Dabrafenib, DABRADX, dabrafenib 75 mg

Manufacturer: Laos Daxiong Pharmaceutical

Introduction: Dabrafenib is a BRAF cancer drug, available in the form of mesylate. On May 29, 2013, the U.S. Food and Drug Administration (FDA) approved the marketing application of dabrafenib and trametinib at the same time. Dabrafenib is approved for the treatment of unresectable melanoma (tumors that cannot be removed by surgery) and metastatic melanoma (tumors that have spread to other organs in the body) with BRAFV600E mutations, but not for the treatment of wild-type BRAF melanoma. Mekinist treats melanoma with BRAFV600E or V600.

【Product name】

Name: Dabrafenib Capsules

Product Name: DABRADX

Chinese name: Dabrafenib capsules

【Specification】

75 mg

【Indications】

•To treat a type of skin cancer called melanoma, either alone or in combination with a medicine called trametinib:

o has spread to other parts of the body or cannot be removed by surgery, and

o Have a certain type of abnormal "BRAF" gene.

• Used with trametinib to help prevent melanoma that has a certain abnormal "BRAF" gene after it has been surgically removed.

• Combined with trametinib to treat a type of lung cancer called non-small cell lung cancer (NSCLC):

o has spread to other parts of the body, and

o Have a certain type of abnormal "BRAF" gene.

• In combination with trametinib to treat a type of parotid gland cancer called anaplastic parotid carcinoma (ATC):

o has spread to other parts of the body and you have no satisfactory treatment options, and

o Have a certain type of abnormal "BRAF" gene.

• In combination with trametinib for the treatment of solid tumors in adults and children 6 years and older

o Cannot be removed with surgery or has spread to other parts of the body and is becoming uncomfortable (progressing) and you have no satisfactory treatment options, and

o Have a certain type of abnormal "BRAF" gene.

DABRADX is not indicated for the treatment of patients with colorectal cancer or solid tumors with wild-type BRAF.

Your healthcare provider will do tests to make sure DABRADX is right for you.

It is not known if DABRADX combined with trametinib is safe and effective in children younger than 6 years of age.

It remains to be seen whether DABRADX alone is safe and effective in children.

【Recommended dose】

• Take DABRADX exactly as your healthcare provider tells you to. Do not change your dose or stop DABRADX unless your healthcare provider tells you to.

• If you experience certain side effects, your healthcare provider may change your DABRADX dose, temporarily stop, or completely stop your DABRADX treatment.

• Take DABRADX 2 times a day, approximately 12 hours apart.

• Take DABRADX at least 1 hour before or 2 hours after a meal.

• Do not open, crush, or break DABRADX capsules.

• If you miss a dose of DABRADX, hurry up and get it when you remember. If it is within 6 hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose.

【Included】

• Violence problems. When DABRADX is taken with trametinib, it can cause serious violence problems, especially in your brain or stomach, which can lead to death. If you have any violence, call your healthcare provider right away and get medical help, including:

o Headache, dizziness, or weakness o Coughing up blood or blood clots

o Vomiting blood or vomit that looks like "coffee grounds" o Red or black stool that looks like tar

• Heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with DABRADX. Call your healthcare provider right away if you have any of the following signs and symptoms of heart disease:

o Feeling your heart racing o Shortness of breath

o Swelling in your ankles or feet o Feeling dizzy

• Eye problems. DABRADX may cause serious eye problems that may cause blindness. Call your healthcare provider right away if you have the following symptoms of eye problems:

o Blurred vision, loss of vision, or other vision changes o Seeing colored dots

o Halos (seeing blurry images around objects) o Eye pain, swelling, or redness

• Fever. Fever is common during treatment with DABRADX, but it can be severe. Fever may be worse or may become more severe when you take DABRADX with trametinib. In some cases, fever may be followed by chills or a hot chill, loss of too much water (dehydration), low blood sugar, dizziness, or kidney problems.

Call your healthcare provider right away if you are taking DABRADX to treat a fever.

If you develop a fever, your healthcare provider may temporarily or permanently stop your treatment, or change your doses of DABRADX and trametinib. Your healthcare provider will prescribe the necessary treatment based on your fever and any signs and symptoms of infection, and should check your kidney function during and after your high fever.

• Severe skin reactions. Skin rash is a common side effect of DABRADX. DABRADX may also cause other skin reactions. In some cases, these rashes and other skin reactions can be severe or very serious and may require hospitalization or result in death.

Tell your healthcare provider if you develop a rash or acne that is bothersome or painful.

Tell your healthcare provider right away if you have any of these severe skin reactions or symptoms, including:

o Blistering or peeling skin o Blisters on the lips, eyes, or around the eyes

o Mouth ulcers o High fever or pus-like symptoms o Breast enlargement

• High blood pressure. Some people may develop high blood sugar or diabetes during treatment with DABRADX. If you have diabetes, your healthcare provider should closely check your high blood pressure levels during treatment with DABRADX. Your diabetes medicine may need to be changed. Tell your healthcare provider if you have any of the following symptoms of severe high blood sugar:

o Increased thirst o Urinating more often than usual or with increased urine volume

• DABRADX may cause healthy red blood cells to break down too early in people with G6PD deficiency. This can cause a type of anemia called hemolytic anemia, in which the body does not have enough healthy red blood cells. Tell your healthcare provider if you have any of the following physical signs or symptoms:

o Yellow skin (non-stop yellow) o Weakness or dizziness o Shortness of breath

The most common side effects of DABRADX alone include:

oThickening of the outer layer of skin o Warts o Sea water o Fever

o Joint pain o Hair loss o Redness, swelling, peeling or tenderness in the hands and feet

For people with melanoma that has spread to other parts of the body or cannot be removed with surgery, the most common side effects of DABRADX when used with trametinib include:

o Onset o Rash o Seawater

o Chills o Joint pain o Cough

When DABRADX is taken with trametinib to help prevent melanoma during a break after surgical resection, the most common side effects include:

o Air ticket o Tiredness o Eating o Headache           o Rash          

o Diarrhea                  o Vomiting o Joint pain o Surgical pain o Chills

In people with NSCLC, the most common side effects of DABRADX when taken with trametinib include:

o Fever o Rash o Fatigue o Loss of appetite                                                   

o Vomiting                 o Chills o Cough                                  

o Dry skin o Bleeding o Shortness of breath                       

o Swelling in the face , arms, and legs begins to go down

In adults whose solid tumors cannot be removed by surgery or have spread to other parts of the body, the most common side effects of DABRADX when used with trametinib include:

o Constipation o Chills o Diarrhea o Headache                                                                            

oFatigue​                   o Cough                   o                   Vomit                   o Rash

o Pain in the removed joint o Swelling in the arms and legs o Bleeding

In children with solid tumors that cannot be removed by surgery or that have spread to other parts of the body, the most common side effects of DABRADX when taken with trametinib include:

o Fever o Cough o Constipation o Diarrhea o Fatigue                                                                                            

oAcne​                       o Rash                       o                       Vomiting o Vomiting                       

o Bleeding o Dry skin                o Pain in the stomach area (abdomen) o Skin infection around the nails or cuticles

DABRADX may cause fertility problems in women. This may affect your ability to become pregnant. If you are concerned about this, talk with your healthcare provider.

DABRADX may cause a decrease in sperm count in men. This may affect the ability to have children. Talk with your healthcare provider if you are concerned about this.

These are not all possible consequences of DABRADX.

Call your doctor for medical advice

【Survivor】

• Store DABRADX at temperatures between 68°F and 86°F (20°C and 30°C) continuously.

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