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Cyramza

Last reviewed on RxList: 7/20/2020
Cyramza Side Effects Center

What Is Cyramza?

Cyramza (ramucirumab) is a recombinant human IgG1 monoclonal antibody used a single-agent is for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

What Are Side Effects of Cyramza?

Common side effects of Cyramza include:

Dosage for Cyramza

The recommended dose of Cyramza Is 8 mg/kg every 2 weeks administered as an intravenous infusion over 60 minutes.

What Drugs, Substances, or Supplements Interact with Cyramza?

Cyramza may interact with other drugs. Tell your doctor all medications and supplements you use.

Cyramza During Pregnancy and Breastfeeding

During pregnancy, Cyramza should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Cyramza (ramucirumab) 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.

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Cyramza Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed, chilled, sweaty, or have chest pain, chest tightness, back pain, trouble breathing, or numbness and tingling.

Ramucirumab can increase your risk of serious bleeding.

Call your doctor at once if you have:

  • signs of stomach bleeding--severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • any wound that will not heal;
  • headache, confusion, change in mental status, vision loss, seizure (convulsions);
  • severe or ongoing nausea, vomiting, or diarrhea;
  • rapid weight gain, especially in your face and midsection;
  • low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
  • kidney problems--puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy;
  • symptoms of a blood clot--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common side effects may include:

  • sores or white patches in or around your mouth, red or swollen gums, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;
  • feeling weak or tired;
  • diarrhea, loss of appetite;
  • nosebleed;
  • low white blood cell counts; or
  • high blood pressure.

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.

Read the entire detailed patient monograph for Cyramza (Ramucirumab Solution for Intravenous Infusion)

Cyramza Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

  • Hemorrhage [see WARNINGS AND PRECAUTIONS].
  • Gastrointestinal Perforations [see WARNINGS AND PRECAUTIONS].
  • Impaired Wound Healing [see WARNINGS AND PRECAUTIONS].
  • Arterial Thromboembolic Events [see WARNINGS AND PRECAUTIONS].
  • Hypertension [see WARNINGS AND PRECAUTIONS].
  • Infusion-Related Reactions [see WARNINGS AND PRECAUTIONS].
  • Worsening of Pre-existing Hepatic Impairment [see WARNINGS AND PRECAUTIONS].
  • Posterior Reversible Encephalopathy Syndrome [see WARNINGS AND PRECAUTIONS].
  • Proteinuria Including Nephrotic Syndrome [see WARNINGS AND PRECAUTIONS].
  • Thyroid Dysfunction [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 data described in the Warnings and Precautions section reflect exposure to CYRAMZA in 2137 patients from six studies: REGARD, RAINBOW, RAISE, REVEL, REACH-2, and RELAY.

Gastric Cancer

The safety of CYRAMZA was evaluated in REGARD and RAINBOW [see Clinical Studies]. Patients in both trials had locally advanced or metastatic gastric cancer (including GEJ adenocarcinoma) and had previously received platinum-or fluoropyrimidine-containing chemotherapy. Patients had Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Both trials excluded patients with uncontrolled hypertension, major surgery within 28 days, or patients receiving chronic anti-platelet therapy other than once daily aspirin. REGARD excluded patients with bilirubin ≥1.5 mg/dL and RAINBOW excluded patients with bilirubin >1.5 times the upper limit of normal (ULN).

CYRAMZA Administered As A Single Agent (REGARD)

Patients received either CYRAMZA 8 mg/kg or placebo intravenously every two weeks. Patients randomized to CYRAMZA received a median of 4 doses; the median duration of exposure was 8 weeks and 32 (14% of 236) patients received CYRAMZA for at least six months.

The most common serious adverse reactions with CYRAMZA were anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients versus 8.7% of patients who received placebo.

The most common adverse reactions (all grades) observed in CYRAMZA-treated patients at a rate of ≥10% and ≥2% higher than placebo were hypertension and diarrhea. Table 2 provides the frequency and severity of adverse reactions (CTCAE, version 4.0) in REGARD.

