Darbepoetin alfa is a recombinant form of human erythropoietin used to increase the differentiation of progenitor cells to red blood cells in the treatment of anemia. Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Darbepoetin alfa injection is used to treat anemia (a lower-than-normal number of red blood cells) in people with chronic kidney failure (a condition in which the kidneys slowly and permanently stop working over a period of time). Darbepoetin alfa injection is also used to treat anemia caused by chemotherapy in people with certain types of cancer. Darbepoetin alfa cannot be used in place of a red blood cell transfusion to treat severe anemia and has not been shown to improve tiredness or poor well-being that may be caused by anemia. Darbepoetin alfa is in a class of medications called erythropoiesis-stimulating agents (ESAs). It works by causing the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.
Mechanism of action
Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. The binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates the activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors that regulate the activation of specific genes involved in cell division or differentiation.
Darbepoetin alfa is used in the treatment of anemia. It is involved in the regulation of erythrocyte differentiation and the maintenance of a physiological level of circulating erythrocyte mass.
Indications
- For the treatment of anemia (from renal transplants or certain HIV treatments)
- Anemia
Use in Cancer
Darbepoetin alfa is approved to treat:
- Anemia is caused by myelosuppressive chemotherapy used for certain types of cancer.
Contraindications
The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:
- are allergic to darbepoetin alfa or any ingredients of the medication
- are allergic to medications made from mammalian cells
- have developed a condition called pure red cell aplasia (PRCA), after using erythropoiesis-stimulating proteins (e.g., darbepoetin alfa, epoetin alfa)
- have uncontrolled high blood pressure
- inadequate folic acid
- inadequate vitamin B12
- porphyria
- anemia from inadequate iron
- high blood pressure
- significant uncontrolled high blood pressure
- a heart attack
- a clot in the lung
- sudden and serious symptoms of heart failure called acute decompensated heart failure
- a stroke
- obstruction of a blood vessel by a blood clot
- a blood clot
- blood clot in a deep vein of the extremities
- seizures
- visible water retention
- a blood clot in a vascular access device
- pure red cell aplasia
Dosage
Strengths: 25 mcg/mL; 40 mcg/mL; 60 mcg/mL; 100 mcg/mL; 200 mcg/mL; 300 mcg/mL; 40 mcg/0.4 mL; 60 mcg/0.3 mL; 100 mcg/0.5 mL; 150 mcg/0.3 mL; 200 mcg/0.4 mL; 500 mcg/mL; 300 mcg/0.6 mL; 150 mcg/0.75 mL; 25 mcg/0.42 mL; 10 mcg/0.4 mL
Anemia Associated with Chronic Renal Failure
Chronic Kidney Disease (CKD) Patients Not on Dialysis
- Initial dose: 0.45 mcg/kg IV or subcutaneously once every 4 weeks as appropriate
- Initiate treatment only when hemoglobin is less than 10 g/dL, the rate of hemoglobin decline indicates the likelihood of requiring RBC transfusion, and reducing the risk of alloimmunization and/or other RBC transfusion-related risks is a goal.
CKD Patients on Dialysis
- Initial dose: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks as appropriate
- Initiate treatment when hemoglobin is less than 10 g/dL.
- IV route is recommended for patients on hemodialysis.
Anemia Associated with Chemotherapy
- Initial dose: 2.25 mcg/kg subcutaneously once a week or 500 mcg subcutaneously once every 3 weeks
- Duration of therapy: Until completion of the chemotherapy course
- Initiate treatment if hemoglobin is less than 10 g/dL and a minimum of 2 additional months of chemotherapy is planned.
- Use the lowest dose necessary to avoid RBC transfusions.
Usual Pediatric Dose
Anemia Associated with Chronic Renal Failure
Less than 18 Years:
Initial dose:
- Chronic Kidney Disease (CKD) Patients Not on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week or 0.75 mcg/kg once every 2 weeks
- CKD Patients on Dialysis: 0.45 mcg/kg IV or subcutaneously once a week
- Initiate treatment when hemoglobin is less than 10 g/dL.
