Rybrevant (Page 2 of 6)

2.5 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 (2.2)]. 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 59°F to 77°F (15°C to 25°C).

2.6 Administration

Administer the diluted solution [see Dosage and Administration (2.5)] 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 (5.1)]. 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
*
Increase the initial infusion rate to the subsequent infusion rate after 2 hours in the absence of infusion-related reactions.
Starting at Week 5, patients are dosed every 2 weeks.
1050 mg Dose
Week Dose(per 250 mL bag) Initial Infusion Rate Subsequent 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(per 250 mL bag) Initial Infusion Rate Subsequent 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

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Infusion-Related Reactions

RYBREVANT can cause infusion-related reactions (IRR); signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension and vomiting.

Based on the safety population [see Adverse Reactions (6.1)], IRR occurred in 66% of patients treated with RYBREVANT. Among patients receiving treatment on Week 1 Day 1, 65% experienced an IRR, while the incidence of IRR was 3.4% with the Day 2 infusion, 0.4% with the Week 2 infusion, and cumulatively 1.1% with subsequent infusions. Of the reported IRRs, 97% were Grade 1–2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range 0.1 to 18 hours) after start of infusion. The incidence of infusion modifications due to IRR was 62%, and 1.3% of patients permanently discontinued RYBREVANT due to IRR.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended [see Dosage and Administration (2.3)]. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 [see Dosage and Administration (2.6)].

Monitor patients for any signs and symptoms of infusion reactions during RYBREVANT infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity [see Dosage and Administration (2.4)].

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