Loading…
RYBREVANT is a brand name for Amivantamab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rybrevant is indicated: • in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations. • in combination with carboplatin and pemetrexed for the…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment with Rybrevant should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Rybrevant should be administered by a healthcare professional with access to appropriate medical support to manage infusion-related reactions (IRRs) if they occur.
Before initiation of Rybrevant therapy, EGFR mutation status in tumour tissue or plasma specimens must be established using a validated test method. If no mutation is detected in a plasma specimen, tumour tissue should be tested if available in sufficient amount and quality due to the potential for false negative results using a plasma-test.
1). Posology Premedications should be administered to reduce the risk of IRRs with Rybrevant (see below “Dose modifications” and “Recommended concomitant medicinal products”). In patients receiving Rybrevant in combination with lazertinib, prophylactic anticoagulants are recommended to be used for the first four months of treatment.
g. low-molecular weight heparin (LMWH). Use of Vitamin K antagonists is not recommended. Patients should be instructed to limit sun exposure during and for 2 months after Rybrevant therapy. For further information about prophylaxis for VTE and skin and nail reactions, see section
Summary of the safety profile In the dataset of amivantamab as monotherapy (N=380), the most frequent adverse reactions in all grades were rash (76%), infusion-related reactions (67%), nail toxicity (47%), hypoalbuminaemia (31%), oedema (26%), fatigue (26%), stomatitis (24%), nausea (23%), and constipation (23%).
1%). Three percent of patients discontinued Rybrevant due to adverse reactions. 5%). Tabulated list of adverse reactions Table 7 summarises the adverse drug reactions that occurred in patients receiving amivantamab as monotherapy. The data reflects exposure to amivantamab in 380 patients with locally advanced or metastatic non-small cell lung cancer after failure of platinum-based chemotherapy.
Patients received amivantamab 1050 mg (for patients < 80 kg) or 1400 mg (for patients ≥ 80 kg). 7 months). Adverse reactions observed during clinical studies are listed below by frequency category. Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 8† Pyrexia Very common 11 0 Injury, poisoning and procedural complications Infusion related reaction Very common 67 2 * Grouped terms † Grade 3 events only Summary of the safety profile In the dataset of amivantamab in combination with carboplatin and pemetrexed (N=301), the most frequent adverse reactions in all grades were rash (83%), neutropenia (57%), nail toxicity (53%), infusion related reactions (51%), fatigue (43%), stomatitis (39%), nausea (43%), thrombocytopenia (40%), constipation (40%), oedema (40%), decreased appetite (33%), hypoalbuminaemia (32%), alanine aminotransferase increased (26%), aspartate aminotransferase increased (23%), vomiting (22%), and hypokalaemia (20%).
4. Every 3 weeks The recommended dosages of Rybrevant, when used in combination with carboplatin and pemetrexed, is provided in Table 1 (see below “Infusion rates” and Table 5).
Table 1:
Recommended dosage of Rybrevant every 3 weeks Body weight at baselinea Rybrevant dose Schedule Number of vials Less than 80 kg 1400 mg Weekly (total of 4 doses) from Weeks 1 to 4 • Week 1 - split infusion on Day 1 and Day 2 4 • Weeks 2 to 4 - infusion on Day 1 1750 mg Every 3 weeks starting at Week 7 onwards 5 1750 mg Weekly (total of 4 doses) from Weeks 1 to 4 • Week 1 - split infusion on Day 1 and Day 2 • Weeks 2 to 4 - infusion on Day 1 5Greater than or equal to 80 kg 2100 mg Every 3 weeks starting at Week 7 onwards 6 a Dose adjustments not required for subsequent body weight changes.
When used in combination with carboplatin and pemetrexed, Rybrevant should be administered after carboplatin and pemetrexed in the following order: pemetrexed, carboplatin and then Rybrevant. 1 and the manufacturer’s prescribing information for dosing instructions for carboplatin and pemetrexed.
Every 2 weeks The recommended dosages of Rybrevant as monotherapy or in combination with lazertinib is provided in Table 2 (see below “Infusion rates” and Table 6).
