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Tykerb

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Tykerb

Tykerb Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tykerb (lapatinib) is 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. It is a cancer medication. Common side effects include nausea, vomiting, upset stomach, mouth sores, mild rash, dry skin, and trouble sleeping. Diarrhea is common and may become severe.

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/mē/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. 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 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, breast-feeding while using this drug is not recommended.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Tykerb in Detail - Patient Information: Side Effects

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

Stop using lapatinib and call your doctor at once if you have a serious side effect such as:

  • fast or pounding heartbeats;
  • extreme dizziness or tired feeling;
  • feeling like you might pass out;
  • severe diarrhea;
  • dry cough, feeling short of breath;
  • white patches or sores inside your mouth or on your lips;
  • nosebleeds; or
  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild diarrhea, upset stomach;
  • pain or redness on the palms of your hands or the soles of your feet;
  • dry skin, mild rash;
  • unusual hair loss; or
  • problems with your fingernails or toenails.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Tykerb Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, upset stomach, mouth sores, mild rash, dry skin, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Diarrhea is a common side effect and may become severe. Tell your doctor immediately if diarrhea occurs or if you have signs of a severe loss of body water (dehydration) such as dizziness or decreased amount of urine. Your doctor should prescribe additional medication to help control your symptoms. If your diarrhea becomes severe, your doctor may need to stop or delay your lapatinib treatment.

Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome (palmar-plantar erythrodysesthesia). Tell your doctor immediately if you experience swelling, pain, redness, peeling, blisters, or tingling/burning of the hands/feet. The symptoms can be made worse by heat/pressure on your hands/feet. Avoid prolonged sun exposure, tanning booths, and sunlamps, as well as unnecessary exposure to heat (e.g., hot dishwater, long hot baths). Use a sunscreen and wear protective clothing when outdoors. Avoid pressure on elbows, knees, and soles of feet (e.g., leaning on elbows, kneeling, taking long walks). Wear loose clothing and comfortable shoes. Depending on how severe your hand-foot syndrome is, your doctor may give you an additional medication to reduce the symptoms, or stop or delay your lapatinib treatment.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, shortness of breath, swelling ankles/feet.

Seek immediate medical attention if any of these rare but serious side effects occur: fast/pounding/irregular heartbeat, dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Tykerb (Lapatinib)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tykerb FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 ( > 20%) during therapy with TYKERB plus capecitabine were gastrointestinal (diarrhea, nausea, and vomiting), dermatologic (palmarplantar 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) were diarrhea and palmar-plantar erythrodysesthesia. Selected laboratory abnormalities are shown in Table 2.

Table 1: Adverse Reactions Occurring in ≥ 10% of Patients

Reactions TYKERB 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
Diarrhea 65 13 1 40 10 0
Nausea 44 2 0 43 2 0
Vomiting 26 2 0 21 2 0
Stomatitis 14 0 0 11 < 1 0
Dyspepsia 11 < 1 0 3 0 0
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia 53 12 0 51 14 0
Rashb 28 2 0 14 1 0
Dry skin 10 0 0 6 0 0
General disorders and administrative site conditions
Mucosal inflammation 15 0 0 12 2 0
Musculoskeletal and connective tissue disorders
Pain in extremity 12 1 0 7 < 1 0
Back pain 11 1 0 6 < 1 0
Respiratory, thoracic, and mediastinal disorders
Dyspnea 12 3 0 8 2 0
Psychiatric disorders
Insomnia 10 < 1 0 6 0 0
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
b Grade 3 dermatitis acneiform was reported in < 1% of patients in the group receiving TYKERB plus capecitabine.

Table 2: Selected Laboratory Abnormalities

Parameters TYKERB 1,250 mg/day + Capecitabine 2,000 mg/m²/day Capecitabine 2,500 mg/m² /day
All Gradesa Grade 3 Grade 4 All Gradesa Grade 3 Grade 4
% % % % % %
Hematologic
Hemoglobin 56 < 1 0 53 1 0
Platelets 18 < 1 0 17 < 1 < 1
Neutrophils 22 3 < 1 31 2 1
Hepatic
Total Bilirubin 45 4 0 30 3 0
AST 49 2 <1 43 2 0
ALT 37 2 0 33 1 0
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

Hormone Receptor-Positive, Metastatic Breast Cancer

In a randomized 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 ≥ 10% of Patients

Reactions TYKERB 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
Diarrhea 64 9 < 1 20 < 1 0
Nausea 31 < 1 0 21 < 1 0
Vomiting 17 1 < 1 11 < 1 < 1
Anorexia 11 < 1 0 9 < 1 0
Skin and subcutaneous tissue disorders
Rashb 44 1 0 13 0 0
Dry skin 13 < 1 0 4 0 0
Alopecia 13 < 1 0 7 0 0
Pruritus 12 < 1 0 9 < 1 0
Nail Disorder 11 < 1 0 < 1 0 0
General disorders and administrative site conditions
Fatigue 20 2 0 17 < 1 0
Asthenia 12 < 1 0 11 < 1 0
Nervous system disorders
Headache 14 < 1 0 13 < 1 0
Respiratory, thoracic, and mediastinal disorders
Epistaxis 11 < 1 0 2 < 1 0
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
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 Parameters TYKERB 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
% % % % % %
AST 53 6 0 36 2 < 1
ALT 46 5 < 1 35 1 0
Total Bilirubin 22 < 1 < 1 11 1 < 1
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

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 ≥ Grade 3 (NCI CTCAE), or a ≥ 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) [see WARNINGS AND PRECAUTIONS]. 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.

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.

Read the entire FDA prescribing information for Tykerb (Lapatinib) »

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Tykerb - User Reviews

Tykerb User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tykerb sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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