Description
Selinexor is used together with bortezomib and dexamethasone to treat multiple myeloma in patients who have received at least 1 previous treatment that did not work well. It is also used together with dexamethasone to treat multiple myeloma that has come back (relapsed) or has not responded to treatment (refractory) in patients who have received at least 4 previous treatments that did not work well and cannot be treated with certain cancer medicines (eg, at least 2 proteosome inhibitors, at least 2 immunomodulatory agents, and an anti-CD38 monoclonal antibody).
Selinexor is also used to treat certain types of diffuse large B-cell lymphoma (DLBCL) that has come back or has not responded to treatment (eg, DLBCL arising from follicular lymphoma) in patients who have received at least 2 previous treatments given by mouth or injection.
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 selinexor 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 selinexor 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:
- Bleeding problems or
- Hyponatremia (low sodium in the blood) or
- Stomach or bowel problems—Use with caution. May make these conditions worse.
- Infection (eg, bacteria, virus, or fungus)—May decrease your body's ability to fight an infection.
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 only 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 Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine at the same time each day.
Swallow the tablet whole with water. Do not break, chew, crush, or divide it.
You may also receive medicines to help prevent nausea and vomiting.
Drink plenty of fluids to help prevent dehydration and eat enough calories to help prevent weight loss during treatment with this medicine.
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 diffuse large B-cell lymphoma:
- Adults—At first, 60 milligrams (mg) on Days 1 and 3 of each week. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For multiple myeloma (in combination with dexamethasone):
- Adults—At first, 80 milligrams (mg) on Days 1 and 3 of each week. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For multiple myeloma (in combination with bortezomib and dexamethasone):
- Adults—At first, 100 milligrams (mg) on Day 1 of each week. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For diffuse large B-cell lymphoma:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Female patients should use effective birth control during treatment and for at least 1 week after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 1 week after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Selinexor can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
Nausea, vomiting, diarrhea, loss of appetite, or weight loss may occur with selinexor, which can be severe and cause dehydration. Your doctor may give you medicine or other treatments for these. Check with your doctor right away if you notice that you are losing weight or have a decrease in appetite.
This medicine may make you dizzy or confused. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Tell your doctor if you are using other medicine that cause dizziness or mental changes.
This medicine may cause hyponatremia (low sodium levels in the blood). Check with your doctor right away if you have loss of consciousness, confusion, seizures, decreased urine output dizziness, fast or irregular heartbeat, muscle pain or cramps, trouble breathing, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
This medicine may cause serious infections. Check with your doctor right away if you have chest pain, fever or chills, confusion, cough or hoarseness, dizziness, fainting, fast heartbeat, lightheadedness, lower back or side pain, painful or difficult urination, sneezing, sore throat, tightness in the chest, or trouble breathing.
This medicine may cause brain or nerve problems. Check with your doctor right away if you have blurred or double vision, confusion as to time, place, or person, difficulty in walking, dizziness, drooping eyelids, fainting, hallucinations, headache, holding false beliefs that cannot be changed by fact, jaw pain, loss of memory, numbness or tingling in the fingers and toes, pain in the fingers and toes, pain in the testicles, problems with memory, unusual excitement, nervousness, or restlessness, or weakness.
This medicine may cause eye problems (eg, cataracts). Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine could cause infertility in some men and women. Talk with your doctor before using this medicine if you plan 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
- bleeding gums
- blindness
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred or decreased vision
- body aches or pain
- bone pain
- burning, numbness, tingling, or painful sensations
- chest pain or tightness
- chills
- confusion
- cough
- coughing up blood
- decreased urination
- diarrhea
- difficult, burning, or painful urination
- difficulty in breathing or swallowing
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- ear congestion
- fainting
- fast or irregular heartbeat
- fever
- flushed, dry skin
- fruit-like breath odor
- hallucinations
- headache
- hoarseness
- holding false beliefs that cannot be changed by fact
- increase in heart rate
- increased hunger or thirst
- increased menstrual flow or vaginal bleeding
- increased urination
- lightheadedness
- loss of appetite
- loss of consciousness
- loss of voice
- lower back or side pain
- mental or mood changes
- muscle cramps or pain
- nausea
- nosebleeds
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- pale skin
- paralysis
- pinpoint red spots on the skin
- problems with memory
- prolonged bleeding from cuts
- rapid breathing
- red or black, tarry stools
- red or dark brown urine
- runny or stuffy nose
- seizures
- sneezing
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- sunken eyes
- sweating
- swollen glands
- tingling of the hands or feet
- ulcers, sores, or white spots in the mouth
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- weakness in the arms, hands, legs, or feet
- wrinkled skin
Less common
- Burning or stinging of the skin
- dilated neck veins
- painful cold sores or blisters on the lips, nose, eyes, or genitals
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
- Change in or loss of taste
- constipation
- trouble sleeping
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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