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Aranesp (Generic Darbepoetin Alfa Injection)

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WARNING

Each patient:

The risk of blood clots forming in or spreading to the legs, lungs, or brain increases with the use of darbepoetin alfa injection. Tell your doctor whether you have heart disease now or previously had it, as well as if you’ve ever experienced a stroke. If you see any of the following symptoms, contact your doctor right away or seek emergency care: Shortness of breath, a persistent or bloody cough, chest pain, or sudden difficulty speaking or understanding speech; pain, tenderness, redness, warmth, and/or swelling in the legs; coolness or paleness in an arm or leg; unexpected difficulty walking, dizziness, loss of balance or coordination, sudden confusion, sudden weakness or numbness of an arm or leg (particularly on one side of the body), or sudden 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 stops functioning normally, let your doctor know.

Your doctor will modify the amount of darbepoetin alfa you receive so that your haemoglobin level—the quantity of a protein contained in red blood cells—is just high enough that you don’t require a red blood cell transfusion to treat severe anaemia. There is a higher chance of developing serious or life-threatening heart conditions, such as heart attack and heart failure, if you receive enough darbepoetin alfa to raise your haemoglobin to a normal or close to 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 response to the darbepoetin alfa injection, your doctor will request specific lab tests. If the tests reveal you are at a high risk of developing serious side effects, your doctor may reduce your dose or advise you to temporarily stop taking darbepoetin alfa injection. Carefully adhere to your doctor’s instructions.

When you start receiving darbepoetin alfa treatment and every time you get a prescription refill, your doctor or pharmacist will provide you the manufacturer’s patient information sheet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Discuss the dangers of using darbepoetin alfa injection with your doctor.

Cancer sufferers:

According to clinical research, patients with certain tumours who had darbepoetin alfa injections experienced tumour growth, a recurrence of their malignancy, or spread more quickly than patients who did not receive the medication. They also had these results or died sooner. If you have cancer, you should only receive the minimal dose of darbepoetin alfa injection. You should only take darbepoetin alfa injection to treat anaemia brought on by chemotherapy if your chemotherapy is expected to endure for at least two months after you start treatment with it and if there is not a high possibility that your cancer will be cured. You should stop getting darbepoetin alfa injections once your chemotherapy treatment is ended.

The ESA APPRISE Oncology Program has been established to reduce the hazards associated with administering darbepoetin alfa injection to treat anaemia brought on by chemotherapy. Before you can receive a darbepoetin alfa injection, your doctor must join in this programme and complete the required training. You will be given written information on the risks of using darbepoetin alfa injection as part of the programme, and you will need to sign a document before you receive the medication to demonstrate that your doctor has talked to you about those risks. Your doctor will explain the programme in more detail and respond to any inquiries you may have regarding it and your darbepoetin alfa injectable therapy.

Why is this medication prescribed?

Anemia (a lower than normal number of red blood cells) is treated with darbepoetin alfa injection in patients with chronic kidney failure (condition in which the kidneys slowly and permanently stop working over a period of time). Injections of darbepoetin alfa are also used to treat anaemia brought on by chemotherapy in patients with specific cancers. Darbepoetin alfa has not been proven to reduce fatigue or a lack of well-being that may be brought on by anaemia, and it cannot be used in place of a red blood cell transfusion to treat severe anaemia. Darbepoetin alfa belongs to the group of drugs known as erythropoiesis-stimulating agents (ESAs). It functions 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?

Darbepoetin alfa injection is available as a solution (liquid) to administer intravenously or subcutaneously (into a vein). Typically, it is injected once every one to four weeks. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Administer darbepoetin alfa injection as prescribed. Use it only as directed by your doctor, neither more nor less often.

Darbepoetin alfa injection dosage will be adjusted by your doctor based on your lab results and how you are feeling after you start taking it. Additionally, your doctor could advise you to temporarily cease using darbepoetin alfa injection. Pay close attention to these directions.

Only if you keep using the darbepoetin alfa injection will it help you treat your anaemia. Before you experience the full benefits of the darbepoetin alfa injection, it could take 2–6 weeks or longer. Even if you feel better, keep using darbepoetin alfa injection. Without consulting your physician, never stop using darbepoetin alfa injection.

