Tykerb

Last updated on RxList: 11/25/2020
Tykerb Side Effects Center

What Is Tykerb?

Tykerb (lapatinib) is a cancer medication used together with another medicine called capecitabine (Xeloda) to treat a certain type of advanced breast cancer that has spread to other parts of the body, and is usually given after other cancer medications have been tried without successful treatment of symptoms.

What Are Side Effects of Tykerb?

Common side effects of Tykerb include:

  • nausea,
  • vomiting,
  • upset stomach,
  • mouth sores,
  • rash,
  • dry skin,
  • pain or redness on the palms of your hands or soles of your feet,
  • hair loss,
  • problems with your fingernails or toenails, and
  • trouble sleeping.

Diarrhea is common and may become severe. Tell your doctor if you have unlikely but serious side effects of Tykerb including:

  • unusual tiredness,
  • shortness of breath, or
  • swelling ankles and feet.

Dosage for Tykerb

The recommended dose of Tykerb is 1,250 mg given orally once daily on Days 1-21 continuously in combination with capecitabine 2,000 mg/m²/day (administered orally in 2 doses approximately 12 hours apart) on Days 1-14 in a repeating 21-day cycle. Take once daily (5 tablets administered all at once), at least one hour before or one hour after a meal.

What Drugs, Substances, or Supplements Interact with Tykerb?

Tykerb may interact with cimetidine, dexamethasone, rifabutin, rifampin, rifapentine, St. John's wort, antibiotics, antifungals, antidepressants, calcium channel blockers, HIV/AIDS medicines, or seizure medications. Tell your doctor all medications you use.

Tykerb During Pregnancy and Breastfeeding

Tykerb is not recommended for use during pregnancy. It may harm a fetus. Consult your doctor to discuss using at least 2 forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Additional Information

Our Tykerb (lapatinib) 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.

QUESTION

A lump in the breast is almost always cancer. See Answer
Tykerb Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Lapatinib can cause severe or fatal liver problems. Call your doctor right away if you have: upper stomach pain, itching, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • severe or ongoing diarrhea; or
  • new or worsening cough, wheezing, chest pain, feeling short of breath.

Common side effects may include:

  • indigestion, loss of appetite;
  • nausea, vomiting, diarrhea;
  • rash, itching, dry skin, acne;
  • pain or redness on the palms of your hands or the soles of your feet;
  • problems with your fingernails or toenails;
  • feeling weak or tired;
  • nosebleeds, mouth sores;
  • thinning hair; or
  • headache.

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 Tykerb (Lapatinib)

SLIDESHOW

Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Tykerb Professional Information

SIDE EFFECTS

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.

HER2-Positive Metastatic Breast Cancer

The safety of TYKERB has been evaluated in more than 12,000 patients in clinical trials. The efficacy and safety of TYKERB in combination with capecitabine in breast cancer was evaluated in 198 patients in a randomized, Phase 3 trial [see Clinical Studies]. Adverse reactions which occurred in at least 10% of patients in either treatment arm and were higher in the combination arm are shown in Table 1.

The most common adverse reactions (greater than 20%) during therapy with TYKERB plus capecitabine were gastrointestinal (diarrhea, nausea, and vomiting), dermatologic (palmar-plantar erythrodysesthesia and rash), and fatigue. Diarrhea was the most common adverse reaction resulting in discontinuation of study medication.

The most common Grade 3 and 4 adverse reactions (NCI CTCAE v3.0) were diarrhea and palmar-plantar erythrodysesthesia. Selected laboratory abnormalities are shown in Table 2.

Table 1: Adverse Reactions Occurring in Greater Than or Equal to 10% of Patients

ReactionsTYKERB 1,250 mg/day + Capecitabine 2,000 mg/m²/day
(N = 198)
Capecitabine
2,500 mg/m²/day
(N = 191)
All Gradesa %Grade 3 %Grade 4 %All Gradesa %Grade 3 %Grade 4 %
Gastrointestinal disorders
Diarrhea6513140100
Nausea44204320
Vomiting26202120
Stomatitis140011< 10
Dyspepsia11< 10300
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia5312051140
Rashb28201410
Dry skin1000600
General disorders and administration site conditions
Mucosal inflammation15001220
Musculoskeletal and connective tissue disorders
Pain in extremity12107< 10
Back pain11106< 10
Respiratory, thoracic, and mediastinal disorders
Dyspnea1230820
Psychiatric disorders
Insomnia10< 10600
a NCI CTCAE, v3.0.
b Grade 3 dermatitis acneiform was reported in less than 1% of patients in the group receiving TYKERB plus capecitabine.

Table 2: Selected Laboratory Abnormalities

ParametersTYKERB 1,250 mg/day + Capecitabine 2,000 mg/m²/dayCapecitabine 2,500 mg/m²/day
All Gradesa %Grade 3 %Grade 4 %All Gradesa %Grade 3 %Grade 4 %
Hematologic
Hemoglobin56< 105310
Platelets18< 1017< 1< 1
Neutrophils223< 13121
Hepatic
Total Bilirubin45403030
AST492< 14320
ALT37203310
a NCI CTCAE, v3.0

Hormone Receptor-Positive, Metastatic Breast Cancer

In a randomized, Phase 3 clinical trial of patients (N = 1,286) with hormone receptor-positive, metastatic breast cancer, who had not received chemotherapy for their metastatic disease, patients received letrozole with or without TYKERB. In this trial, the safety profile of TYKERB was consistent with previously reported results from trials of TYKERB in the advanced or metastatic breast cancer population. Adverse reactions which occurred in at least 10% of patients in either treatment arm and were higher in the combination arm are shown in Table 3. Selected laboratory abnormalities are shown in Table 4.

