Darbepoetin Alfa (dar-be-POE-e-tin AL-fa)
Treats anemia that is caused by kidney failure or chemotherapy.
There may be other brand names for this medicine.
When This Medicine Should Not Be Used
You should not use this medicine if you have had an allergic reaction to darbepoetin alfa, albumin, or polysorbate 80, or if you have uncontrolled high blood pressure or a rare bone marrow disease called pure red cell aplasia.
How to Use This Medicine
- Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin or into a vein.
- A nurse or other trained health professional will give you this medicine.
- You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
- This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
- You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.
- Use a new needle and syringe each time you inject your medicine.
- Never shake the vial or syringe of darbepoetin alfa. Shaking the liquid can cause the medicine to lose its strength. Protect from direct light. Always store the medicine in the original carton until ready to use.
- 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.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
If a dose is missed:
- Call your doctor or pharmacist for instructions.
How to Store and Dispose of This Medicine
- If you store this medicine at home, keep it in the refrigerator. Do not freeze.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed. Use each vial or syringe only one time and then throw it away.
- Keep all medicine away from children and never share your medicine with anyone.
- Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
Drugs and Foods to Avoid
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
Warnings While Using This Medicine
- Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a blood disorder (such as hemolytic anemia, porphyria, thalassemia, or sickle cell disease). Also tell your doctor if you have a history of blood clots, cancer, heart disease, high blood pressure, kidney disease, epilepsy or a history of seizures, or if you are scheduled for any type of surgery.
- Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments. You may also need to monitor your blood pressure at home. If you notice any changes to your recommended 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 serious heart and blood vessel problems such as heart attack, congestive heart failure, or stroke. Check with your doctor right away if you start having chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.
- Darbepoetin alfa may also 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.
- 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.
- One form of darbepoetin alfa is made 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.
- This medicine 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.
- Keep using this medicine for as long as your doctor tells you to. Do not stop using it without first checking with your doctor, even if you feel better.
Possible Side Effects While Using This Medicine
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Change in how much or how often you urinate, or painful urination.
- Chest pain or coughing up blood.
- Dry mouth, increased thirst, or muscle cramps.
- Fever, chills, cough, sore throat, or other signs of infection.
- Lightheadedness, dizziness, or fainting.
- Numbness or weakness in your arm or leg, or on one side of your body.
- Pain or swelling in your lower leg (calf).
- Pain, redness, swelling, bleeding, or blood clots where the shot or IV was given.
- Rapid weight gain.
- Severe tiredness or weakness.
- Shortness of breath, cold sweat, and bluish-colored skin.
- Skin rash or itching.
- Sudden or severe headache, problems with vision, speech, or walking.
- Swelling in your hands, ankles, or feet.
- Unusual bleeding or bruising.
- Unusually fast, slow, or uneven heartbeat.
If you notice these less serious side effects, talk with your doctor:
- Constipation, diarrhea, nausea, vomiting, or stomach pain.
- Mild headache.
- Muscle or joint pain, back pain, or pain in your arms or legs.
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088
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