ENTECAVIR

Hepatitis B: Your hepatitis B symptoms may get worse or become very serious if you stop taking entecavir.

Liver problem: Entecavir has rarely caused serious (possibly fatal) liver enlargement and/or lactic acid build-up in the blood (lactic acidosis). Get medical help right away if you develop any of the following symptoms: unusual tiredness (fatigue), severe drowsiness, muscle pain, difficult or rapid breathing, irregular heartbeat.

Lactic acidosis: This is more likely to occur in patients who have: kidney or liver disease, conditions that may cause a low level of oxygen in the blood or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), excessive alcohol use, a lack of body fluids (dehydration), X-ray or scanning procedure drugs (contrast agents), major surgery, or a serious infection.

Coinfection of HIV and Hepatitis B: This medication is not recommended if you have both HIV and hepatitis B and are not receiving effective treatment for HIV. This drug does not treat HIV, and it can cause certain HIV medications to become ineffective. Therefore, have an HIV test before starting this medication, and get tested again anytime you may have become infected. Consult your doctor for more details.

Some of the side effects that can occur with entecavir may not need medical attention:

Less common

• Acid or sour stomach
• belching
• headache
• heartburn
• indigestion
• stomach discomfort, upset, or pain

Rare

• Trouble sleeping

Unusual drowsiness

Precautions

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

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug, and to side effects such as lactic acidosis.

• Medical History: Before using this medication, tell your doctor or pharmacist if you had: HIV infection, kidney disease.

Pregnancy Risk: Category C (Risk cannot be ruled out)

Breastfeeding: It is unknown if this drug passes into breast milk. Breast-feeding is not recommended while using this drug if you also have HIV. Otherwise, consult your doctor before breast-feeding.

Interactions

• Coadministration of entecavir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., kidney and liver tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

The bottle with the medication should be stored in the original carton to protect from light.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Brands

Available Brands:

Baraclude [Bristol- Myers Squibb]

Entegard [InnoGen Pharmaceuticals]