Table 3: Adverse Reactions Occurring in Greater Than or Equal to 10% of Patients

ReactionsTYKERB 1,500 mg/day +
Letrozole 2.5 mg/day
(N = 654)
Letrozole 2.5 mg/day
(N = 624)
All Gradesa %Grade 3 %Grade 4 %All Gradesa %Grade 3 %Grade 4 %
Gastrointestinal disorders
Diarrhea649< 120< 10
Nausea31< 1021< 10
Vomiting171< 111< 1< 1
Anorexia11< 109< 10
Skin and subcutaneous tissue disorders
Rashb44101300
Dry skin13< 10400
Alopecia13< 10700
Pruritus12< 109< 10
Nail Disorder11< 10< 100
General disorders and administration site conditions
Fatigue202017< 10
Asthenia12< 1011< 10
Nervous system disorders
Headache14< 1013< 10
Respiratory, thoracic, and mediastinal disorders
Epistaxis11< 102< 10
a NCI CTCAE, v3.0
b In addition to the rash reported under “Skin and subcutaneous tissue disorders”, 3 additional subjects in each treatment arm had rash under “Infections and infestations”; none were Grade 3 or 4.

Table 4: Selected Laboratory Abnormalities

Hepatic ParametersTYKERB 1,500 mg/day +
Letrozole 2.5 mg/day
Letrozole 2.5 mg/day
All Gradesa %Grade 3 %Grade 4 %All Gradesa %Grade 3 %Grade 4 %
AST5360362< 1
ALT465< 13510
Total Bilirubin22< 1< 1111< 1
a NCI CTCAE, v3.0.

Hormone Receptor-Positive, HER2+ Metastatic Breast Cancer

In another randomized, Phase 3 clinical trial of postmenopausal patients (N = 355) with hormone receptor positive (HR+), HER2-positive metastatic breast cancer (MBC) which had progressed after prior trastuzumab-containing chemotherapy and endocrine therapies patients received TYKERB with trastuzumab and an aromatase inhibitor (AI) (letrozole, exemestane, or anastrozole), TYKERB with an AI, or trastuzumab with an AI. In this trial, the safety profile of the treatment groups was consistent with the known safety of these agents. The most frequent study treatment-related AEs (>10%) in each of the TYKERB-containing treatment arms were diarrhea, rash, paronychia, nausea, stomatitis, dermatitis acneiform, and decreased appetite, which were infrequent to absent in the trastuzumab treatment arm. The frequency of cardiac AEs (mostly decrease in ejection fraction) was 7% in the TYKERB+trastuzumab+AI group, 2% in the TYKERB+AI group and 3% in the trastuzumab+AI group. Adverse reactions which occurred in at least 10% of patients in the treatment arms are shown in Table 5.

Table 5: Adverse Reactions Occurring in Greater Than or Equal to 10% of Patients

ReactionsTYKERB (1000mg) +Trastuzumab +AI
(N=118)
TYKERB (1500 mg) + AI
(N=119)
Trastuzumab +AI
(N=116)
All Gradesa (%)Grade 3 (%)Grade 4 (%)All Gradesa (%)Grade 3(%)Grade 4 (%)All Gradesa (%)Grade 3 (%)Grade 4 (%)
Gastrointestinal disorders
Diarrhea691305160900
Nausea22002220900
Stomatitis170013<10300
Vomiting10001400<1<10
Skin and subcutaneous tissue disorders
Rashb54004430500
Palmar-plantar erythrodysesthesia10008<10<100
Alopecia1000700200
General disorders and administration site conditions
Fatigue12<1014201000
Musculoskeletal and connective tissue disorders
Arthralgia13<1014001200
Pain in extremity7<101000300
Respiratory, thoracic, and mediastinal disorders
Cough8008001500
Metabolism and nutrition disorders
Decreased appetite18001300300
Infections and infestations
Paronychia30001520000
Investigations
Alanine aminotransferase increased700153<1640
Aspartate aminotransferase increased6001750940
Nervous system disorders
Headache500162010<10
a NCI CTCAE, v3.0.
b Includes multiple adverse reaction terms for rash.

Decreases In Left Ventricular Ejection Fraction

Due to potential cardiac toxicity with HER2 (ErbB2) inhibitors, LVEF was monitored in clinical trials at approximately 8-week intervals. LVEF decreases were defined as signs or symptoms of deterioration in left ventricular cardiac function that are greater than or equal to Grade 3 (NCI CTCAE v3.0), or a greater than or equal to 20% decrease in left ventricular cardiac ejection fraction relative to baseline which is below the institution's lower limit of normal. Among 198 patients who received combination treatment with TYKERB/capecitabine, 3 experienced Grade 2 and one had Grade 3 LVEF adverse reactions (NCI CTCAE v3.0). Among 654 patients who received combination treatment with TYKERB/letrozole, 26 patients experienced Grade 1 or 2 and 6 patients had Grade 3 or 4 LVEF adverse reactions [see WARNINGS AND PRECAUTIONS].

Hepatotoxicity

TYKERB has been associated with hepatotoxicity [see BOXED WARNING and WARNINGS AND PRECAUTIONS].

Interstitial Lung Disease/Pneumonitis

TYKERB has been associated with interstitial lung disease and pneumonitis in monotherapy or in combination with other chemotherapies [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of TYKERB. Because these 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.

Immune System Disorders

Hypersensitivity reactions including anaphylaxis [see CONTRAINDICATIONS].

Skin and Subcutaneous Tissue Disorders

Nail disorders including paronychia. Severe cutaneous adverse reactions including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).

Cardiac Disorders

Ventricular arrhythmias/Torsades de Pointes (TdP). Electrocardiogram (ECG) QT prolongation.

Read the entire FDA prescribing information for Tykerb (Lapatinib)

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

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