Details for: ISTODAX
Company: CELGENE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02414295 | ISTODAX | ROMIDEPSIN | 10 MG / VIAL | POWDER FOR SOLUTION | INTRAVENOUS |
| 02414295 | ISTODAX | ROMIDEPSIN | 10 MG / VIAL | KIT | INTRAVENOUS |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ISTODAX is a prescription medicine used to treat people
with a type of blood cancer called peripheral T-cell
lymphoma (PTCL) who cannot receive a stem cell transplant,
after at least one other type of medicine by mouth or
injection has been tried.
What is peripheral T-cell lymphoma:
Peripheral T-cell lymphoma (PTCL) is a disease in which
certain cells of the lymph system called T-cells develop into
cancer cells which develop and grow abnormally. The term
“peripheral” means that this cancer develops in mature Tcells outside of the bone marrow such as lymph nodes,
spleen, gastrointestinal tract, and skin. It is often not known
why someone develops PTCL.
What it does
ISTODAX belongs to a group of medicines called cytostatic drugs which work by preventing the growth of cancer cells.
When it should not be used
Do not use ISTODAX if you are allergic to romidepsin or to any of the other ingredients of ISTODAX.
What the medicinal ingredient is
romidepsin
What the non-medicinal ingredients are
Povidone. The diluent contains 80% propylene glycol and 20% dehydrated alcohol.
What dosage form it comes in
ISTODAX is supplied as a sterile freeze-dried powder. Each vial delivers 10 mg of romidepsin.
Warnings and precautions
Serious Warnings and Precautions
ISTODAX should only be prescribed by a doctor experienced in the use of anti-cancer drugs. Serious side effects may occur with the use of ISTODAX and could include:
- decrease in the production of blood cells resulting in very low levels of red blood cells, white blood cells, and platelets (pancytopenia)
- abnormal heart beat (QTc prolongation)
- life-threatening infections (including pneumonia and sepsis)
- tumor lysis syndrome due to rapid breakdown of cancer cells; this can result in damage to the kidneys, heart and liver
- birth defects or death of an unborn baby
ISTODAX has not been studied in patients with kidney
disease.
ISTODAX is not recommended in patients with severe liver
disease.
BEFORE you use ISTODAX talk to your doctor or pharmacist if you:
- have kidney problems
- have liver problems
- have nausea, vomiting, or diarrhea
- have any other medical conditions
- have any heart problems, including an irregular or fast heartbeat
- have QT/QTc prolongation or a family history of QT/QTc prolongation;
- have heart disease
- have a personal history of fainting spells
- have a family history of sudden cardiac death at <50 years
- have electrolyte disturbances (e.g., low blood potassium or magnesium levels) or conditions that could lead to electrolyte disturbances (e.g., vomiting, diarrhea, dehydration)
- have had previous viral infection (e.g. hepatitis B, cytomegalovirus (CMV), herpes, Epstein-Barr virus)
Female patients:
- if you are pregnant or plan to become pregnant, there are specific risks you should discuss with your doctor.
- Avoid becoming pregnant while receiving ISTODAX. It may harm your unborn baby or may cause you to lose the pregnancy. You should use effective methods of birth control while receiving ISTODAX. Keep using birth control for 8 weeks after your last dose of ISTODAX. Tell your doctor right away if you become pregnant while taking ISTODAX.
- For women who can get pregnant: a pregnancy test should be done before you start treatment with ISTODAX.
- It is not known if ISTODAX passes into your breast milk. You should not breast feed your baby if you are being treated with ISTODAX.
Male patients:
- Your partner should not become pregnant while you are receiving ISTODAX.
- You should use effective contraception to prevent pregnancy in your partner while you are receiving ISTODAX. Keep using these birth control methods for 1 month after your last dose.
- You should use a condom with spermicide even if you have had a vasectomy.
It is not known if ISTODAX is safe and effective in children
under 18 years of age.
ISTODAX has an effect on the electrical activity of the heart
known as QT/QTc prolongation. This effect can be
measured as a change in the electrocardiogram (ECG). In
very rare cases, drugs with this effect on the ECG can lead to
disturbances in heart rhythm (arrhythmias/dysrhythmias) that
could result in dizziness, palpitations (sensation of rapid,
pounding, or irregular heart beat), fainting or death. These
heart rhythm disturbances are more likely in patients with
risk factors, such as heart disease, or in the presence of
certain interacting drugs. In general, females and people
more than 65 years in age are at higher risk. It is important to
follow the instructions of your doctor with regard to dosing
or any special tests. If you experience any symptoms of a
possible heart rhythm disturbance, such as dizziness,
palpitations (sensation of rapid, pounding, or irregular heart
beat), fainting, or seizures, you should seek immediate
medical attention.
Electrocardiograms (ECGs) and blood tests may be required
periodically to monitor the risk of potentially serious side
effects during treatment with ISTODAX.
Driving cars and using machines: ISTODAX is known to
cause fatigue and weakness. Avoid driving, using machines
or performing hazardous tasks if you experience these side
effects.
