Details for: AZACITIDINE FOR INJECTION
Company: DR REDDY'S LABORATORIES LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02462826 | AZACITIDINE FOR INJECTION | AZACITIDINE | 100 MG / VIAL | POWDER FOR SUSPENSION | SUBCUTANEOUS |
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
AZACITIDINE FOR INJECTION is used in adults with either myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML) who are not eligible for stem cell transplantation. Both MDS and AML are blood disorders.
- In MDS, the bone marrow does not function and fails to produce enough healthy blood cells. You will only be given AZACITIDINE FOR INJECTION if your form of MDS is considered “higher risk”. Higher risk means that there is a danger that the disease will be fatal or that the patient could develop AML.
- AML is a type of cancer affecting the bone marrow, where blood cells develop. Blood cells that are not fully formed and do not work well are found in the blood.
What it does
In patients with MDS and AML, AZACITIDINE FOR INJECTION works by helping to correct the problem with the growth of immature cells in the bone marrow. AZACITIDINE FOR INJECTION may also kill cells in bone marrow that have been reproducing abnormally.
When it should not be used
Do not use AZACITIDINE FOR INJECTION:
- If you are allergic to azacitidine or to any of the other ingredients of AZACITIDINE FOR INJECTION
- If you have advanced liver cancer
What the medicinal ingredient is
azacitidine
What the non-medicinal ingredients are
Mannitol. Preservative free. Latex-free stopper.
What dosage form it comes in
AZACITIDINE FOR INJECTION is supplied as a sterile freeze dried powder. After it is mixed with sterile water, it forms a suspension that can be injected subcutaneously (under the skin). Each vial contains 100 mg of azacitidine.
Warnings and precautions
AZACITIDINE FOR INJECTION should be prescribed and managed only by a doctor experienced in the use of anticancer drugs.
AZACITIDINE FOR INJECTION can cause serious side effects:
- thrombocytopenia (abnormally small number of platelets in the blood);
- in rare cases, kidney failure, which can be life- threatening.
While taking AZACITIDINE FOR INJECTION, you may receive supportive care to protect you from serious bleeding, anemia, infection, nausea and vomiting.
BEFORE you use AZACITIDINE FOR INJECTION talk to your doctor or pharmacist if you:
- have low blood cell count (platelets, red or white blood cells)
- have kidney disease
- have liver disease
- have congestive heart failure
- are breastfeeding, pregnant or are planning to get pregnant
AZACITIDINE FOR INJECTION may cause harm to an unborn baby. Females who could become pregnant should use effective contraception during treatment and up to 3 months after stopping treatment with AZACITIDINE FOR INJECTION. Male patients should not father a child while receiving treatment with AZACITIDINE FOR INJECTION and for 6 months after the last dose.
AZACITIDINE FOR INJECTION may cause tumor lysis syndrome (metabolic abnormalities caused by the death of tumor cells), injection site necrosis (a serious condition due to the death of cells and tissue at the injection site) necrotizing fasciitis (a severe, life-threatening bacterial infection of the skin and soft tissue) and pyoderma gangrenosum (painful skin ulceration).
AZACITIDINE FOR INJECTION is not recommended for use in children and adolescents below the age of 18.
Interactions with this medication
Interaction with other drugs is not known. You should tell your doctor or pharmacist about your other medicines including any that you bought without a prescription. These include vitamins and herbal products. While taking AZACITIDINE FOR INJECTION, you should check with your doctor or pharmacist before taking any other medicines.
Proper use of this medication
Your doctor will give you another medicine to prevent nausea and vomiting.
- Your doctor will choose your dose of AZACITIDINE FOR INJECTION depending on your general condition, height and weight.
- AZACITIDINE FOR INJECTION is given to you as an injection under the skin (subcutaneously) by a doctor or nurse. It may be given under the skin on your thigh, stomach or upper arm.
Usual dose
- The usual dose is 75 mg per square meter of your body surface area.
