Description
Panobinostat is used in combination with bortezomib and dexamethasone to treat patients with multiple myeloma (plasma cell cancer) who have received at least 2 other treatments.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
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 panobinostat 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 panobinostat in the elderly. However, elderly patients are more likely to have unwanted effects, which may require caution and an adjustment in the dose for 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bacillus of Calmette and Guerin Vaccine, Live
- Bepridil
- Cisapride
- Dengue Tetravalent Vaccine, Live
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Measles Virus Vaccine, Live
- Mesoridazine
- Mumps Virus Vaccine, Live
- Pimozide
- Piperaquine
- Rubella Virus Vaccine, Live
- Saquinavir
- Smallpox Monkeypox Vaccine
- Sparfloxacin
- Terfenadine
- Thioridazine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atomoxetine
- Azithromycin
- Bedaquiline
- Boceprevir
- Buprenorphine
- Buserelin
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cholera Vaccine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
- Pomegranate
- Starfruit
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:
- Anemia or
- Bleeding problems or
- Diarrhea or
- Electrolyte imbalance or
- Heart disease or
- Heart rhythm problems (eg arrhythmia, QT prolongation) or
- Liver disease (mild or moderate) or
- Neutropenia (low white blood cells) or
- Thrombocytopenia (low count of platelets)—Use with caution. May make these conditions worse.
- Angina (severe chest pain), unstable or
- Heart attack, recent
- Severe liver disease—Use is not recommended in patients with these conditions.
- Infection—May decrease your body's ability to fight infections.
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.
The medicine should come with a Medication Guide. 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 or without food.
Swallow the capsule whole with a cup of water. Do not open, crush, break, or chew it.
Be careful not to handle crushed or broken capsules. If you have contact with broken or crushed capsules, wash your skin with soap and clear water. If the medicine gets into your eyes, rinse them with water.
Avoid eating grapefruit, star fruit, or pomegranate and drinking grapefruit or pomegranate juice while using this medicine.
If you vomit after taking a dose, do not take another capsule. Wait and take your next dose at your usual time.
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 (capsules):
- For multiple myeloma in combination with bortezomib and dexamethasone
- Adults—At first, 20 milligrams (mg) once every other day for 3 doses per week (on Days 1, 3, 5, 8, 10, and 12) of weeks 1 and 2 of each 21-day cycle for 8 cycles. Your doctor may want you to continue treatment for an additional 8 cycles for a total of 16 cycles (48 weeks).
- Children—Use and dose must be determined by your doctor.
- For multiple myeloma in combination with bortezomib and dexamethasone
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.
Do not take this medicine if it has been more than 12 hours since you missed your last dose.
Storage
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Store blister pack in the original carton to protect from light.
Precautions
It is very important that your doctor check your progress while you are using this medicine to see if it is working properly and to check for unwanted effects. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control (eg, condoms) to keep from getting pregnant during therapy and for 1 month after the last dose (for sexually-active females), and for 3 months after the last dose (for sexually-active men). If you think you or your partner have become pregnant while using the medicine, tell your doctor right away.
Cancer medicines can cause diarrhea, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
Panobinostat 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 the 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.
This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
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
- Abdominal or stomach pain or tenderness
- black, tarry stools
- bloating or swelling of the face, arms, hands, lower legs, or feet
- clay colored stools
- confusion
- cough or sore throat
- dark or bloody urine
- decreased appetite
- decreased frequency or amount of urine
- dizziness, faintness, or lightheadedness especially when getting up suddenly from a lying or sitting position
- fast, irregular, pounding, or racing heartbeat or pulse
- fever, chills, or sweating
- headache
- increased thirst
- itching or skin rash
- loss of appetite
- lower back or side pain
- muscle spasms or twitching
- nausea or vomiting
- nervousness
- painful or difficult urination
- pinpoint red spots on the skin
- pounding in the ears
- rapid breathing
- seizures
- severe diarrhea
- slow or fast heartbeat
- swelling of the face, fingers, feet, or lower legs
- tingling of the hands or feet
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- yellow eyes or skin
Less common
- Chest pain or discomfort
- coughing up blood
- difficulty with swallowing
- increased menstrual flow or vaginal bleeding
- nosebleeds
- pain in the shoulders, arms, jaw, or neck
- paralysis
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
- Acid or sour stomach
- belching or passing gas
- change or loss in taste
- depressed mood
- dry mouth
- hair loss
- heartburn or indigestion
- hoarseness or husky voice
- fatigue or feeling lethargic
- redness of the skin
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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