Amivantamab
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Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Important Dosage Information To reduce the risk of infusion-related reactions, administer premedications before each RYBREVANT infusion as recommended [see Dosage and Administration ]. To reduce the risk of infusion-related reactions, administer RYBREVANT via peripheral line for Week 1 Day 1 and 2 and Week 2 [see Dosage and Administration ].
To reduce the risk and severity of dermatologic adverse reactions with RYBREVANT, prophylactic and concomitant medications are recommended [see Dosage and Administration ] . To reduce the risk of venous thromboembolic (VTE) events when administering RYBREVANT in combination with lazertinib, administer anticoagulant prophylaxis for the first four months of treatment [see Dosage and Administration ].
Administer diluted RYBREVANT intravenously according to the infusion rates in Tables 8 and 9, with the initial dose as a split infusion on Week 1 on Day 1 and Day 2 [see Dosage and Administration ]. When administering RYBREVANT in combination with lazertinib, administer lazertinib orally any time before the RYBREVANT infusion [see Dosage and Administration ].
When administering RYBREVANT in combination with carboplatin and pemetrexed, infuse pemetrexed first, carboplatin second, and RYBREVANT last [see Dosage and Administration ].
Recommended Premedications to Reduce the Risk of Infusion-Related Reactions Administer premedications as described in Table 5 . After prolonged dose interruptions, restart the following Week 1 Day 1 premedications upon re-initiation: intravenous dexamethasone, diphenhydramine, and acetaminophen. [See table below.] Diphenhydramine 25 mg to 50 mg (or equivalent) one dose Oral 30 to 60 minutes Intravenous 15 to 30 minutes Acetaminophen 650 mg to 1,000 mg one dose Oral 30 to 60 minutes Intravenous 15 to 30 minutes Initial dose as a split infusion Dexamethasone 10 mg (or equivalent) Intravenous 45 to 60 minutes Week 1 Day 2 one dose Diphenhydramine 25 mg to 50 mg (or equivalent) one dose Oral 30 to 60 minutes Intravenous 15 to 30 minutes Acetaminophen 650 mg to 1,000 mg one dose Oral 30 to 60 minutes Intravenous 15 to 30 minutes All subsequent infusions Diphenhydramine 25 mg to 50 mg (or equivalent) one dose Oral 30 to 60 minutes Intravenous 15 to 30 minutes Acetaminophen 650 mg to 1,000 mg one dose Oral 30 to 60 minutes Intravenous 15 to 30 minutes Optional: Dexamethasone 10 mg (or equivalent) one dose Intravenous 45 to 60 minutes
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 and number of RYBREVANT vials needed based on patient's baseline weight [see Dosage and Administration (2.3 , 2.4) ] . Each vial of RYBREVANT contains 350 mg of amivantamab-vmjw. Withdraw and then discard a volume of either 5% Dextrose Injection or 0.9% Sodium Chloride Injection 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 (59°F to 77°F).
Administration Administer the diluted RYBREVANT solution [see Dosage and Administration ] 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). Administration sets must be made of either polyurethane (PU), polybutadiene (PBD), PVC, PP, or PE.
The administration set with filter, must be primed with either 5% Dextrose Injection or 0.9% Sodium Chloride Injection prior to the initiation of each RYBREVANT infusion. Do not infuse RYBREVANT concomitantly in the same intravenous line with other agents. RYBREVANT in Combination with Lazertinib or RYBREVANT as a Single Agent Administer RYBREVANT as a single agent infusion every 2 weeks intravenously until disease progression or unacceptable toxicity according to the infusion rates in Table 8.
Administer RYBREVANT via a peripheral line on Week 1 and Week 2, to reduce the risk of infusion-related reactions during initial treatment [see Warnings and Precautions ]. 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.
When given in combination with lazertinib, administer RYBREVANT any time after lazertinib when given on the same day. [See table below.] Week 4 1,050 mg 125 Week 5 1,050 mg 125 Week 6 No dose Week 7 and every 2 weeks thereafter 1,050 mg 125 Body Weight Greater Than or Equal to 80 kg Week Dose (per 250 mL bag) Initial Infusion Rate (mL/hr) Subsequent Infusion Rate (mL/hr) Week 1 (split dose infusion) Week 1 Day 1 350 mg 50 75 Week 1 Day 2 1,050 mg 35 50 Week 2 1,400 mg 65 Week 3 1,400 mg 85 Week 4 1,400 mg 125 Week 5 1,400 mg 125 Week 6 No dose Week 7 and every 2 weeks thereafter 1,400 mg 125 RYBREVANT in Combination with Carboplatin and Pemetrexed Administer RYBREVANT in combination with carboplatin and pemetrexed infusions every 3 weeks intravenously until disease progression or unacceptable toxicity according to the infusion rates in Table 9.
Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of infusion-related reactions during initial treatment [see Warnings and Precautions ]. 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 the pemetrexed infusion first, carboplatin infusion second, and the RYBREVANT infusion last. [See table below.] Weeks 5 and 6 No dose Week 7 and every 3 weeks thereafter 1,750 mg 125 Body Weight Greater Than or Equal to 80 kg Week Dose (per 250 mL bag) Initial Infusion Rate (mL/hr) Subsequent Infusion Rate (mL/hr) Week 1 (split dose infusion) Week 1 Day 1 350 mg 50 75 Week 1 Day 2 1,400 mg 25 50 Week 2 1,750 mg 65 Week 3 1,750 mg 85 Week 4 1,750 mg 125 Week 5 and 6 No dose Week 7 and every 3 weeks thereafter 2,100 mg 125
| Body weight at BaselineDose adjustment is not required for subsequent body weight changes. | Recommended Dose | Dosing Schedule |
|---|---|---|
| Less than 80 kg | 1,050 mg | Weekly (total of 5 doses) from Weeks 1 to 5 Week 1 - split infusion on Day 1 and Day 2Weeks 2 to 5 - infusion on Day 1Week 6 – no dose |
| Every 2 weeks starting at Week 7 onwards | ||
| Greater than or equal to 80 kg | 1,400 mg | Weekly (total of 5 doses) from Weeks 1 to 5 Week 1 - split infusion on Day 1 and Day 2Weeks 2 to 5 - infusion on Day 1Week 6 – no dose |
| Every 2 weeks starting at Week 7 onwards |
| Body weight at Baseline Dose adjustment is not required for subsequent body weight changes. | Recommended Dose | Dosing Schedule |
|---|---|---|
| Less than 80 kg | 1,400 mg | Weekly (total of 4 doses) from Weeks 1 to 4 Week 1 - split infusion on Day 1 and Day 2Weeks 2 to 4 - infusion on Day 1Weeks 5 and 6 – no dose |
| 1,750 mg | Every 3 weeks starting at Week 7 onwards | |
| Greater than or equal to 80 kg | 1,750 mg | Weekly (total of 4 doses) from Weeks 1 to 4 Week 1 - split infusion on Day 1 and Day 2Weeks 2 to 4 - infusion on Day 1Weeks 5 and 6 – no dose |
| 2,100 mg | Every 3 weeks starting at Week 7 onwards |
| Premedication Schedule | Medication and Frequency | Route of Administration | Dosing Window Prior to RYBREVANT Administration |
|---|---|---|---|
| Initial dose as a split infusion | Dexamethasone 8 mg (or equivalent) | Oral | 48 hours |
| Week 1 Day -2 | twice daily | ||
| Initial dose as a split infusion | Dexamethasone 8 mg (or equivalent) | Oral | 24 hours |
| Week 1 Day -1 | twice daily | ||
| Initial dose as a split infusion | Dexamethasone 8 mg (or equivalent) | Oral | One hour |
| Week 1 Day 1 | one dose | ||
| Dexamethasone 20 mg (or equivalent) one dose | Intravenous | 45 to 60 minutes | |
| Diphenhydramine 25 mg to 50 mg (or equivalent) one dose | Oral | 30 to 60 minutes | |
| Intravenous | 15 to 30 minutes | ||
| Acetaminophen 650 mg to 1,000 mg one dose | Oral | 30 to 60 minutes | |
| Intravenous | 15 to 30 minutes | ||
| Initial dose as a split infusion | Dexamethasone 10 mg (or equivalent) | Intravenous | 45 to 60 minutes |
| Week 1 Day 2 | one dose | ||
| Diphenhydramine 25 mg to 50 mg (or equivalent) one dose | Oral | 30 to 60 minutes | |
| Intravenous | 15 to 30 minutes | ||
| Acetaminophen 650 mg to 1,000 mg one dose | Oral | 30 to 60 minutes | |
| Intravenous | 15 to 30 minutes | ||
| All subsequent infusions | Diphenhydramine 25 mg to 50 mg (or equivalent) one dose | Oral | 30 to 60 minutes |
| Intravenous | 15 to 30 minutes | ||
| Acetaminophen 650 mg to 1,000 mg one dose | Oral | 30 to 60 minutes | |
| Intravenous | 15 to 30 minutes | ||
| Optional: Dexamethasone 10 mg (or equivalent) one dose | Intravenous | 45 to 60 minutes |
Contraindications
None. None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on the mechanism of action and findings in animal models, RYBREVANT can cause fetal harm when administered to a pregnant woman. There are no available data on the use of RYBREVANT in pregnant women or animal data to assess the risk of RYBREVANT in pregnancy. Disruption or depletion of EGFR in animal models resulted in impairment of embryo-fetal development including effects on placental, lung, cardiac, skin, and neural development. The absence of EGFR or MET signaling has resulted in embryo lethality, malformations, and post-natal death in animals (see Data ). Advise pregnant women of the potential risk to a fetus. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data No animal studies have been conducted to evaluate the effects of amivantamab-vmjw on reproduction and fetal development; however, based on its mechanism of action, RYBREVANT can cause fetal harm or developmental anomalies. In mice, EGFR is critically important in reproductive and developmental processes including blastocyst implantation, placental development, and embryo-fetal/postnatal survival and development.
Reduction or elimination of embryo-fetal or maternal EGFR signaling can prevent implantation, can cause embryo-fetal loss during various stages of gestation (through effects on placental development) and can cause developmental anomalies and early death in surviving fetuses. Adverse developmental outcomes were observed in multiple organs in embryos/neonates of mice with disrupted EGFR signaling. Similarly, knock out of MET or its ligand HGF was embryonic lethal due to severe defects in placental development, and fetuses displayed defects in muscle development in multiple organs.
Human IgG1 is known to cross the placenta; therefore, amivantamab-vmjw has the potential to be transmitted from the mother to the developing fetus.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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