Registered Rwanda · Rwanda FDA

DERISE-25

DARBEPOETIN ALFA

Rwanda FDA-HMP-MA-0063 SOLUTION FOR INJECTION 25MCG/0.42ML blood and blood forming organs

What it does

Alfa is a medication used to treat various health conditions.

Read more in plain English ↓

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

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Registration & product details

Registration no.
Rwanda FDA-HMP-MA-0063
Registration date
01/06/2021
Expiry date
01/06/2026
Status
Registered
Active ingredient
DARBEPOETIN ALFA
Strength
25MCG/0.42ML
Pack size
1ML
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: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:39 · updated 2026-09-17 02:30:44

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About alfa

Alfa is a medication used to treat various health conditions.

How it works

Alfa works by affecting the body's systems to help manage certain conditions.

Who it's for

This medication is suitable for patients with specific health issues as determined by a healthcare professional.

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

About darbepoetin

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: alfa

Alfa is a pharmacological agent that may refer to a variety of products depending on the context, but lacks a specific chemical or therapeutic classification in this instance. It is essential to clarify the exact nature of 'alfa' to provide comprehensive information, as it could pertain to a range of compounds used in clinical practice.

Dosage

Children: Refer to specific drug information for paediatric dosing guidelines, as this will also vary.

Adults: Refer to specific drug information for dosing guidelines, as this will vary widely.

Mechanism of action

The mechanism of action for 'alfa' cannot be defined without specific identification of the drug. Each compound named 'alfa' will have distinct mechanisms, typically involving receptor interaction, enzyme inhibition, or modulation of physiological pathways.

Pharmacodynamics

Pharmacodynamics will vary widely depending on the specific agent referred to as 'alfa'. Generally, pharmacodynamics describes how a drug affects the body, including its therapeutic effects, side effects, and the relationship between drug concentration and effect.

Pharmacokinetics

The pharmacokinetics of 'alfa' would also depend on the particular drug profile, including absorption, distribution, metabolism, and excretion (ADME). Parameters such as bioavailability, half-life, and clearance rates would need to be defined based on the specific agent.

Pregnancy

Consult healthcare provider for risk assessment.

Breast-feeding

Consult healthcare provider for risk assessment.

Storage

Store in a cool, dry place away from direct sunlight.

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

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.