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Tykerb (lapatinib)

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Tykerb may cause allergic reactions (may include a sudden severe drop in blood pressure; rapid heart rate; skin rash, itching, hives; itchy, runny, congested nose; red itchy, watery eyes; shortness of breath, wheezing, cough, hoarseness, chest tightness; nausea, vomiting, abdominal cramps, diarrhea; irritation of the stomach and esophagus).

This drug may also cause the following symptoms that are related to allergic reactions:

Anaphylaxis

Medical Source Information
Yellow highlights indicate symptoms related to allergic reactions.

Hypersensitivity side effects including anaphylaxis have been reported.

Hypersensitivity reactions including anaphylaxis have been reported. Lapatinib is contraindicated in patients with known severe hypersensitivity (e.g., anaphylaxis) to this product or any of its components.

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 any of these serious side effects: uneven heart rate; extreme dizziness or fainting; severe diarrhea; dry cough, feeling short of breath; white patches or sores inside your mouth or on your lips; or nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Less serious side effects may include upset stomach, mild diarrhea; pain or redness on the palms of your hands or the soles of your feet; tired feeling; dry skin; back pain; or sleep problems (insomnia). 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.

Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:

Abnormal heart rate, fluttering in the chest, weakness, faintness, dizziness or loss of consciousness (signs of a serious condition called "torsade de pointe or QT prolongation" in which irregular heartbeats occur)
Abnormal bruising or signs of bleeding such as bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash (signs of problems with blood clot formation)

Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):

EKG (electrocardiogram) - at the start of treatment
liver function tests, bilirubin and alkaline phosphatase - at start of treatment and then every 6 weeks
Blood tests to assess normal clotting - in people who develop signs of bleeding such as abnormal bruising or signs of bleeding including bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash
EKG - if abnormal heartbeats (rapid slow or irregular) develop

References

Product Information. Tykerb (lapatinib). Anonymous GlaxoSmithKline, Research Triangle Park, NC.

Multum version: 154.0 (Jun 16, 2010)

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