Dose Adjustments
All chronic kidney disease (CKD) patients
- May increase dose no more than every 4 weeks; may decrease dose more frequently. Avoid frequent dose adjustments.
- If hemoglobin increases by more than 1 g/dL in 2 weeks, reduce the dose by 25% or more as needed to reduce rapid responses.
- If hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%.
- For patients who do not respond adequately over a 12-week escalation period, further dose increases are unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue if responsiveness does not improve.
CKD patients on dialysis
- If hemoglobin approaches or exceeds 11 g/dL, reduce or interrupt the dose of this drug.
CKD patients not on dialysis
- If hemoglobin exceeds 10 g/dL, reduce or interrupt the dose and use the lowest dose sufficient to reduce need for RBC transfusions.
Pediatric CKD patients
- If hemoglobin approaches or exceeds 12 g/dL, reduce or interrupt the dose of this drug.
Conversion from epoetin alfa to this drug in CKD patients on dialysis
- Maintain the route of administration when converting.
- Administer this drug once weekly in patients who were receiving epoetin alfa 2 to 3 times weekly; administer once every 2 weeks in patients who were receiving epoetin alfa once weekly.
- Previous weekly epoetin alfa dose (units/week): Darbepoetin alfa dose (mcg/week)
- Less than 1500: Adults: 6.25; Pediatric: Unknown
- 1500 to 2499: Adults: 6.25; Pediatric: 6.25
- 2500 to 4999: Adults: 12.5; Pediatric: 10
- 5000 to 10999: Adults: 25; Pediatric: 20
- 11000 to 17999: Adults: 40; Pediatric: 40
- 18000 to 33999: Adults: 60; Pediatric: 60
- 34000 to 89999: Adults: 100; Pediatric: 100
- 90000 or greater: Adults: 200; Pediatric: 200
Conversion from epoetin alfa to this drug in CKD patients not on dialysis
- Refer to doses for CKD patients on dialysis. Dose conversion does not accurately estimate the once-monthly dose of this drug.
All chemotherapy patients
- If hemoglobin increases greater than 1 g/dL in 2 weeks or reaches a level needed to avoid RBC transfusion, reduce the dose by 40%.
- If hemoglobin exceeds a level needed to avoid RBC transfusion, withhold the dose until hemoglobin approaches a level where RBC transfusions may be required and reinitiate at a dose 40% below the previous dose.
- If hemoglobin increases by less than 1 g/dL and remains below 10 g/dL after 6 weeks of therapy, increase the dose to 4.5 mcg/kg/week, if on the weekly dosing schedule. If on the every 3 week dosing schedule, no dose adjustment is recommended.
- If there is no response as measured by hemoglobin levels or if RBC transfusions are still required after 8 weeks of therapy, or if the chemotherapy course is complete, discontinue this drug.
Side Effects
The Most Common
- cough
- stomach pain
- redness, swelling, bruising, itching, or a lump at the spot where you injected darbepoetin alfa
- heart attack symptoms–chest pain or pressure, shortness of breath, pain spreading to your jaw or shoulder, nausea, sweating;
- signs of a stroke–sudden numbness or weakness (especially on one side of the body), confusion, sudden severe headache, slurred speech, problems with vision or balance;
- signs of a blood clot–pain, swelling, warmth, redness, cold feeling, or pale appearance of an arm or leg; or
- increased blood pressure–severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed.
- rash
- itching
- difficulty breathing or swallowing
- wheezing
- hoarseness
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- fast pulse
- excessive tiredness
- lack of energy
- dizziness
- fainting
- pale skin
More Common
- a general feeling of tiredness or weakness
- pain, stinging, redness, or swelling around the injection site
- clotting of the vascular access site (for people on hemodialysis)
- dehydration
- diarrhea
- edema (swelling of the face, fingers, ankles, feet, or lower legs)
- headache
- increased or decreased blood pressure, dizziness, or feeling faint
- muscle aches and pain
- nausea
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
Rare
- chest pain
- signs of an allergic reaction (symptoms may include skin rash or hives, trouble breathing, sweating, abnormal heart rate, or decreased blood pressure)
- signs of blood clots (pain or swelling in the legs, worsening shortness of breath)
- signs of severe skin reactions (blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
- signs of stroke (confusion, severe headache, sudden weakness, dizziness, trouble speaking, or vision problems)
- a light-headed feeling, like you, might pass out;
- unusual weakness or tiredness;
- a seizure (convulsions); or
- shortness of breath (even with mild exertion), swelling, and rapid weight gain.
