Amivantamab and hyaluronidase (human recombinant)
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Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Endoglycosidase
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 and Administration Information RYBREVANT FASPRO is for subcutaneous use only. Do not administer RYBREVANT FASPRO intravenously. RYBREVANT FASPRO must be administered by a healthcare professional. To reduce the risk of medication errors, prior to administration, check the vial labels to ensure that the drug being prepared and administered is subcutaneous RYBREVANT FASPRO and not intravenous amivantamab.
RYBREVANT FASPRO has different recommended dosage and administration than intravenous amivantamab products. Do not substitute RYBREVANT FASPRO for or with intravenous amivantamab products. Adult patients currently receiving intravenous amivantamab at an every 2-week dosing regimen may switch to subcutaneous RYBREVANT FASPRO at an every 2-week dosing regimen or at an every 4-week dosing regimen at their next scheduled dose on or after Week 5.
Adult patients currently receiving intravenous amivantamab at an every 3-week dosing regimen may switch to subcutaneous RYBREVANT FASPRO at an every 3-week dosing regimen at their next scheduled dose on or after Week 4. Adult patients currently receiving RYBREVANT FASPRO at an every 2-week dosing regimen may switch to an every 4-week dosing regimen at their next scheduled dose on or after Week 5.
RYBREVANT FASPRO is not indicated for use in pediatric patients. Administer premedications before each RYBREVANT FASPRO dose as recommended, to reduce the risk of administration-related reactions (ARRs) [see Dosage and Administration ] . Administer each injection of RYBREVANT FASPRO subcutaneously in the abdomen over approximately 5 minutes to minimize injection site irritation.
Do not inject into tattoos or scars or areas where the skin is red, bruised, tender, hard, not intact or within 2 inches (5 cm) around the periumbilical area. If the total dose requires multiple injections of RYBREVANT FASPRO, administer each injection consecutively in separate quadrants of the abdomen, with each injection taking approximately 5 minutes.
Rotate injection sites at the next scheduled dose. Pause or slow the delivery rate if the patient experiences pain. In the event pain is not alleviated by pausing or slowing down delivery rate, a second injection site may be chosen on the opposite side of the abdomen to deliver the remainder of the dose. If administering with a subcutaneous infusion set, ensure that the full dose is delivered through the infusion set, 0.9% sodium chloride solution may be utilized to flush remaining drug product through the line.
Discard unused portion.
Preparation Instructions For important information on RYBREVANT FASPRO dosage and administration, see Dosage and Administration . Do not dilute RYBREVANT FASPRO. RYBREVANT FASPRO does not contain an antimicrobial preservative. Administer RYBREVANT FASPRO dose in prepared syringes immediately. If the RYBREVANT FASPRO dose is not administered immediately, refer to "Storage" [see Dosage and Administration ] .
RYBREVANT FASPRO is a clear to opalescent and colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is discolored, or cloudy, or if foreign particles are present.
Remove the appropriate number of RYBREVANT FASPRO vial(s) from refrigeration and equilibrate RYBREVANT FASPRO to room temperature [15 °C to 30 °C (59 °F to 86 °F)] for at least 15 minutes. Do not warm RYBREVANT FASPRO in any other way. Do not shake. Withdraw the required injection volume of RYBREVANT FASPRO (see Table 9 ) from the vial(s) into a syringe(s) using a transfer needle.
Discard unused portion. RYBREVANT FASPRO is compatible with stainless steel injection needles, polypropylene and polycarbonate syringes, and polyethylene, polyurethane, and polyvinylchloride subcutaneous infusion sets. Use 0.9% Sodium Chloride Injection to flush an infusion set, if needed. Administer using a 21G to 23G needle or infusion set to ensure ease of administration.
If immediate administration is not possible, replace the transfer needle with a syringe closing cap for transport. Divide doses requiring greater than 15 mL into approximately equal volumes in two syringes and administer at separate injection sites. Do NOT exceed 15 mL in each syringe. The dose volumes are provided in Table 9. [See table below.] Storage If immediate administration is not possible, store the prepared syringes of RYBREVANT FASPRO refrigerated at 2 °C to 8 °C (36 °F to 46 °F) for up to 24 hours followed by at room temperature of 15 °C to 30 °C (59 °F to 86 °F) for up to 24 hours.
