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RYBREVANT is a brand name for Amivantamab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rybrevant subcutaneous formulation 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. • as monotherapy for treatment of…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment with Rybrevant subcutaneous formulation should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Before initiation of Rybrevant subcutaneous formulation, 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). Rybrevant subcutaneous formulation should be administered by a healthcare professional with access to appropriate medical support to manage administration- related reactions if they occur.
Posology Premedications should be administered to reduce the risk of administration-related reactions with Rybrevant subcutaneous formulation (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 Rybrevant as monotherapy In the dataset of Rybrevant intravenous formulation 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 4 summarises the adverse drug reactions that occurred in patients receiving Rybrevant as monotherapy. The data reflects exposure to Rybrevant intravenous formulation 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 Rybrevant in combination with lazertinib Overall, the safety profile of Rybrevant subcutaneous formulation was consistent with the established safety profile of Rybrevant intravenous formulation, with a lower incidence of administration-related reactions and VTEs observed with the subcutaneous formulation compared to the intravenous formulation.
In the dataset of Rybrevant (either intravenous or subcutaneous formulations) in combination with lazertinib (N=752), the most frequent adverse reactions of any grade (≥ 20% patients) were rash (87%), nail toxicity (67%), hypoalbuminaemia (48%), hepatotoxicity (43%), stomatitis (43%), oedema (42%), fatigue (35%), paraesthesia (29%), constipation (26%), diarrhoea (26%), dry skin (25%), decreased appetite (24%), nausea (24%), and pruritus (23%).
4. The recommended dosages of Rybrevant subcutaneous formulation in combination with lazertinib or as monotherapy based on baseline body weight, are provided in Table 1.
Table 1:
Recommended dosage of Rybrevant subcutaneous formulation Body weight at baseline* Recommended dose Dosing schedule Less than 80 kg 1600 mg • Weekly (total of 4 doses) from Weeks 1 to 4 • Every 2 weeks starting at Week 5 onwards Greater than or equal to 80 kg 2240 mga • Weekly (total of 4 doses) from Weeks 1 to 4 • Every 2 weeks starting at Week 5 onwards * Dose adjustments not required for subsequent body weight changes.
a See SmPC for Rybrevant 2240 mg solution for injection. When given in combination with lazertinib, it is recommended to administer Rybrevant subcutaneous formulation 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 subcutaneous formulation until disease progression or unacceptable toxicity. Missed dose If a dose of Rybrevant subcutaneous formulation is missed between Weeks 1 to 4, it should be administered within 24 hours.
If a dose of Rybrevant subcutaneous formulation is missed from Week 5 onward, it should be administered within 7 days. Otherwise, the missed dose should not be administered and the next dose should be administered per the usual dosing schedule.
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 2.
See also specific dose modifications for specific adverse reactions below Table 2. 2 of the lazertinib Summary of Product Characteristics for information about dose modifications.
1.
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Clinically relevant differences between the intravenous and subcutaneous formulations, when given in combination with lazertinib, were observed for administration-related reactions (63% for intravenous vs. 14% for subcutaneous) and VTE (37% for intravenous vs.
11% for subcutaneous). 5%). Seven percent of patients discontinued Rybrevant subcutaneous formulation due to adverse reactions. 5%). Tabulated list of adverse reactions The adverse reactions for Rybrevant (either intravenous or subcutaneous formulation) when received in combination with lazertinib are summarised in Table
Table 2:
Recommended dose modifications for adverse reactions Dose* Dose after 1st interruption for adverse reaction Dose after 2nd interruption for adverse reaction Dose after 3rd interruption for adverse reaction 1600 mg 1050 mg 700 mg 2240 mga 1600 mg 1050 mg Discontinue Rybrevant subcutaneous formulation * Dose at which the adverse reaction occurred a See SmPC for Rybrevant 2240 mg solution for injection.
Administration-related reactions Premedications should be administered to reduce the risk of administration-related reactions with Rybrevant subcutaneous formulation (see “Recommended concomitant medicinal products”). Injections should be interrupted at the first sign of administration-related reactions.
4). • Grade 1-3 (mild-severe): Upon recovery of symptoms, resume Rybrevant subcutaneous formulation injections. Concomitant medicinal products should be administered at the next dose, including dexamethasone (20 mg) or equivalent (see Table 3).
• Recurrent Grade 3 or Grade 4 (life-threatening): Permanently discontinue Rybrevant. , respiratory failure or cardiac dysfunction), both drugs should be withheld 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. 4). 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 2).
If the patient develops a Grade 3 skin or nail reaction, supportive care should be initiated as clinically indicated, and interruption of Rybrevant subcutaneous formulation should be considered until the adverse reaction improves. Upon recovery of the skin or nail reaction to ≤ Grade 2, Rybrevant subcutaneous formulation should be resumed at a reduced dose.
4). Interstitial lung disease Rybrevant subcutaneous formulation should be withheld if interstitial lung disease (ILD) or ILD-like adverse reactions (pneumonitis) is suspected. 4). Recommended concomitant medicinal products Prior to the initial dose (Week 1, Day 1), antihistamines, antipyretics, and glucocorticoids should be administered to reduce the risk of administration-related reactions (see Table 4).
For subsequent doses, antihistamines and antipyretics are required to be administered. Glucocorticoids should also be re-initiated after prolonged dose interruptions. Antiemetics […]