Table 2: Adverse Reactions Occurring in ≥5% of Patients with a≥2% Difference Between Arms in REGARD

Adverse ReactionsCYRAMZA
(N=236)
Placebo
(N=115)
All Grades (%)Grade 3-4 (%)All Grades (%)Grade 3-4 (%)
Vascular
Hypertensiona16883
Gastrointestinal
Diarrhea14192
Nervous System
Headache9030
Metabolism and Nutrition
Hyponatremia6321
a Hypertension is a consolidated term.

Clinically relevant adverse reactions reported in ≥1% and <5% of CYRAMZA-treated patients in REGARD were:

  • Neutropenia (4.7%)
  • Epistaxis (4.7%)
  • Rash (4.2%)
  • Intestinal obstruction (2.1%)
  • Arterial thromboembolic events (1.7%)

Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including Grade ≥3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and IRR. In REGARD, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria versus 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in REGARD was 0.8% and the rate of IRR was 0.4%.

CYRAMZA Administered In Combination With Paclitaxel (RAINBOW)

Patients received paclitaxel 80 mg/m² on Days 1, 8, and 15 of each 28-day cycle with either CYRAMZA 8 mg/kg or placebo intravenously every two weeks. Patients randomized to CYRAMZA received a median of 9 doses; the median duration of exposure was 18 weeks, and 93 (28% of 327) patients received CYRAMZA for at least six months.

The most common serious adverse reactions in patients who received CYRAMZA with paclitaxel were neutropenia (3.7%) and febrile neutropenia (2.4%); 19% of patients who received CYRAMZA with paclitaxel received granulocyte colony-stimulating factors.

Adverse reactions resulting in discontinuation of any component of the CYRAMZA with paclitaxel combination in ≥2% of patients in RAINBOW were neutropenia (4%) and thrombocytopenia (3%).

The most common adverse reactions (all grades) observed in patients who received CYRAMZA with paclitaxel at a rate of ≥30% and ≥2% higher than placebo with paclitaxel were fatigue/asthenia, neutropenia, diarrhea, and epistaxis. Table 3 provides the frequency and severity of adverse reactions (CTCAE, version 4.0) in RAINBOW.

Table 3: Adverse Reactions Occurring in ≥5% of Patients with a≥2% Difference Between Arms in RAINBOW

Adverse ReactionsCYRAMZA + Paclitaxel
(N=327)
Placebo + Paclitaxel
(N=329)
All Grades (%)Grade ≥3 (%)All Grades (%)Grade ≥3 (%)
General
Fatigue/Asthenia5712446
Peripheral edema252141
Hematology
Neutropeniaa54413119
Thrombocytopenia13262
Gastrointestinal
Diarrhea324232
Stomatitis20171
Gastrointestinal hemorrhage eventsa,b10462
Respiratory, Thoracic, and Mediastinal
Epistaxis31070
Vascular
Hypertensiona251563
Renal and Urinary
Proteinuriaa17160
Metabolism and Nutrition
Hypoalbuminemiaa11151
a Neutropenia, gastrointestinal hemorrhage events, hypertension, proteinuria, and hypoalbuminemia are consolidated terms.
b Includes 1 fatal event in the CYRAMZA arm.

Clinically relevant adverse reactions reported in ≥1% and <5% of patients receiving CYRAMZA with paclitaxel were:

  • Sepsis (3.1%), including 5 fatal events
  • Gastrointestinal perforations (1.2%), including 1 fatal event

Non-Small Cell Lung Cancer

CYRAMZA Administered In Combination With Erlotinib (RELAY)

The safety of CYRAMZA was evaluated in RELAY [see Clinical Studies]. Patients had previously untreated EGFR exon 19 deletion or exon 21 (L858R) substitution mutation-positive metastatic NSCLC. Patients had ECOG PS 0 or 1. RELAY excluded patients with bilirubin greater than the ULN, central nervous system (CNS) metastases, clinically active interstitial lung disease (ILD), uncontrolled hypertension, major surgery within 28 days, radiographic evidence of major blood vessel invasion or encasement by cancer or intra-tumor cavitation, or gross hemoptysis within the preceding 2 months. The study also excluded patients receiving chronic nonsteroidal anti-inflammatory agents (NSAIDs) or anti-platelet therapy other than once daily aspirin.

