How to use Istodax Vial
Read the Patient Information Leaflet if available from your pharmacist before your first romidepsin treatment and each time you get another dose. If you have any questions regarding the information, ask your doctor or pharmacist.
This medication is mixed in a solution and given slowly into a vein over 4 hours by a health care professional as directed by your doctor. It is usually given on day 1, day 8, and day 15, every 28 days.
The dosage is based on your medical condition, body size, and response to treatment. Before each cycle, you should have blood tests to find the best dose for you and to see whether you need to wait before receiving this drug again.
People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.
This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. These infections can occur during treatment and within 30 days after stopping treatment. Your doctor will order blood tests to check for side effects. It is important to keep all medical/lab test appointments. Tell your doctor right away if you develop any of the following symptoms: easy bruising/bleeding, pale skin, unusual tiredness, signs of infection (such as fever, chills, cough, shortness of breath, persistent sore throat, painful/burning urination).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), current/recent infection.
This drug may make you tired. Alcohol or marijuana (cannabis) can make you more tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Romidepsin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using romidepsin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using romidepsin safely.
Romidepsin can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using romidepsin. Romidepsin may harm an unborn baby. Women and men using this medication should ask about reliable forms of birth control during treatment and for 1 month after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication. See also Drug Interactions section.
It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this medication and for 1 week after stopping this medication. Consult your doctor before breast-feeding.
See also Precautions section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Other medications can affect the removal of romidepsin from your body, thereby affecting how romidepsin works. These drugs include azole antifungals (such as itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (such as clarithromycin), HIV drugs (such as ritonavir), nefazodone, rifamycins (such as rifabutin, rifampin), St. John's wort, and some drugs used to treat seizures (such as carbamazepine), among others.
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication and for 1 month after stopping treatment. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
Many drugs besides romidepsin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Laboratory and/or medical tests (such as complete blood count, potassium/magnesium blood levels, EKG, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Keep all regular medical and laboratory appointments.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.
Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised December 2018. Copyright(c) 2018 First Databank, Inc.
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