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Farydak (Generic Panobinostat)

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WARNING

Serious gastrointestinal (GI; affecting the stomach or intestines) side effects from panobinostat include severe diarrhea. Call your doctor right away if you have any of the following symptoms: stomach pains, loose stools, diarrhoea, vomiting, or other symptoms of dehydration such dry mouth, dark urine, lessened perspiration, dry skin, or stomach cramps. If you get diarrhea while taking panobinostat, discuss what to do with your doctor. Before using any laxatives or stool softeners while taking this medication, consult your doctor as well.

During your treatment with panobinostat, heart problems could become severe or even fatal. Inform your physician if you’ve recently experienced a heart attack, have long QT syndrome (a disease that raises the chance of having an abnormal heartbeat that could result in fainting or sudden death), angina (chest discomfort), or any other heart issues. To determine whether taking panobinostat is safe for you, your doctor will prescribe tests such an electrocardiogram (ECG; test that records the electrical activity of the heart) both before and throughout your therapy. Call your doctor right away if you have any of the following signs or symptoms: Chest pain, an erratic, pounding, or rapid heartbeat, faintness, lightheadedness, vertigo, blue lips, shortness of breath, or swelling of the hands, arms, feet, ankles, or lower legs are among symptoms that might occur.

Keep all of your appointments with your physician and the lab. In order to monitor your body’s reaction to panobinostat, your doctor will prescribe a number of tests.

Whenever you need a prescription refill for panobinostat, your doctor or pharmacist will give you the medication guide (patient information sheet) provided by the manufacturer. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The hazards of taking panobinostat should be discussed with your doctor.

Why is this medication prescribed?

Patients with multiple myeloma (a kind of bone marrow cancer) who have already received treatment with two different drugs, including bortezomib (Velcade), are given panobinostat together with dexamethasone. The drug panobinostat belongs to a group of drugs known as histone deacetylase (HDAC) inhibitors. It eliminates cancer cells to work.

How should this medicine be used?

Panobinostat is available as a pill to swallow. It is often taken once day, with or without food, on particular days of a 21-day cycle. It is possible to repeat the cycle up to 16 times. Take panobinostat every day as directed at roughly the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take panobinostat as prescribed by your doctor. Never take it in larger or less amounts or more frequently than directed by your doctor.

Do not open, crush, chew, or chew the capsules; instead, swallow them whole with a glass of water. Avoid touching the capsules as much as possible. Wash that region of your body with soap and water if you come in contact with a broken panobinostat capsule or the medication inside the capsule. If any of the medication from the capsule goes into your mouth, nose, or eyes, rinse thoroughly with water.

Do not take another dose of panobinostat if you vomit after taking it. Continue taking your medication as usual.

During your treatment, be sure to let your doctor know how you are feeling. If you have panobinostat adverse effects, your doctor may lower your dose or temporarily or permanently stop your therapy.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking panobinostat,

  • If you have an allergy to panobinostat, any other medications, or any of the substances in panobinostat capsules, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Incorporate any of the following: antifungal medications such itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend); the beta-blocker amiodarone (Cordarone, Nexterone, Pacerone); bepridil (Vascor, no longer sold in the United States), atomoxetine (Strattera), boceprevir (Victrelis), carbamazepine (Carbatrol, Tegretol, Teril, among others), chloroquine (Aralen), clarithromycin (Biaxin, as PrevPac); conivaptan (Vaprisol), desipramine (Norpramin), dextromethorphan, disopyramide (Norpace), dolasetron (Anzemet), and some HIV drugs like indinavir (Crixivan) are examples of medications, nelfinavir (Viracept), ritonavir (Norvir, in Kaletra, in Viekira Pak), saquinavir (Invirase), methadone (Dolophine, Methadose), and lopinavir/ritonavir (Kaletra); nefazodone, ondansetron (Zofran, Zuplenz), metoprolol (Lopressor, Toprol-XL), moxifloxacin (Avelox), perphenazine, pimozide (Orap), phenobarbital, and phenytoin (Dilantin, Phenytek); rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); procainamide; quinidine (in Nuedexta); sotalol (Betapace, Sorine, Sotylize); telithromycin (Ketek), tolterodine (Detrol), thioridazine, telaprevir (Incivek; no longer sold in the United States), and venlafaxine (Effexor). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Please let your doctor know if you are taking any herbal supplements, especially St. John’s wort.
  • Inform your doctor if you have an infection, bleeding issues now or in the past, or liver illness.
  • If you are pregnant or plan to become pregnant, let your doctor know. The fetus could suffer from panobinostat. Utilize birth control to avoid getting pregnant while receiving panobinostat treatment and for at least a month after the last dose. You should use a condom while taking this medicine and for 90 days after your treatment is over if you’re a guy and your partner has the potential to become pregnant. If you have any queries regarding the birth control methods that will be effective for you, speak with your doctor. Dial your doctor right away if you get pregnant while taking panobinostat.
  • If you are breastfeeding, let your doctor know. While taking panobinostat, you shouldn’t breastfeed.
  • Inform the surgeon or dentist that you are taking panobinostat if you need surgery, including dental surgery.

What special dietary instructions should I follow?

While taking this medication, avoid consuming pomegranate, grapefruit, star fruit, or pomegranate juice.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it if it has been less than 12 hours since your usual dose. Skip the dose and carry on with your regular dosing plan if it has been more than 12 hours since your scheduled dose. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Symptoms of panobinostat usage may develop. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Slim down
  • Headache

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Bloody, dark, or tarry stools
  • Vomit that has blood in it or looks like coffee grounds
  • Significant bruising or bleeding
  • Brown or pink urine
  • Blood in the mucus
  • Confusion
  • Alterations to your speech
  • A fever, cough, chills, sweating, or other infection-related symptoms
  • Light skin
  • Nausea, vomiting, weight loss, an inability to concentrate, dark urine, stomach pain, excessive fatigue, a lack of vitality, or a yellowing of the skin or the whites of the eyes

Other negative effects of panobinostat are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and away from light, excessive heat, and moisture.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the best way to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Diarrhea
  • Nausea
  • Vomiting
  • Reduction in appetite

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Farydak®
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