Patients received either CYRAMZA 10 mg/kg or placebo intravenously every two weeks in combination with erlotinib 150 mg taken orally once daily. Patients randomized to CYRAMZA received a median of 21 doses; the median duration of exposure was 11 months, and 90 (41% of 221) patients received CYRAMZA for at least 12 months.

The most common serious adverse reactions in patients who received CYRAMZA with erlotinib were pneumonia (3.2%), cellulitis (1.8%), and pneumothorax (1.8%). Red blood cell transfusions were given to 3.2% of CYRAMZA-treated patients versus 0 patients who received placebo.

Treatment discontinuation of all study drugs due to adverse reactions occurred in 13% of CYRAMZA with erlotinib-treated patients, with increased alanine aminotransferase (1.4%) and paronychia (1.4%) being the most common. The most common adverse reactions leading to treatment discontinuation of CYRAMZA were proteinuria (8.6%) and hyperbilirubinemia (6%).

The most common adverse reactions (all grades) observed in CYRAMZA with erlotinib-treated patients at a rate of ≥30% of patients and ≥2% higher than placebo with erlotinib-treated patients were infections, hypertension, stomatitis, proteinuria, alopecia, and epistaxis. The most common laboratory abnormalities ≥30% and ≥2% higher than the placebo were increased alanine aminotransferase, increased aspartate aminotransferase, anemia, thrombocytopenia, and neutropenia. Table 4 provides the frequency and severity of adverse reactions (CTCAE, version 4.0) and Table 5 provides the incidence and severity of laboratory abnormalities in RELAY.

Table 4: Adverse Reactions Occurring in ≥5% of Patients with a ≥2% Difference Between Arms in RELAY

Adverse ReactionsCYRAMZA + Erlotinib
(N=221)
Placebo + Erlotinib
(N=225)
All Grades (%)Grade ≥3 (%)All Grades (%)Grade ≥3 (%)
Infections
Infectionsa,b8117767
Vascular
Hypertension4524125
Gastrointestinal
Diarrhea707711
Stomatitis422361
Gastrointestinal hemorrhagec1013<1
Gingival bleeding9010
Renal and Urinary
Proteinuriac34380
Skin and Subcutaneous Tissue
Alopecia34N/Ad20N/Ad
Respiratory, Thoracic, and Mediastinal
Epistaxis340120
Pulmonary hemorrhagec,e7<12<1
General
Peripheral edema23<140
Nervous System
Headache15<170
Abbreviations: N/A = not applicable.
a Includes all preferred terms that are part of the System Organ Class Infections and Infestations. Most common (≥1%) Grade ≥3 infections and frequencies for CYRAMZA with erlotinib compared to placebo with erlotinib, respectively, include pneumonia (3% versus 0%), cellulitis (1% versus 0%), paronychia (4% versus 3%), skin infection (1% versus 0%), and urinary tract infection (1% versus 0%).
b Includes 3 fatal events in the CYRAMZA arm.
cGastrointestinal hemorrhage, proteinuria, and pulmonary hemorrhage are consolidated terms.
d Grade ≥3 does not exist in CTCAE.
e Includes 1 fatal event in the CYRAMZA arm.

Table 5: Laboratory Abnormalities Worsening from Baseline in ≥20% (All Grades) of Patients Receiving CYRAMZA with Erlotinib with a Difference Between Arms of ≥2% in RELAY

Laboratory AbnormalityCYRAMZA + ErlotinibaPlacebo + Erlotiniba
All Grades (%)Grade ≥3 (%)All Grades (%)Grade ≥3 (%)
Chemistry
Alanine aminotransferase increased74116013
Aspartate aminotransferase increased716474
Alkaline phosphatase increased25<1161
Hypokalemia245182
Hematology
Anemia425252
Thrombocytopenia413123
Neutropenia337214
a The denominator used to calculate the incidence varied based on the number of patients with a baseline and at least one on-study laboratory measurement: CYRAMZA-treated patients (range 215-218 patients) and placebo-treated patients (range 224-225 patients).

