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.

Table 4: Premedications
Medication Dose Route of Administration Dosing Window Prior to RYBREVANT Administration
*
Required at all doses.
Required at initial dose (Week 1 Day 1)
Required at second dose (Week 1 Day 2); optional for subsequent doses.
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.

Table 5: Dose Reductions for Adverse Reactions for RYBREVANT
Dose * 1 st Dose Reduction 2 nd Dose Reduction 3 rd Dose Reduction
*
Dose at which the adverse reaction occurred
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.

Table 6: Recommended Dosage Modifications and Management for Adverse Reactions for RYBREVANT
Adverse Reaction Severity Dosage Modifications
Infusion-related reactions (IRR) [see Warnings and Precautions (5.1)] Grade 1 to 2
  • Interrupt RYBREVANT infusion if IRR is suspected and monitor patient until reaction symptoms resolve.
  • Resume the infusion at 50% of the infusion rate at which the reaction occurred.
  • If there are no additional symptoms after 30 minutes, the infusion rate may be escalated (see Tables 7and 8).
  • Include corticosteroid with premedications for subsequent dose (see Table 4).
Grade 3
  • Interrupt RYBREVANT infusion and administer supportive care medications. Continuously monitor patient until reaction symptoms resolve.
  • Resume the infusion at 50% of the infusion rate at which the reaction occurred.
  • If there are no additional symptoms after 30 minutes, the infusion rate may be escalated (see Tables 7and 8).
  • Include corticosteroid with premedications for subsequent dose (see Table 4). For recurrent Grade 3, permanently discontinue RYBREVANT.
Grade 4
  • Permanently discontinue RYBREVANT.
Interstitial Lung Disease (ILD)/pneumonitis [see Warnings and Precautions (5.2)] Any Grade
  • Withhold RYBREVANT if ILD/pneumonitis is suspected.
  • Permanently discontinue RYBREVANT if ILD/pneumonitis is confirmed.
Dermatologic Adverse Reactions (including dermatitis acneiform, pruritus, dry skin) [see Warnings and Precautions (5.3)] Grade 1
  • Initiate supportive care management.
  • Reassess after 2 weeks.
Grade 2
  • Initiate supportive care management.
  • Reassess after 2 weeks; if rash does not improve, consider dose reduction.
Grade 3
  • Withhold RYBREVANT and initiate supportive care management.
  • Upon recovery to ≤ Grade 2, resume RYBREVANT at reduced dose.
  • If no improvement within 2 weeks, permanently discontinue treatment.
Grade 4
  • Permanently discontinue RYBREVANT.
Severe bullous, blistering or exfoliating skin conditions (including toxic epidermal necrolysis (TEN)
  • Permanently discontinue RYBREVANT.
Other Adverse Reactions [see Adverse Reactions (6.1)] Grade 3
  • Withhold RYBREVANT until recovery to ≤ Grade 1 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 if recovery does not occur within 4 weeks.
Grade 4
  • Withhold RYBREVANT until recovery to ≤Grade 1 or baseline.
  • Resume at reduced dose if recovery occurs within 4 weeks.
  • Permanently discontinue if recovery does not occur within 4 weeks.
  • Permanently discontinue for recurrent Grade 4 reactions.

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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