Injections of darbepoetin alfa may be administered by a doctor, nurse, or friend or relative. Alternatively, your doctor may determine that you can administer the injections yourself. Before using darbepoetin alfa injection for the first time at home, you and the person administering the injections should read the manufacturer’s information for the patient that is included with the medication. Ask your doctor to demonstrate how to inject the drug to you or the person who will administer it.

Both prefilled syringes and vials to be used with disposable syringes are available for the injection of darbepoetin alfa. Your doctor or pharmacist will advise you on the appropriate syringe to use if you are administering darbepoetin alfa injection from vials. Use just the prescribed type of syringe to avoid getting the incorrect dosage.

Darbepoetin Alfa injection shouldn’t be shaken. Darbepoetin injection may appear frothy when shaken and should not be used.

Darbepoetin Alfa should always be injected from its own syringe. It should not be mixed with any other medications or diluted with any beverage.

The front of your middle thighs, the upper outer parts of your buttocks, and the upper outer areas of your upper arms are all acceptable locations to inject darbepoetin alfa injection. The 2-inch (5-centimeter) area around your navel (belly button) is the only exception. Each time you administer darbepoetin alfa, pick a new location. Darbepoetin alfa should not be injected into an area that is painful, swollen, red, bruised, or hard, or that contains scars or stretch marks.

Your physician 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) (place where dialysis tubing is connected to your body). If you have any concerns about injecting your medication, speak with your doctor.

Before injecting, always check the darbepoetin alfa injectable solution. Ascertain that the prefilled syringe or vial is labelled with the precise drug name, dosage form, and expiration date. If you’re using a prefilled syringe, make sure the needle is covered by the grey cover and that the yellow plastic sleeve hasn’t been pulled over it. If you’re using a vial, make sure it has a coloured cap. Additionally, 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 pharmacist.

Never utilise darbepoetin alfa injectable vials, disposable syringes, or prefilled syringes more than once. Used syringes should be disposed of in a container that won’t puncture. For disposal instructions on the puncture-resistant container, consult your doctor or pharmacist.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before using darbepoetin alfa injection,

  • If you have an allergy to darbepoetin alfa, epoetin alfa (Epogen, Procrit), any other drugs, or any of the chemicals in darbepoetin alfa injection, let your doctor and pharmacist know right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist. If you plan to use the prefilled syringes, be sure to let your doctor know if you or the person administering the injection has a latex allergy.
  • 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). Darbepoetin alfa injection may not be recommended by your physician.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that 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.
  • If you have seizures now or ever had them, let your doctor know. Tell your doctor if you have cancer if you’re taking darbepoetin alfa injection to treat anaemia brought on by chronic kidney 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 taking darbepoetin alfa injection.
  • Inform your doctor or dentist that you are receiving darbepoetin alfa injection treatment before undergoing any type of surgery, including dental surgery. If you are having a coronary artery bypass graft (CABG) procedure or surgery to address a bone condition, it is very vital to let your doctor know if you are using darbepoetin alfa injection. To avoid blood clots during surgery, your doctor may prescribe an anticoagulant (sometimes known as a “blood thinner”).

What special dietary instructions should I follow?

To ensure that the darbepoetin alfa injection functions 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 your darbepoetin alfa injection, 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?

The injection of darbepoetin alfa may have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Cough
  • Stomach ache
  • Bruising, itching, redness, swelling, or a lump where you gave the darbepoetin alfa injection

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you encounter any of the symptoms below or those in the IMPORTANT WARNING section:

  • Rash
  • Itching
  • Breathing or swallowing challenges
  • Wheezing
  • Hoarseness
  • Swelling of the lower legs, hands, feet, ankles, or face, neck, tongue, lips, eyes, or mouth
  • Rapid heartbeat
  • Excessive fatigue
  • Not enough energy
  • Dizziness
  • Fainting
  • Light skin

Other negative effects of darbepoetin alfa injection are possible. If you experience any strange issues or feel unwell while taking this medicine, contact your doctor right once.

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 packed in the carton it was packaged in and out of the reach of children. Keep a vial or prefilled syringe covered to shield it from room light after removing it from its carton until the dose is administered. Do not freeze darbepoetin alfa injection; instead, store it in the refrigerator. Any frozen medication should be thrown away.

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 pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As 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. http://www.upandaway.org

In case of emergency/overdose

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

What other information should I know?

Keep all of your doctor’s appointments. Throughout your darbepoetin alfa injection therapy, your doctor will frequently check your blood pressure.

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

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

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

  • Aranesp®
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