Table 2:
Recommended dosage of Rybrevant every 2 weeks Body weight at baselinea Rybrevant dose Schedule Number of vials Weekly (total of 4 doses) from Weeks 1 to 4 • Week 1 - split infusion on Day 1 and Day 2 • Weeks 2 to 4 - infusion on Day 1 Less than 80 kg 1050 mg Every 2 weeks starting at Week 5 onwards 3 Weekly (total of 4 doses) from Weeks 1 to 4 • Week 1 - split infusion on Day 1 and Day 2 • Weeks 2 to 4 - infusion on Day 1 Greater than or equal to 80 kg 1400 mg Every 2 weeks starting at Week 5 onwards 4 a Dose adjustments not required for subsequent body weight changes.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
0%). Eight percent of patients discontinued Rybrevant due to adverse reactions. 0%). Table 8 summarises the adverse drug reactions that occurred in patients receiving amivantamab in combination with chemotherapy. The data reflects exposure to amivantamab in combination with carboplatin and pemetrexed in 301 patients with locally advanced or metastatic non-small cell lung cancer.
Patients received amivantamab 1400 mg (for patients < 80 kg) or 1750 mg (for patients ≥ 80 kg) weekly for 4 weeks. Starting at Week 7, patients received amivantamab 1750 mg (for patients < 80 kg) or 2100 mg (for patients ≥ 80 kg) every 3 weeks.
1 months). Adverse reactions observed during clinical studies are listed below by frequency category. Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); and not known (frequency cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 3 Aspartate […]
When given in combination with lazertinib, it is recommended to administer Rybrevant any time after lazertinib when given on the same day. 2 of the lazertinib Summary of Product Characteristics for recommended lazertinib dosing information.
Duration of treatment It is recommended that patients are treated with Rybrevant until disease progression or unacceptable toxicity. Missed dose If a planned dose is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
Dose modifications Dosing should be interrupted for Grade 3 or 4 adverse reactions until the adverse reaction resolves to ≤ Grade 1 or baseline. If an interruption is 7 days or less, restart at the current dose. If an interruption is longer than 7 days, it is recommended restarting at a reduced dose as presented in Table 3.
See also specific dose modifications for specific adverse reactions below Table 3. 2 of the lazertinib Summary of Product Characteristics for information about dose modifications.
Table 3:
Recommended dose modifications for adverse reactions Dose at which the adverse reaction occurred Dose after 1st interruption for adverse reaction Dose after 2nd interruption for adverse reaction Dose after 3rd interruption for adverse reaction 1050 mg 700 mg 350 mg 1400 mg 1050 mg 700 mg 1750 mg 1400 mg 1050 mg 2100 mg 1750 mg 1400 mg Discontinue Rybrevant Infusion-related reactions Infusion should be interrupted at the first sign of IRRs.
4). • Grade 1-3 (mild-severe): Upon recovery of symptoms, resume infusion at 50% of the previous rate. If there are no additional symptoms, the rate may be increased per the recommended infusion rate (see Tables 5 and 6). Concomitant medicinal products should be administered at the next dose (including dexamethasone (20 mg) or equivalent (see Table 4).
• Recurrent Grade 3 or Grade 4 (life-threatening): Permanently discontinue Rybrevant. , respiratory failure or cardiac dysfunction), both medicinal products should be held until the patient is clinically stable. Thereafter, both medicinal products can be resumed at the same dose, at the discretion of the treating physician.
In the event of recurrence despite therapeutic level anticoagulation, the combination of Rybrevant and lazertinib should be permanently discontinued. Treatment can continue with either Rybrevant or lazertinib, but not both at the discretion of the treating physician.
Skin and nail reactions Prophylactic therapy with oral and topical antibiotics is recommended to reduce the risk and severity of skin and nail reactions in patients receiving Rybrevant. Non-comedogenic skin moisturiser (ceramide-based or other formulations that provide long lasting skin hydration and exclude drying agents are preferred) on the face and whole body (except scalp) and chlorhexidine solution to wash hands and feet is also recommended.
Patients should be instructed to limit sun exposure during and for 2 months after Rybrevant therapy. 4. If the patient develops a Grade 1-2 skin or nail reaction, supportive care should be initiated as clinically indicated; if there is no improvement after 2 weeks, dose reduction should be considered for persistent Grade 2 rash (see Table 3).
If the patient develops a Grade 3 skin or nail reaction, supportive care should be initiated as clinically indicated, and interruption of Rybrevant should be considered until the adverse reaction improves. Upon recovery of the skin or nail reaction to ≤ Grade 2, Rybrevant should be resumed at a reduced dose.
4). […]