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רייברבנט RYBREVANT (AMIVANTAMAB)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

תוך-ורידי : I.V

צורת מינון:

תרכיז להכנת תמיסה לאינפוזיה : CONCENTRATE FOR SOLUTION FOR INFUSION

Posology : מינונים

5 DOSAGE AND ADMINISTRATION
5.1 Patient Selection

Select patients for treatment with RYBREVANT based on the presence of EGFR exon 20 insertion mutations [see Clinical Studies (15.1)].

5.2 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.
Table 1:     Recommended Dose of RYBREVANT Based on Baseline Body Weight Body Weight at Baseline*                   Recommended             Number of 350 mg/7 mL Dose                 RYBREVANT Vials
Less than 80 kg                              1050 mg                                     3 Greater than or equal to 80 kg               1400 mg                                     4 * Dose adjustments not required for subsequent body weight changes.


Table 2:     Dosing schedule for RYBREVANT
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 (5.3)]. 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 (5.5), (5.6)]. Administer RYBREVANT until disease progression or unacceptable toxicity.

5.3 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 (8.1)] 
Table 3:      Premedications

Medication                            Dose                           Route of         Dosing Window Administration         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 Intravenous                 45 to 60 minutes (40 mg) or equivalent

*         Required at all doses.
‡         Required at initial dose (Week 1, Days 1 and 2); optional for subsequent doses.

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.

5.4 Dosage Modifications for Adverse Reactions

The recommended RYBREVANT dose reductions for adverse reactions are listed in Table 4.
Table 4:      RYBREVANT Dose Reductions for Adverse Reactions
Body Weight at           Initial       1st Dose Reduction        2nd Dose Reduction        3rd Dose Reduction Baseline                  Dose


Less than 80 kg         1050 mg              700 mg                    350 mg                 Discontinue RYBREVANT
Greater than or         1400 mg             1050 mg                    700 mg equal to 80 kg


The recommended RYBREVANT dosage modifications for adverse reactions are provided in Table 5.
Table 5:   Recommended RYBREVANT Dosage Modifications for Adverse Reactions Adverse Reaction        Severity         Dosage Modifications
Infusion-related            Grade 1 to 2        • Interrupt RYBREVANT infusion if IRR is reactions (IRR) [see                              suspected and monitor patient until reaction Warnings           and                            symptoms resolve.
Precautions (8.1)]                              • 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 Table 6).
• Include corticosteroid with premedications for subsequent dose (see
Table 3).
Grade 3            • Interrupt RYBREVANT infusion and administer supportive care medications. 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
Table 6).
• Include corticosteroid with premedications for subsequent dose (see Table 3). For recurrent
Grade 3, permanently discontinue RYBREVANT.
Grade 4
• Permanently discontinue RYBREVANT.
Interstitial Lung Disease   Any Grade           • Withhold RYBREVANT if ILD/pneumonitis (ILD)/pneumonitis [see                            is suspected.
Warnings and                                    • Permanently discontinue RYBREVANT Precautions (8.2)].                               if ILD/pneumonitis is confirmed.
Dermatologic Adverse         Grade 2             • Initiate supportive care management.
Reactions (including
• Reassess after 2 weeks; if rash does not improve,
dermatitis acneiform,
consider dose reduction.



pruritus, dry skin) [see      Grade 3               • Withhold RYBREVANT and initiate supportive Warnings and Precautions                              care management.
(8.3)]                                              • 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,
• Permanently discontinue RYBREVANT.
blistering or exfoliating skin conditions
(including toxic epidermal necrolysis (TEN)
Other Adverse Reactions       Grade 3               • Withhold RYBREVANT until recovery to ≤ Grade [see Adverse Reactions (9.1)]                         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.


5.5       Preparation
Dilute and prepare RYBREVANT for intravenous infusion before administration.
•         Check that the RYBREVANT solution is colorless to pale yellow. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if discoloration or visible particles are present.


•          Determine the dose required (either 1050 mg or 1400 mg) and number of RYBREVANT vials needed based on patient’s baseline weight [see Dosage and Administration (5.2)]. Each vial of RYBREVANT contains 350 mg of amivantamab-vmjw.

•          Withdraw and then discard a volume of either 5% dextrose solution or 0.9% sodium chloride solution from the 250 mL infusion bag equal to the volume of RYBREVANT to be added (i.e., discard 7 mL diluent from the infusion bag for each RYBREVANT vial). Only use infusion bags made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE), or polyolefin blend (PP+PE).

•          Withdraw 7 mL of RYBREVANT from each vial and add it to the infusion bag. The final volume in the infusion bag should be 250 mL. Discard any unused portion left in the vial.

•          Gently invert the bag to mix the solution. Do not shake.

•          Diluted solutions should be administered within 10 hours (including infusion time) at room temperature 15°C to 25°C.

5.6 Administration

Administer the diluted solution [see Dosage and Administration (5.5)] by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.2 micrometer) primed with diluent only. Administration sets must be made of either polyurethane (PU), polybutadiene (PBD) PVC, PP, or PE.

Do not infuse RYBREVANT concomitantly in the same intravenous line with other agents.

Administer RYBREVANT via a peripheral line on Week 1 and Week 2 given the high incidence of infusion-related reactions during initial treatment [see Warnings and Precautions (8.1)]. RYBREVANT may be administered via central line for subsequent weeks. For the initial infusion, prepare RYBREVANT as close to administration time as possible to allow for the possibility of extended infusion time in the event of an infusion-related reaction.

Administer RYBREVANT infusion intravenously according to the infusion rates in Table 6.
Table 6:     Infusion Rates for RYBREVANT Administration
1050 mg Dose
Week                                      Dose                  Initial                    Subsequent (per 250 mL bag)        Infusion Rate                 Infusion Rate† Week 1 (split dose infusion)

Week 1 Day 1                            350 mg                   50 mL/hr                  75 mL/hr Week 1 Day 2                            700 mg                   50 mL/hr                  75 mL/hr Week 2                                  1050 mg                               85 mL/hr Week 3                                  1050 mg                               125 mL/hr Week 4                                  1050 mg                               125 mL/hr Subsequent weeks*                       1050 mg                               125 mL/hr 1400 mg Dose

Week                          Dose                       Initial             Subsequent (per 250 mL bag)             Infusion Rate           Infusion Rate† Week 1 (split dose infusion)


Week 1 Day 1                             350 mg                  50 mL/hr                    75 mL/hr Week 1 Day 2                            1050 mg                  35 mL/hr                    50 mL/hr Week 2                                    1400 mg                  65 mL/hr Week 3                                    1400 mg                                 85 mL/hr Week 4                                    1400 mg                                125 mL/hr Subsequent weeks*                         1400 mg                                125 mL/hr * Starting at Week 5, patients are dosed every 2 weeks.
† Increase the initial infusion rate to the subsequent infusion rate after 2 hours in the absence of infusion- related reactions.


6 DOSAGE FORMS AND STRENGTHS
Injection: 350 mg/7 mL (50 mg/mL) colorless to pale yellow solution in a single-dose vial.

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