Rybrevant (Page 2 of 9)
2.5 Recommended Premedications
Prior to the initial infusion of RYBREVANT (Week 1, Day 1 and 2), administer premedication as described in Table 4 to reduce the risk of infusion-related reactions [see Warnings and Precautions (5.1)].
Glucocorticoid administration is required for Week 1, Day 1 and 2 dose only and upon re-initiation after prolonged dose interruptions, then as necessary for subsequent infusions (see Table 4). Administer both antihistamine and antipyretic prior to all infusions.
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 (20 mg) or equivalent | Intravenous | 45 to 60 minutes |
Glucocorticoid ‡ | Dexamethasone (10 mg) or equivalent | Intravenous | 45 to 60 minutes |
2.6 Dosage Modifications for Adverse Reactions
The recommended dose reductions for adverse reactions for RYBREVANT are listed in Table 5.
Dose * | 1 st Dose Reduction | 2 nd Dose Reduction | 3 rd Dose Reduction |
---|---|---|---|
| |||
1050 mg | 700 mg | 350 mg | Discontinue RYBREVANT |
1400 mg | 1050 mg | 700 mg | |
1750 mg | 1400 mg | 1050 mg | |
2100 mg | 1750 mg | 1400 mg |
The recommended dosage modifications and management for adverse reactions for RYBREVANT are provided in Table 6.
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 1 |
|
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 |
|
Recommended Dosage Modifications for Adverse Reactions for RYBREVANT in Combination with Carboplatin and Pemetrexed
When administering RYBREVANT in combination with carboplatin and pemetrexed, modify the dosage of one or more drugs. Withhold or discontinue RYBREVANT as shown in Table 6. Refer to prescribing information for carboplatin and pemetrexed for additional dosage modification information.
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