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Drug overview for RYBREVANT (amivantamab-vmjw):
Generic name: amivantamab-vmjw
Drug class: Antineoplastic - Bispecific EGFR and MET Rec Inhibitor MC Ab
Therapeutic class: Antineoplastics
Amivantamab, a human immunoglobulin G1-based bispecific antibody directed against the epidermal growth factor receptor (EGFR) and the mesenchymal-epithelial transition (MET) receptor, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: amivantamab-vmjw
Drug class: Antineoplastic - Bispecific EGFR and MET Rec Inhibitor MC Ab
Therapeutic class: Antineoplastics
Amivantamab, a human immunoglobulin G1-based bispecific antibody directed against the epidermal growth factor receptor (EGFR) and the mesenchymal-epithelial transition (MET) receptor, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for RYBREVANT (amivantamab-vmjw) have been approved by the FDA:
Indications:
Non-small cell lung cancer with EGFR exon 19 deletion
Non-small cell lung cancer with EGFR exon 20 insertion mutation
Non-small cell lung cancer with EGFR exon 21 L858R substitution mutation
Professional Synonyms:
EGFR exon 19 deletion mutation-positive NSCLC
EGFR exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC)
EGFR L858R substitution mutation-positive non-small cell lung cancer (NSCLC)
Epidermal growth factor receptor (EGFR) exon 20 insertion positive non-small cell lung cancer
NSCLC with EGFR Ex19Del
NSCLC with EGFR exon 20 insertion
NSCLC with EGFR exon 21 Leu858Arg substitution
Indications:
Non-small cell lung cancer with EGFR exon 19 deletion
Non-small cell lung cancer with EGFR exon 20 insertion mutation
Non-small cell lung cancer with EGFR exon 21 L858R substitution mutation
Professional Synonyms:
EGFR exon 19 deletion mutation-positive NSCLC
EGFR exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC)
EGFR L858R substitution mutation-positive non-small cell lung cancer (NSCLC)
Epidermal growth factor receptor (EGFR) exon 20 insertion positive non-small cell lung cancer
NSCLC with EGFR Ex19Del
NSCLC with EGFR exon 20 insertion
NSCLC with EGFR exon 21 Leu858Arg substitution
The following dosing information is available for RYBREVANT (amivantamab-vmjw):
If adverse effects occur during amivantamab-vmjw therapy, temporary interruption of therapy, dosage reduction, and/or permanent discontinuance of the drug may be necessary. If dosage modification is required, the dosage of amivantamab-vmjw should be reduced as described in Table 4.
Table 4. Recommended Dosage Reductions for Amivantamab-vmjw Adverse Reactions.
Body weight at Initial dose First dose Second dose Third dose baseline reduction reduction reduction <80 kg 1050 mg 700 mg 350 mg Discontinue therapy >=80 kg 1400 mg 1050 mg 700 mg Discontinue therapy
Temporary interruption of therapy, dosage reduction, and/or permanent discontinuance of amivantamab-vmjw may be necessary in patients experiencing certain adverse effects (see Table 5).
Table 5. Recommended Dosage Modifications and Management for Amivantamab-vmjw Toxicity.
Adverse reaction and severity Dosage modifications and management Infusion-related reactions (Grade 1 Stop infusion and monitor until to 2) symptom resolution. Resume infusion at 50% of the infusion rate at which the reaction occurred. Increase the infusion rate if there are no additional symptoms after 30 minutes.
Give corticosteroid premedication before subse quent infusions. Infusion-related reactions (Grade 3) Stop infusion and administer supportive care medications. Monitor until resolution of symptoms.
Resume infusion at 50% of the infusion rate at which the reaction occurred. Increase the infusion rate if there are no additional symptoms after 30 minutes. Gi ve corticosteroid premedication before subsequent infusions.
