Pms-Decitabine 50 mg

1. Dose:

- 50 mg

2. What Pms-Decitabine is and what is it used for:

Pms-Decitabine is used in the treatment of adult patients with myelodysplastic syndrome (MDS). In the case of myelodysplasia, the bone marrow does not make enough healthy mature blood cells Instead, immature blood cells accumulate, known as aromas in the bone marrow and blood. These aromas do not work properly and cause the presence of blood cells, white blood cells, and less healthy plates. It works by helping to correct the problem associated with the growth of aromas in the bone marrow and may kill cells in the bone marrow that reproduce abnormally.

3. What you need to know before you take Pms-Decitabine:

Do not use Pms-Decitabine if:

- You are allergic to Decitabine or any of the ingredients in the medicine.

- You are breastfeeding. It is not known if Pms-Decitabine passes into breast milk, you and your doctor must decide whether to take Pms-Decitabine or to breastfeed, you should not do both at the same time. Talk to your doctor about the best way to feed your baby while you are being treated with Pms-Decitabine.

To avoid side effects and ensure appropriate use, talk to your doctor before taking Pms-Decitabine, and talk about any health conditions or problems you may have, including:

- If your red blood cell count is low.

- If you have infections or flu-like symptoms.

- If you have kidney or liver disease.

- If you have a heart disorder.

- If You are pregnant or plan to become pregnant, avoid pregnancy while receiving treatment with Pms- Decitabine, you must use an effective contraception while receiving Pms-Decitabine, it is not known how long after Pms-Decitabine treatment it is possible to become pregnant safely, talk to your doctor about how long you should continue to use method of contraception after your last dose. If you become pregnant while receiving Pms-Decitabine tell your doctor immediately, Pms-Decitabine can harm your unborn child.

- If you are planning to have a child, your partner should not become pregnant while you are using Pms-Decitabine, you must use a method of contraception to prevent your partner from getting pregnant while you are being treated with Pms-Decitabine for 3 months after your last dose if your partner becomes pregnant while you are receiving Pms-Decitabine, tell your doctor immediately, Pms-Decitabine can harm an unborn child.

Driving and Using Machines: You may feel weak, tired, dizzy, confused, or have blurred vision while using Pms-Decitabine, give yourself time after taking PmsDecitabine to see how you feel before driving a vehicle or using machinery.

Infertility: For both men and women, Pms-Decitabine may decrease your ability to have a child. Talk to your doctor about this if you want to have a child.

Blood Tests: Blood tests will be done before you receive Pms-Decitabine for the first time.

4. Warnings and Precautions:

- Decitabine, the active ingredient in Pms-Decitabine may cause cancer or damage to the genetic material in cells (DNA).

- Tell your doctor about all the medicines you take.

5. How and When to Take Pms-Decitabine:

Pms-Decitabine will be given to you by a trained doctor. The Pms-Decitabine powder will be first mixed into a solution. This solution will then be given through a tube placed in your vein. This is called an intravenous (IV) infusion.

Usual Dose: There are two possible treatment options for Pms-Decitabine. Your doctor will decide which treatment option is best for you. For each option, the amount of Pms-Decitabine you receive will depend on your height and weight:

- Treatment Option 1: a dose of 15 mg/m2 is given by IV infusion over a period of 3 hours. This is repeated every 8 hours for 3 days and is called a treatment cycle. Cycles are repeated every 6 weeks.

- Treatment Option 2: a dose of 20 mg/m2 is given by IV infusion over a 1-hour period. This is repeated each day for 5 days for one treatment cycle. Cycles are repeated every 4 weeks

You will receive at least 4 cycles of Pms-Decitabine unless you experience severe side effects. Your treatment with Pms-Decitabine will continue as long as you are feeling well and your disease has not gotten worse. Your doctor may need to delay your treatment and reduce your dose if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with Pms-Decitabine.

Overdose: The infusion schedule will be set by your doctor. Your doctor will monitor your response and condition to determine what treatment is needed. If you think you have received too much Pms-Decitabine, contact your doctor , hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose: If you think you have missed a dose of Pms-Decitabine, tell your doctor immediately.

6. Possible Side Effects:

These are not all the possible side effects may feel when taking Pms-Decitabine. If you experience any side effects not listed here, contact your doctor: Diarrhea, constipation, nausea, vomiting, painful sores on mouth, lip or tongue, loss of appetite, indigestion, difficulty swallowing, abdominal pain, swelling, bloating, rash, skin redness, itching, redness, swelling, pain where the needle enters your skin during injection, muscle, joint, bone pain, fatigue, headache, dizziness, numbness, confusion, blurred vision, trouble sleeping, hair loss.

Very common side effects:

i. If severe talk to your doctor:

- Neutropenia or leukopenia: infections, fatigue, fever, aches, pains, flu-like symptoms.

- Thrombocytopenia, tiny red or purple spots on the skin or inside the mouth, bruising, bleeding more easily, bleeding from gums or nose, blood in urine or stool.

- Anemia , feeling weak, tired or short of breath, or looking pale.

- Edema. Unusual swelling of the arms.

ii. Talk to your doctor if:

- Febrile neutropenia. Fever, chills, sores in the mouth, toothache, abdominal pain, pain near the anus, diarrhoea, pain when urinating or urinating often, cough, feeling short of breath, any redness, swelling or pain of skin, unusual vaginal discharge or itching.

- Infection, fever, chills, sore throat, cough, runny nose, sore sinuses, burning sensation when urinating, urge to urinate often, cloudy urine, or blood in the urine.

- Pneumonia. Chest pain or shortness of breath.

- Cellulitis. Redness, swelling, pain and tenderness, warm to the touch.

- Hyperglycemia. Extreme thirst, frequent urination, extreme hunger, weakness, blurred vision

Common side effects:

i. If severe talk to your doctor:

- Depression. A sad mood that doesn’t go away.

ii. Talk to your doctor if:

- Sepsis. Fever, chills, fast heartbeat, feeling short of breath, producing less urine than usual, extreme weakness, and changes in mental ability.

- Bleeding in the brain. Difficulty speaking, moving, understanding or seeing, sudden severe headache, seizure, numbness, or weakness in any part of the body.

- Hypotension. Dizziness, fainting, and lightheadedness.

- Hypertension. Headaches, vision disorders, nausea and vomiting.

- Pulmonary edema. Difficult breathing that is worse when lying down, coughing up blood, and blood-tinged froth.

Rare side effects:

Talk to your doctor if:

- Allergic reaction. Difficulty swallowing or breathing, swelling of the face, lips, tongue or throat itching, rash, hives, dizziness.

Side effects with unknown frequency:

Talk to your doctor if:

- Sweet's Syndrome. Red raised painful patches on the skin and fever.

- Liver failure. Jaundice, abdominal pain or swelling, bleeding, dark urine, and vomiting.

- Enterocolitis. Abdominal swelling, diarrhoea, bloody stool, and vomiting.

- Interstitial lung disease, shortness of breath, generally feeling unwell, and dry cough.

- Tumor lysis syndrome. Seizure, irregular heart rate, tingling around mouth, hands or feet, muscle weakness, cramps or spasms, and less urine than usual.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your doctor.