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What you should know 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.

Pediatrics

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

No information is available on the relationship of age to the effects of darbepoetin alfa in children with cancer. Safety and efficacy have not been established.

Geriatric

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

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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 fibrosis (osteofibrosis cystica) or
  • Bone marrow fibrosis or
  • Folic acid deficiency or
  • Infections or
  • Iron deficiency or
  • Vitamin B-12 deficiency—May cause a delay in response to treatment.
  • Blood problems (e.g., hemolytic anemia, sickle cell anemia) or
  • Pure red cell aplasia (rare bone marrow disease)—Should not use in patients with these conditions.
  • Blood vessel disease or
  • Heart disease or
  • High blood pressure—May become worse with this medicine.

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