Darbepoetin Alfa (Injection)

Darbepoetin Alfa(Aranesp)is a medicine used in the treatment of patients with severe anemia due to chronic kidney failure or chemotherapy.

Overview

Darbepoetin Alfa is the generic name for the US brand name injection solution, Aranesp. The solution is supplied as individual single-doses in glass bottles (vials), prefilled syringes or autoinjectors. It is given to patients who have severe anemia due to chronic kidney failure. It is also used in patients with certain cancers who developed severe anemia due to chemotherapy.

The injection is given by a doctor, nurse or other healthcare professional at a hospital or clinic. Some patients are allowed to self-inject the medicine at home. It is injected into a vein (intravenously) or under the skin (subcutaneously).

It works by stimulating the bone marrow to make more red blood cells. The medicine may take a few weeks before it becomes fully effective in increasing the level of red blood cells. The drug can control the anemia for as long as treatment continues, but is not an alternative in patients who require red blood cell transfusion. It also cannot be used to treat symptoms of anemia.

Even after they begin to feel better, patients are required to continue taking the other medications prescribed for treating the chronic kidney failure or cancer they already have.

Darbepoetin Alfa is available by doctor's prescription only. This bone marrow stimulant may be used to treat other medical conditions not discussed here.

Your doctor may help you decide if darbepoetin alfa injection is safe for you, and determine how to treat you. Routine tests may be done before, during, and after treatment to check your body's response to the medicine.

Tell your doctor if you have had an unusual or allergic reaction to the medicine, or if you are allergic to other medications, including epoetin alfa. Some patients may be allergic to inactive ingredients in the darbepoetin alfa.

In discussing allergies, let your doctor know if you have any allergy to foods, preservatives, dyes, animals, latex or natural rubber. The cover of the prefilled syringe needle contains dry natural rubber and can trigger an allergic reaction in people sensitive to latex.

Darbepoetin alfa and epoetin alfa are erythropoiesis-stimulating agents (ESAs). Some patients treated with these agents developed pure red cell aplasia (PRCA). Tell your doctor of any other medical problem you have or have a history of, especially pure red cell aplasia (PRCA), high blood pressure, cancer, or seizures. The anti-anemia drug has worsened the health of patients with certain types of cancers and even shortened their survival time.

Pediatric

Safety and efficacy have not been established for using the medicine in children with cancer, or children with chronic kidney failure who are below the age of 1.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, may be pregnant or plan to become pregnant, or if you are breastfeeding.

If you fall within any of these groups, your doctor may need to take necessary precautions in deciding if (and how) to treat you, based on the potential benefits and risks of using the medicine.

Type Of Medicine

  • Erythropoiesis-stimulating agent (ESA)

Condition treated:

  • Severe anemia

Side Effects

Side effects do occur during treatment with this medicine. Some of them may be serious and require immediate or even emergency medical attention.

When to call your doctor right away

The medicine may increase the risk of serious side effects. Call your doctor right away if you experience the following symptoms. They may be signs of a serious adverse reaction.

High blood pressure: Blood pressure readings that change from normal to a higher reading.

Anaphylaxis: Rash; swelling of the face, throat or tongue; itching; chest pain; or trouble breathing after you receive the medicine. Stop using the medicine right away and get emergency medical care. This may be signs of a serious allergic reaction.

Blood clots: Redness; pain or swelling of the arms or legs; or shortness of breath. These may be signs of blood clots.

Heart or blood vessel problems: Chest pain; dizziness; severe tiredness; trouble breathing seeing, walking, or speaking; or headaches that are sudden or severe. These may be signs of heart or blood vessel problems which include stroke, heart attack, and congestive heart failure.

Also call your doctor right away if you experience the following side effects:

More commonly occur

  • Fever
  • Wheezing
  • Chills
  • Blurry vision
  • Diarrhea
  • Sweating
  • Weight gain
  • Headache
  • Rapid breathing
  • Wrinkly skin
  • Confusion
  • Sunken eyes
  • Cough with mucus
  • Dilated neck veins
  • Unusual thirst
  • Fatigue (severe)
  • Unconsciousness
  • Nausea or vomiting
  • Reduced amount of urine
  • Heartbeats that are irregular, slow or fast
  • Tiredness (unusual or severe)
  • Lack of energy
  • Dryness of the mouth
  • Feeling of pounding in the ear
  • Stomach or abdominal pain
  • Pain in the back, jaw or arm
  • A build-up of pus or inflammation
  • Abnormal pulse (pounding or rapid)
  • Lightheadedness, dizziness or fainting
  • Difficulty breathing (including shortness of breath)
  • Discoloration of the skin where the medicine was injected
  • Swelling, tenderness, warmness, or pain at the injection site
  • Swelling of the face, hands, fingers, ankles, lower legs or feet
  • Pain or discomfort in the chest (or a sense of heaviness or tightness)

