Patient Medication Information: uses, side effects, how to take - Reddy-Azacitidine
ABOUT THIS MEDICATION
What the medication is used for:
Reddy-Azacitidine 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 Reddy-Azacitidine 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, Reddy-Azacitidine works by helping to correct the problem with the growth of immature cells in the bone marrow. Reddy-Azacitidine may also kill cells in bone marrow that have been reproducing abnormally.
When it should not be used:
Do not use Reddy-Azacitidine:
- If you are allergic to azacitidine or to any of the other ingredients of Reddy-Azacitidine
- If you have advanced liver cancer
What the medicinal ingredient is:
azacitidine
What the important nonmedicinal ingredients are: Mannitol
What dosage forms it comes in:
Reddy-Azacitidine 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
Reddy-Azacitidine should be prescribed and managed only by a doctor experienced in the use of anticancer drugs.
Reddy-Azacitidine 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 Reddy-Azacitidine, you may receive supportive care to protect you from serious bleeding, anemia, infection, nausea and vomiting.
BEFORE you use Reddy-Azacitidine 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
Reddy-Azacitidine 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 Reddy-Azacitidine. Male patients should not father a child while receiving treatment with Reddy-Azacitidine and for 6 months after the last dose.
Reddy-Azacitidine 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).
Reddy-Azacitidine 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 Reddy-Azacitidine, 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 Reddy-Azacitidine depending on your general condition, height and weight.
- Reddy-Azacitidine 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.
- Reddy-Azacitidine 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 Reddy-Azacitidine, 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 Reddy-Azacitidine 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 Reddy-Azacitidine, tell your healthcare provider immediately.
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
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, Reddy-Azacitidine 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.
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
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 | ✓ | ||
| Common | Coughing, fever, with shortness of breath / Pneumonia | ✓ | ||
| Common | Frequent need to urinate, pain or burning when you urinate, urine cloudy or smells bad, fever, chills / Urinary tract infection | ✓ | ||
| Common | Nosebleed, bleeding from the eye or mouth | ✓ | ||
| Common | Seizures, loss of consciousness, severe headache / Bleeding in the brain | ✓ | ||
| Common | Blood in stool and urine | ✓ | ||
| Uncommon | Allergic reaction | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking Reddy-Azacitidine, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15 to 30°C). Keep out of reach 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 (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ index-eng.php) 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 Pr Reddy-Azacitidine: Talk to your healthcare professional.
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication 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
The information in this document is current as of the last revision date shown below
DIN Owner:
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 INDIA
1-855-845-1739
druginfo@drreddys.com
Canadian Importer by:
Dr. Reddy’s Laboratories Canada Inc.,
2425 Matheson Blvd East, #754
Mississauga, ON L4W 5K4 CANADA