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Ogivri Side Effects

Generic Name: trastuzumab

Note: This document contains side effect information about trastuzumab. Some of the dosage forms listed on this page may not apply to the brand name Ogivri.

For the Consumer

Applies to trastuzumab: intravenous powder for solution

Along with its needed effects, trastuzumab (the active ingredient contained in Ogivri) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking trastuzumab:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • chest pain
  • chills
  • cough
  • cracked lips
  • decreased frequency or amount of urine
  • diarrhea
  • difficult or labored breathing
  • difficulty in swallowing
  • dry mouth
  • fever
  • headache
  • hoarseness
  • increased blood pressure
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • lower back or side pain
  • mood changes
  • muscle aches, pain, or cramps
  • nausea
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • peeling of the skin
  • pinpoint red spots on the skin
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stuffy or runny nose
  • swelling of the face, fingers, or lower legs
  • swollen glands
  • tightness in the chest
  • troubled breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common
  • Bladder pain
  • bloody nose
  • blurred vision
  • body aches or pain
  • burning or stinging of the skin
  • cloudy urine
  • dilated neck veins
  • dizziness
  • ear congestion
  • extreme tiredness or weakness
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • irregular breathing
  • joint pain
  • loss of voice
  • nasal congestion
  • nervousness
  • pain or tenderness around the eyes and cheekbones
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pounding in the ears
  • shivering
  • sneezing
  • sweating
  • trouble sleeping
Rare
  • Chest discomfort
  • hives, itching, skin rash
  • joint stiffness or swelling
  • neck tenderness or swelling
  • redness of the skin
  • tightness in the chest

Some side effects of trastuzumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficulty in moving
  • feeling of warmth
  • muscle stiffness
  • redness of the face, neck, arms and occasionally, upper chest
  • sudden sweating
Less common

For Healthcare Professionals

Applies to trastuzumab: intravenous powder for injection

General

The most common adverse events were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, stomatitis, weight loss, thrombocytopenia, mucosal inflammation, nasopharyngitis, dysgeusia, and myalgia.[Ref]

Hematologic

Very common (10% or more): Neutropenia (78%), leukopenia (52%), anemia (36%), febrile neutropenia (23%), thrombocytopenia (16%)
Frequency not reported: Hypoprothrombinemia[Ref]

Cardiovascular

Very common (10% or more): LVEF decrease (44%), congestive heart failure (28%), cardiomyopathy (15%), peripheral edema (10%), tachycardia (10%)
Common (1% to 10%): Hypertension, hypotension, asymptomatic cardiac dysfunction, ejection fraction decreased, palpitation, cardiac arrhythmia, cardiac failure, heart beat irregular, cardiac flutter, lymphedema, hot flush, thrombotic adverse event, supraventricular tachyarrhythmia, vasodilation
Uncommon (0.1% to 1%): Ventricular dysfunction, pericardial effusion
Frequency not reported: Cardiogenic shock, pericarditis, bradycardia, gallop rhythm present, S3 gallop[Ref]

Hypersensitivity

Very common (10% or more): Infusion-related reactions (54%)
Common (1% to 10%): Hypersensitivity, allergic reaction
Frequency not reported: Anaphylactic reaction, anaphylactic shock[Ref]

Respiratory

Very common (10% or more): Cough (43%), dyspnea (42%), rhinitis (22%), Grade 2 to 5 pulmonary toxicity (14%), nasopharyngitis (13%), wheezing, epistaxis, rhinorrhea
Common (1% to 10%): Pharyngolaryngeal pain, sinusitis, epistaxis, upper respiratory infection, rhinitis, asthma, lung disorder, pleural effusion
Uncommon (0.1% to 1%): Pulmonary infiltrates, pulmonary hypertension, interstitial pneumonitis
Frequency not reported: Pulmonary insufficiency, pulmonary fibrosis, respiratory distress, respiratory failure, lung infiltration, acute pulmonary edema, acute respiratory distress syndrome, bronchospasm, hypoxia, oxygen saturation decreased, laryngeal edema, pulmonary edema, orthopnea
Postmarketing reports: Bronchospasm, hypoxia, pleural effusions, non-cardiogenic pulmonary edema[Ref]