- Your doctor will check your progress and may change your dose if necessary.
- AZACITIDINE FOR INJECTION is given every day for 7 days in a row, followed by a rest period of 3 weeks. This “treatment cycle” will be repeated every 4 weeks. The treatment usually consists of at least 6 cycles.
Overdose
If you think you have taken too much AZACITIDINE FOR INJECTION, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
If you think that you have been given AZACITIDINE FOR INJECTION more frequently than you should, or too high a dose, tell your healthcare provider immediately or contact your local poison control centre immediately.
Missed Dose
If you think that you have missed a dose of AZACITIDINE FOR INJECTION, tell your healthcare provider immediately.
Side effects and what to do about them
Like all medicines, AZACITIDINE FOR INJECTION can cause side effects. Side effects are usually more common during the first 2 cycles of treatment. They may be less common with further treatment.
Tell your doctor right away if you notice any of the following side effects:
- Fever - This may be due to an infection due to having a low white blood cell count.
- Chest pain or shortness of breath with or without fever - This may be due to an infection in your lungs called “pneumonia”.
- Unexpected bleeding.
- Difficulty breathing, swelling of the lips, itching, or rash, which may be due to an allergic reaction.
Very common: Reduced red and/or white blood count; reduced platelet count; constipation; diarrhea; nausea; vomiting; pneumonia; chest pain; being short of breath; feeling tired; redness, pain or a skin reaction at the location where the needle enters your skin during injection; loss of appetite; joint aches; bruising; rash; red or purple spots under your skin; pain in your belly; itching; fever; sore nose and throat; dizziness; headache
Common: Bleeding inside your brain; blood infection; bone marrow failure leading to low red or white blood cell counts, or a low platelet count; low red and white blood cell counts, with a low platelet count occurring at the same time; urinary infection; cold sores (a viral infection); bleeding gums; bleeding in the stomach or gut; bleeding from hemorrhoids; bleeding in your eye; bleeding under your skin, or into your skin; blood in your urine; ulcers of your mouth or tongue; side effects where the needle went into your skin, including swelling, a hard lump, bruising, bleeding into your skin, rash, itching and/or changes in the color of the skin; redness of your skin; infection of the nose and throat, or sore throat; sore or runny nose or sinuses, low levels of potassium in your blood; high or low blood pressure; shortness of breath when you move; pain in your throat and voice box; indigestion; weight loss; lethargy; feeling generally unwell; muscle aches; anxiety or having trouble sleeping; being confused, hair loss
Uncommon: Allergic reaction
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Very Common | |||
| Fever / Infection or fever with low neutrophil count | ✔ | ||
| Common | |||
| Feeling weak or tired with or without fever, unexpected bruises of any size, looking pale, chest pain, shortness of breath, palpitations / Blood system disorders | ✔ | ||
| Coughing, fever, with shortness of breath / Pneumonia | ✔ | ||
| Frequent need to urinate, pain or burning when you urinate, urine cloudy or smells bad, fever, chills / Urinary tract infection | ✔ | ||
| Nosebleed, bleeding from the eye or mouth | ✔ | ||
| Seizures, loss of consciousness, severe headache / Bleeding in the brain | ✔ | ||
| Blood in stool and urine | ✔ | ||
| Uncommon | |||
| Allergic reaction | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking AZACITIDINE FOR INJECTION, 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 side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about AZACITIDINE FOR INJECTION:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website at http://hc-sc.gc.ca/index-eng.php; the manufacturer’s website www.drreddys.com, or by calling 1-855-845-1739
This leaflet is prepared by Dr. Reddy’s Laboratories Limited
Last Revised: November 12, 2019
Manufacturer:
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 INDIA
Questions / Concerns / Problèmes
1-855-845-1739
Importer & Distributor:
Dr. Reddy’s Laboratories Canada Inc.
Mississauga, ON L4W 4Y1 Canada