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Erythropoietin Human Glycoform alpha (Generic Epoetin Alfa Injection)

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Every patient:

Blood clots may form in or travel to the legs, lungs, or brain when using products containing epoetin alfa injection. A deep vein thrombosis (DVT), a pulmonary embolus (PE), a stroke, heart illness, a blood clot in the lungs, a deep vein thrombosis, or impending surgery should all be disclosed to your doctor. Inform your surgeon or dentist that you are using an epoetin alfa injection product before having any surgery, including dental surgery. This is especially important if you are undergoing orthopaedic surgery or coronary artery bypass graft (CABG) surgery. To avoid blood clots during surgery, your doctor may prescribe an anticoagulant (sometimes known as a “blood thinner”). If you encounter any of the following signs, call your doctor right away or seek emergency medical assistance: discomfort, soreness, redness, warmth, and/or swelling in the legs; chest pain, a chilly or pale arm or leg, difficulty breathing or understanding speech suddenly, coolness or paleness in such areas; unexpected difficulty walking, dizziness, or loss of balance or coordination; sudden weakness or numbness of an arm or leg (particularly on one side of the body), or of the face; or fainting. A blood clot may form in your vascular access if you are receiving hemodialysis treatment (treatment to eliminate waste from the blood when the kidneys are not functioning) (place where the hemodialysis tubing connects to your body). If your vascular access is not functioning normally, let your doctor know.

In order to avoid a red blood cell transfusion (transfer of one person’s red blood cells into the body of another person to treat severe anaemia), your doctor will change the dosage of an epoetin alfa injection medication you are taking. Hemoglobin is a protein found in red blood cells. There is a higher chance of developing serious or life-threatening heart conditions, such as heart attack or heart failure, if you receive enough of an epoetin alfa medication to raise your haemoglobin to a normal or near-normal level. If you suffer any of the following signs, call your doctor right away or seek emergency assistance: Shortness of breath; nausea; dizziness; sweating; chest pain, pressure, or tightness; arm, shoulder, neck, jaw, or back pain; or swollen hands, feet, or ankles are some early symptoms of a heart attack.

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to epoetin alfa injection products, your doctor will request specific lab tests. If the tests reveal that you are at a high risk of developing serious adverse effects, your doctor may lower your dose or instruct you to temporarily cease using an epoetin alfa injection product. Carefully adhere to your doctor’s instructions.

When you start receiving therapy with an epoetin alfa injection product and each time your prescription is filled, your doctor or chemist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the information and ask your doctor or chemist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The dangers of utilising an epoetin alfa injection product should be discussed with your doctor.

Cancer sufferers:

In clinical trials, those with specific cancers who received epoetin alfa injections suffered tumour growth, a return of their cancer, or cancer that spread earlier than those who did not get the drug. These outcomes were observed in both clinical trials. If your chemotherapy is anticipated to last for at least two months after you begin your treatment with epoetin alfa injection and if there is not a high likelihood that your cancer will be cured, then you should only be given epoetin alfa injection products to treat anaemia brought on by chemotherapy. When your chemotherapy regimen is finished, your treatment with epoetin alfa injection products should be discontinued.

Surgery patients:

To lessen the possibility that blood loss after some types of surgery would result in anaemia and the need for a blood transfusion, you might be given an epoetin alfa injection product. The risk that you will experience a dangerous blood clot during or after surgery may, however, increase if you receive an epoetin alfa injection product before and after surgery. Most likely, your doctor will recommend a medicine to help avoid blood clots.

Why is this medication prescribed?

Those with chronic renal failure can treat anaemia (a lower-than-normal number of red blood cells) using epoetin alfa injectable products (condition in which the kidneys slowly and permanently stop working over a period of time). Epoetin alfa injection products are also used to treat anaemia brought on by zidovudine (AZT, Retrovir, in Trizivir, in Combivir), a drug used to treat human immunodeficiency virus, or anaemia brought on by chemotherapy in patients with certain forms of cancer (HIV). As a preventative measure against the need for blood transfusions (the transfer of one person’s blood to another person’s body) brought on by blood loss during surgery, epoetin alfa injectable products are also administered prior to and during some forms of surgery. When a person is having surgery on their heart or blood arteries, epoetin alfa injection products shouldn’t be used to reduce the likelihood that transfusions will be required. Moreover, epoetin alfa injection products shouldn’t be utilised to treat patients who are able and willing to donate blood ahead of time so that their bodies can replenish this blood before or after surgery. Epoetin alfa injection products have not been proved to reduce fatigue or a lack of well-being that may be brought on by anaemia and cannot be used in place of a red blood cell transfusion to treat severe anaemia. Products containing epoetin alfa belong to the group of drugs known as erythropoiesis-stimulating agents (ESAs). They function by increasing the production of red blood cells in the bone marrow, which is a soft substance found inside the bones.

How should this medicine be used?

Products for injecting epoetin alfa come as solutions (liquids) that can be given intravenously or subcutaneously (into a vein). Typically, it is injected one to three times each week. Epoetin alfa injection products are occasionally injected once daily for 10 days prior to surgery, on the day of surgery, and for 4 days following surgery in order to reduce the likelihood that blood transfusions will be necessary. Instead, once weekly injections of epoetin alfa injectable products can be administered starting three weeks before to surgery and ending the day of the procedure.

Your doctor will start you on a modest dose of an epoetin alfa injection product and change your dose as needed, typically no more than once per month, based on your lab results and how you are feeling. Also, your doctor could advise you to temporarily stop taking an epoetin alfa injection medication. Pay close attention to these directions.