Drug Interactions
There may be an interaction between darbepoetin alfa and any of the following:
DRUG | INTERACTION |
---|---|
Abemaciclib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Abemaciclib. |
Abiraterone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Abiraterone. |
Afatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Afatinib. |
Aldesleukin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Aldesleukin. |
Alectinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Alectinib. |
Alemtuzumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Alemtuzumab. |
Alitretinoin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Alitretinoin. |
Alpelisib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Alpelisib. |
Altretamine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Altretamine. |
Aminoglutethimide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Aminoglutethimide. |
Aminolevulinic acid | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Aminolevulinic acid. |
Amsacrine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Amsacrine. |
Anagrelide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Anagrelide. |
Anastrozole | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Anastrozole. |
Apalutamide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Apalutamide. |
Arsenic trioxide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Arsenic trioxide. |
Artesunate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Artesunate. |
Asciminib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Asciminib. |
Asparaginase Erwinia chrysanthemi | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Asparaginase Erwinia chrysanthemi. |
Asparaginase Escherichia coli | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Asparaginase Escherichia coli. |
Atezolizumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Atezolizumab. |
Avelumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Avelumab. |
Axicabtagene ciloleucel | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Axicabtagene ciloleucel. |
Axitinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Axitinib. |
Azacitidine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Azacitidine. |
Belinostat | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Belinostat. |
Belzutifan | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Belzutifan. |
Bendamustine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Bendamustine. |
Bevacizumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Bevacizumab. |
Bexarotene | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Bexarotene. |
Bicalutamide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Bicalutamide. |
Binimetinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Binimetinib. |
Bleomycin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Bleomycin. |
Blinatumomab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Blinatumomab. |
Bortezomib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Bortezomib. |
Bortezomib D-mannitol | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Bortezomib D-mannitol. |
Bosutinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Bosutinib. |
Brentuximab vedotin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Brentuximab vedotin. |
Brexucabtagene autoleucel | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Brexucabtagene autoleucel. |
Brigatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Brigatinib. |
Buserelin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Buserelin. |
Busulfan | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Busulfan. |
Cabazitaxel | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cabazitaxel. |
Cabergoline | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cabergoline. |
Cabozantinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cabozantinib. |
Capecitabine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Capecitabine. |
Capmatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Capmatinib. |
Carboplatin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Carboplatin. |
Carfilzomib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Carfilzomib. |
Carmustine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Carmustine. |
Catumaxomab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Catumaxomab. |
Cemiplimab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cemiplimab. |
Ceritinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ceritinib. |
Cetuximab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cetuximab. |
Chlorambucil | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Chlorambucil. |
Cisplatin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cisplatin. |
Cladribine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cladribine. |
Clofarabine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Clofarabine. |
Cobimetinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cobimetinib. |
Copanlisib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Copanlisib. |
Crizotinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Crizotinib. |
Curcumin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Curcumin. |
Cyclophosphamide | The risk or severity of pulmonary toxicity can be increased when Darbepoetin alfa is combined with Cyclophosphamide. |
Cyproterone acetate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cyproterone acetate. |
Cytarabine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Cytarabine. |
Dabrafenib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dabrafenib. |
Dacarbazine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dacarbazine. |
Dacomitinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dacomitinib. |
Dactinomycin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dactinomycin. |
Daratumumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Daratumumab. |
Darolutamide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Darolutamide. |
Dasatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dasatinib. |
Daunorubicin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Daunorubicin. |
Decitabine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Decitabine. |
Degarelix | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Degarelix. |
Denileukin diftitox | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Denileukin diftitox. |
Dexamethasone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dexamethasone. |
Dienogest | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dienogest. |
Dinutuximab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dinutuximab. |
Docetaxel | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Docetaxel. |
