Description
Sunvozertinib is used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or nearby tissues (locally advanced) in patients who have an abnormal epidermal growth factor receptor (EGFR) gene (exon 20 insertion mutations) and have received other cancer medicines (eg, platinum) but did not work well. Your doctor will perform a test before you take this medicine.
Sunvozertinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.
This medicine is available only with your doctor's prescription.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of sunvozertinib in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sunvozertinib in the elderly. However, elderly patients are more likely to have serious unwanted effects, which may require caution in patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Eye or vision problems, history of or
- Lung or breathing problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Take this medicine at the same time each day with food. Swallow the tablet whole. Do not split, crush, chew, or dissolve it.
Use alcohol-free (eg, isopropanol-free, ethanol-free) moisturizing cream during treatment with this medicine. Do not use skin products that has retinol, retinoic acid, and benzoyl peroxide.
Do not use contact lenses until your eye problems are checked and for at least 1 week after your symptoms have been treated.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablet):
- For non-small cell lung cancer:
- Adults—200 milligrams (mg) once a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For non-small cell lung cancer:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If a dose is missed within 12 hours, take the missed dose. If a dose is missed by more than 12 hours, skip the missed dose. Take the next dose at the regular scheduled time.
If you vomit after taking a dose, do not take an extra dose. Take the next dose at the regular time.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment and for 2 weeks after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for 2 weeks after the last dose. If you think you have become pregnant, tell your doctor right away.
This medicine may cause serious lung or breathing problems, including pneumonitis, interstitial lung disease, which can be life-threatening and require immediate medical attention. The symptoms may be similar to the symptoms of lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.
Check with your doctor right away if you have severe diarrhea, nausea, and vomiting. These may be symptoms of stomach or bowel problems. Your doctor will ask you to take medicines or to drink fluids to treat your symptoms.
This medicine may cause serious skin reactions. Check with your doctor right away if you have blistering, crusting, irritation, itching, or reddening of the skin, cracked, dry, or scaly skin, or swelling.
Check with your doctor right away if you have blurred vision, dry eye, or eye redness, irritation, or pain. These may be symptoms of eye or vision problems. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).
Some men and women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- blurred vision or blue-green halos seen around objects
- burning, numbness, tingling, or painful sensations
- chest pain or tightness
- constipation
- cough
- decreased weight
- diarrhea
- difficult, burning, or painful urination
- dizziness
- dry skin
- eye redness, irritation, or pain
- fainting
- fast, slow, or irregular heartbeat
- fever or chills
- frequent urge to urinate
- full or bloated feeling
- itching skin
- loosening of the fingernails
- lower back or side pain
- nausea
- pressure in the stomach
- redness or soreness around fingernails
- sensitivity of the eyes to light
- sneezing
- sore throat
- stomach pain
- swelling
- swelling of the stomach area
- swelling or inflammation of the mouth
- trouble breathing
- unsteadiness or awkwardness
- vomiting
- weakness in the arms, hands, legs, or feet
Less common
- Body aches
- headache
- loss of taste or smell
- stuffy or runny nose
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
- unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Decreased appetite
- general feeling of discomfort or illness
- muscle or joint pain
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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