Permanently discontinue for recurrent Grade 3 infusion-related reactions. Infusion-related reactions (Grade 4) Permanently discontinue therapy. Interstitial lung Withhold therapy if interstitial disease/pneumonitis (any grade) lung disease/pneumonitis is suspected and permanently discontinue if confirmed.
Dermatologic adverse reactions Provide supportive care. Consider including dermatitis acneiform, dose reduction if rash does not pruritus, dry skin (Grade 2) improve after 2 weeks. Dermatologic adverse reactions Withhold therapy and provide (Grade 3) supportive care.
Resume therapy at a reduced dose upon recovery to <= Grade 2. Permanently discontinue therapy if there is no improvement within 2 weeks. Dermatologic adverse reactions Permanently discontinue therapy.
(Grade 4) Dermatologic adverse reactions Permanently discontinue therapy. (severe bullous, blistering or exfoliating skin conditions including toxic epidermal necrolysis (TEN)) Other adverse reactions (Grade 3) Withhold therapy until recovery to <=Grade 1 or baseline. Resume at the same dose if recovery occurs in <1 week.
Resume at a reduced dose if recovery occurs after 1 but within 4 weeks. Permanently discontinue therapy if recovery does not occur within 4 week s. Other adverse reactions (Grade 4) Withhold therapy until recovery to <=Grade 1 or baseline.
Resume at a reduced dose if recovery occurs within 4 weeks. Permanently discontinue therapy if recovery does not occur within 4 weeks. Permanently discontinue therapy for recurrent Grade 4 reactions .
Table 4. Recommended Dosage Reductions for Amivantamab-vmjw Adverse Reactions.
Body weight at Initial dose First dose Second dose Third dose baseline reduction reduction reduction <80 kg 1050 mg 700 mg 350 mg Discontinue therapy >=80 kg 1400 mg 1050 mg 700 mg Discontinue therapy
Temporary interruption of therapy, dosage reduction, and/or permanent discontinuance of amivantamab-vmjw may be necessary in patients experiencing certain adverse effects (see Table 5).
Table 5. Recommended Dosage Modifications and Management for Amivantamab-vmjw Toxicity.
Adverse reaction and severity Dosage modifications and management Infusion-related reactions (Grade 1 Stop infusion and monitor until to 2) symptom resolution. Resume infusion at 50% of the infusion rate at which the reaction occurred. Increase the infusion rate if there are no additional symptoms after 30 minutes.
Give corticosteroid premedication before subse quent infusions. Infusion-related reactions (Grade 3) Stop infusion and administer supportive care medications. Monitor until resolution of symptoms.
Resume infusion at 50% of the infusion rate at which the reaction occurred. Increase the infusion rate if there are no additional symptoms after 30 minutes. Gi ve corticosteroid premedication before subsequent infusions.
Permanently discontinue for recurrent Grade 3 infusion-related reactions. Infusion-related reactions (Grade 4) Permanently discontinue therapy. Interstitial lung Withhold therapy if interstitial disease/pneumonitis (any grade) lung disease/pneumonitis is suspected and permanently discontinue if confirmed.
Dermatologic adverse reactions Provide supportive care. Consider including dermatitis acneiform, dose reduction if rash does not pruritus, dry skin (Grade 2) improve after 2 weeks. Dermatologic adverse reactions Withhold therapy and provide (Grade 3) supportive care.
Resume therapy at a reduced dose upon recovery to <= Grade 2. Permanently discontinue therapy if there is no improvement within 2 weeks. Dermatologic adverse reactions Permanently discontinue therapy.
(Grade 4) Dermatologic adverse reactions Permanently discontinue therapy. (severe bullous, blistering or exfoliating skin conditions including toxic epidermal necrolysis (TEN)) Other adverse reactions (Grade 3) Withhold therapy until recovery to <=Grade 1 or baseline. Resume at the same dose if recovery occurs in <1 week.