Dostarlimab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Dostarlimab. |
Doxorubicin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Doxorubicin. |
Durvalumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Durvalumab. |
Duvelisib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Duvelisib. |
Elotuzumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Elotuzumab. |
Enasidenib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Enasidenib. |
Encorafenib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Encorafenib. |
Enfortumab vedotin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Enfortumab vedotin. |
Entrectinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Entrectinib. |
Enzalutamide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Enzalutamide. |
Epirubicin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Epirubicin. |
Erdafitinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Erdafitinib. |
Eribulin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Eribulin. |
Erlotinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Erlotinib. |
Estramustine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Estramustine. |
Etoposide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Etoposide. |
Everolimus | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Everolimus. |
Exemestane | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Exemestane. |
Fedratinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Fedratinib. |
Floxuridine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Floxuridine. |
Fludarabine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Fludarabine. |
Fluorouracil | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Fluorouracil. |
Flutamide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Flutamide. |
Formestane | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Formestane. |
Fulvestrant | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Fulvestrant. |
Futibatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Futibatinib. |
Gallium nitrate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Gallium nitrate. |
Gefitinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Gefitinib. |
Gemcitabine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Gemcitabine. |
Gemtuzumab ozogamicin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Gemtuzumab ozogamicin. |
Gilteritinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Gilteritinib. |
Glasdegib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Glasdegib. |
Goserelin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Goserelin. |
Hydroxyprogesterone caproate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Hydroxyprogesterone caproate. |
Hydroxyurea | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Hydroxyurea. |
Ibrutinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ibrutinib. |
Idarubicin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Idarubicin. |
Idecabtagene vicleucel | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Idecabtagene vicleucel. |
Idelalisib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Idelalisib. |
Ifosfamide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ifosfamide. |
Imatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Imatinib. |
Infigratinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Infigratinib. |
Inotuzumab ozogamicin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Inotuzumab ozogamicin. |
Interferon alfa-2a | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Interferon alfa-2a. |
Interferon alfa-2b | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Interferon alfa-2b. |
Ipilimumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ipilimumab. |
Irinotecan | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Irinotecan. |
Isatuximab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Isatuximab. |
Ivosidenib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ivosidenib. |
Ixabepilone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ixabepilone. |
Ixazomib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ixazomib. |
Lanreotide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lanreotide. |
Lapatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lapatinib. |
Larotrectinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Larotrectinib. |
Lenalidomide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lenalidomide. |
Lenvatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lenvatinib. |
Letrozole | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Letrozole. |
Leuprolide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Leuprolide. |
Lisocabtagene maraleucel | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lisocabtagene maraleucel. |
Lomustine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lomustine. |
Loncastuximab tesirine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Loncastuximab tesirine. |
Lorlatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lorlatinib. |
Lurbinectedin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Lurbinectedin. |
Margetuximab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Margetuximab. |
Masoprocol | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Masoprocol. |
Mechlorethamine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mechlorethamine. |
Medroxyprogesterone acetate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Medroxyprogesterone acetate. |
Megestrol acetate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Megestrol acetate. |
Melphalan | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Melphalan. |
Mercaptopurine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mercaptopurine. |
Methotrexate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Methotrexate. |
Methylprednisolone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Methylprednisolone. |
Methylprednisolone hemisuccinate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Methylprednisolone hemisuccinate. |
Methyltestosterone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Methyltestosterone. |
Midostaurin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Midostaurin. |
Miltefosine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Miltefosine. |
Mitomycin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mitomycin. |
Mitotane | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mitotane. |
Mitoxantrone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mitoxantrone. |
Mogamulizumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mogamulizumab. |
Mosunetuzumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mosunetuzumab. |
