Dabrafenib is a targeted therapy used to treat melanoma that has spread.

WHAT IS DABRAFENIB?

Dabrafenib is a drug called a kinase inhibitor or a cancer growth blocker. It can only be used to treat cancers that have a change in a gene called BRAF. Your doctors will test a piece of tissue from a previous surgery to see if the cancer cells have this change.

HOW DOES DABRAFENIB WORK?

Kinases are proteins produced by cells. They send important chemical signals to the cells telling them when to grow. Cancers that have a change in the BRAF gene generate a kinase that tells the cancer cells to grow and divide in an uncontrolled way. Dabrafenib blocks this defective kinase and halts the growth and division of the cancer cells.

WHEN IS DABRAFENIB GIVEN?

Dabrafenib is given to treat melanoma with a BRAF gene change when the cancer has spread or cannot be eliminated with surgery. Dabrafenib can also be given as part of a clinical trial to treat melanoma and other types of cancer with a change in the BRAF gene.

TAKING DABRAFENIB CAPSULES

Dabrafenib is taken twice daily, with 12 hours between each dose. Take the pills on an empty stomach with a glass of water. Do not eat for two hours before taking dabrafenib and for one hour after taking it.

If you forget a dose and there are more than six hours left before the following dose, take it as soon as you remember. If there are fewer than six hours before the next scheduled dose, don't take it; rather, take the next dose at the scheduled time. Never take a double dose to make up for a missed one.

There are some other important things to remember:

• Swallow the capsules whole. Do not chew or crush them.
• Do not drink grapefruit juice while taking dabrafenib.
• Keep the capsules in their original packaging at room temperature.
• Keep them safe and out of the reach of children.
• Get a new prescription before your previous one runs out.
• Return any remaining capsules to the hospital if the treatment is discontinued.

POSSIBLE SIDE EFFECTS OF DABRAFENIB

Each person reacts differently to a given drug. Some people have very few side effects, while others may develop more. The side effects described here will not affect everyone who is treated with dabrafenib.

Here we outline the most common side effects, though we have left out the rarer ones. If you notice you develop any side effects that are not listed here, talk to your doctor or nurse.

FEVER AND HIGH TEMPERATURE

Dabrafenib can cause high temperature. You may feel hot or cold and have chills, pain, or dizziness. This side effect normally starts in the first month of treatment. It is important to let your doctor or nurse know if this happens to you. Some people become severely ill because of their high temperature.

Contact your hospital immediately if your temperature is:

• 38 ° C for over an hour
• or 38.5 ° C.

If your temperature is high, your doctor or nurse may ask you to go to the hospital to evaluate you or they may ask you to stop taking dabrafenib. When your temperature improves, they will tell you whether to begin taking it again. Doctors sometimes tell patients to lower the dose and/or give the patient additional drugs such as paracetamol to help control their temperature.

PAIN AND REDNESS IN THE PALMS OF THE HANDS AND SOLES OF THE FEET

This is known as palmar-plantar syndrome or hand-foot syndrome. The inflammation gets better when the treatment ends. Your doctor or nurse can prescribe creams to improve the symptoms. It may help to keep your hands and feet cool and avoid wearing tight-fitting socks, shoes, and gloves.

NAUSEA

Nausea is a common side effect, though it is normally mild and easily controllable. If necessary, your doctor will prescribe anti-nausea drugs (antiemetics) to help prevent or control your nausea. Take the medicine exactly as your nurse or pharmacist tells you.

DIARRHEA

If you have diarrhea, your doctor may prescribe drugs to help control it. Make sure you drink at least two liters of fluids each day if you have diarrhea.

Rarely, diarrhea can be more severe. It is important to get in touch with your hospital if this happens. If you have more than 3 episodes of diarrhea a day, contact the hospital.

CONSTIPATION

You may feel constipated and have abdominal pain. Drinking at least two liters of fluids each day will help if this is the case. Try to eat more high-fiber foods such as fruit, vegetables, and whole-grain bread and get some light exercise.