Resume at a reduced dose if recovery occurs after 1 but within 4 weeks. Permanently discontinue therapy if recovery does not occur within 4 week s. Other adverse reactions (Grade 4) Withhold therapy until recovery to <=Grade 1 or baseline.
Resume at a reduced dose if recovery occurs within 4 weeks. Permanently discontinue therapy if recovery does not occur within 4 weeks. Permanently discontinue therapy for recurrent Grade 4 reactions .
Amivantamab-vmjw is administered as an IV infusion after dilution. Administer IV infusions once weekly for 4 weeks, then once every 2 weeks starting at Week 5. Administer the initial amivantamab dose (Week 1) as a split infusion on Days 1 and 2 as described in Tables 2 and 3.
During Weeks 1 and 2, administer the infusion via a peripheral line due to the potential for infusion-related reactions during therapy initiation. Starting in Week 3, amivantamab may be administered with a central line. Administer amivantamab-vmjw with an infusion set made of polyurethane, polybutadiene, PVC, PP, or PE that contains a flow regulator and an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone 0.2
micron filter. Prime the infusion set with either 5% dextrose or 0.9% sodium chloride only.
Do not infuse concurrently in the same IV line as other medications. Store amivantamab-vmjw vials in a refrigerator at 2-8degreesC in the original carton to protect from light. Do not freeze.
Amivantamab is compatible with 5% dextrose and 0.9% sodium chloride for dilution prior to IV infusion. No other compatibility information is available.
During Weeks 1 and 2, administer the infusion via a peripheral line due to the potential for infusion-related reactions during therapy initiation. Starting in Week 3, amivantamab may be administered with a central line. Administer amivantamab-vmjw with an infusion set made of polyurethane, polybutadiene, PVC, PP, or PE that contains a flow regulator and an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone 0.2
micron filter. Prime the infusion set with either 5% dextrose or 0.9% sodium chloride only.
Do not infuse concurrently in the same IV line as other medications. Store amivantamab-vmjw vials in a refrigerator at 2-8degreesC in the original carton to protect from light. Do not freeze.
Amivantamab is compatible with 5% dextrose and 0.9% sodium chloride for dilution prior to IV infusion. No other compatibility information is available.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| RYBREVANT 350 MG/7 ML VIAL | Maintenance | Adults infuse 1,050 mg by intravenous route every 2 weeks |
No generic dosing information available.
The following drug interaction information is available for RYBREVANT (amivantamab-vmjw):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for RYBREVANT (amivantamab-vmjw):
Drug contraindication overview.
*None.
*None.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Interstitial lung disease |
| Pregnancy |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Keratitis |
| Uveitis |
The following adverse reaction information is available for RYBREVANT (amivantamab-vmjw):
Adverse reaction overview.
Adverse effects reported in >=20% of patients receiving amivantamab-vmjw include rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. Laboratory abnormalities reported in >=2% of patients receiving amivantamab-vmjw include decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased gamma-glutamyl transferase, and decreased sodium.
Adverse effects reported in >=20% of patients receiving amivantamab-vmjw include rash, infusion-related reactions, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. Laboratory abnormalities reported in >=2% of patients receiving amivantamab-vmjw include decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased alkaline phosphatase, increased glucose, increased gamma-glutamyl transferase, and decreased sodium.
