XOVOLTIB 30 MG TABLETS

Xovoltib Afatinib is a prescription drug. It comes as a tablet you take by mouth. It is a type of biological therapy called a tyrosine kinase inhibitor (TKI).

XOVOLTIB USES

 Xovoltib is used to treat non-small cell lung cancer (NSCLC) that is metastatic (spread to other parts of your body besides your lungs), and has abnormal epidermal growth factor (EGF) receptor genes. These abnormal genes promote the growth of cancer cells.

XOVOLTIB COMMON SIDE EFFECTS:

·         Mouth sores, diarrhea, pain/redness/swelling of lips, dry/itchy skin, acne, nose bleed, runny nose, and nausea/vomiting, or loss of appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

·         Tell your doctor right away if you have any serious side effects, including: signs of eye disease (such as vision changes, eye redness/pain, light sensitivity, eye discharge).

·         Signs of low level of potassium in the blood (such as muscle cramps, weakness, irregular heartbeat).

·         Signs of bladder infection (such as burning/pain when you urinate, urgent or frequent urination, fever).

·         Signs of skin infection around nails/toenails (such as skin irritation/redness around the nail, change in nail color).

·         Symptoms of lung problems (such as trouble breathing, chest pain), symptoms of heart failure (such as swelling ankles/feet, unusual tiredness).

SAFETY INFORMATION PRECAUTIONS:

·         Before taking afatinib, 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: kidney problems, liver problems, eye disease (such as severe dry eyes, keratitis), use of contact lenses.

·         This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

·         This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

·         Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

·         This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while taking this medication and for at least 2 weeks after treatment. Therefore, females must use reliable forms of birth control (such as condoms, birth control pills) during treatment and for at least 2 weeks after the end of treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

·         Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

·         It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 2 weeks after stopping this drug is not recommended. Consult your doctor before breast-feeding.

STORAGE REQUIREMENT:

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Dispense in original bottle; protect from high humidity and light.

XOVOLTIB INTERACTIONS:

Afatinib can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.