【Drug Name】

Name:Mitotane Tablets

Product Name: TUKADX

【Specification】150mg

【Indications】

TUKADX is a prescription medicine used to treat adults with:

• a type of breast cancer called human epidermal growth factor receptor-2 (HER2)-positive breast cancer. TUKADX is used with the medicines trastuzumab and capecitabine, when your cancer has spread to other parts of the body such as the brain (metastatic), or cannot be removed by surgery, and you have received one or more anti-HER2 breast cancer treatments.

• a type of colorectal cancer called RAS wild-type HER2-positive colorectal cancer. TUKADX is used with the medicine trastuzumab, when your cancer has spread to other parts of the body (metastatic), or cannot be removed by surgery, and you have received treatment with 

fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and it did not work or is no longer working.

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

【Recommended Dosage】

• Take TUKADX exactly as your healthcare provider tells you.

• TUKADX is used with the medicine trastuzumab for colorectal cancer or with trastuzumab and capecitabine for breast cancer. Your healthcare provider will tell you the dose of trastuzumab and capecitabine you will take and how you will receive them.

• Take TUKADX 2 times a day, with or without a meal.

• Take TUKADX about 12 hours apart or at the same times every day.

• Swallow TUKADX tablets whole. Do not chew, crush, or split TUKADX tablets before swallowing. Do not take TUKADX tablets if they are broken, cracked, or damaged.

• If you vomit or miss a dose of TUKADX, take your next dose at your regular time.

【Side Effects】

TUKADX may cause serious side effects, including:

• Diarrhea. Diarrhea is common with TUKADX and can sometimes be severe. Tell your healthcare provider if you have a change in your bowel movements or severe diarrhea. Severe diarrhea can lead to loss of too much body fluids (dehydration), low blood pressure, kidney problems and death. Your healthcare provider may prescribe medicines to treat your diarrhea during treatment with TUKADX.

• Liver Problems. TUKADX can cause severe liver problems. Your healthcare provider will do blood tests to check your liver function before and every 3 weeks during treatment with TUKADX, or as needed. Tell your healthcare provider right away if you have any signs and symptoms of liver problems including:

o itching

o yellowing of your skin or eyes

o feel very tired

o decreased appetite

o dark or brown urine (tea-colored)

o pain in the upper right side of your stomach-area (abdomen)

o bleeding or bruising more easily than normal

The most common side effects of TUKADX in combination with trastuzumab and capecitabine in adults with HER2-positive breast cancer include:

• diarrhea

• rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet

• nausea

• increased liver function blood tests

• vomiting

• mouth sores (stomatitis)

• decreased appetite

• low red blood cell counts (anemia)

• rash

The most common side effects of TUKADX in combination with trastuzumab in adults with RAS wild-type HER2- positive colorectal cancer include:

• diarrhea

• tiredness

• rash

• nausea

• stomach-area (abdomen) pain

• infusion-related reactions

• fever

Your healthcare provider may change your dose of TUKADX, temporarily stop, or permanently stop treatment with TUKADX if you have certain side effects.

TUKADX may cause fertility problems in males and females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

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

【Storage】

• Store TUKADX at room temperature 68°F to86°F (20ºC to 30ºC).

• Keep TUKADX in its original container. The TUKADX bottle contains a desiccant packet to help keep your tablets dry (protect from moisture). Keep the desiccant in the bottle.

• Tightly close the bottle of TUKADX after you take your dose.

• TUKADX must be used within 3 months after opening the bottle. Throw away (discard) any unused tablets 3 months after opening the bottle.

Keep TUKADX and all medicines out of reach of children.