Immunologic

Very common (10% or more): Infection (47%), herpes simplex (38%), antibody to trastuzumab (the active ingredient contained in Ogivri) (15%), flu syndrome (12%)
Common (1% to 10%): Neutropenic sepsis, postoperative wound infection, herpes zoster
Uncommon (0.1% to 1%): Sepsis[Ref]

Renal

Very common (10% or more): Renal impairment/failure (18%)
Common (1% to 10%): Grade 3 or 4 renal failure, renal disorder, hyperbilirubinemia
Frequency not reported: Glomerulonephritis membranous, glomerulonephropathy, renal failure
Postmarketing reports: Nephrotic syndrome with pathological evidence of glomerulopathy[Ref]

Gastrointestinal

Very common (10% or more): Nausea (76%), vomiting (53%), diarrhea (45%), abdominal pain (34%), stomatitis (24%), anorexia (14%)
Common (1% to 10%): Constipation, dyspepsia, dysphagia, lip swelling, pancreatitis, hemorrhoids, dry mouth[Ref]

Nervous system

Very common (10% or more): Headache (44%), asthenia (42%), fatigue (35%), insomnia (29%), dizziness (24%), paresthesia (23%), peripheral neuritis (23%), neuropathy (13%), dysgeusia (10%), dizziness (13%), tremor, hypoesthesia
Common (1% to 10%): Hypertonia, somnolence, ataxia
Rare (less than 0.1%): Paresis
Frequency not reported: Brain edema[Ref]

Dermatologic

Very common (10% or more): Rash (38%), nail changes (12%), acne (11%), rash/desquamation (11%), erythema, swelling face, palmar-plantar erythrodysesthesia syndrome, alopecia
Common (1% to 10%): Pruritus, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, onychoclasis, dermatitis, contusion, skin infection, erysipelas, cellulitis
Uncommon (0.1% to 1%): Urticaria
Frequency not reported: Angioedema[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (37%), back pain (34%), bone pain (24%), muscle tightness, myalgia
Common (1% to 10%): Muscle spasm, neck pain, pain in extremity, arthritis[Ref]

Metabolic

Very common (10% or more): Anorexia (31%), hypokalemia (28%), weight loss (23%)
Frequency not reported: Hyperkalemia
Postmarketing reports: Volume overload[Ref]

Other

Very common (10% or more): Asthenia (62%), pain (61%), fever (56%), chills (41%), accidental injury (13%)
Common (1% to 10%): Malaise
Uncommon (0.1% to 1%): Deafness
Rare (less than 0.1%): Sudden death
Postmarketing reports: Oligohydramnios or oligohydramnios sequence (including pulmonary hypoplasia, skeletal abnormalities, and neonatal death)[Ref]

Hepatic

Common (1% to 10%): Hepatocellular injury, hepatitis, liver tenderness
Rare (less than 0.1%): Jaundice
Frequency not reported: Hepatic failure[Ref]

Ocular

Very common (10% or more): Conjunctivitis, lacrimation increased
Common (1% to 10%): Dry eye
Frequency not reported: Papilledema, retinal hemorrhage[Ref]

Genitourinary

Common (1% to 10%): Breast inflammation/mastitis, urinary tract infection, cystitis[Ref]

Psychiatric

Very common (10% or more): Depression (20%), insomnia (14%)
Common (1% to 10%): Anxiety, thinking abnormal
Uncommon (0.1% to 1%): Depression[Ref]

Endocrine

Uncommon (0.1% to 1%): Autoimmune thyroiditis[Ref]

Oncologic

Frequency not reported: Malignant neoplasm progression, neoplasm progression[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Ogivri (trastuzumab)." Mylan GmbH, Morgantown, WV.

3. "Product Information. Herceptin (trastuzumab)." Genentech, South San Francisco, CA.

4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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