Rybrevant

• Generic Name: amivantamab-vmjw for injection
• Brand Name: Rybrevant
• Drug Class: How Do Antineoplastic EGFR Inhibitors Work?, MET Tyrosine Kinase Inhibitors

Rybrevant (Amivantamab-vmjw for Injection) side effects drug center

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PROFESSIONAL

SIDE EFFECTS

• Overview
• Professional Information

Rybrevant Side Effects Center

What Is Rybrevant?

Rybrevant (amivantamab-vmjw) is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA- approved test, whose disease has progressed on or after platinum-based chemotherapy.

What Are Side Effects of Rybrevant?

Side effects of Rybrevant include:

• rash,
• infusion related reactions,
• Infection of the skin surrounding the fingernails or toenails,
• musculoskeletal pain,
• shortness of breath,
• nausea,
• fatigue,
• fluid retention (edema),
• inflammation of the mouth and lips,
• cough,
• constipation,
• vomiting,
• decreased white blood cells,
• decreased albumin,
• decreased phosphate,
• decreased potassium,
• increased alkaline phosphatase,
• increased glucose,
• increased gamma-glutamyl transferase, and
• decreased sodium.

Dosage for Rybrevant

The recommended dosage of Rybrevant is based on baseline body weight and administered as an intravenous infusion after dilution. For body weight (at baseline) of less than 80 kg, the recommended dose of Rybrevant is 1050 mg (3 vials). For body weight (at baseline) that is 80 kg or more, the recommended dose of Rybrevant is 1400 mg (4 vials).

Rybrevant In Children

The safety and efficacy of Rybrevant have not been established in pediatric patients.

What Drugs, Substances, or Supplements Interact with Rybrevant?
 

Rybrevant may interact with other medicines.

Tell your doctor all medications and supplements you use.

Rybrevant During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Rybrevant; it may harm a fetus. The pregnancy status of females of reproductive potential should be verified prior to starting Rybrevant. Females of reproductive potential are advised to use effective contraception during treatment and for 3 months after the final dose of Rybrevant. It is unknown if Rybrevant passes into breast milk. Because of the potential for serious adverse reactions from Rybrevant in breastfed infants, breastfeeding is not recommended during treatment with Rybrevant and for 3 months after the final dose.

Additional Information

Our Rybrevant (amivantamab-vmjw) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Rybrevant Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the labeling:

• Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS]
• Interstitial Lung Disease/Pneumonitis [see WARNINGS AND PRECAUTIONS]
• Dermatologic Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Ocular Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to RYBREVANT as a single agent in the CHRYSALIS study in 302 patients with locally advanced or metastatic NSCLC who received a dose of 1050 mg (for patients <80 kg) or 1400 mg (for patients ≥80 kg) once weekly for 4 weeks, then every 2 weeks thereafter. Among 302 patients who received RYBREVANT, 36% were exposed for 6 months or longer and 12% were exposed for greater than one year. In the safety population, the most common (≥ 20%) adverse reactions were rash, infusion-related reaction, paronychia, musculoskeletal pain, dyspnea, nausea, edema, cough, fatigue, stomatitis, constipation, vomiting and pruritus. The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes, decreased phosphate, decreased albumin, increased glucose, increased gamma glutamyl transferase, decreased sodium, decreased potassium, and increased alkaline phosphatase.

The data described below reflect exposure to RYBREVANT at the recommended dosage in 129 patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. Among patients who received RYBREVANT, 44% were exposed for 6 months or longer and 12% were exposed for greater than one year.

The median age was 62 years (range: 36 to 84 years); 61% were female; 55% were Asian, 35% were White, and 2.3% were Black; and 82% had baseline body weight <80 kg.

Serious adverse reactions occurred in 30% of patients who received RYBREVANT. Serious adverse reactions in ≥ 2% of patients included pulmonary embolism, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

Permanent discontinuation of RYBREVANT due to an adverse reaction occurred in 11% of patients. Adverse reactions resulting in permanent discontinuation of RYBREVANT in ≥1% of patients were pneumonia, IRR, pneumonitis/ILD, dyspnea, pleural effusion, and rash.

Dose interruptions of RYBREVANT due to an adverse reaction occurred in 78% of patients. Infusion-related reactions (IRR) requiring infusion interruptions occurred in 59% of patients. Adverse reactions requiring dose interruption in ≥5% of patients included dyspnea, nausea, rash, vomiting, fatigue, and diarrhea.

Dose reductions of RYBREVANT due to an adverse reaction occurred in 15% of patients. Adverse reactions requiring dose reductions in ≥ 2% of patients included rash and paronychia.

The most common adverse reactions (≥ 20%) were rash, IRR, paronychia, musculoskeletal pain, dyspnea, nausea, fatigue, edema, stomatitis, cough, constipation, and vomiting. The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes, decreased albumin, decreased phosphate, decreased potassium, increased glucose, increased alkaline phosphatase, increased gamma-glutamyl transferase, and decreased sodium.