Moxetumomab pasudotox | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Moxetumomab pasudotox. |
Nandrolone decanoate | The therapeutic efficacy of Darbepoetin alfa can be increased when used in combination with Nandrolone decanoate. |
Nandrolone phenpropionate | The therapeutic efficacy of Darbepoetin alfa can be increased when used in combination with Nandrolone phenpropionate. |
Necitumumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Necitumumab. |
Nedaplatin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Nedaplatin. |
Nelarabine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Nelarabine. |
Neratinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Neratinib. |
Nilotinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Nilotinib. |
Nilutamide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Nilutamide. |
Nintedanib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Nintedanib. |
Niraparib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Niraparib. |
Nivolumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Nivolumab. |
Obinutuzumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Obinutuzumab. |
Octreotide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Octreotide. |
Ofatumumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ofatumumab. |
Olaparib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Olaparib. |
Olaratumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Olaratumab. |
Omacetaxine mepesuccinate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Omacetaxine mepesuccinate. |
Osimertinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Osimertinib. |
Oxaliplatin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Oxaliplatin. |
Paclitaxel | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Paclitaxel. |
Palbociclib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Palbociclib. |
Pamidronic acid | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pamidronic acid. |
Panitumumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Panitumumab. |
Panobinostat | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Panobinostat. |
Pazopanib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pazopanib. |
Pegaspargase | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pegaspargase. |
Peginterferon alfa-2a | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Peginterferon alfa-2a. |
Pembrolizumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pembrolizumab. |
Pemetrexed | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pemetrexed. |
Pemigatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pemigatinib. |
Pentostatin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pentostatin. |
Pertuzumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pertuzumab. |
Pexidartinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pexidartinib. |
Pipobroman | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pipobroman. |
Pirfenidone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pirfenidone. |
Pixantrone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pixantrone. |
Plicamycin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Plicamycin. |
Polatuzumab vedotin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Polatuzumab vedotin. |
Pomalidomide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pomalidomide. |
Ponatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ponatinib. |
Porfimer sodium | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Porfimer sodium. |
Pralatrexate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pralatrexate. |
Pralsetinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Pralsetinib. |
Prednisolone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Prednisolone. |
Prednisone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Prednisone. |
Prednisone acetate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Prednisone acetate. |
Procarbazine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Procarbazine. |
Radium Ra 223 dichloride | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Radium Ra 223 dichloride. |
Raltitrexed | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Raltitrexed. |
Ramucirumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ramucirumab. |
Regorafenib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Regorafenib. |
Ribociclib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ribociclib. |
Ripretinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ripretinib. |
Rituximab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Rituximab. |
Romidepsin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Romidepsin. |
Roxadustat | The risk or severity of adverse effects can be decreased when Roxadustat is combined with Darbepoetin alfa. |
Rucaparib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Rucaparib. |
Ruxolitinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Ruxolitinib. |
Sacituzumab govitecan | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Sacituzumab govitecan. |
Selinexor | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Selinexor. |
Selpercatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Selpercatinib. |
Selumetinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Selumetinib. |
Siltuximab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Siltuximab. |
Sonidegib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Sonidegib. |
Sorafenib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Sorafenib. |
Sotorasib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Sotorasib. |
Streptozocin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Streptozocin. |
Sunitinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Sunitinib. |
Tafasitamab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tafasitamab. |
Tagraxofusp | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tagraxofusp. |
Talazoparib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Talazoparib. |
Talimogene laherparepvec | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Talimogene laherparepvec. |
Tamoxifen | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tamoxifen. |
Taurolidine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Taurolidine. |
Tebentafusp | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tebentafusp. |
Tegafur | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tegafur. |
Temoporfin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Temoporfin. |
Temozolomide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Temozolomide. |
Temsirolimus | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Temsirolimus. |
Teniposide | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Teniposide. |
Tepotinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tepotinib. |
Testolactone | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Testolactone. |
Thalidomide | The risk or severity of thromboembolism can be increased when Thalidomide is combined with Darbepoetin alfa. |
Thiotepa | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Thiotepa. |
Tioguanine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tioguanine. |
Tisagenlecleucel | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tisagenlecleucel. |
Tisotumab vedotin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tisotumab vedotin. |
Tivozanib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tivozanib. |
Topotecan | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Topotecan. |
Toremifene | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Toremifene. |
Tositumomab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tositumomab. |
Trabectedin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Trabectedin. |
Trametinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Trametinib. |
Trastuzumab | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Trastuzumab. |
Trastuzumab deruxtecan | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Trastuzumab deruxtecan. |
Trastuzumab emtansine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Trastuzumab emtansine. |
Treosulfan | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Treosulfan. |
Tretinoin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tretinoin. |
Trifluridine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Trifluridine. |
Trilostane | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Trilostane. |
Trimetrexate | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Trimetrexate. |
Triptorelin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Triptorelin. |
Tucatinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Tucatinib. |
Umbralisib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Umbralisib. |
Uracil mustard | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Uracil mustard. |
Urethane | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Urethane. |
Valproic acid | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Valproic acid. |
Valrubicin | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Valrubicin. |
Vandetanib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vandetanib. |
Vemurafenib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vemurafenib. |
Venetoclax | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Venetoclax. |
Vinblastine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vinblastine. |
Vincristine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vincristine. |
Vindesine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vindesine. |
Vinflunine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vinflunine. |
Vinorelbine | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vinorelbine. |
Vismodegib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vismodegib. |
Vorinostat | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Vorinostat. |
Zanubrutinib | The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Zanubrutinib. |
Pregnancy and Lactation
FDA Pregnancy Category C
Pregnancy
This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Limited available data on pregnant women are insufficient to determine a drug-associated risk of major birth defects or miscarriage; in animal reproductive and developmental toxicity studies, the drug increased early post-implantation loss at doses approximating clinical recommended starting doses; consider benefits and risks for the mother and possible risks to a fetus when prescribing to a pregnant woman
Breast-feeding
It is not known if darbepoetin alfa passes into breast milk. If you are a breastfeeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breastfeeding. The safety and effectiveness of using this medication have not been established for children.
What special precautions should I follow?
Before using darbepoetin alfa injection,
- tell your doctor and pharmacist if you are allergic to darbepoetin alfa, epoetin alfa (Epogen, Procrit), any other medications, or any of the ingredients in darbepoetin alfa injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients. If you will be using the prefilled syringes, tell your doctor if you or the person who will be injecting the medication is allergic to latex.
- tell your doctor if you have or have had high blood pressure, and if you have ever had pure red cell aplasia (PRCA; a type of severe anemia that may develop after treatment with an ESA such as darbepoetin alfa injection or epoetin alfa injection). Your doctor may tell you not to use darbepoetin alfa injection.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had seizures. If you are using darbepoetin alfa injection to treat anemia caused by chronic kidney disease, tell your doctor if you have or have ever had cancer.
- tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using darbepoetin alfa injection, call your doctor.
- before having surgery, including dental surgery, tell your doctor or dentist that you are being treated with darbepoetin alfa injection. It is especially important to tell your doctor that you are using darbepoetin alfa injection if you are having coronary artery bypass graft (CABG) surgery or surgery to treat a bone problem. Your doctor may prescribe an anticoagulant (‘blood thinner’) to prevent clots from forming during surgery.
Warning
- Allergies: This medication can cause severe allergic and skin reactions. Contact your doctor immediately if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.
- Blood clots: This medication may increase the chance of blood clot formation, causing a reduction of blood flow to organs or the extremities, and which in some cases can cause death. Your doctor will monitor your hemoglobin level closely with blood tests during treatment with this medication. If you experience symptoms such as sharp pain and swelling in the leg, or difficulty breathing, contact your doctor immediately.
- Cancer: Darbepoetin alfa is used to treat anemia caused by the chemotherapy treatment of non-myeloid cancers. It is not used to treat anemia that is due to cancer itself. Under some conditions, this medication may cause tumors to progress or reoccur more quickly than for people who are not using darbepoetin alfa. It may also increase the chances of cardiovascular complications (e.g., heart attack, stroke, blood clots, and death). The lowest possible dose needed to avoid blood transfusion should be used for cancer patients.