CYRAMZA Administered In Combination With Docetaxel (REVEL)

The safety of CYRAMZA was evaluated in REVEL [see Clinical Studies]. Patients had NSCLC with disease progression on or after one platinum-based therapy for locally advanced or metastatic disease and ECOG PS 0 or 1. REVEL excluded patients with bilirubin greater than the ULN, uncontrolled hypertension, major surgery within 28 days, radiographic evidence of major airway or blood vessel invasion by cancer, radiographic evidence of intra-tumor cavitation, or gross hemoptysis within the preceding 2 months, and patients receiving therapeutic anticoagulation or chronic anti-platelet therapy other than once daily aspirin.

Patients received either CYRAMZA 10 mg/kg or placebo intravenously in combination with docetaxel 75 mg/m² intravenously every 21 days. Due to an increased incidence of neutropenia and febrile neutropenia in patients enrolled in East Asian sites, REVEL was amended and 24 patients (11 patients receiving CYRAMZA with docetaxel, 13 patients receiving placebo with docetaxel) at East Asian sites received a starting dose of docetaxel at 60 mg/m² every three weeks. Patients randomized to CYRAMZA received a median of 4.5 doses; the median duration of exposure was 3.5 months, and 195 (31% of 627) patients received CYRAMZA for at least six months.

The most common serious adverse reactions in patients who received CYRAMZA with docetaxel were febrile neutropenia (14%), pneumonia (6%), and neutropenia (5%). The use of granulocyte colony-stimulating factors was 42% in CYRAMZA with docetaxel-treated patients versus 37% in patients who received placebo with docetaxel.

The most common adverse reactions leading to treatment discontinuation of CYRAMZA were IRR (0.5%) and epistaxis (0.3%). For patients with non-squamous histology, the overall incidence of pulmonary hemorrhage was 7% and the incidence of Grade ≥3 pulmonary hemorrhage was 1% for CYRAMZA with docetaxel compared to 6% overall incidence and 1% for Grade ≥3 pulmonary hemorrhage for placebo with docetaxel. For patients with squamous histology, the overall incidence of pulmonary hemorrhage was 10% and the incidence of Grade ≥3 pulmonary hemorrhage was 2% for CYRAMZA with docetaxel compared to 12% overall incidence and 2% for Grade ≥3 pulmonary hemorrhage for placebo with docetaxel. Treatment discontinuation due to adverse reactions occurred more frequently in CYRAMZA with docetaxel-treated patients (9%) than in placebo with docetaxel-treated patients (5%).

The most common adverse reactions (all grades) observed in CYRAMZA with docetaxel-treated patients at a rate of ≥30% and ≥2% higher than placebo with docetaxel were neutropenia, fatigue/asthenia, and stomatitis/mucosal inflammation. Table 6 provides the frequency and severity of adverse reactions (NCI CTCAE, version 4.0) in REVEL.

Table 6: Adverse Reactions Occurring in ≥5% of Patients with a ≥2% Difference Between Arms in REVEL

Adverse ReactionsCYRAMZA + Docetaxel
(N=627)
Placebo + Docetaxel
(N=618)
All Grades (%)Grade 3-4 (%)All Grades (%)Grade 3-4 (%)
Hematology
Neutropeniaa55494640
Febrile neutropenia16161010
Thrombocytopeniaa1335<1
General
Fatigue/Asthenia55145011
Peripheral edema1609<1
Gastrointestinal
Stomatitis/Mucosal inflammation377192
Respiratory, Thoracic, and Mediastinal
Epistaxis19<17<1
Eye
Lacrimation increased13<150
Vascular
Hypertensiona11652
a Neutropenia, thrombocytopenia, and hypertension are consolidated terms.

Clinically relevant adverse drug reactions reported in ≥1% and <5% of CYRAMZA with docetaxel-treated patients in REVEL were:

  • Hyponatremia (4.8%)
  • Proteinuria (3.3%)

Colorectal Cancer

The safety of CYRAMZA was evaluated in RAISE [see Clinical Studies]. Patients had mCRC with disease progression on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine and ECOG PS 0 or 1. RAISE excluded patients with uncontrolled hypertension, major surgery within 28 days, and those who experienced any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event; Grade 4 hypertension; Grade 3 proteinuria; a Grade 3-4 bleeding event; or bowel perforation.

