Every patient:

Blood clots could form in or travel to the legs, lungs, or brain if you use darbepoetin alfa injection. If you have or have previously had heart disease or a stroke, let your doctor know. If you suffer any of the following signs, call your doctor right away or seek emergency assistance: Leg discomfort, tenderness, redness, warmth, and/or swelling; a chilly or pale arm or leg, loss of breath, a persistent cough that causes blood to come up; chest discomfort, abrupt speech or hearing difficulty, bewilderment, sudden weakness or numbness of an arm, leg, or face, especially on one side of the body; abrupt fainting, dizziness, or problems with balance or coordination. 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 as usual, 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 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 (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

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

cancer sufferers:

In clinical investigations, patients with specific tumours who received darbepoetin alfa injection suffered tumour growth, a return of their malignancy, or spread more quickly than patients who did not receive the drug. They also died sooner or experienced these outcomes. Darbepoetin alfa injection should be administered in the smallest amount possible if you have cancer. Only if your chemotherapy is anticipated to last for at least two months after you begin treatment with darbepoetin alfa injection and if there is not a great likelihood that your cancer will be cured should you take darbepoetin alfa injection to treat anaemia brought on by chemotherapy. When your chemotherapy course is finished, you should cease receiving darbepoetin alfa injections.

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.

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.

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 chemist 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. Also, 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.

A doctor or nurse can administer darbepoetin alfa injections, or your doctor may determine that you can inject the medication yourself or that you can have a friend or family member administer it on your behalf. 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 included with the medication. Get instruction on how to inject the drug from your doctor so that you or the recipient can perform it.

Both prefilled syringes and vials to be used with disposable syringes are available for the injection of darbepoetin alfa. Your doctor or chemist 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. 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.

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 chemist.

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

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, inform your doctor and chemist right away. For a list of the ingredients, consult the Medication Guide or speak with your chemist. 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). Your doctor could advise against using darbepoetin alfa injection.
• Inform your doctor and chemist 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 any, 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”).

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.

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.

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 pain
• Redness, swelling, bruising, itching, or a lump where you injected darbepoetin alfa are possible side effects.

Certain 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 CAUTION section:

• Rash
• Itching
• Respiration or swallowing challenges
• Wheezing
• Hoarseness
• Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
• Rapid heartbeat
• Extreme fatigue
• Not enough energy
• Dizziness
• Fainting
• Light skin

Further 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).

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 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 http://goo.gl/c4Rm4p for additional information.

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. http://www.upandaway.org

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, 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.

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 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.