- Cardiovascular disease: This medication often affects blood pressure and can contribute to symptoms of heart disease. If you have high blood pressure, heart disease such as heart failure, angina, or a previous heart attack, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you are taking blood pressure pills to control blood pressure, it is important to continue taking them regularly while you are on darbepoetin alfa. Your doctor will monitor your hemoglobin (the protein in red blood cells that carry oxygen) until an appropriate dose of darbepoetin alfa has been determined.
- Kidney disease: This medication may be used by people with chronic kidney disease who are receiving dialysis and who are not receiving dialysis – the dose may be different for each. Your doctor will monitor you closely for your response to the medication.
- Pure red cell aplasia: Cases of pure red cell aplasia (PRCA) have been reported among people treated with darbepoetin alfa. PRCA is a condition in which a person’s bone marrow stops producing red blood cells, leading to severe anemia. People who develop PRCA may experience a new or worsening feeling of tiredness or shortness of breath. If you are experiencing such symptoms, call your doctor as soon as possible. Do not stop your medication without contacting your doctor first.
- Seizure: This medication may contribute to an increase in seizures although the relationship between darbepoetin and seizures is not clear. If you experience seizures or have a history of seizure disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
- Stroke: Darbepoetin can increase the risk of blood clots forming in the blood vessels. If you have a past history of stroke, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
- Increased mortality, myocardial infarction, stroke, and thromboembolism: Using ESAs to target a hemoglobin level of greater than 11 g/dL increases the risk of serious adverse cardiovascular reactions and has not been shown to provide additional benefit (see Black Box Warnings)
- Hypertensive encephalopathy and seizures reported in patients with CKD; appropriately control hypertension before initiation of and during treatment; reduce or withhold Aranesp if blood pressure becomes difficult to control; advise patients of the importance of compliance with antihypertensive therapy and dietary restrictions
- For lack or loss of hemoglobin response to therapy, initiate a search for causative factors (eg, iron deficiency, infection, inflammation, bleeding); if typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA; in absence of PRCA, follow dosing recommendations for the management of patients with insufficient hemoglobin response to therapy
- Use caution in known porphyria, sickle cell anemia, thalassemia
- Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur; immediately and permanently discontinue therapy and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs
- Decrease dose if Hgb increase exceeds 1 g/dL in any 2 wk period
- Increased mortality and/or increased risk of tumor progression or recurrence in patients with cancer
- Increases the risk for seizures in patients with CKD; increases monitoring of these patients for changes in seizure frequency or premonitory symptoms
- If severe anemia and low reticulocyte count develop during treatment, withhold therapy and evaluate for pure red cell aplasia
- Blistering and skin exfoliation reactions including erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), reported in the post-marketing setting; discontinue therapy immediately if a severe cutaneous reaction, such as SJS/TEN, suspected
- Two different excipients are available: polysorbate 80 or human albumin
- May use supplemental iron if serum ferritin is less than 100 mcg/L [0.225 pmol/L] or serum transferrin saturation is less than 20%
- IV route preferred for patients on hemodialysis
- Patients may require adjustments in their dialysis prescriptions after initiation of therapy; patients receiving treatment may require increased anticoagulation with heparin to prevent clotting of the extracorporeal circuit during hemodialysis
- Autoinjector for SC administration only
- The dose increase no more frequently than once monthly
- Cases of PRCA and severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin reported predominantly in patients with CKD receiving ESAs by subcutaneous administration; also reported in patients receiving therapy for anemia related to hepatitis C treatment (indication not approved)
- If severe anemia and low reticulocyte count develop during treatment, withhold therapy and evaluate patients for neutralizing antibodies to erythropoietin; contact Amgen (1-800-77-AMGEN) to perform assays for binding and neutralizing antibodies
- Permanently dhttps://www.webmd.com/drugs/2/drug-144492/darbepoetin-alfa-in-polysorbate-injection/details/list-contraindicationsiscontinue therapy in patients who develop PRCA following treatment; do not switch patients to other ESA.
References