【Drug Name】

Name: Ixazomib Capsules

Product Name: ISADX

【Specification】

4mg

【Indications】

ISADX is a prescription medicine used to treat multiple myeloma in combination with the medicines lenalidomide and dexamethasone, in people who have received at least one prior treatment for their multiple myeloma.

It is not known if ISADX is safe and effective in children.

【Recommended Dosage】

· Take ISADX exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking ISADX without talking to your healthcare provider first.

· ISADX is taken in “cycles.” Each cycle lasts 4 weeks (28 days).

o The usual dose of ISADX is 1 capsule taken 1 time each week, on the same day of the week for the first 3 weeks of each cycle.

o Take each dose of ISADX at about the same time of day.

o Take REVLIMID (lenalidomide) and dexamethasone exactly as your healthcare provider tells you to.

o Your healthcare provider will do blood tests during treatment with ISADX to check for side effects.

o Your healthcare provider may change your dose or stop ISADX, REVLIMID (lenalidomide), or

dexamethasone if you have side effects.

· Take ISADX at least 1 hour before or at least 2 hours after food.

· On the days that you take both ISADX and dexamethasone, do not take ISADX and dexamethasone at the same time. Take dexamethasone with food.

· Swallow ISADX capsules whole with water. Do not crush, chew or open the capsule.

· Avoid direct contact with the capsule contents. If you accidentally get powder from the ISADX capsule on your skin, wash the area well with soap and water. If you accidentally get powder from the ISADX capsule in your eyes, flush your eyes well with water.

· If you miss a dose of ISADX, or if you are late taking a dose, take the dose as long as the next scheduled dose is more than 3 days (72 hours) away. Do not take a missed dose of ISADX if it is within 3 days (72 hours) of your next scheduled dose.

· If you vomit after taking a dose of ISADX, do not repeat the dose. Take your next dose of ISADX on the next scheduled day and time.

· If you take more ISADX than your healthcare provider tells you to take, call your healthcare provider right away or go to the nearest hospital emergency room.

【Side Effects】

· Low platelet counts (thrombocytopenia). Low platelet counts are common with ISADX, and can

sometimes be serious. You may need platelet transfusions if your counts are too low. Tell your healthcare provider if you have any signs of low platelet counts, including bleeding and easy bruising.

· Stomach and intestinal (gastrointestinal) problems. Diarrhea, constipation, nausea, and vomiting are common with ISADX, and can sometimes be severe. Call your healthcare provider if you get any of these symptoms and they do not go away during treatment with ISADX. Your healthcare provider may prescribe medicine to help treat your symptoms.

· Nerve problems. Nerve problems are common with ISADX and may also be severe. Tell your healthcare provider if you get any new or worsening symptoms, including:

o tingling

o numbness

o pain

o a burning feeling in your feet or hands

o weakness in your arms or legs

· Swelling. Swelling is common with ISADX and can sometimes be severe. Tell your healthcare provider if you develop swelling in your arms, hands, legs, ankles, or feet, or if you gain weight from swelling.

· Skin reactions. Tell your healthcare provider if you get a new or worsening rash.

· Liver problems. Tell your healthcare provider if you get these signs of a liver problem:

o yellowing of your skin or the whites of your eyes

o pain in your right upper stomach-area

Back pain is also common with ISADX.

These are not all the possible side effects of ISADX. Call your doctor for medical advice about side effects.

【Storage】

· Store ISADX at room temperature. Do not store above 86°F (30°C).

· Do not freeze ISADX.

· Store ISADX capsules in the original packaging until just before each use.

· Ask your pharmacist or healthcare provider about how to dispose of (throw away) unused ISADX.

Keep ISADX and all medicines out of the reach of children.