Tykerb

DRUG DESCRIPTION

Lapatinib is a small molecule and a member of the 4-anilinoquinazoline class of kinase inhibitors. It is present as the monohydrate of the ditosylate salt, with chemical name N-(3- chloro-4-{[(3-fluorophenyl)methyl]oxy}phenyl)-6-[5-({[2- (methylsulfonyl)ethyl]amino}methyl)-2-furanyl]-4-quinazolinamine bis(4- methylbenzenesulfonate) monohydrate. It has the molecular formula C29H26ClFN4O4S (C7H8O3S)2 H2O and a molecular weight of 943.5. Lapatinib ditosylate monohydrate has the following chemical structure:

TYKERB (lapatinib) Structural Formula Illustration

Lapatinib is a yellow solid, and its solubility in water is 0.007 mg/mL and in 0.1N HCl is 0.001 mg/mL at 25C.

Each 250 mg tablet of TYKERB contains 405 mg of lapatinib ditosylate monohydrate, equivalent to 398 mg of lapatinib ditosylate or 250 mg lapatinib free base.

The inactive ingredients of TYKERB are: Tablet Core: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate. Coating: Orange film-coat: FD&C yellow No. 6/sunset yellow FCF aluminum lake, hypromellose, macrogol/PEG 400, polysorbate 80, titanium dioxide.

What are the possible side effects of lapatinib (Tykerb)?

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,...

Read All Potential Side Effects and See Pictures of Tykerb

What are the precautions when taking lapatinib (Tykerb)?

Before taking lapatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat), liver disease.

Lapatinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are...

Read All Potential Precautions of Tykerb


Tykerb Consumer (continued)

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.

PRECAUTIONS: Before taking lapatinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., irregular heartbeat), liver disease.

Lapatinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using lapatinib, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using lapatinib safely.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable 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 immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Tykerb Patient Information Including Side Effects

Brand Names: Tykerb

Generic Name: lapatinib (Pronunciation: la PA tin ib)

  • What is lapatinib (Tykerb)?
  • What are the possible side effects of lapatinib (Tykerb)?
  • What is the most important information I should know about lapatinib (Tykerb)?
  • What should I discuss with my health care provider before taking lapatinib (Tykerb)?
  • How should I take lapatinib (Tykerb)?
  • What happens if I miss a dose (Tykerb)?
  • What happens if I overdose (Tykerb)?
  • What should I avoid while taking lapatinib (Tykerb)?
  • What other drugs will affect lapatinib (Tykerb)?
  • Where can I get more information?

What is lapatinib (Tykerb)?

Lapatinib is a cancer medication.

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.

Lapatinib is usually given after other cancer medications have been tried without successful treatment of symptoms.

Lapatinib may also be used for other purposes not listed in this medication guide.

What are the possible side effects of lapatinib (Tykerb)?

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.

What is the most important information I should know about lapatinib (Tykerb)?

This medication can cause harm to an unborn baby. Do not use lapatinib without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Before using lapatinib, tell your doctor if you have heart disease, liver disease, or a history of "Long QT syndrome."

Lapatinib is usually taken together with another cancer medicine called capecitabine (Xeloda). Lapatinib is given once daily for 21 days in a row, and capecitabine is given twice daily for only the first 14 days in a row. This 21-day cycle is then repeated, unless your condition gets worse or you have serious side effects.

The usual dose of lapatinib is equal to 5 tablets. You may swallow each tablet one at a time, but take the entire lapatinib dose at the same time each day.

Take lapatinib on an empty stomach, at least 1 hour before or 1 hour after eating.

Be sure to also read the medication guide or patient instructions for capecitabine (Xeloda).

Stop using lapatinib and call your doctor at once if you have serious side effects such as severe diarrhea or vomiting, or uneven heart rate with extreme dizziness or fainting.

Before taking lapatinib, tell your doctor if you are also using antibiotics, ulcer medications, seizure medications, HIV or AIDS medications, herbal supplements, heart or blood pressure medication, or an antidepressant.

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