Darbecure 40mcg Injection(Pfs) 1's

Haematopoiesis Rx required
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INTRODUCTION

DARBECURE 40MCG INJECTION(PFS) contains Darbepoetin alfa which belongs to the group of medicines called Erythropoiesis-stimulating agents. It is used to treat 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 DARBECURE 40MCG INJECTION(PFS) treatment, 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 treatment.

DARBECURE 40MCG INJECTION(PFS) is not recommended for use in patients having high blood pressure which is not being controlled. Before receiving DARBECURE 40MCG INJECTION(PFS), 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 treat anemia, latex allergy or hepatitis C.

DARBECURE 40MCG INJECTION(PFS) should be used with caution in pregnant women. Patients must not breastfeed while receiving DARBECURE 40MCG INJECTION(PFS). No data is available regarding DARBECURE 40MCG INJECTION(PFS) use in children (less than 1 month old) with CKD receiving and not receiving dialysis. The safety and efficacy of DARBECURE 40MCG INJECTION(PFS) in children with cancer have not been established so, consult your child’s doctor for advice.

The most common side effects of receiving DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS)

Treats symptomatic anemia

  • associated with chronic renal failure (CRF) in adults and children
  • with non-myeloid malignancies receiving chemotherapy in adult cancer patients

HOW DARBECURE 40MCG INJECTION(PFS) WORKS

DARBECURE 40MCG INJECTION(PFS) 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.

DIRECTIONS FOR USE

DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS) unless your doctor advises you to stop.

SIDE EFFECTS OF DARBECURE 40MCG INJECTION(PFS)

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 DARBECURE 40MCG INJECTION(PFS) 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

DARBECURE 40MCG INJECTION(PFS) 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

DARBECURE 40MCG INJECTION(PFS) 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

DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS) treatment depending on your age, body weight and disease condition. Consult your doctor before receiving DARBECURE 40MCG INJECTION(PFS).

LIVER

DARBECURE 40MCG INJECTION(PFS) should be used with caution in patients with liver disease and hepatitis C. Consult your doctor before receiving DARBECURE 40MCG INJECTION(PFS).

ALLERGY

Before receiving DARBECURE 40MCG INJECTION(PFS) 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

DARBECURE 40MCG INJECTION(PFS) is not recommended for use in patients with high blood pressure which is not being controlled with other medicines. DARBECURE 40MCG INJECTION(PFS) should be used with caution in patients with high blood pressure which is being controlled. Consult your doctor before receiving DARBECURE 40MCG INJECTION(PFS).

OTHERS

Before receiving DARBECURE 40MCG INJECTION(PFS), inform your doctor if you have:

  • sickle cell anemia
  • epileptic fits (seizures)
  • convulsions
  • lack of response to certain medicines used to treat anemia

Use in pediatrics:

No data is available regarding DARBECURE 40MCG INJECTION(PFS) use in children (less than 1-month-old) with CKD receiving and not receiving dialysis. The safety and efficacy of DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS).

INTERACTIONS

A. Drug-Drug interactions:

Before receiving DARBECURE 40MCG INJECTION(PFS), inform your doctor if you are taking any of the following medicines:

  • cyclosporin and tacrolimus (used to suppress the immune system)

Overdosage:

DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS) out of reach from children
  • Store DARBECURE 40MCG INJECTION(PFS) in a refrigerator (2-8°C). Do not freeze

FAQs ABOUT DARBECURE 40MCG INJECTION(PFS)

Can DARBECURE 40MCG INJECTION(PFS) affect blood pressure?

Yes. DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS). If you have any other concerns, consult your doctor.

Can there be reasons for not responding to DARBECURE 40MCG INJECTION(PFS)?

You may not respond to DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS) be used in healthy individuals?

Misuse of DARBECURE 40MCG INJECTION(PFS) 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 DARBECURE 40MCG INJECTION(PFS)?

Please stick to the prescribed schedule agreed upon with your doctor for optimal efficacy of DARBECURE 40MCG INJECTION(PFS) treatment. 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)

PRODUCT DETAILS

    Net Qty
    1 N
    Shelf Life
    36 months
    Item Weight
    20 g
    Ingredient
    DARBEPOETIN ALFA 40 MCG
    Hsn Code
    30045010
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