose during Wk 6). If administered in combination with lazertinib, give amivantamab any time after giving lazertinib when given on the same day. Continue until disease progression or unacceptable toxicity.
IV (Adults <80 kg): 1050 mg once weekly for 5 wk (on Wk 1, split infusion on Days 1 and 2; on Wk 2–5, give infusion on Day 1); then 1050 mg every 2 wk starting on Wk 7 (no dose during Wk 6). If administered in combination with lazertinib, give amivantamab any time after giving lazertinib when given on the same day. Continue until disease progression or unacceptable toxicity.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a kinase inhibitor that targets EGFR and mesenchymal-epithelial transition, including EGFR exon 20 insertion mutations, which ultimately reduces cancer cell growth.

Therapeutic effects:

Decreased progression of and improved progression-free survival of NSCLC.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: monoclonal antibodies, epidermal growth factor receptor egfr inhibitors, kinase inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Not extensively distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 11.3 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Advise patient about signs/symptoms of infusion-related reactions and that they may occur with the 1st infusion. Advise patient to notify health care professional immediately for any signs/symptoms of infusion-related reactions or new or worsening respiratory symptoms.
Advise patient about photosensitivity and that they should limit sun exposure during and for 2 mo after treatment. Advise patient to wear protective clothing and use broad-spectrum UVA/UVB sunscreen. Advise patients of the risk of dermatologic adverse reactions. Advise patient to apply alcohol-free (isopropanol-free, ethanol-free) emollient cream to ↓ the risk of skin reactions. Consider prophylactic measures (use of oral antibiotics) to ↓ the risk of these reactions.
Advise patient of the risk of ocular toxicity. Advise patient to contact their ophthalmologist if they develop eye symptoms and advise discontinuation of contact lenses until symptoms are evaluated.
Advise patients of the risk of paronychia. Advise patients to contact health care professional for signs or symptoms of any infection or inflammation of the skin around the fingernails or toenails.
Educate patient about the risks of serious and life-threatening venous thromboembolic events, including DVT and PE, when amivantamab is used in combination with lazertinib. Advise patient that prophylactic anticoagulants are recommended to be used for the 1st 4 mo of treatment and to immediately contact health care professional for signs and symptoms of venous thromboembolism.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise patient not to breastfeed during treatment and for 3 mo after last dose. Advise patient who could become pregnant to use effective contraception during therapy and for 3 mo after the last amivantamab dose.

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Indications ⬇