Patients received either CYRAMZA 8 mg/kg or placebo intravenously in combination with FOLFIRI intravenously every two weeks. Patients randomized to CYRAMZA received a median of 8 doses (range 1-68); the median duration of exposure was 4.4 months, and 169 (32% of 529) patients received CYRAMZA for at least six months.

The most common serious adverse reactions with CYRAMZA with FOLFIRI were diarrhea (3.6%), intestinal obstruction (3.0%), and febrile neutropenia (2.8%).

Treatment discontinuation of any study drug due to adverse reactions occurred more frequently in CYRAMZA with FOLFIRI-treated patients (29%) than in placebo with FOLFIRI-treated patients (13%). The most common adverse reactions leading to discontinuation of any component of CYRAMZA with FOLFIRI as compared to placebo with FOLFIRI were neutropenia (12.5% versus 5.3%) and thrombocytopenia (4.2% versus 0.8%). The most common adverse reactions leading to treatment discontinuation of CYRAMZA were proteinuria (1.5%) and gastrointestinal perforation (1.7%).

The most common adverse reactions (all grades) observed in CYRAMZA with FOLFIRI-treated patients at a rate of ≥30% and ≥2% higher than placebo with FOLFIRI were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis. Twenty percent of patients treated with CYRAMZA with FOLFIRI received granulocyte colony-stimulating factors. Table 7 provides the frequency and severity of adverse reactions (CTCAE, version 4.0) in RAISE.

Table 7: Adverse Reactions Occurring in ≥5% of Patients with a ≥2% Difference Between Arms in RAISE

Adverse ReactionsCYRAMZA + FOLFIRI
(N=529)
Placebo + FOLFIRI
(N=528)
All Grades (%)Grade ≥3 (%)All Grades (%)Grade ≥3 (%)
Gastrointestinal
Diarrhea60115110
Decreased appetite372272
Stomatitis314212
Gastrointestinal hemorrhage eventsa,b12271
Hematology
Neutropeniaa59384623
Thrombocytopeniaa28314<1
Respiratory, Thoracic, and Mediastinal
Epistaxis330150
Vascular
Hypertension261193
General
Peripheral edema20<190
Renal and Urinary
Proteinuriaa,c1735<1
Skin and Subcutaneous Tissue
Palmar-plantar erythrodysesthesia syndrome1315<1
Metabolism and Nutrition
Hypoalbuminemiaa6120
a Gastrointestinal hemorrhage events, neutropenia, thrombocytopenia, hypertension, proteinuria, and hypoalbuminemia, are consolidated terms.
b Includes 3 fatal events in the CYRAMZA arm.
cIncludes 3 patients with nephrotic syndrome in the CYRAMZA arm.

Clinically relevant adverse reactions reported in ≥1% and <5% of patients receiving CYRAMZA with FOLFIRI were:

  • Gastrointestinal perforation (1.7%) including 4 fatal events

Thyroid stimulating hormone (TSH) levels were evaluated in 224 patients (115 CYRAMZA with FOLFIRI-treated patients and 109 placebo with FOLFIRI-treated patients) with normal baseline TSH levels. Patients underwent periodic TSH laboratory assessments until 30 days after the last dose of study treatment. Increased TSH levels were observed in 53 (46%) patients treated with CYRAMZA with FOLFIRI compared with 4 (4%) patients treated with placebo with FOLFIRI.

Hepatocellular Carcinoma

The safety of CYRAMZA was evaluated in REACH-2 [see Clinical Studies]. Patients had Barcelona Clinic Liver Cancer (BCLC) stage B HCC who were no longer amenable to locoregional therapy, or BCLC stage C HCC, Child-Pugh score A, and baseline AFP ≥400 ng/mL. Patients had ECOG PS 0 or 1. REACH-2 excluded patients with clinically meaningful ascites, history of or current hepatic encephalopathy, uncontrolled hypertension, major surgery within 28 days, bilirubin >1.5 times ULN, severe variceal bleeding in the 3 months prior to treatment or with varices at high risk of bleeding, and patients receiving therapeutic anticoagulation or chronic anti-platelet therapy other than once daily aspirin.

