Description
Gedatolisib injection is used in combination with other medicines (eg, fulvestrant, with or without palbociclib) to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic (cancer that has spread) breast cancer without an abnormal PIK3CA gene in patients whose cancer has come back and has spread after receiving at least 1 previous hormone (endocrine) treatment. Your doctor will test for the presence of the mutation.
Gedatolisib injection 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 to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Powder for Solution
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 gedatolisib injection 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 gedatolisib injection 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—Use with caution. May make this condition 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.
A nurse or other trained health professional will give you this medicine. This medicine is given through an IV catheter that is placed into one of your veins. It must be injected slowly, so your IV will need to stay in place for at least 30 minutes. This medicine is given once a week for 3 weeks followed by 1 week off (28-day cycle).
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor will ask you to use a steroid-containing mouthwash 4 times a day for the first 8 weeks of treatment to help prevent or treat mouth sores. Do not eat or drink for at least 1 hour after using the mouthwash.
Missed Dose
This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Receiving 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 receiving this medicine. It can also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 2 weeks after the last dose. Males with female partners who can become pregnant must use an effective birth control during treatment and for 2 weeks after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
Check with your doctor right away if you have swelling or inflammation of the mouth. These may be symptoms of stomatitis.
This medicine may cause serious skin reactions. Check with your doctor right away if you have skin rash. Avoid overexposing your skin to sunlight.
This medicine may cause severe high blood sugar. Your doctor may give you medicine before starting treatment with this medicine. Check with your doctor 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, if you notice a change in the results of your urine or blood sugar tests, or if you have any questions.
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 or nurse immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- chest pain
- chills
- cough
- difficult, burning, or painful urination
- dizziness
- fever
- frequent urge to urinate
- general feeling of discomfort or illness
- headache
- lower back or side pain
- nervousness
- pounding in the ears
- slow or fast heartbeat
- swelling or inflammation of the mouth
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- thickening of bronchial secretions
- trouble breathing
Rare
- Blue lips, fingernails, or skin
- no blood pressure or pulse
- stopping of the heart
- unconsciousness
Incidence not known
- Dry mouth
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- nausea
- stomach pain
- sweating
- vomiting
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
- Constipation
- cough
- decreased appetite
- diarrhea
- double vision
- muscle or joint pain
- seeing double
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.
DRG-80011920