Discard the prepared syringe(s) if stored for more than 24 hours refrigerated or more than 24 hours at room temperature. If stored in the refrigerator, allow the solution to come to room temperature before administration.
| Dose at which the adverse reaction occurred | 1st Dose Reduction | 2nd Dose Reduction | 3rd Dose Reduction |
|---|---|---|---|
| 1,600 mg amivantamab and 20,000 units hyaluronidase | 1,050 mg amivantamab and 13,200 units hyaluronidaseThe dose volume should be 6.6 mL for 1,050 mg amivantamab and 13,200 units hyaluronidase dose. | 700 mg amivantamab and 8,800 units hyaluronidaseThe dose volume should be 4.4 mL for 700 mg amivantamab and 8,800 units hyaluronidase dose. | Discontinue RYBREVANT FASPRO |
| 2,240 mg amivantamab and 28,000 units hyaluronidase | 1,600 mg amivantamab and 20,000 units hyaluronidaseThe dose volume should be 10 mL for 1,600 mg amivantamab and 20,000 units hyaluronidase dose. | 1,050 mg amivantamab and 13,200 units hyaluronidase | |
| 2,400 mg amivantamab and 30,000 units hyaluronidase | 1,600 mg amivantamab and 20,000 units hyaluronidase | 1,050 mg amivantamab and 13,200 units hyaluronidase | |
| 3,360 mg amivantamab and 42,000 units hyaluronidase | 2,240 mg amivantamab and 28,000 units hyaluronidaseThe dose volume should be 14 mL for 2,240 mg amivantamab and 28,000 units hyaluronidase dose. | 1,600 mg amivantamab and 20,000 units hyaluronidase | |
| 3,520 mg amivantamab and 44,000 units hyaluronidase | 2,400 mg amivantamab and 30,000 units hyaluronidaseThe dose volume should be 15 mL for 2,400 mg amivantamab and 30,000 units hyaluronidase dose. | 1,600 mg amivantamab and 20,000 units hyaluronidase | |
| 4,640 mg amivantamab and 58,000 units hyaluronidase | 3,360 mg amivantamab and 42,000 units hyaluronidaseThe dose volume should be 21 mL for 3,360 mg amivantamab and 42,000 units hyaluronidase dose. | 2,240 mg amivantamab and 28,000 units hyaluronidase |
| RYBREVANT FASPRO Total Dose | Total Dose Volume |
|---|---|
| 1,600 mg amivantamab and 20,000 units hyaluronidase | 10 mL |
| 2,240 mg amivantamab and 28,000 units hyaluronidase | 14 mL |
| 2,400 mg amivantamab and 30,000 units hyaluronidase | 15 mL |
| 3,360 mg amivantamab and 42,000 units hyaluronidase | 21 mLFor the 21 mL dose volume, the entire contents of the 3,520 mg amivantamab and 44,000 units hyaluronidase/22 mL vial will not be needed. Discard unused portion.Divide the dose volume approximately equally into two syringes (each syringe should not exceed 15 mL). |
| 3,520 mg amivantamab and 44,000 units hyaluronidase | 22 mL |
| 4,640 mg amivantamab and 58,000 units hyaluronidase | 29 mLFor the 29 mL dose volume, use one 2,240 mg amivantamab and 28,000 units hyaluronidase/14 mL vial and one 2,400 mg amivantamab and 30,000 units hyaluronidase/15 mL vial to minimize waste. If a different combination of vials is used, discard unused portion. |
Drug interactions
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- Amivantamab and hyaluronidase (human recombinant)
Contraindications
4 CONTRAINDICATIONS RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients. Patients with known hypersensitivity to hyaluronidase or to any of its excipients. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for amivantamab and hyaluronidase (human recombinant). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animal models, RYBREVANT FASPRO can cause fetal harm when administered to a pregnant woman. There are no available data on the use of RYBREVANT FASPRO in pregnant women or animal data to assess the risk of RYBREVANT FASPRO 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 and females of reproductive potential 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 RYBREVANT FASPRO for subcutaneous injection contains amivantamab and hyaluronidase [see Description (11) ]. Amivantamab: No animal studies have been conducted to evaluate the effects of amivantamab on reproduction and fetal development; however, based on its mechanism of action, RYBREVANT FASPRO 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 has the potential to be transmitted from the mother to the developing fetus. Hyaluronidase: In an embryo-fetal study, mice were dosed daily by subcutaneous injection during the period of organogenesis with hyaluronidase (recombinant human) at dose levels up to 2,200,000 U/kg, which is > 3600 times higher than the human dose. The study found no evidence of teratogenicity.
Reduced fetal weight and increased numbers of fetal resorptions were observed, with no…
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)
Price ladder
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