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Introduction About DARBA 60 INJECTION
DARBA 60 INJECTION contains Darbepoetin alfa which belongs to the group of medicines called Erythropoiesis-stimulating agents. It is used to manage symptomatic anemia associated with chronic renal failure (CRF) in adults and children. In kidney failure, the kidney does not produce enough erythropoietin (a natural hormone) which can often cause anemia.
Before DARBA 60 INJECTION management, your doctor may want you to take blood tests to measure how your anaemia is responding and may adjust your dose to maintain long-term control of your condition. Your blood pressure will also be checked regularly, especially at the beginning of your management.
DARBA 60 INJECTION is not recommended for use in patients having high blood pressure which is not being controlled. Before receiving DARBA 60 INJECTION, inform your doctor if you have or ever had high blood pressure which is being controlled with medicines, sickle cell anemia, fits, liver disease, lack of response to medicines used to manage anemia, latex allergy or hepatitis C.
DARBA 60 INJECTION should be used with caution in pregnant women. Patients must not breastfeed while receiving DARBA 60 INJECTION. No data is available regarding DARBA 60 INJECTION use in children (less than 1 month old) with CKD receiving and not receiving dialysis. The safety and efficacy of DARBA 60 INJECTION in children with cancer have not been established so, consult your child’s doctor for advice.
The most common side effects of receiving DARBA 60 INJECTION are high blood pressure, allergic reactions, pain around the area injected and rash or redness of the skin. Call your doctor if any of the symptoms worsen.
Uses Of DARBA 60 INJECTION
Manages symptomatic anemia
- associated with chronic renal failure (CRF) in adults and children
- with non-myeloid malignancies receiving chemotherapy in adult cancer patients
How DARBA 60 INJECTION Works
DARBA 60 INJECTION increases red blood cell counts by stimulating the bone marrow (soft tissue inside the bones where blood is made) to make more red blood cells.
How to use DARBA 60 INJECTION
DARBA 60 INJECTION will be given to you only by a doctor or a nurse either under your skin (subcutaneous) or into a vein (intravenous). Your doctor will decide on a proper dose and duration depending on your age, body weight and disease condition. Do not stop receiving DARBA 60 INJECTION unless your doctor advises you to stop.
Side Effects Of DARBA 60 INJECTION
Common
- high blood pressure
- allergic reactions
- stroke
- pain around the area of injection
- rash or redness of the skin
- blood clots
- fluid retention (swelling)
Uncommon
- convulsions (fits and seizures)
- bruising and bleeding at the site of injection
- blood clots in a dialysis access
Rare
Stop receiving DARBA 60 INJECTION and contact your doctor immediately if you experience any of the following side effects:
- serious skin rashes like Stevens-Johnson syndrome and toxic epidermal necrolysis (reddish macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and fever or flu-like symptoms)
- severe headache, drowsiness, confusion, eyesight problem, nausea, vomiting or fits (could imply very high blood pressure)
- lack of energy and tiredness (pure red cell aplasia (PRCA)), which means that the body has stopped or reduced the production of red blood cells which causes severe anemia
How To Manage Side Effects
Skin rash:
Avoid hot showers as they can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. If the symptom persists, contact your doctor.
Drowsiness:
Try a few lifestyle changes to improve your energy levels when you feel drowsy such as taking and maintaining a consistent sleep schedule. Exercise regularly (such as a daily walk or running) and eat a nutritious diet with plenty of whole grains, legumes, fruits and vegetables. If the symptom persists, contact your doctor.
Headache:
Drink plenty of water and get adequate rest. Try to be relaxed and stress-free. Call your doctor before taking any medicine for headaches. If the headache persists, consult your doctor.
Nausea:
Take regular sips of a cold drink. Have ginger or peppermint tea. Stick to simple meals. Avoid eating oily or spicy foods. If the symptom persists, contact your doctor.
Vomiting:
Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like it – no need to eat or avoid any specific foods. If the symptom persists, contact your doctor.
Warning & Precautions
Pregnancy
DARBA 60 INJECTION should be used with caution in pregnant women. If you are pregnant, think you may be pregnant or are planning for a baby, consult your doctor before receiving it.
Breastfeeding
DARBA 60 INJECTION is not recommended for use in breastfeeding women because it is not known if it is excreted in breast milk. Consult your doctor before receiving it.
Driving and Using Machines
DARBA 60 INJECTION should not affect the ability to drive or use machines.
Kidney
In patients with chronic kidney failure, your doctor will adjust the correct dose and duration of DARBA 60 INJECTION management depending on your age, body weight and disease condition. Consult your doctor before receiving DARBA 60 INJECTION.