There are 27 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hypokalemia Hyponatremia Hypophosphatemia Hypotension Increased alanine transaminase Increased alkaline phosphatase Increased aspartate transaminase Leukopenia Lymphopenia Neutropenic disorder Thrombocytopenic disorder |
Deep venous thrombosis Hemorrhage Pneumonia Pulmonary thromboembolism |
| Rare/Very Rare |
|---|
|
Acute cerebral infarction Acute myocardial infarction Acute respiratory distress syndrome Acute respiratory failure Bullous dermatitis Interstitial lung disease Interstitial pneumonitis Keratitis Pleural effusions Sepsis Toxic epidermal necrolysis Uveitis |
There are 41 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Chest discomfort Chills Constipation Cough Dyspnea Edema Fatigue Flushing Hypoalbuminemia Musculoskeletal pain Nail disorders Nausea Paronychia Skin rash Stomatitis Vomiting |
Abnormal hepatic function tests Acute abdominal pain Anemia Anorexia Blepharitis Diarrhea Dizziness Dry skin Fever Headache disorder Hypersensitivity drug reaction Hypocalcemia Hypomagnesemia Paresthesia Peripheral sensory neuropathy Pruritus of skin Trichomegaly |
| Rare/Very Rare |
|---|
|
Acneiform eruption Anaphylaxis Blurred vision Conjunctival hyperemia Dry eye Muscle weakness Ocular itching Visual changes |
The following precautions are available for RYBREVANT (amivantamab-vmjw):
Safety and efficacy of amivantamab have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Amivantamab may cause fetal harm if administered to pregnant women based on its mechanism of action and animal findings. Disruption or depletion of EGFR in animal models resulted in impairment of embryofetal development, including effects on placental, lung, cardiac, skin, and neural development.
It is not known whether amivantamab or its metabolites are distributed into human milk. The effects of the drug on breastfed infants or on the production of milk are unknown. Because of the potential for serious adverse reactions to amivantamab in nursing infants, advise women not to breastfeed while receiving the drug and for 3 months after the final dose.
In clinical trials, 41% of patients receiving amivantamab were 65 years of age or older, while 9% were 75 years of age or older. No overall differences in safety and efficacy were observed between geriatric patients and younger adults.
The following prioritized warning is available for RYBREVANT (amivantamab-vmjw):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for RYBREVANT (amivantamab-vmjw)'s list of indications:
| Non-small cell lung cancer with EGFR exon 19 deletion | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| C39.9 | Malignant neoplasm of lower respiratory tract, part unspecified |
| Non-small cell lung cancer with EGFR exon 20 insertion | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| C39.9 | Malignant neoplasm of lower respiratory tract, part unspecified |
| NSCLC with EGFR exon 21 l858R substitution mutation | |
| C34 | Malignant neoplasm of bronchus and lung |
| C34.0 | Malignant neoplasm of main bronchus |
| C34.00 | Malignant neoplasm of unspecified main bronchus |
| C34.01 | Malignant neoplasm of right main bronchus |
| C34.02 | Malignant neoplasm of left main bronchus |
| C34.1 | Malignant neoplasm of upper lobe, bronchus or lung |
| C34.10 | Malignant neoplasm of upper lobe, unspecified bronchus or lung |
| C34.11 | Malignant neoplasm of upper lobe, right bronchus or lung |
| C34.12 | Malignant neoplasm of upper lobe, left bronchus or lung |
| C34.2 | Malignant neoplasm of middle lobe, bronchus or lung |
| C34.3 | Malignant neoplasm of lower lobe, bronchus or lung |
| C34.30 | Malignant neoplasm of lower lobe, unspecified bronchus or lung |
| C34.31 | Malignant neoplasm of lower lobe, right bronchus or lung |
| C34.32 | Malignant neoplasm of lower lobe, left bronchus or lung |
| C34.8 | Malignant neoplasm of overlapping sites of bronchus and lung |
| C34.80 | Malignant neoplasm of overlapping sites of unspecified bronchus and lung |
| C34.81 | Malignant neoplasm of overlapping sites of right bronchus and lung |
| C34.82 | Malignant neoplasm of overlapping sites of left bronchus and lung |
| C34.9 | Malignant neoplasm of unspecified part of bronchus or lung |
| C34.90 | Malignant neoplasm of unspecified part of unspecified bronchus or lung |
| C34.91 | Malignant neoplasm of unspecified part of right bronchus or lung |
| C34.92 | Malignant neoplasm of unspecified part of left bronchus or lung |
| C39.9 | Malignant neoplasm of lower respiratory tract, part unspecified |
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