Less commonly occur

  • Double vision
  • Anxiety
  • Numbness or tingling of the face, legs or arms
  • Trouble speaking (including slurred speech)
  • Trouble thinking
  • Convulsions
  • Unable to move the face muscles, legs or arms
  • Trouble walking

Rarely occur

  • Skin rash
  • Hives
  • Itching
  • Pale skin
  • Fever
  • Soreness of the throat
  • Tiredness or weakness that is unusual

Some side effects may occur, but may not need medical attention. This is because they tend to go away on their own as your body gets used to the medicine. They include the following:

More commonly occur

  • Runny nose
  • Sneezing
  • Shivering
  • Constipation
  • Loss of appetite
  • Trouble sleeping
  • Joint pain
  • Feeling generally ill
  • Loss or lack of strength
  • General feeling of discomfort
  • Stiffness, aches, or pains in the muscles

This is not a complete list of all possible side effects. All the effects may not occur at the same time, nor all in one single patient.

If you notice other unusual symptoms that are not serious, but become bothersome or do not go away, call your doctor or healthcare professional. You may ask them about ways to prevent or reduce side effects.

You may call the FDA at 1-800-FDA-1088 to report side effects.

Dosage

Darbepoetin alfa injection is usually given by a doctor, nurse or healthcare professional at a hospital or clinic. Some patients are directed to take it on their own, at home.

You may be given a low dose at the start of your treatment. It may then be adjusted based on the results of routine lab tests and your body's response to the medicine.

If you are instructed to take the injection at home, take your dose exactly as directed. Dosage information is usually written on the prescription label. Carefully follow it and any other directions given to you by your doctor, pharmacist or healthcare professional.

Ask for more information if you are not sure what to do.

The following information is a general dosage guide.

Dosage is set based on body weight. The strength of the dose, time of the day you take it, the time between each dose, and the duration of the treatment (e.g. once a week for 4 weeks) should be written on the prescription label.

Do not change your dose or any other directions given to you unless your doctor or healthcare professional tells you to.

Treating anemia due to chronic kidney failure

Adults: The dose starts at 0.45 to 0.75 microgram (mcg) per kilogram (kg) of body weight. It should be injected under your skin or into one of your veins. This is done once a week, or once every 2 weeks. Your doctor may adjust the dose if necessary.

Children: The decision to treat, and dosage, must be determined by a doctor.

Treating anemia due to chemotherapy

Adults: The dose starts at 2.25 micrograms (mcg) per kilogram (kg) of body weight, to be injected under your skin once a week, or 500 mcg to be injected once every 3 weeks. Your doctor may adjust the dose if necessary.

Children: The decision to treat, and dosage, must be determined by a doctor.

To get the best out of your treatment, carefully read the patient information leaflet provided in the medicine packet.

Ask your doctor to show you how to inject the medicine. You may also ask the doctor to show any other person who will be giving the medicine to you. Your pharmacist should tell you what special type of disposable syringe is needed to use medicine that comes in a vial.

Use a new disposable syringe and needle to take each dose. Inject the medicine under your skin or into a vein. Take only the amount prescribed for each dose.

You may inject the medicine in the following areas of the body:

  • Buttocks (the outer area at the top)
  • Middle of thighs (in front of)
  • Upper arms (outer area)
  • Stomach (avoid the 2 inches of area around the belly button)

Change the spot where you take the injection each time you take it. Avoid spots that are hard, tender, bruised, red, or have stretch marks or scars.

Patients being treated, who are also being given dialysis, may be told to inject the medicine solution into the dialysis tubing connected to the body.

Before you take each shot, ensure that the label on the vial, prefilled syringe or autoinjector has the name of the medication, the strength of the dose, and that it is not expired. The vial should have a colored cap and the prefilled syringe should have a grey cover.

Handle the medicine with care to prevent shaking it. This may cause it to become foamy. Foamy solutions are not safe to use. The injection solution is also unsafe to use if diluted with liquid or any other medicine.

Ensure the solution is clear and colorless and free of particles, flakes, and lumps. Medicine in any of these conditions is not safe to use and should be reported to your doctor or pharmacist. They may direct you on what to do next.

If your doctor places you on a special diet or advises you to take iron, folic acid, or vitamin B12, follow those instructions. This may help maintain your health during treatment.

Missed dose

If you miss a dose of your medicine, call your doctor for instructions.

Overdose

Overdose on this medicine has caused severe high blood pressure. Call your doctor, or local poison control center at 1-800-222-1222 if you overdose on this drug. If the patient collapses or is not breathing, call 911.

Interactions

Other medicines, health products, food, alcohol or tobacco may cause an adverse interaction with darbepoetin alfa injection. This may affect how the medicine works or increase the risk of side effects.

Other medications

To maintain the health of some patients, it may be necessary to use other medications during treatment with the injection. Tell your doctor of all prescription and over-the-counter medicines (OTCs) you are taking or plan to take. Also let your doctor know if you are using or plan to use vitamins, nutritional supplements or herbal products.

