Registered Tanzania · TMDA

Derise 25

Darbepoetin 25/0.42 mcg/ml

TZ 17 H 0227 Injection 25/0.42 blood and blood forming organs

What it does

Darbepoetin is a medication that helps increase red blood cell production in the body.

Commonly used for: anemia (low red blood cell count), chronic kidney disease, cancer-related anemia

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
TZ 17 H 0227
Registration date
2022-09-10
Expiry date
2027-09-09
Status
Registered/Compliant
Active ingredient
Darbepoetin 25/0.42 mcg/ml
Dosage form
Injection
Strength
25/0.42
Pack size
-
Therapeutic class
-
ATC class (WHO)
B03XA - Other antianemic preparations
RxNorm RxCUI
283838
Manufacturer / MAH
Hetero Biopharma
Applicant / LTR
HETERO BIOPHARMA LIMITED
Country of origin
INDIA
Manufacturer location
#8-3-166/1 & 2, 105 to 108, 1st Floor, G Block, East Wing, Challa Estates, Sultan Bagh, Erragadda, Hyderabad, Telangana 500114, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:45:59 · updated 2026-10-19 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Darbepoetin is a medication that helps increase red blood cell production in the body.

What it treats

  • anemia (low red blood cell count)
  • chronic kidney disease
  • cancer-related anemia

How it works

It stimulates the bone marrow to produce more red blood cells, which can help improve energy levels and reduce fatigue.

Who it's for

It is used for patients who have low red blood cell counts due to chronic kidney disease or certain types of cancer treatment.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: darbepoetin

Darbepoetin is a synthetic form of erythropoietin, a glycoprotein hormone that stimulates the production of red blood cells. It is primarily used in the treatment of anemia associated with chronic kidney disease and in patients undergoing chemotherapy. Darbepoetin has an extended half-life compared to natural erythropoietin, allowing for less frequent dosing.

Indications

  • Anemia due to chronic kidney disease
  • Anemia in patients with cancer undergoing chemotherapy
  • Reduction of allogeneic blood transfusions in patients undergoing elective surgery

Dosage

Children: Refer to the BNF for Children for specific dosing information tailored to paediatric patients.

Adults: Refer to the BNF for specific dosing guidelines based on the condition being treated.

Mechanism of action

Darbepoetin binds to the erythropoietin receptor on erythroid progenitor cells in the bone marrow, promoting their proliferation and differentiation into red blood cells. This action stimulates erythropoiesis, increasing hemoglobin levels in the blood.

Pharmacodynamics

The pharmacodynamic effects of darbepoetin include increased red blood cell count and hemoglobin levels, leading to improved oxygen delivery to tissues. The onset of action may take several weeks as erythropoiesis is a gradual process, and the peak effects are usually observed after 2 to 6 weeks of treatment.

Pharmacokinetics

Darbepoetin has a longer half-life than recombinant erythropoietin, allowing for less frequent administration. It is primarily eliminated by the kidneys, and its pharmacokinetics are influenced by renal function. The peak plasma concentration occurs approximately 24 to 48 hours after subcutaneous administration.

Contra-indications

  • Hypersensitivity to darbepoetin or any of its components
  • Uncontrolled hypertension
  • Pure red cell aplasia that begins after treatment with erythropoiesis-stimulating agents

Adverse effects

  • Hypertension
  • Headache
  • Fatigue
  • Nausea
  • Diarrhea
  • Edema
  • Thrombotic events such as myocardial infarction or stroke

Interactions

  • Antihypertensive medications may require adjustment due to potential increases in blood pressure
  • Iron supplementation may be necessary for optimal response to therapy

Precautions

  • Monitor hemoglobin levels regularly to avoid excessive increases
  • Evaluate iron status before and during treatment
  • Use with caution in patients with a history of cardiovascular disease

Pregnancy

Darbepoetin is categorized as pregnancy category C. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether darbepoetin is excreted in human milk. Caution should be exercised when administering to a nursing mother.

Storage

Store in the refrigerator at 2 to 8 degrees Celsius. Do not freeze. Protect from light.

Formulations

  • Injectable solution for subcutaneous or intravenous use

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.