HEADACHES

You may get headaches. If this happens, tell your doctor or nurse. They can give you painkillers for this.

MUSCLE AND JOINT PAIN

You may have pain in your joints or muscles during the treatment. These can sometimes be severe. Tell your doctor if this happens so they can prescribe you some painkillers. Let them know if your pain doesn't go away. They can normally increase the painkillers you are taking or put you on different ones.

TIREDNESS

Feeling very tired is a common side effect. Try to maintain a good rhythm and rest as much as you need. Get some light exercise, such as taking short walks. If you feel drowsy, don't drive or operate heavy machinery.

HAIR LOSS

Your hair may thin out, though it is unlikely you will lose it altogether. It is almost always temporary, and the hair will continue to grow after you finish your treatment. Your nurse can give you advice on how to cope with losing your hair.

COUGH

You may develop a cough. Tell your doctor if this happens. They can give you drugs to help.

SKIN CHANGES

Some changes to the skin are common. These include rashes, flushing, itchiness, dry, rough or scaly skin, or small growths resembling warts. Tell your nurse or doctor if you have any of these changes. They can advise you and prescribe creams or medication that may help.

LESS COMMON SIDE EFFECTS OF DABRAFENIB

SECOND CANCER

Sometimes, people who are taking dabrafenib can develop other types of skin cancer, such as squamous-cell cancer and, more rarely, basal-cell skin cancer. These can normally be removed surgically. You will be asked to check your skin regularly for signs of these types of cancer; these signs may include a small bump or an area that looks scaly or bleeds. Your nurse or doctor will tell you what to look out for and will also check your skin. If you notice anything unusual between appointments, tell your nurse or doctor.

Rarely, people can develop a new melanoma or skin cancer. Overall, however, the benefits of the treatment far outweigh this risk. Your doctor can talk to you about this.

CHANGES IN THE HEART

Dabrafenib can affect the way the heart functions. This is normally temporary. You may have tests done before, during, and after your treatment to see how your heart is working.

Tell your doctor immediately if you have pain or tightness in your chest, feel out of breath, or notice changes in your heart rate at any time during or after treatment. These symptoms could be caused by other conditions, but it important to have them looked at by a doctor.

HIGH BLOOD SUGAR LEVELS

Dabrafenib can raise your blood sugar. The symptoms of raised blood sugar include a feeling of thirstiness, a need to urinate more frequently, and feeling tired. Tell your doctor or nurse if you have these symptoms.

If you have diabetes, your blood sugar levels may be higher than usual. Your doctor will talk to you about how to manage this. You may need for your insulin dose to be changed.

MORE INFORMATION ABOUT DABRAFENIB

OTHER MEDICINES

Dabrafenib can interact with many different drugs. This includes other heart medication, anticoagulants, and tablets for epilepsy. Over-the-counter medications available in stores and pharmacies, such as St. John's Wort or drugs to reduce stomach acid, can also be harmful.

Tell your doctor if you are taking any medicines, including over-the-counter drugs, complementary therapies, and herbal remedies.

FERTILITY

It is not known whether dabrafenib affects fertility. If this worries you, you can talk to your doctor or nurse before beginning treatment.

Contraception

Your doctor will advise you not to become pregnant or have children during the treatment. This is because dabrafenib can harm developing babies.

It is important to use effective methods of contraception during chemotherapy and for a few months after the treatment ends. Dabrafenib reduces the effectiveness of contraceptive pills, injections, and patches. You will need to use a condom or another type of barrier contraceptive.

SEX

If you have sex while undergoing the treatment, you will have to use a condom to protect your partner in case there is dabrafenib in semen or vaginal fluid.

BREASTFEEDING

Women are recommended not to breastfeed during treatment and for a few months after their chemotherapy has concluded. This is in case there is dabrafenib in their breast milk.

MEDICAL AND DENTAL TREATMENT

If you have to go to the hospital for whatever reason other than cancer, always tell the doctors and nurses that you are taking dabrafenib.

Talk to your cancer doctor or nurse if you think you need dental treatment. Always let your dentist know that you are having dabrafenib.