Darbepoetin Alfa (Injection Route)

If the body does not produce enough red blood cells, severe anemia can occur. This often occurs in people with chronic kidney failure whose kidneys are not working properly. Darbepoetin may be used for patients on kidney dialysis or for those not on dialysis. Anemia can also occur in people who are receiving chemotherapy to treat cancer. Darbepoetin alfa is used to treat severe anemia in these patients.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darbepoetin alfa injection in children with chronic kidney failure who are over 1 year of age. Safety and efficacy have not been established in children with chronic kidney failure who are less than 1 year of age.

Appropriate studies have not been performed on the relationship of age to the effects of darbepoetin alfa injection in children with cancer. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of darbepoetin alfa injection in the elderly.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Thalidomide

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Aluminum poisoning, severe or


• Bleeding, severe or


• Bone marrow fibrosis (osteofibrosis cystica) or


• Folic acid deficiency or


• Infections, inflammation, or cancer or


• Iron deficiency or


• Vitamin B12 deficiencya€”May cause a delay in response to treatment .

• Blood clots (history of) or other problems with the blood or


• Congestive heart failure or


• Heart attack, history of or


• Heart bypass surgery or


• Heart or blood vessel disease or


• Stroke, history of or


• Thrombosis, at risk fora€”The chance of side effects may be increased .

• High blood pressure, uncontrolled or


• Pure red cell aplasia (rare bone marrow disease)a€”Should not be used in patients with these conditions.

• Seizures, history ofa€”May make this condition worse.

Proper Use

This medicine should come with a medication guide and patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Darbepoetin alfa is usually given by a doctor . However, medicines given by injection are sometimes used at home . If you will be using darbepoetin alfa at home, your doctor will teach you how the injections are to be given. Be sure you understand exactly how the medicine is to be injected.

This medicine is available in 3 forms. You may use a vial, a prefilled syringe with an UltraSafeA® Needle Guard, or a prefilled SureClicka„˘ autoinjector.

This medicine may be given as a shot under your skin or into a vein . If your doctor tells you to inject it a certain way, follow your doctor`s instructions.

If you are giving this medicine at home:

• Use a new needle and syringe each time you inject your medicine.


• Do not use more medicine or use it more often than your doctor tells you to.


• You will be shown the body areas where this shot can be given.


• Throw away used needles and syringes in a hard, closed container that the needles cannot poke through (puncture-resistant). Keep this container away from children and pets.

Do not shake the container of medicine before you use it, and protect it from bright light.

Carefully follow your doctor`s instructions about any special diet. You may need to eat foods that contain iron, folic acid, or vitamin B12 such as eggs, certain cereals, meats, and vegetables, or you may take an iron, folic acid, or vitamin B12 supplement while you are using this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  
  
  • For anemia from chronic kidney failure:
    
    
    
    • Adultsa€”Dose is based on body weight and must be determined by your doctor . The starting dose is 0.45 to 0.75 microgram (mcg) per kilogram (kg) of body weight injected into a vein or under the skin once a week or once every 2 weeks. Your doctor may adjust the dose if needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For anemia from cancer chemotherapy:
    
    
    
    • Adultsa€”Dose is based on body weight and must be determined by your doctor . The starting dose is 2.25 micrograms (mcg) per kilogram (kg) of body weight once a week or 500 mcg once every 3 weeks injected under the skin . Your doctor may adjust the dose if needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Store in the refrigerator. Do not freeze .

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

People with severe anemia usually feel very tired and sick . When darbepoetin alfa begins to work, usually in about 6 weeks, most people start to feel better. Some people are able to be more active . But darbepoetin alfa only corrects anemia. It has no effect on kidney disease, cancer, or any other medical problem that needs regular medical attention . Even if you are feeling much better, it is very important that you do not miss any appointments with your doctor or any dialysis treatments.

It is very important that your doctor check your blood regularly while you are taking this medicine. You may also need to monitor your blood pressure at home . If you notice any changes to your normal blood pressure, call your doctor right away.

Darbepoetin alfa may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention . Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble with breathing; or chest pain after you get the injection .

This medicine may increase your risk of having blood clots. This is more likely in patients who use high doses of this medicine, or who use this medicine before major surgery. If you have shortness of breath, or pain, redness, or swelling in your arms or legs while using this medicine, call your doctor right away. If you are getting kidney dialysis treatments, tell your doctor right away if you notice blood clots at your injection site . Your doctor may give you a blood thinner before surgery to help prevent blood clots.

This medicine may also increase your risk of having serious heart and blood vessel problems such as a heart attack, congestive heart failure, or stroke. Check with your doctor right away if you start having dizziness, fainting spells, severe tiredness, chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.

When used in patients with certain types of cancer (e.g. breast, cervix, lymphoid, lung, head, or neck cancer), this medicine has shortened survival time and worsened the cancer in some patients. If you are concerned about this, talk with your doctor .

Darbepoetin alfa sometimes causes convulsions (seizures), especially during the first few months of treatment . During this time, it is best to avoid driving, operating heavy machinery, or other activities that could cause a serious injury if a seizure occurs while you are performing them.

One form of darbepoetin alfa injection has an ingredient that comes from donated human blood . Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you have a latex allergy before you start using this medicine.

Many people with kidney problems need to be on a special diet. Also, people with high blood pressure (which may be caused by kidney disease or by darbepoetin alfa treatment) may need to be on a special diet or to take medicine to keep their blood pressure under control. After their anemia has been corrected, some people feel so much better that they want to eat more than before. To keep your kidney disease or your high blood pressure from getting worse, it is very important that you follow your special diet and take your medicines regularly, even if you are feeling better.

In addition to darbepoetin alfa, your body needs iron and vitamins to make red blood cells. Your doctor may direct you to take iron or vitamin supplements. Be sure to follow your doctor`s orders carefully. Darbepoetin alfa will not work well if you do not have enough iron or vitamins in your body .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Abdominal or stomach pain


• Accumulation of pus


• Arm, back, or jaw pain


• Blurred vision


• Breathing problems (irregular, noisy, or trouble when resting)


• Chest pain, discomfort, tightness, or heaviness


• Chills


• Confusion


• Cough producing mucus


• Decrease in the amount of urine


• Diarrhea


• Dilated neck veins


• Dizziness, fainting, or lightheadedness


• Dry mouth


• Fast, slow, or irregular heartbeat


• Fatigue or tiredness (extreme or unusual)


• Fever


• Headache


• Nausea


• Pain, tenderness, swelling, or warmth over injection site


• Pounding in the ears


• Rapid breathing


• Rapid or pounding pulse


• Shortness of breath


• Skin discoloration at the injection site


• Sunken eyes


• Sweating


• Swelling of the ankles, face, fingers, feet, hands, or lower legs


• Thirst


• Trouble with breathing


• Unconsciousness


• Vomiting


• Weight gain


• Wheezing


• Wrinkled skin

Less common

• Anxiety


• Convulsions


• Difficulty with speaking (slow speech or unable to speak)


• Double vision


• Trouble with thinking


• Trouble with walking


• Unable to move arms, legs, or face muscles (including numbness and tingling)

Rare

• Fever and sore throat


• Hives


• Itching


• Pale skin


• Skin rash


• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation


• General feeling of discomfort or illness


• Lack or loss of strength


• Loss of appetite


• Muscle aches, pains, or stiffness


• Pain in the joints


• Runny nose


• Shivering


• Sneezing


• Trouble with sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.