Introduction
Initer Safe 2000 is a medicine that helps your bone marrow to produce more red blood cells. It is used to treat a type of anemia caused by kidney disease. It is also used to treat anemia caused by cancer chemotherapy and by taking medicines to treat HIV.
Initer Safe 2000 is given by injection either under the skin or into a vein which will be decided by your doctor. Usually the injections are given by a nurse or doctor. The dose depends on your body weight and the cause of your anemia. Iron supplements both before and during treatment may make this treatment more effective. Initer Safe 2000 needs to be stored in a fridge but used at room temperature.
The most common side effects of taking this medicine include nausea, vomiting and increased blood pressure. It may also cause flu-like symptoms such as headache, tiredness, dizziness and aches and pains. These side effects are most common at the start of treatment but if they persist your doctor may be able to suggest ways of preventing or reducing them. Tell your doctor straight away if you get any serious side effects, including seizures (fits). Sometimes this medicine can cause serious blood clots which need urgent medical attention.
Before using Initer Safe 2000 you should tell your doctor if you have uncontrolled high blood pressure, heart disease or gout (disease of joint pain). You should also tell him/her what other medicines you are taking in case they affect this treatment. Your blood pressure should be checked often during this treatment by you or your doctor. You may also need other regular medical tests to be sure this medicine is not causing harmful effects. It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant, plan to become pregnant or are breastfeeding.
Uses of Initer Safe 2000
- Anemia due to chronic kidney disease
- Anemia due to cancer chemotherapy
Side effects of Initer Safe 2000
Common
- High blood pressure
- Nausea
- Fever
- Vomiting
How to use Initer Safe 2000
Your doctor or nurse will give you this medicine. Kindly do not self administer.
How Initer Safe 2000 works
Initer Safe 2000 is an erythropoiesis-stimulating agent (ESA). It works by stimulating the bone marrow (soft tissue inside the bones which produces red blood cells) to produce more red blood cells.
What if you forget to take Initer Safe 2000?
If you miss a dose of Initer Safe 2000, please consult your doctor.
Indication
Anemia associated with Chronic Renal Failure, including patients on dialysis (ESRD) and patients not on dialysis, Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy, Anemic patients (hemoglobin > 10 to < 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions, Anemia related to therapy with zidovudine in HIV-infected patients.
Adult Dose
Chronic Kidney Disease-Associated Anemia
Reduction of need for red blood cell (RBC) transfusion in patients with chronic kidney disease (CKD)
Patient not on dialysis: 50-100 units/kg IV/SC 3 times weekly initially
Initiate only when (1) hemoglobin level <10 g/dL, (2) rate of hemoglobin decline indicates likely necessity of RBC transfusion, and (3) reducing risk of alloimmunization or other risks related to RBC transfusion is goal; if hemoglobin level >10 g/dL, reduce or interrupt dose and use lowest dose sufficient to reduce need for RBC transfusion
Patient on dialysis: 50-100 units/kg IV 3 times weekly initially
Initiate when hemoglobin level <10 g/dL; if hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose
Zidovudine-Related Anemia
Treatment of anemia due to zidovudine administered at <4200 mg/week in HIV-infected patients with endogenous serum erythropoietin levels of <500 milliunits/mL
100 units/kg IV/SC 3 times weekly initially
Chemotherapy-Related Anemia
Treatment of anemia in patients with nonmyeloid malignancies where anemia is due to effect of concomitant myelosuppressive chemotherapy for >2 months
150 units/kg IV/SC 3 times weekly initially; alternatively, 40,000 units SC once weekly until completion of chemotherapy course
Preparation for Surgery With High Risk of Blood Loss
Reduction of need for allogeneic RBC transfusions in patients with perioperative hemoglobin >10 g/dL but ?13 g/dL who are at high risk for perioperative blood loss from elective, noncardiac, nonvascular surgery
300 units/kg SC once daily for 15 consecutive days (10 days preceding surgery, day of surgery, 4 days following surgery); alternatively, 600 units/kg SC in 4 doses administered 21, 14, and 7 days before surgery and on day of surgery
Child Dose
Chronic Kidney Disease-Associated Anemia
<1 month: Safety and efficacy not established
>1 month: 50 units/kg IV/SC 3 times weekly initially; if patient on dialysis, IV route recommended
Initiate when hemoglobin level <10 g/dL; if hemoglobin level approaches or exceeds 11 g/dL, reduce or interrupt dose
Prematurity-Related Anemia
25-100 units/kg SC 3 times weekly or 200-400 units/kg SC/IV q24-48hr for 2-6 weeks
Zidovudine-Related Anemia
<8 months: Safety and efficacy not established
8 months-17 years: 50-400 units/kg SC/IV 2-3 times weekly
Chemotherapy-Related Anemia
<5 years: Safety and efficacy not established
5-18 years: 600 units/kg IV once weekly; not to exceed 40,000 units
Contraindication
Uncontrolled hypertension, hypersensitivity to mammalian cell products and human albumin.
Mode of Action
Erythropoietin regulates erythropoiesis by stimulating the differentiation and proliferation of erythroid precursors, stimulating the release of reticulocytes into the circulation, and synthesis of cellular haemoglobin. Recombinant human erythropoietin is available as epoetin alfa and epoetin beta which are used in the management of anaemias associated with CRF, cancer chemotherapy and anti-AIDS drug zidovudine.
Precaution
Erythropoietin should be used with caution in those patients with controlled hypertension, ischaemic vascular disease, history of seizures, or suspected allergy to the product. Iron evaluation: Prior to and during Epoetin therapy, the patient's iron stores, including transferrin saturation and serum ferritin, should be evaluated. Transferrin saturation should be at least 20%, and ferritin should be at least 100 ng/mL. Virtually all patients will require supplemental iron to increase or maintain transferrin saturation to levels that will adequately support erythropoiesis.
Lactation: Unknown whether drug is excreted in breast milk; use with caution; avoid administering multidose vials
Side Effect
>10%
Pyrexia (10-42%),Nausea (11-35%),Hypertension (14-27%),Cough (4-26%),Vomiting (12-28%),Pruritus (12-21%),Rash (2-19%),Headache (5-18%),Arthralgias (10-16%)
1-10%
Arthralgia (10%),Myalgia (10%),Stomatitis (10%),Diarrhea (9%),Dizziness (9%),Edema (9%),Fatigue (9%),Weight decrease (9%),Medical device malfunction (artificial kidney clotting during dialysis) (8%),Vascular occlusion (vascular access thrombosis) (8%),Vomiting (8%),Asthenia (7%),Chest pain (7%),Injection-site irritation (7%),Muscle spasm (7%),Upper respiratory tract infection (URTI) (7%),Urticaria (3%),Seizures (2.5%),Pulmonary embolism (1%),Respiratory tract congestion (1%)
Potentially Fatal: Hypertensive crisis with encephalopathy-like symptoms e.g. headache, confusion, generalised seizures. Thrombosis.
Interaction
Haematinics enhance efficiency. Increased dose of heparin in patients undergoing dialysis.