Patients received either CYRAMZA 8 mg/kg or placebo intravenously every two weeks. Patients received a median of 6 doses (range 1-51) of CYRAMZA; the median duration of exposure was 12 weeks (range 2-107 weeks) and 48 patients (24% of 197) received CYRAMZA for at least six months.

The most common serious adverse reactions with CYRAMZA were ascites (3%) and pneumonia (3%).

Treatment discontinuations due to adverse reactions occurred in 18% of CYRAMZA-treated patients, with proteinuria being the most frequent (2%).

The most common adverse reactions reported in ≥15% of patients and ≥2% higher than placebo were fatigue, peripheral edema, hypertension, abdominal pain, decreased appetite, proteinuria, nausea, and ascites. The most common laboratory abnormalities ≥30% and ≥2% higher than placebo were thrombocytopenia, hypoalbuminemia, and hyponatremia. Table 8 provides the frequency and severity of adverse reactions (CTCAE, version 4.0) and Table 9 provides the incidence and severity of laboratory abnormalities in REACH-2.

Table 8: Adverse Reactions Occurring in ≥10% of Patients with a ≥2% Difference Between Arms in REACH-2

Adverse ReactionsCYRAMZA
(N=197)
Placebo
(N=95)
All Grades (%)Grade ≥3 (%)All Grades (%)Grade ≥3 (%)
General
Fatiguea365203
Peripheral edema252140
Decreased appetite232201
Insomnia11061
Pyrexia10030
Vascular
Hypertensiona2513135
Gastrointestinal
Abdominal Paina252162
Nausea190120
Ascitesb18471
Vomiting10070
Renal and Urinary
Proteinuriaa,c20240
Nervous System
Headache14051
Respiratory, Thoracic, and Mediastinal
Epistaxis14<130
Musculoskeletal
Back Pain10<171
a Fatigue, hypertension, abdominal pain, and proteinuria are consolidated terms.
b Includes 1 fatal event in the CYRAMZA arm.
cIncludes 1 patient with nephrotic syndrome in the CYRAMZA arm.

Clinically relevant adverse drug reactions reported in ≥1% and <10% of CYRAMZA-treated patients in REACH-2 were:

  • IRR (9%)
  • Hepatic encephalopathy (5%) including 1 fatal event
  • Hepatorenal syndrome (2%) including 1 fatal event

Table 9: Laboratory Abnormalities Worsening from Baseline in ≥15% (All Grades) of Patients Receiving CYRAMZA with a Difference Between Arms of ≥2% in REACH-2

Laboratory AbnormalityaCYRAMZAbPlacebob
All Grades (%)Grade ≥3 (%)All Grades (%)Grade ≥3 (%)
Hematology
Thrombocytopenia468151
Neutropenia248123
Chemistry
Hypoalbuminemia33<1160
Hyponatremia3216255
Hypocalcemia16250
a Laboratory abnormalities were not included if the ≥ Grade 3 percentage was less than placebo-treated patients.
b The denominator used to calculate the incidence varied based on the number of patients with a baseline and at least one on study laboratory measurement: CYRAMZA-treated patients (range 179-193 patients) and placebo-treated patients (range 84-92 patients).

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 incidence of antibodies to CYRAMZA with the incidences of antibodies to other products may be misleading.

In clinical trials, 86/2890 (3%) of CYRAMZA-treated patients tested positive for treatment-emergent anti-ramucirumab antibodies by an enzyme-linked immunosorbent assay (ELISA). Neutralizing antibodies were detected in 14 of the 86 patients who tested positive for treatment-emergent anti-ramucirumab antibodies.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CYRAMZA. Because such reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Blood and lymphatic system: Thrombotic microangiopathy
  • Neoplasms benign, malignant and unspecified: Hemangioma
  • Respiratory, thoracic, and mediastinal: Dysphonia
  • Vascular: Arterial (including aortic) aneurysms, dissections, and rupture

Read the entire FDA prescribing information for Cyramza (Ramucirumab Solution for Intravenous Infusion)

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© Cyramza Patient Information is supplied by Cerner Multum, Inc. and Cyramza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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