Interactions with this medication
Tell your doctor about all of the medicines you take,
including prescription and non-prescription medicines,
vitamins, and herbal supplements.
Some medicines may affect how ISTODAX works, or
ISTODAX may affect how your other medicines work.
Drugs that may interact with ISTODAX include:
- Blood thinner medicine (e.g. warfarin sodium). Ask your doctor if you are not sure if you are taking a blood thinner. Your doctor may want to test your blood more often.
- Drugs to treat abnormal heart beats (e.g. quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dronedarone, flecainide, propafenone).
- Drugs to treat schizophrenia and other psychiatric disease (e.g. chlorpromazine, pimozide, haloperidol, droperidol, ziprasidone)
- Drugs to treat HIV infections (e.g. atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)
- Drugs to treat seizures (e.g. phenytoin, carbamazepine, phenobarbital)
- Birth control that contains estrogen, such as the “pills”, patches, implants, or Intrauterine devices (IUDs). ISTODAX may reduce the effectiveness of estro-gencontaining contraceptives. You may become pregnant.
- St. John’s Wort (Hypericum perforatum), an herbal treatment for depression
- Domperidone, used to treat gastrointestinal disorder.
- Methadone (an opioid)
- Medicine for:
- depression (e.g. fluoxetine, citalopram, venlafaxine, amitriptyline, imipramine, maprotiline, nefazodone)
- bacterial infections (antibiotics such as erythromycin, clarithromycin, telithromycin, tacrolimus, moxifloxacin, levofloxacin, ciprofloxacin, rifampin, rifabutin, rifapentine)
- malaria (e.g. quinine, chloroquine)
- fungal infections (e.g. ketoconazole, fluconazole, voriconazole, itraconazole)
- nausea (e.g. dolasetron, ondansetron)
- cancer (e.g. vandetanib, sunitinib, nilotinib, lapatinib, vorinostat)
- asthma (e.g. salmeterol, formoterol)
Any medicine that cause imbalance in the electrolytes in your body:
- diuretics (water pills)
- laxatives and enemas
- amphotericin B
- high dose corticosteroids
This list includes some, but not all, of the drugs that may
increase the risk of side effects while receiving ISTODAX.
Tell your doctor or pharmacist if you are taking these or any
other medicines even those not prescribed (including any
over the counter drugs, vitamins, or herbal medicines).
Proper use of this medication
Usual Dose
ISTODAX will be given to you by a healthcare provider as
an intravenous (IV) injection into your vein usually over 4
hours. Your doctor will choose the starting dose of
ISTODAX that is right for you. This will be based on how
well your liver is working.
ISTODAX is usually given on Day 1, Day 8, and Day 15 of a
28 day cycle of treatment.
Your doctor will decide for how long you will receive
treatment with ISTODAX. Your doctor may interrupt or stop
your treatment or reduce your dose. This will depend on
how you are feeling or if your disease has gotten worse.
Your doctor will check your blood cell counts and will
perform other blood tests regularly during your treatment
with ISTODAX. Your doctor may decide to do further tests
to check your health as needed.
Overdose
Missed Dose
This medicine needs to be given on fixed schedule. If you miss an appointment, call your doctor for instructions.
Side effects and what to do about them
These are not all the possible side effects you may feel while
receiving ISTODAX. If you experience any side effects not
listed here or if you have any side effect that bothers you or
does not go away, contact your healthcare professional
Side effects include:
- nausea, diarrhea, constipation, and loss of appetite
- tiredness
ISTODAX may cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Very Common | |||
| Vomiting | ✔ | ||
| Neutropenia (low level of white blood cells): fever, infections, fatigue, aches, pains and flu-like symptoms | ✔ | ||
| Anemia (low level of red blood cells): fatigue, tiredness, weakness, shortness of breath, pale skin | ✔ | ||
| Thrombocytopenia (low level of platelets, which help with blood clotting): bruising, bleeding from the gums or other sites, fatigue, weakness | ✔ | ||
| Common | |||
| Infection: fever, significant fatigue, shortness of breath, cough, burning on urination, flu-like symptoms, muscle aches, worsening skin problems | ✔ | ||
| Electrocardiogram (ECG) changes (changes in the electrical activity of your heart seen on ECG) or increased heart rate: Irregular or abnormal heart beats, chest pain, shortness of breath, dizziness, palpitations, fainting, seizures | ✔ | ||
| Tumor lysis syndrome (caused by the rapid breakdown of cancer cells): lack of urination, severe muscle weakness, heart rhythm disturbances, and seizures | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ISTODAX, contact your doctor or pharmacist.
How to store
Store at room temperature (15 to 30°C). Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 1908C
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
The information in this document is current as of the last
revision date shown below. The most current information
can be found at: http://www.celgenecanada.net or by
contacting the sponsor, Celgene Inc. at:
1-888-712-2353.
This leaflet was prepared by Celgene Inc.
© 2019 Celgene Corporation
®ISTODAX is a registered trademark of Celgene Corporation
Last revised: July 25, 2019