Liver
DARBA 60 INJECTION should be used with caution in patients with liver disease and hepatitis C. Consult your doctor before receiving DARBA 60 INJECTION.
Allergy
Before receiving DARBA 60 INJECTION inform your doctor if you are allergic to Darbepoetin alfa or any of the other ingredients of this medicine or latex (Ex. needle cap on the pre-filled syringe).
Heart Disease
DARBA 60 INJECTION is not recommended for use in patients with high blood pressure which is not being controlled with other medicines. DARBA 60 INJECTION should be used with caution in patients with high blood pressure which is being controlled. Consult your doctor before receiving DARBA 60 INJECTION.
Others
Before receiving DARBA 60 INJECTION, inform your doctor if you have:
- sickle cell anemia
- epileptic fits (seizures)
- convulsions
- lack of response to certain medicines used to manage anemia
Use in pediatrics:
No data is available regarding DARBA 60 INJECTION use in children (less than 1-month-old) with CKD receiving and not receiving dialysis. The safety and efficacy of DARBA 60 INJECTION in children with cancer have not been established so, consult your child’s doctor for advice.
Use in geriatrics:
No differences in safety or efficacy have been observed between older and younger patients. Consult your doctor before receiving DARBA 60 INJECTION.
Interactions
A. Drug-Drug interactions:
Before receiving DARBA 60 INJECTION, inform your doctor if you are taking any of the following medicines:
- cyclosporin and tacrolimus (used to suppress the immune system)
Overdosage:
DARBA 60 INJECTION will be administered to you only by a doctor or a nurse in a hospital, so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms like high blood pressure.
Synopsis
| Drug | : | Darbepoetin alfa |
| Pharmacological Category | : | Erythropoiesis-stimulating agent |
| Therapeutic Indication | : | Symptomatic anemia associated with chronic renal failure (CRF) and chemotherapy |
| Dosage Forms | : | Injection, Prefilled syringe |
More Information
- Keep DARBA 60 INJECTION out of reach from children
- Store DARBA 60 INJECTION in a refrigerator (2-8°C). Do not freeze
FAQs About DARBA 60 INJECTION
Can DARBA 60 INJECTION affect blood pressure?
Yes. DARBA 60 INJECTION can affect blood pressure. Blood pressure should be monitored initially and those who have high blood pressure should take appropriate measures to control blood pressure. Consult your doctor for advice.
How long does it take for DARBA 60 INJECTION to start working?
You will be able to notice an increase in the count of red blood cells (haemoglobin levels) within 2-6 weeks of starting DARBA 60 INJECTION. If you have any other concerns, consult your doctor.
Can there be reasons for not responding to DARBA 60 INJECTION?
You may not respond to DARBA 60 INJECTION if you have pure red cell aplasia, deficiencies of iron, folic acid or vitamin B12. It is important to correct these deficiencies. Consult your doctor for advice.
Can DARBA 60 INJECTION be used in healthy individuals?
Misuse of DARBA 60 INJECTION by healthy people can cause very serious problems with the heart or blood vessels. Consult your doctor if you or any other healthy person is about to use it.
What if I forget to receive a dose of DARBA 60 INJECTION?
Please stick to the prescribed schedule agreed upon with your doctor for optimal efficacy of DARBA 60 INJECTION management. Notify your doctor whenever you miss receiving any dose. Do not take the medicine two times to make up for the missed dose.
References
1. Tilo Grosser, Emer Smyth and Garret A. FitzGerald. Hematopoietic agents. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1437.
2. John Powell and Cheryle Gurk-Turner. Darbepoetin alfa (Aranesp). NIH National Library of Medicine, National center for biotechnology information. PubMed Central. July 2002. [Accessed on 4th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1276633/
3. Amgen. A Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle Chemotherapy. NIH U.S. National Library of Medicine. ClinicalTrials.gov. [Revised in May 2017] [Accessed on 4th June 2022] https://clinicaltrials.gov/ct2/show/NCT00118638
4. Amgen Technology (Ireland) Unlimited Company. Electronic Medicines Compendium (EMC). [Revised in March 2022] [Accessed on 4th June 2022] https://www.medicines.org.uk/emc/files/pil.7993.pdf , https://www.medicines.org.uk/emc/product/7993/smpc
5. Amgen Inc. U.S. Food & Drug Administration. [Revised in January 2019] [Accessed on 4th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103951s5378lbl.pdf
Useful Diagnostic Tests
- Complete Blood Count (CBC)
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