Your doctor may decide to treat you although you may be using other medications but may change the dose or how often you use them.

Food, alcohol or tobacco

Your doctor may also warn you to avoid smoking tobacco, drinking alcohol, or eating certain foods. Follow these warnings.

Other medical problems

The presence of other medical problems in patients taking the injection may affect how the medicine works or increase the risk of side effects. The drug can worsen existing medical problems, such as in patients with high blood pressure or certain cancers.

Remember to tell your doctor if you have any other medical condition, especially the following:

  • Heart attack (or history of)
  • Stroke (or history of)
  • Heart bypass surgery
  • Congestive heart failure
  • Heart or blood vessel disease
  • Cancer (or other types of)
  • Seizures (or history of)
  • Bleeding (severe)
  • Bone marrow fibrosis
  • Vitamin B12 deficiency
  • Deficiency in iron or folic acid
  • Inflammation or infections
  • Aluminum poisoning (severe)
  • Blood clots or blood problems (or history of)
  • Thrombosis (or at risk for)
  • High blood pressure (uncontrolled)

The injection should not be used in patients with the following conditions:

  • Pure red cell aplasia(PRCA): These are patients with a rare bone marrow disease.
  • Bone marrow problems: These are patients who may have sickle cell anemia, thalassemia, hemolytic anemia or porphyria. Safety and efficacy have not been established for use in these patients.

Warnings

  • Take your dose of darbepoetin alfa exactly as directed, unless your doctor adjusts it.
  • Do not stop taking the injection even if you feel well, unless your doctor tells you to.
  • Do get the correct amount of medication from the vial, use only the disposable syringe recommended by the pharmacist.
  • Do not use the same syringe or needle more than once. You should have a new syringe and needle for each shot you will take.
  • Do not shake the medicine solution or use it if it is foamy, flaky, lumpy, discolored or has particles in it.
  • Do not dilute the medicine with any liquid and do not mix it with any other medicines.
  • Do not save medicine left over from an open vial or syringe. Use these only once and safely discard, right away.
  • Avoid injecting the medicine into an area that is hard, has scars or stretch marks, or is tender or irritated.
  • Before any lab test, tell your doctor and the lab technician that you are using this drug.
  • Do not undergo coronary artery bypass graft (CABG) surgery, or surgery to treat a bone problem, unless you tell your doctor and the person performing the surgery that you are being treated with darbepoetin alfa.

This can help them take necessary precautions, including prescribing a ‘blood thinner' (anticoagulant medication) to prevent blood clots during surgery.

  • Seizures can be caused by using this medicine. This side effect usually occurs during the first few months of treatment. To prevent serious injury to yourself or others if a seizure occurs, you should avoid driving a vehicle or operating heavy or dangerous machinery.
  • Do not share your medication with anyone else, even if they have a similar medical problem as you or similar symptoms.
  • Keep all follow-up appointments, especially if you suffer from high blood pressure. Your doctor will need to monitor your blood pressure and overall health during treatment.

Storage

Darbepoetin alfa injection should be kept stored in the package it came in. Once removed from the original package, keep it tightly closed and away from heat and direct light.

Store in a refrigerator, but keep from freezing.

Keep out of the reach of children.

You should not flush the medicine down the toilet. Safely dispose of it in a puncture-resistant container once it expires or is no longer needed.

You may ask your pharmacist or local waste disposal agency about safe and proper ways to dispose of the medicine, containers, needles, and syringes.

Summary

Darbepoetin alfa injection is a medicine specially designed to treat patients with severe anemia associated with chronic kidney failure or chemotherapy. The anemic condition (severe low red blood cell level) is usually due to these two medical conditions. What the medicine does is stimulate the bone marrow, causing it to make more red blood cells.

The injection solution may be considered ‘slow-acting,' because it takes about 2 to 6 weeks to ‘kick in.' Patients are encouraged to continue the treatment even if they do not feel better right away unless their doctor advises them to stop. Once it becomes fully effective in the body, the red blood cell level begins to increase, and the patient begins to feel better.

Darbepoetin alfa should not be used at all or should be used with caution in patients with certain medical conditions. It includes patients who experience seizures, or have heart or blood vessel problems, or other types of cancers. The drug is known to worsen the health of some patients who have certain types of cancers. It has even shortened their survival time.

There seems to be no list of medications that may cause adverse interaction with the injection. To prevent or reduce the risk of other adverse effects, patients should tell their doctor of all medicines they are taking or plan to take.

Darbepoetin alfa is a support medicine for patients with severe anemia. It cannot treat cancer or chronic kidney failure. As such, patients must continue to take the medications prescribed for treating these other medical conditions.

Although the medicine effectively treats severe anemia in patients with these conditions, it cannot treat other types of anemia. It also cannot treat side effects or other symptoms of anemia.