Table 6 summarizes the adverse reactions in CHRYSALIS.

Table 6: Adverse Reactions (≥ 10%) in Patients with NSCLC with Exon 20 Insertion Mutations Whose Disease Has Progressed on or after Platinum-based Chemotherapy and Received RYBREVANT in CHRYSALIS

Adverse Reactions	RYBREVANT (N=129)
	All Grades (%)	Grades 3 or 4 (%)
Skin and subcutaneous tissue disorders
Rasha	84	3.9
Pruritus	18	0
Dry skin	14	0
General disorders and administration site conditions
Infusion related reaction	64	3.1
Fatigueb	33	2.3
Edemac	27	0.8
Pyrexia	13	0
Infections and infestations
Paronychia	50	3.1
Pneumoniad	10	0.8
Musculoskeletal and connective tissue disorders
Musculoskeletal paine	47	0
Respiratory, thoracic and mediastinal disorders
Dyspneaf	37	2.3
Coughg	25	0
Gastrointestinal disorders
Nausea	36	0
Stomatitish	26	0.8
Constipation	23	0
Vomiting	22	0
Diarrhea	16	3.1
Abdominal Paini	11	0.8
Vascular disorders
Hemorrhagej	19	0
Metabolism and nutrition disorders
Decreased appetite	15	0
Nervous system disorders
Peripheral neuropathyk	13	0
Dizziness	12	0.8
Headachel	10	0.8
a Rash: acne, dermatitis, dermatitis acneiform, eczema, eczema asteatotic, palmar-plantar erythrodysesthesia syndrome, perineal rash, rash, rash erythematous, rash maculo-papular, rash papular, rash vesicular, skin exfoliation, toxic epidermal necrolysis b Fatigue: asthenia, fatigue c Edema: eyelid edema, face edema, generalized edema, lip edema, edema, edema peripheral, periorbital edema, peripheral swelling d Pneumonia: atypical pneumonia, lower respiratory tract infection, pneumonia, pneumonia aspiration, and pulmonary sepsis e Musculoskeletal pain: arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, spinal pain f Dyspnea: dyspnea, dyspnea exertional g Cough: cough, productive cough, upper airway cough syndrome h Stomatitis: aphthous ulcer, cheilitis, glossitis, mouth ulceration, mucosal inflammation, pharyngeal inflammation, stomatitis i Abdominal pain: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and epigastric discomfort j Hemorrhage: epistaxis, gingival bleeding, hematuria, hemoptysis, hemorrhage, mouth hemorrhage, mucosal hemorrhage k Peripheral neuropathy: hypoesthesia, neuralgia, paresthesia, peripheral sensory neuropathy l Headache: headache, migraine

Clinically relevant adverse reactions in <10% of patients who received RYBREVANT included ocular toxicity, ILD/pneumonitis, and toxic epidermal necrolysis (TEN).

Table 7 summarizes the laboratory abnormalities in CHRYSALIS.

Table 7: Select Laboratory Abnormalities (≥ 20%) That Worsened from Baseline in Patients With Metastatic NSCLC with EGFR Exon 20 Insertion Mutations Whose Disease Has Progressed on or After Platinum-based Chemotherapy and Who Received RYBREVANT in CHRYSALIS

Laboratory Abnormality	RYBREVANT+ (N=129)
	All Grades (%)	Grades 3 or 4 (%)
Chemistry
Decreased albumin	79	8
Increased glucose	56	4
Increased alkaline phosphatase	53	4.8
Increased creatinine	46	0
Increased alanine aminotransferase	38	1.6
Decreased phosphate	33	8
Increased aspartate aminotransferase	33	0
Decreased magnesium	27	0
Increased gamma-glutamyl transferase	27	4
Decreased sodium	27	4
Decreased potassium	26	6
Hematology
Decreased lymphocytes	36	8
+ The denominator used to calculate the rate was 126 based on the number of patients with a baseline value and at least one post-treatment value.

Immunogenicity

As with all therapeutic proteins, there is the potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other amivantamab products may be misleading.

In CHRYSALIS, 3 of the 286 (1%) patients who were treated with RYBREVANT and evaluable for the presence of anti-drug antibodies (ADA), tested positive for treatment-emergent anti-amivantamab-vmjw antibodies (one at 27 days, one at 59 days and one at 168 days after the first dose) with titers of 1:40 or less. There are insufficient data to evaluate the effect of ADA on the pharmacokinetics, safety, or efficacy of RYBREVANT.

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Rybrevant (Amivantamab-vmjw for Injection)

&Copy; Rybrevant Patient Information is supplied by Cerner Multum, Inc. and Rybrevant Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.