Description
Inavolisib is used in combination with other medicines (eg, fulvestrant, palbociclib) to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CAmutated, advanced or metastatic (cancer that has spread) breast cancer that has come back after hormonal (endocrine) treatment. Your doctor will test for the presence of the mutation.
Inavolisib interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal cells may also be affected by the medicine, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
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 inavolisib 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 inavolisib in the elderly.
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:
- Diabetes, history of or
- Kidney disease—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 using 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.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food. Take it at the same time each day.
Swallow the tablet whole. Do not chew, crush, or split it.
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 (tablets):
- For breast cancer:
- Adults—9 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 breast cancer:
Missed Dose
If you miss a dose of this medicine and it is within 9 hours from your usual dose, take the missed dose and go back to your regular schedule. If you miss a dose and it is more than 9 hours from your usual dose, skip the missed dose and go back to your regular dosing schedule.
If you vomit after you take this medicine, do not take an extra dose on the same day. Take your next dose at your usual time the next day.
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. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Female patients should use an effective form of birth control to keep from getting pregnant during treatment and for 1 week after your last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may affect your blood sugar levels. Check with your provider right away if you have blurred vision, dry mouth, flushed, dry skin, increased hunger, increased thirst, increased urination, nausea, stomach pain, sweating, trouble breathing, unexplained weight loss, unusual tiredness or weakness, or vomiting. Talk to your doctor if you notice a change in the results of your urine or blood sugar tests, or if you have any questions.
Check with your doctor right away if you have pain, redness, swelling, or ulcers in your mouth. These may be symptoms of stomatitis.
This medicine may cause diarrhea, and in some cases it can be severe. Your provider may give you medicine to treat diarrhea. Drink plenty of fluids to prevent dehydration and kidney problems. Call your provider right away if you have stomach pain, mucus or blood in your stool, or you have diarrhea that gets worse.
If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).
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
- Black, tarry stools
- bladder pain
- bloody or cloudy urine
- blurred vision
- chills
- cough
- diarrhea
- difficult, burning, or painful urination
- dry mouth
- fever
- flushed, dry skin
- frequent urge to urinate
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- lower back or side pain
- nausea
- painful or difficult urination
- pale skin
- sore throat
- stomach pain
- stuffy or runny nose
- sweating
- swelling or inflammation of the mouth
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unexplained weight loss
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
Less common
- Bleeding gums
- blood in urine or stools
- body aches or pain
- ear congestion
- loss of voice
- pinpoint red spots on the skin
Rare
- Inability to speak
- seizures
- slurred speech
- temporary blindness
- vomiting of blood or material that looks like coffee grounds
- weakness in the arm and/or leg on one side of the body, sudden and severe
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
- decreased weight
- dry skin
- loss or thinning of the hair
- skin rash
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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