Only if you keep using epoetin alfa injection products will they help you manage your anaemia. Before you experience the full benefits of an epoetin alfa injection medication, it could take 2–6 weeks or longer. Without consulting your physician, never cease using an epoetin alfa injection medication.

You can be instructed to inject the drug at home or given epoetin alfa injection products by a doctor or nurse. If you plan to inject the drug at home, carefully read the instructions on the prescription label and ask your doctor or chemist to clarify any information you are unsure of. Follow the instructions on an epoetin alfa injection product precisely. Mark a calendar to note when you need to receive a dose of an epoetin alfainjection product to assist you remember to use it. Use it only as directed by your doctor, neither more nor less often.

A healthcare professional will demonstrate how to inject the drug if you are using an epoetin alfa injection product at home. Make sure you comprehend these instructions. You and the person administering the injections should read the manufacturer’s information for the patient that is included with the epoetin alfaproduct before using it for the first time. If you have any concerns regarding where on your body to inject the drug, how to administer the injection, what kind of syringe to use, or how to discard used needles and syringes after you inject the medication, see your healthcare professional. A spare syringe and needle should always be on hand.

A product for epoetin alfa injection should not be shaken. The drug may appear frothy when shaken and should not be taken.

The outer area of the upper arms, the centre of the front thighs, the stomach (except from a 2-inch [5-centimeter] area around the navel [belly button]), and the outer area of the buttocks are all acceptable locations to administer an epoetin alfa injection product just under the skin. Avoid administering an epoetin alfa injection product to a sore, red, bruised, hard, or scarred area. Every time you administer the medication, choose a different location, as advised by your doctor.

Your doctor might advise you to administer the drug through your venous access port if you are receiving dialysis (a procedure to remove waste from the blood when the kidneys are not functioning). If you have any concerns about injecting your medication, speak with your doctor.

When injecting a solution, always check it out. Make that the container is labelled with the appropriate drug name, dosage strength, and a current expiration date. Moreover, make sure the solution is clear, colourless, and free of any lumps, flakes, or other foreign objects. Do not inject your drug if there are any issues with it; instead, call your chemist.

Other uses for this medicine

Other prescriptions for this drug are possible. The dangers of using this drug for your illness should be discussed with your doctor.

What special precautions should I follow?

Before using an epoetin alfa injection product,

  • If you have an allergy to epoetin alfa, epoetin alfa-epbx, darbepoetin alfa (Aranesp), any other medications, or any of the chemicals in epoetin alfa injection products, let your doctor and chemist know right once. For a list of the ingredients, consult the Medication Guide or speak with your chemist.
  • Inform your doctor and chemist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your physician if you have or have ever had high blood pressure as well as any history of pure red cell aplasia (PRCA; a type of severe anaemia that may develop after treatment with an ESA such as darbepoetin alfa injection or epoetin alfa injection). You can be advised by your doctor not to use an epoetin alfa injection product.
  • If you have seizures now or ever had any, let your doctor know. Inform your doctor if you have ever had cancer if you are using an epoetin alfa injection medication to treat anaemia brought on by chronic renal disease.
  • Inform your doctor if you are expecting, intend to get pregnant, or are nursing a baby. Call your doctor if you become pregnant while using an epoetin alfa injection product.
  • Inform the surgeon or dentist that you are using an epoetin alfa injection product if you are having surgery, including dental surgery.

What special dietary instructions should I follow?

To ensure that an epoetin alfa injection product works as effectively as possible, your doctor may advise you to follow a particular diet to help control your blood pressure and raise your iron levels. If you have any questions, see your physician or dietitian before implementing these recommendations.

What should I do if I forget a dose?

If you forget to take a dose of an epoetin injectable medication, call your doctor to find out what to do. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be negative effects from epoetin alfa injectable products. If any of these symptoms are severe or do not go away, consult your doctor:

  • Headache
  • Pain or soreness in the joints or muscles
  • Nausea
  • Vomiting
  • Slim down
  • Throat and mouth sores
  • Having trouble falling or staying asleep
  • Depression
  • Muscular spasms
  • Congestion, sneezing, and a runny nose
  • Cold, cough, or fever
  • Inflammation, discomfort, or itchiness at the injection site

Some adverse effects may be severe. The following symptoms, as well as those in the URGENT WARNING section, should be reported to your doctor right away, or you should seek emergency medical attention:

  • Rash
  • Hives
  • Itching
  • Swelling of the lips, eyes, tongue, cheeks, or throat
  • Skin rashes or skin that is peeling
  • Wheezing
  • Breathing or swallowing challenges
  • Strange fatigue
  • Not enough energy
  • Dizziness
  • Fainting
  • Seizures

Such negative effects could be brought on by epoetin alfa injection products. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly wrapped, away from children, and in the original container it came in. Epoetin alfa and epoetin alfa-epbx should be kept in the refrigerator rather than being frozen. Any medication that has been frozen should be thrown away. After using a multidose vial of epoetin alfa injection once, discard it 21 days later.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your chemist or the garbage/recycling agency in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

  • Quick or frantic heartbeat

What other information should I know?

Keep all of your doctor’s appointments. Throughout the course of your epoetin alfa injectable therapy, your doctor will frequently check your blood pressure.

Inform the lab staff and your doctor that you are using an epoetin alfa injection product prior to any laboratory test.

Do not share your medication with anybody else. Any queries you may have regarding prescription refills should be directed to your chemist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Epogen®(Epoetin Alpha)
  • Eprex®(Epoetin Alpha)
  • Procrit® (Epoetin Alpha)
  • Retacrit®(Epoetin Alpha-epbx)
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