Rybrevant
RYBREVANT- amivantamab injection
Janssen Biotech, Inc.
1 INDICATIONS AND USAGE
RYBREVANT is indicated for the 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 [see Dosage and Administration (2.1)] , whose disease has progressed on or after platinum-based chemotherapy.
This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients for treatment with RYBREVANT based on the presence of EGFR exon 20 insertion mutations in tumor or plasma specimens [see Clinical Studies (14)]. If no mutation is detected in a plasma specimen, test tumor tissue. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics.
2.2 Recommended Dosage
The recommended doses of RYBREVANT, based on baseline body weight, are provided in Table 1, and the dosing schedule is provided in Table 2.
Body Weight at Baseline * | Recommended Dose | Number of 350 mg/7 mL RYBREVANT Vials |
---|---|---|
| ||
Less than 80 kg | 1050 mg | 3 |
Greater than or equal to 80 kg | 1400 mg | 4 |
Weeks | Schedule |
---|---|
Weeks 1 to 4 | Weekly (total of 4 doses) |
| Week 1 — split infusion on Day 1 and Day 2 |
| Weeks 2 to 4 — infusion on Day 1 |
Week 5 onwards | Every 2 weeks starting at Week 5 |
Administer premedications before each RYBREVANT infusion as recommended [see Dosage and Administration (2.3)]. Administer diluted RYBREVANT intravenously according to the infusion rates in Table 6, with the initial dose as a split infusion on Week 1 on Day 1 and Day 2 [see Dosage and Administration (2.5), (2.6)]. Administer RYBREVANT until disease progression or unacceptable toxicity.
2.3 Recommended Premedications
Prior to initial infusion of RYBREVANT (Week 1, Days 1 and 2), administer premedication as described in Table 3 to reduce the risk of infusion-related reactions: [see Warnings and Precautions (5.1)]
Medication | Dose | Route of Administration | Dosing Window Prior to RYBREVANT Administration |
---|---|---|---|
Antihistamine * | Diphenhydramine (25 to 50 mg) or equivalent | Intravenous | 15 to 30 minutes |
Oral | 30 to 60 minutes | ||
Antipyretic * | Acetaminophen (650 to 1,000 mg) | Intravenous | 15 to 30 minutes |
Oral | 30 to 60 minutes | ||
Glucocorticoid † | Dexamethasone (10 mg) or Methylprednisolone (40 mg) or equivalent | Intravenous | 45 to 60 minutes |
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.
2.4 Dosage Modifications for Adverse Reactions
The recommended RYBREVANT dose reductions for adverse reactions (see Table 5) are listed in Table 4.
Body Weight at Baseline | Initial Dose | 1st Dose Reduction | 2nd Dose Reduction | 3rd Dose Reduction |
---|---|---|---|---|
Less than 80 kg | 1050 mg | 700 mg | 350 mg | Discontinue RYBREVANT |
Greater than or equal to 80 kg | 1400 mg | 1050 mg | 700 mg |
The recommended RYBREVANT dosage modifications for adverse reactions are provided in Table 5.
Adverse Reaction | Severity | Dosage Modifications |
---|---|---|
Infusion-related reactions (IRR) [see Warnings and Precautions (5.1)] | Grade 1 to 2 |
|
Grade 3 |
| |
Grade 4 |
| |
Interstitial Lung Disease (ILD)/pneumonitis [see Warnings and Precautions (5.2)] | Any Grade |
|
Dermatologic Adverse Reactions (including dermatitis acneiform, pruritus, dry skin) [see Warnings and Precautions (5.3)] | Grade 2 |
|
Grade 3 |
| |
Grade 4 |
| |
Severe bullous, blistering or exfoliating skin conditions (including toxic epidermal necrolysis (TEN) |
| |
Other Adverse Reactions [see Adverse Reactions (6.1)] | Grade 3 |
|
Grade 4 |
|
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